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  • A fully authorized and accredited distributor that focuses in pharmaceutical products for the healthcare and veterinary sectors is looking for suppliers of Degarelix Acetate (10 g) API for development purposes. The suppliers must support this enquiry with USDMF & CoA.
    02 Jul 2024
    A company that focuses on research, manufacturing and distribution of various veterinary finished formulations is looking for suppliers of IP Grade Methionine (250 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    02 Jul 2024

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  • A company that focuses on research, manufacturing and distribution of various veterinary finished formulations is looking for suppliers of IP Grade Cyanocobalamin (100 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    02 Jul 2024
    A company that focuses on research, manufacturing and distribution of various veterinary finished formulations is looking for suppliers of IP Grade Butafosfan (450 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    02 Jul 2024

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  • A company that focuses on development and manufacturing of various ointments, liquid (oral) medicines, coated and uncoated tablets for various therapeutic categories is looking for suppliers of USP Grade Dexpanthenol (MOQ) API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    02 Jul 2024

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    A company that focuses on development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases is looking for suppliers of Everolimus (1 kg) API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    02 Jul 2024
  • A company that focuses on marketing and distribution of various nephrology and general finished formulations is looking for suppliers of Darbepoetin Alfa (40 mcg) Injection dossier for commercial purposes.
    29 Jun 2024
    A large pharmaceutical company based in India that devotes itself to R&D, production, marketing and sales of active pharmaceutical ingredients and pharmaceutical intermediates is looking for suppliers of Various Finished Dosage Formulations for commercial purposes. The initial required quantity is MOQ for each. The suppliers must support this enquiry with dossier.
    1. Dimenhydrinate (40 mg) + Cinnarizine (20 mg) Tablets
    2. Diosmin & Hesperidin (1000 mg) Capsules
    3. Vortioxetine Hydrobromide (5 mg, 10 mg & 20 mg) Tablets
    21 Jun 2024
  • A consulting company that focuses on providing licensing services for pharmaceuticals and medical devices is looking for suppliers of various dossiers for commercial purposes.
    1. Paracetamol (500 mg) Tablet
    2. Paracetamol (125 mg) Syrup for Pediatric use
    3. Ibuprofen (200 mg & 400 mg) Tablet
    4. Ibuprofen (100 mg/ ml) Syrup for Pediatric use
    30 May 2024
    A CMO which focuses on manufacturing and delivering branded, generic formulations and active pharmaceutical ingredients (API’s) of essential phospholipids to customers is looking for suppliers of Various Finished Formulations for commercial purposes. The required quantity is 2,00,000 Units.
    1. Trimeperidine 2% Injection
    2. Rifampicin (0.15 mg/ml) Injection
    14 May 2024
  • A company that focuses on the development and manufacturing of various long-acting injectables, eye drops, oral solid finished formulations, and active pharmaceutical ingredients is looking for USFDA & GMP certified CMO to manufacture Eye Drops. The geographical preference for service provider is India.
    01 Jul 2024

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    A company that focuses on development and manufacturing of various finished formulations and active pharmaceutical ingredients is looking for GMP certified CMO for Site Transfer of Oncology APIs which will be used in manufacturing of powdered dosage form. The required packaging is size is 1 kg, 5 kg & 10 kg.
    14 Jun 2024
  • A global healthcare leading company that focuses on the research, development and manufacturing of branded generic medicines, medical devices & nutritional products is looking for GMP certified CMO for hormonal gel manufacturing for topical application. The required packaging is customized plastic tube. The project launch time is in 2031. The geographical preference for service provider is Europe.
    23 May 2024
    A company that provides a range of full R&D pharmaceutical services and drug delivery solutions is looking for GMP & EMEA/ USFDA Certified CDMO to manufacture powders & granules. The required packaging is PET-glass bottle/ sachet stick pack. The country of distribution is Europe & United States. The geographical preference for service provider is Canada, EMEA & United States.
    19 Apr 2024
  • A company that focuses on research, development and manufacturing of tablets, capsules, liquid & lyophilized injections is looking for suppliers of Povidone K12 Excipient for development purposes. The required quantity is 5 kg. The supplier must support this enquiry with CoA.
    02 Jul 2024
    A company that focuses manufacturing and exporting of various finished formulations is looking for suppliers of Oleyl Alcohol (500 kg - 600 kg) Solvent for commercial purposes. The supplier must support this enquiry with CoA.
    01 Jul 2024
  • A company that focuses on manufacturing and development of various finished formulations and APIs is looking for suppliers of IP/BP/USP Grade Hydroxyethyl Cellulose Excipient for commercial purposes. The supplier must support this enquiry with CoA.
    27 Jun 2024
    A U.S.- domiciled publicly traded generics and specialty pharmaceutical company is looking for suppliers of Injectable/ USP Grade Cottonseed Oil (5 kg) Excipient for development purposes. The supplier must support this enquiry with GMP & CoA.
    25 Jun 2024

Interviews #SpeakPharma

  • "Axplora’s leading position in ADCs and how it is well-placed to serve the burgeoning GLP1 market"
    This week, SpeakPharma interviews Martin Meeson, CEO of Axplora, a leading and reliable API manufacturing partner to some of the world’s biggest pharma and biotech companies. Meeson discusses Axplora’s expansion in the antibody-drug-conjugate (ADC) space and how it is well-placed to serve the exciting market for glucagon-like peptide 1 (GLP-1) drugs with its industrial footprint and purification technologies across several sites. 🔑 HIGHLIGHTS// API manufacturing partner to some of the world’s biggest pharma and biotech companies As a leader in the pharmaceutical industry, what inspired you to join Axplora? And, what do you consider the most rewarding aspect of your role as its CEO? When you look at Axplora as the custodian of strong brands like Farmabios, Pharmazell and Novasep you cannot help but be intrigued by what such breadth of offering and depth of technical expertise can achieve. Well, I was certainly intrigued! As a leader in the pharma space, the opportunity to guide an organization with several decades of experience is inspiring for me. For example, our site in Leverkusen was founded over 150 years ago by Alfred Nobel. With every meeting and site visit, I get increasingly impressed by the capabilities of the people that I meet. Now, it is my job to make sure that these capabilities are given the best opportunity to serve. In this sector, we have the privilege of working with our partners to supply and develop medicines that have such a positive impact on people’s lives. This for me is the most rewarding thing that we do. Sometimes the work that we do can seem a little far away from the patient. I always take time to remind myself, my staff, and hopefully also your readers of what we are doing and how our work impacts others. 🔑 HIGHLIGHTS// strong brands like Farmabios, Pharmazell and Novasep / positive impact on people’s lives How have recent industry developments influenced both API manufacturing and CDMO sectors, and what specific strategies has Axplora implemented to adapt to these changing market dynamics while maintaining its commitment to quality and innovation? As a CDMO, when you partner with us, there is always a focus on reliable supply, and we are still haunted by the challenges all of us faced during the pandemic. At Axplora, we have implemented numerous initiatives to increase the robustness of supply, particularly in looking at advances in sourcing and horizontal integration both within and across our network. At the same time, we have a strong focus on the impact that we are having on the planet and Axplora’s work in this area is tremendous — from increasing the amount and efficacy of waste management, notably the current programs around solvent recovery and recycling, to implementing more environment-friendly technologies such as electrochemistry. I am particularly excited by the cutting-edge work on moving to completely new processes that are water-based rather than solvent-based, creating a step change in impact for us and our partners. In addition, as a CDMO you have to constantly look at where your services fit within evolving markets. Axplora’s expansion in the ADC sector is an excellent example of tracking and investing in emerging technologies. Of note also is the current demand for GLP-1 medicines, and Axplora is well-placed to serve this exciting market with our industrial footprint in small molecules and purification technologies across several sites in our network. 🔑 HIGHLIGHTS// increase the robustness of supply / efficient waste management programs and environment-friendly technologies Can you discuss any recent advancement or breakthrough in API manufacturing or CDMO services at Axplora that have contributed to the company’s success? Our investment in ADC expansion is a key strength. Our Novasep business has some of the world’s leading capabilities in API manufacturing and purification. It is known worldwide for these capabilities. With increasing demand for GLP-1 drugs and the amazing impact they are having on patients globally, we are ready to support this growth across our extensive network. The race to oral dose medicines in this space is particularly exciting, and Axplora is looking forward to treating the vast patient population in diabetes and obesity. 🔑 HIGHLIGHTS// expansion in the ADC sector / treat the vast patient population in diabetes and obesity Looking ahead, what are some of the trends or developments you foresee in API manufacturing and CDMO services, and how is Axplora preparing to stay ahead of the curve in this ever-evolving pharmaceutical landscape? Whilst the landscape is evolving rapidly, regulations are not necessarily able to keep pace with the development of new molecules. The pandemic revealed that things can move more quickly. When I look at the challenging new regulation in adjacent spaces like cell therapy, I wonder how that pace can be applied to our sectors. To that end, you have to remain agile and responsive to customer needs. We have to ensure we invest to grow our capacity in the right areas. Our recent investments in Farmabios in Gropello Cairoli (Italy) to support our thriving steroids business and in Pharmazell in Vizag (India) to advance our specialty business are clear indications of how we can do this very successfully. It would be easier if I could point to just one thing that we are doing, but that is not how we win. The only way to stay ahead is by making a myriad of large and small adjustments and evolutions and that is where the Axplora group excels. Finally, one element I should mention is that we are part of a global supply chain. Therefore, our broad network stands ready to supply medicines to multiple geographies. Our investments reflect our worldwide customer base and ambitions. We are here to serve our partners and their patients. 🔑 HIGHLIGHTS// recent investments in Farmabios in Italy and Pharmazell in India / ready to supply medicines to multiple geographies

    Impressions: 2018

    https://www.pharmacompass.com/speak-pharma/axplora-s-leading-position-in-adcs-and-how-it-is-well-placed-to-serve-the-burgeoning-glp1-market

    23 May 2024

Data Compilation & Company Tracker #PharmaFlow

  • FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea
    Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim).  Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015,  FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 —  down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira.  In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.

    Impressions: 680

    https://www.pharmacompass.com/radio-compass-blog/fda-approves-record-eight-biosimilars-in-h1-2024-okays-first-interchangeable-biosimilars-for-eylea

    #PharmaFlow by PharmaCompass
    27 Jun 2024

Monthly Stock Recap #PipelineProspector

  • Pipeline Prospector May 2024: J&J inks two deals for eczema drugs; Novo scores trial wins in hemophilia, kidney disease
    Pharma indices have rebounded after ending March and April in the red. May saw the Nasdaq Biotechnology Index (NBI) spike 5.6 percent from 4,168.63 to 4,401.1 and the SPDR S&P Biotech ETF (XBI) index rise 5.1 percent from 84.82 to 89.13. The S&P Biotechnology Select Industry Index (SPSIBI) saw a 5.3 percent gain to 6,930.67 from 6,584.4 at the end of April.The month didn’t see very many approvals from the US Food and Drug Administration (FDA). But what May lacked in approvals, it made up in acquisitions, deals, and trial news. Among the noteworthy approvals were Amgen’s (stock up 9 percent) Imdelltra, which won FDA’s accelerated approval to treat adults in the advanced stages of small cell lung cancer (SCLC). The agency okayed Tris Pharma’s Onyda XR, a once-a-day treatment for attention deficit hyperactivity disorder (ADHD) for patients six years and older. This makes it the first liquid non-stimulant ADHD drug approved in the US.Bristol Myers Squibb’s Breyanzi saw two FDA approvals in May. The agency first expanded its use to treat adults with a type of blood cancer known as follicular lymphoma. FDA then okayed it to treat relapsed or refractory mantle cell lymphoma. With five approvals, Breyanzi is the only CAR T cell therapy approved in the US for four distinct subtypes of non-Hodgkin lymphoma, bringing this personalized therapy to the broadest array of patients with B-cell malignancies. And FDA approved Moderna’s (stock up 39 percent) mRESVIA, an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel)J&J pays US$ 2.1 bn for eczema drug assets; Merck to buy EyeBio for up to US$ 3 bnSeeking to address the significant need in atopic dermatitis (eczema), J&J spent US$ 2.1 billion on bispecific antibody candidates. This included acquiring Proteologix for US$ 850 million and rights to Numab Therapeutics` NM26 for US$ 1.25 billion. NM26 is a promising phase 2-ready treatment. Bolstering its ophthalmology portfolio, Merck is acquiring EyeBio for up to US$ 3 billion. The deal includes an upfront payment of US$ 1.3 billion and grants Merck access to EyeBio`s lead candidate, Restoret, for diabetic macular edema and neovascular age-related macular degeneration.In a US$ 1.8 billion deal (including US$ 1.15 billion upfront), Biogen acquired Human Immunology Biosciences (HI-Bio) to gain access to felzartamab, a potential cure for various immune-mediated diseases. Expanding its oncology portfolio, Novartis acquired Mariana Oncology for US$ 1 billion upfront and US $750 million in milestone payments. Mariana focuses on developing novel radioligand therapies to treat cancers with high unmet needs. Aiming to become a major player in the pharmaceutical industry, Japanese conglomerate Asahi Kasei offered US$ 1.1 billion to acquire Swedish drugmaker Calliditas Therapeutics.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Sanofi bails out Novavax with US$ 1.2 bn deal; Takeda nabs option to license Alzheimer’s therapiesNovavax has received a timely shot in the arm, as Sanofi will pay the former up to US$ 1.2 billion in exchange for a license to commercialize its existing Covid vaccine and develop a combo jab to protect against Covid and influenza. The struggling Maryland biotech’s management, or lack thereof, had come under fire from investors. Sanofi also gets a minority 4.9 percent stake in Novavax. Following this, Novavax raised its 2024 revenue guidance from between US$ 800 million and US$ 1 billion to between US$ 970 million and US$ 1.17 billion. Novavax’s stock rocketed 200 percent in May.Japanese pharmaceutical giant Takeda made two significant moves. After an upfront payment of US$ 100 million, Takeda now has the exclusive option to secure global rights to AC Immune`s Alzheimer`s vaccine and immunotherapies targeting amyloid beta for another US$ 2.1 billion. Additionally, Takeda partnered with Shanghai-based Degron Therapeutics in a deal valued at up to US$1.2 billion. This collaboration focuses on discovering and developing novel cancer, neurological, and inflammatory drugs using a promising new approach called "molecular glue degraders."Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Novo scores late-stage wins in hemophilia, kidney disease; Lilly’s weekly insulin proves to be as effective as daily dosesNovo Nordisk’s Mim8 has hit its primary endpoint in a late-stage trial to treat people with hemophilia A. This paves the way for filing for approval later this year and competing with Roche’s blockbuster Hemlibra. Meanwhile, Ozempic lowered the risk of death in type 2 diabetes patients with chronic kidney disease. A late-stage trial with 3,533 people showed weekly semaglutide injections reduced kidney failure and death due to kidney complications by 24 percent.However, Novo did suffer a setback this month. FDA’s advisory panel voted seven to four that the benefits of Novo’s once-weekly insulin, Awiqli, do not outweigh its risks. The Danish drugmaker is in a race with Lilly to bring to market weekly injections with long-acting insulins, which would lower the treatment burden for diabetes patients. An increased risk of low blood sugar was flagged by the advisors in patients with type 1 diabetes. Novo`s sales increased 24 percent to DKK 65.3 billion (US$ 9.4 billion) in the first quarter of 2024.Eli Lilly’s once-weekly insulin jab, efsitora, showed blood sugar reduction consistent with the daily insulins widely used today by patients with type 2 diabetes. Efsitora met its primary endpoints in two phase 3 trials. The Indiana drugmaker said it is investing an additional US$ 5.3 billion at its Lebanon (Indiana, US) manufacturing site to boost the supply of Zepbound and Mounjaro.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Novartis tees up two rare kidney disease therapy approvals; Bayer’s menopause drug reduces hot flashes Novartis touted two promising late-stage readouts for rare kidney disease treatments as it tees up two potential approvals in the renal therapy space. The Swiss drugmaker’s experimental drug, atrasentan, reduced proteinuria (elevated protein in the urine) by 36.1 percent in IgA nephropathy patients. Fabhalta achieved a 35.1 percent proteinuria reduction in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). C3G currently has no approved therapies.Bayer said its non-hormonal drug, elinzanetant, significantly reduced debilitating bursts of body heat (hot flashes) associated with menopause. This tees it up to become only the second non-hormonal drug to do so after Astellas’ Veozah.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Our viewFor long, mental health researchers have been captivated by psychoactive ingredients found in cannabis and LSD. However, advocates suffered a setback in early June when an FDA advisory panel voted against the first MDMA treatment for post-traumatic stress disorder (PTSD). Still, June kicked off with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, which saw tons of developments in treating cancers. It is shaping up to be an interesting month with over a dozen Prescription Drug User Fee Act (PDUFA) dates including for two drugs to treat chronic obstructive pulmonary disease (COPD) – Dupixent and ensifentrine.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel)  

    Impressions: 1614

    https://www.pharmacompass.com/pipeline-prospector-blog/j-j-inks-two-deals-totaling-us-2-1-bn-for-eczema-drugs-novo-scores-late-stage-wins-in-hemophilia-kidney-disease

    #PipelineProspector by PharmaCompass
    06 Jun 2024

Weekly News Recap #Phispers

  • Novo invests US$ 4.1 bn to boost Wegovy, Ozempic supply; Verona’s COPD therapy bags FDA nod
    This week saw a couple of developments in the lucrative US market for glucagon-like peptide-1 (GLP-1) drugs that treat diabetes and obesity. Novo Nordisk is investing US$ 4.1 billion to develop a new facility in North Carolina to boost the supply of Ozempic and Wegovy. And Israel’s Teva Pharmaceuticals has launched a generic version of Novo Nordisk’s Victoza to treat type 2 diabetes.In approvals, the US Food and Drug Administration (FDA) has approved Verona Pharma’s drug for chronic obstructive pulmonary disease (COPD), a chronic lung disease. The agency has expanded the use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy (DMD) in patients aged four and above who cannot walk, despite the drug failing in its late-stage trial. Additionally, FDA granted an accelerated approval to BMS’s Krazati, to be used in combination with cetuximab, as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.In late-stage trials, Gilead’s twice yearly HIV prevention drug proved to be superior to its daily pill Truvada, which could make it a game changer in the pre-exposure prophylaxis (PrEP) space. AstraZeneca’s blockbuster drug Imfinzi meaningfully improved survival in patients with muscle-invasive bladder cancer. And Merck KGaA has had to scrap a phase 3 trial after its once promising candidate xevinapant failed to show significant survival benefits in patients with locally advanced head and neck cancer.Novo invests US$ 4.1 billion in new facility in US to boost Ozempic, Wegovy supplyNovo Nordisk is investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US). The funds will be used to create a 1.4 million square foot facility that fills Ozempic and Wegovy (both semaglutide) injector pens. The Danish drugmaker already operates three facilities at the site. This new 56-acre facility is expected to add 1,000 new jobs to the 2,500 already employed at the other three facilities.Teva launches first GLP-1 generic in US: Teva Pharmaceuticals has launched a generic version of Novo Nordisk’s Victoza (liraglutide) to treat type 2 diabetes patients, rendering it the first generic for a GLP-1 drug in the United States.FDA okays Verona’s COPD therapy; AbbVie-Genmab’s Epkinly bags second approvalFDA has approved a therapy for COPD — Ohtuvayre — from Verona Pharma. Ohtuvayre is a new, inhaled non-steroidal, maintenance treatment for COPD in adult patients. The chronic condition causes restricted airflow and breathing problems. According to the company, Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.Epkinly okayed for follicular lymphoma: After bagging an FDA approval last year for diffuse large B-cell lymphoma (DLBCL), AbbVie and Genmab’s Epkinly (epcoritamab-bysp) has now bagged an accelerated approval in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior treatments.First drug for excessive underarm sweating okayed: FDA has approved the first drug to treat primary axillary hyperhidrosis (excessive underarm sweating). To be sold as a gel, Botanix Pharmaceuticals’ Sofdra (sofpironium) is a new chemical entity that presents a safe and effective solution to patients who suffer from this socially challenging medical condition, the company said.Gilead’s twice yearly HIV prevention drug found to be superior to daily pill TruvadaIn a late-stage study, Gilead’s long-acting injection has proven to be more effective in preventing HIV infection in women compared to the daily pill Truvada (emtricitabine/tenofovir). This is the first time that an HIV pre-exposure prophylaxis (PrEP) has shown zero infections in a phase 3 trial, the drugmaker said. Dosed just twice a year, lenacapavir could be a game-changer in HIV prevention.Astra’s Imfinzi chalks up win in treating bladder cancer: AstraZeneca’s Imfinzi (durvalumab) meaningfully improved event-free survival and overall survival in patients with muscle-invasive bladder cancer (MIBC) in a late-stage trial. In the study, Imfinzi was used in combination with chemotherapy before surgery, and as a monotherapy after, and was compared with pre-surgical chemotherapy alone.Merck KGaA scraps trial after failure in head, neck cancer: Merck KGaA said its candidate xevinapant has failed in a late-stage trial to show significant survival benefits in patients with locally advanced head and neck cancer. An independent data monitoring committee said xevinapant is unlikely to meet the primary endpoint of the study and the German drugmaker is discontinuing it. Xevinapant was seen as a promising drug and Merck had paid €188 million (about US$ 226 million) in upfront cash to acquire its global rights from Debiopharm International.FDA expands use of Sarepta’s Duchenne gene therapy despite late-stage failureFDA has granted accelerated approval for the use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy (DMD) in patients aged four and above who cannot walk. The agency okayed Elevidys (delandistrogene moxeparvovec) for this group despite it missing its primary goals of a late-stage trial. FDA also granted Elevidys a traditional approval for DMD in patients four years of age and above who can walk.Argenx’s Vyvgart Hytrulo okayed for autoimmune disease: FDA has approved Argenx’s Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy (CIDP), making it a new treatment option for patients with this rare and debilitating neuromuscular disorder. This marks the first drug with a novel, precision mechanism of action in over 30 years for CIDP, Argenx said.BMS’ Krazati okayed for colorectal cancer: FDA has granted Krazati (adagrasib) an accelerated approval, when used in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer. This is the second approval for Krazati, which works by targeting a mutated form of the gene known as KRAS. It was previously approved to treat KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer.Lilly, OpenAI join hands to fight antimicrobial resistance; Glenmark recalls drugEli Lilly has partnered OpenAI to leverage its generative AI to invent novel antimicrobials that can be used to treat drug-resistant bacteria. Antimicrobial resistance is one of the top public health and development threats across the world.Glenmark recalls 114 batches of potassium drug: Glenmark has recalled 114 batches in the US of 750 mg potassium chloride extended-release capsules because of failed dissolution. As a result, the capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest, the company said. The recall is voluntary and Glenmark hasn’t received any reports of serious side effects yet.

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    27 Jun 2024

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    View Sharp's clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass. What is pharmaceutical contract packaging and how is Sharp a reliable packaging partner for the pharmaceutical and biotech industries? Pharmaceutical packaging can be defined as a set of operations including filling, sealing, packaging, and labeling of semi-finished or finished products. Pharma packaging is an economical means to present, preserve, identify, provide information, maintain product integrity, and ensure stability. It also plays a crucial role in the transportation of sensitive and strictly controlled products. Pharmaceutical contract packaging refers to packaging that is executed and supplied by a licensed third-party service provider that comprises both initial packaging and repackaging. These contract packaging service providers may offer clinical and commercial packaging solutions for pharmaceutical products. Pharmaceutical contract packaging organizations are well-equipped to offer a comprehensive range of primary, secondary, and tertiary packaging solutions. Primary packaging surrounds the pharmaceutical formulation and includes bottles, blisterings, pouches, sachets, tubes, auto-injector pens, etc. Whereas secondary packaging offers further external protection and includes artwork design, labeling for parenteral and injectables, child-resistant and compliance prompting packaging, etc. Additionally, tertiary packaging is used during transportation to absorb physical impacts, moisture, and dust and includes cardboard boxes, stretch wraps, shrink films, and wooden and plastic pallets. Sharp is a leading contract packaging organizations that offer pharmaceutical packaging services among others. It has more than 70 years of experience in pharmaceutical clinical packaging, clinical trial supply services, and small-scale sterile manufacturing. Sharp has more than 2,000 employees who work in its state-of-the-art GMP facilities in the US, UK, Belgium, and the Netherlands. Sharp, offers contract manufacturing and packaging services and support from phase I clinical trial supplies to commercial launch and lifecycle management to its pharmaceutical and biotechnology partners across the world. It has deep expertise in clinical trial packaging and labeling along with a skilled global design team that utilizes cutting-edge software and technology ensuring patient-friendly and differentiated packaging for drug products. Apart from this, Sharp is also a reliable partner for sourcing packaging material and offers integrated pharmaceutical packaging and labeling services along with over-encapsulation of oral solids and the production of placebo capsules for study blinding. Sharp is a contract packaging organization that offers commercial packaging services including contract blister packaging services, bottle packaging, sachet packaging, injectable packaging, and other solid dose packaging solutions. Additionally, it offers clinical packaging and labeling solutions such as clinical trial material packaging, clinical trial packaging and labeling, clinical trial logistics and packaging, and clinical trial supply services, or clinical supplies. Its clinical and commercial packaging services are outlined below: Clinical Packaging Solutions Sharps clinical packaging solutions encompass primary packaging and labeling and secondary packaging. Its pharmaceutical primary packaging offers reliable clinical packaging services, clinical supply chain services, primary packaging solutions, and cold-chain secondary packaging and labeling at 2-8°C, -20°C, and even at -70°C. Sharp also provides reliable clinical pharma packaging services and labeling, secondary packaging solutions, pharmaceutical clinical packaging and labeling solutions along with expertise and capabilities in handling cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C. Commercial Packaging Solutions For more than 65 years, Sharp has been providing a full range of commercial primary and secondary packaging solutions, blister packaging, and contract manufacturing and packaging services for pharmaceutical oral solid dosage forms. It offers contract blister packaging services and bottle packaging for pharmaceutical drug products. Apart from this Sharp provides pharma packaging contract services for small and large-volume batch sizes of injectables. It offers pharmaceutical packaging services for cold chain storage, packaging in temperature- and light-controlled environments, serialization, and customized distribution. Additionally, Sharp is involved in the pharma packaging of oral solids, liquids, and semi-solids. Moreover, Sharp is a premier commercial packaging service provider for high-value, low-volume gene therapy. It also offers pharmaceutical packaging services, expertise, and powerful technology that facilitates product serialization and aggregation. Therefore, Sharp’s pharma packaging contract services, spanning from clinical supplies to commercial include pharma clinical trial material manufacturing, clinical primary packaging services, clinical secondary packaging solutions, clinical trial packaging and labeling, and clinical trial logistics and packaging. Furthermore, Sharp’s contract manufacturing and packaging services encompass commercial pharma packaging solutions and labeling and supply services. Consequently, all the aforementioned offerings position Sharp as a one-stop-shop contract pharmaceutical packaging service provider for clinical and commercial scales. How does Sharp address challenges related to clinical labeling and secondary packaging? Sharp has over 70 years of experience and is a pioneer in clinical trial supply services and pharmaceutical packaging. Dedicated to the right-first-time principle, Sharp is a reliable partner for secondary packaging and clinical pharmaceutical labeling and packaging. It offers a wide range of quick, scalable clinical trial packaging services and labeling and packaging solutions in all formats, with capabilities spanning the complete lifespan of investigational medicinal products (IMPs). Moreover, Sharp can also address challenges related to packaging and labeling and offers pharmaceutical packaging and labeling services and clinical packaging and labeling services to its clients. Additionally, its clinical packaging and labeling solutions also include in-house auxiliary variable data printing outsourced booklet labels, client-supplied randomization fully supported, and annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design. Sharp's pharmaceutical packaging and labeling services include single and multi-panel labels and booklets, 2D barcoding capabilities, randomized and open, 128 barcoding. It also offers regulatory and translation services, sequentially numbered, variable text, code break, and randomized generation among other clinical packaging and labeling solutions. Sharp is a leader in providing pharmaceutical clinical packaging, contract packaging services, and labeling and supply services in compliance with strict regulatory guidelines. It has special pharma packaging and labeling expertise and capabilities for packaging drug products. Sharp addresses various challenges related to pharma packaging and labeling which includes: Sharp can provide cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C for drug products that need low temperatures for their transportation and storage. Sharp can support the secondary packaging for most complex drug candidates, such as controlled substance packaging (DEA schedule I-V), and has the capabilities to scale up to commercial supplies. Its design and logistics staff can also assist with the challenges of blinding products and syringes for clinical trial services. Sharp does this by providing annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design, client-supplied randomization fully supported, and in-house auxiliary variable data printing outsourced booklet labels. With issues related to timely delivery and efficient labeling, Sharp provides pharmaceutical labeling and packaging solutions by using Scan assembly technology and Interactive Response Technologies (IRT), storage, and distribution. To overcome the label readability issues for clients worldwide, Sharp designs and prints multilingual clinical labels. Therefore, Sharp acts as a one-stop-shop packaging organization that provides pharmaceutical contract packaging services, clinical primary packaging services, primary and secondary clinical packaging, and labeling and supply services to its clients worldwide. What range of packaging design and kitting services does Sharp offer? Sharp is a market leader in the design and delivery of primary and secondary packaging. Due to its structural, graphic, and design engineers as well as its understanding of supply chain and regulatory issues, Sharp excels in pharmaceutical packaging. Sharp has years of experience in creating cutting-edge pharma packaging solutions. It is skilled in brand creation, modifying current artwork, marketing research, FDA filing standards, 3D rendering, senior, child-friendly, or child-resistant design, and labeling and supply services. Sharp's global design team provides the creativity and accuracy required to design highly functional and compliant primary and secondary commercial and clinical pharma packaging services. Sharp offers a wide range of design services and pharmaceutical packaging solutions using the latest tools and technologies to guarantee premium and user-friendly product packaging. Additionally, it provides structural and graphic design development for quick launch and regular upgrades for commercial artwork. Sharp’s wide range of packaging design services for pharmaceutical products includes: Artwork Design Services: Sharp can provide pharma packaging contract services including customized artwork as per specific markets from initial mock-ups to product registration. Packaging Samples: Sharp’s contract pharmaceutical packaging services can create production-quality models for use in marketing presentations, human factor research, and photography that closely match the commercial package. Tray Design: Sharp precisely assesses product components to create a tray design that best suits the drug. 3D Printing: Sharp can rapidly confirm that all product components fit by using its technology to create 3D printed prototypes of trays and other packaging component designs. Shipper and Pallet Design: The structural designers at Sharp develop pallet layouts and shippers based on finished items to guarantee drug safety during distribution and storage. CR/SF Compliant Design and Testing: Sharp offers pharmaceutical contract packaging services and can determine the level of toxicity in child-friendly packaging. Various structural design services offered by Sharp include end-user interactions and compliance, child-resistant, senior-friendly (CR/SF) design, tamper evident features, multiple-component kitting requirements, and sustainable or specified materials. Additionally, Sharp’s graphic design capabilities include serialization artwork, brand identity, complete package graphics, product and package illustrations, and late-stage customization. Sharp’s broad range of tailored kitting options for medical devices, pharmaceuticals, and biotechnology calls for the packaging of multiple components into a single, self-contained unit. The design team at Sharp offers commercial packaging solutions and helps clients create a kit that best meets the end-user needs and product specifications. Its kitting services include labeling, tray packing, and boxing with comprehensive verification inspection to ensure the highest level of quality. How does Sharp manage the packaging of sterile formulations to ensure product integrity? Sharp has almost seven decades of packaging experience and it provides pharmaceutical packaging solutions for sterile and non-sterile formulations while maintaining the integrity and quality of products. It offers contract pharmaceutical packaging services and package design services from its US and EU facilities for injectables containing both small and large-volume batch sizes. For product launch and sample programs, its international design team works with clients to provide pharma packaging solutions and determine the optimal vial, prefilled syringe, and autoinjector packaging options. Through its partnership with Berkshire Sterile Manufacturing (BSM), Sharp also offers small-scale isolator-based sterile fill-finish options. It specializes in pharmaceutical clinical packaging and commercial packaging in cold chain storage, packaging in temperature and light-controlled environments, and specialty distribution for injectable drug products.  It also supports multi-country launches from the US and EU. Sharp has experience in parenteral and injectable format labeling and packaging such as vials, autoinjectors, syringes, and pens. Its specialized commercial and clinical services for injectables and parenterals include primary and secondary labeling of vials, IV bags, pre-filled syringes, and IV bottles in ambient, cold and ultra-cold environments, custom label generation, kitting, serialization and aggregation, and storage and distribution. Some of Sharp’s sterile packaging capabilities for injectable drug products include: Vial Labeling and Packaging: Sharp has decades of packaging experience and offers pharmaceutical packaging and labeling services for vials. Its contract packaging services include an automated visual inspection of labeling, tray and carton packing, cartoning of single and multipacks, tamper-evident solutions, cold-chain storage (2-8°C), and ultra-low temperature freezer banks (-20°C/-70°C). In addition to these services, Sharp provides package design, kitting, and segregated suites to handle highly potent APIs (HPAPI), cytotoxins, hormones, serialization and aggregation, and specialty distribution. Autoinjector and Pen Assembly, Labeling, and Packaging: Sharp excels in managing the complexities related to autoinjector or pen device labeling and packaging from its US and EU facilities. Moreover, its YpsoMate autoinjector device delivers a high level of technical accuracy required for the assembly of prefilled syringes into YpsoMate autoinjectors. Sharp’s experts also offer clinical trial packaging services and specialize in managing the challenges related to clinical trial logistics and packaging of biological formulations. Pre-Filled Syringe Assembly, Labeling, and Packaging: Sharp is a leader in the assembly, labeling, and packaging of pre-filled syringes and safety devices. It provides customized commercial and clinical pharma packaging services for both small and large-volume batch sizes for injectables. Small Scale Sterile Fill-Finish: Sharp partners with Berkshire Sterile Manufacturing (BSM) and offers high-quality, manufacturing, packaging, and distribution solutions for flexible fillers, BSM fills vials, cartridges, syringes, and lyophilization. Gene Therapy Clinical and Commercial Packaging: Sharp has over 70 years of experience in packaging complex pharmaceuticals such as low-volume, high-value gene therapies. Sharp is also engineered to provide demand-led supply commercial and clinical services including batch sizes as small as 1 vial, or packaging, labeling, and distribution in cold, ultra-cold, or cryogenic conditions. Sharp also has dedicated facilities in Bethlehem, PA, US, Heerenveen, and the Netherlands for handling gene therapies. These facilities are equipped with HEPA air handling systems, controlled temperature, humidity and dew point, full-sized -80°C freezer banks in dedicated production suites, constant monitoring of time-out-of-refrigeration, and specific freeze-thaw cycles. These facilities help in providing clinical trial packaging services and clinical secondary packaging solutions along with commercial packaging of sterile formulations. What range of pharmaceutical packaging solutions does Sharp offer for solid and liquid drug products? With a history spanning more than 70 years, Sharp is a pioneer in providing pharmaceutical packaging services that include primary and secondary packaging of solid, liquid, and semi-solid drug products for clinical and commercial scales from its state-of-the-art facilities. Sharp offers innovative and economical clinical packaging services for investigational medicinal products (IMP). It also supports the packaging of various dosage forms including bottling of solid formulations, and thermo and cold forming blister packaging for oral solids. Sharp also supports the packaging of powder and OSDs in sachets and pouches, oral and transdermal films in strips, and injectables in vials, syringes, and cartridges. Moreover, it is also involved in the packaging of semi-solids such as cream and ointment in tubes. Some of Sharp’s pharmaceutical packaging solutions for solid and liquid drug products are mentioned below: Bottle Packaging for Solids and Semi-solids: Sharp provides pharma packaging contract services for bottle packaging that include component sourcing, carton printing and in-line cartoning or bundling, comprehensive onsite engineering and validation support, serialization and aggregation, and strict quality control for packaged drugs. Sharp also offers high-quality nitrogen flush bottles and bottle packaging for moisture and oxygen-sensitive drugs. Blister Packaging for Oral Solids: Sharp provides various blister packaging solutions including thermoform and cold form blisters, patient packs, hospital unit dose packs, wallet cards, child-resistant lidding, sustainable foil and blister materials, and multiple products per blister. Apart from this, Sharp’s contract blister packaging services also involve multi-color foil printing, in-house tooling design and fabrication, polymer laminates (Aclar, PVC/PVDC, etc.) heat-seal coating resins, and automated visual inspection. Pouches and Sachets for Solids and Transdermal Patches (Primary and Secondary Packaging Services): Sharp has expertise in pouch and sachet packaging filled with solid dose, powder, thin film, and transdermal patch drug products. Sharp’s solid dose packaging solutions offer considerable pouch and sachet packaging backed by quality operations and project management knowledge. Sharp is home to a sizable assemblage of form, fill, and seal technologies. Based on decades of practical expertise, Sharp uses a wide range of innovative film structure materials, such as coated papers, high-barrier foils, and polymer laminates, and offers pharma packaging contract services. It also can support the production of multiple dosage forms for pharmaceutical products. Oral Thin Film and Transdermal Patches: Sharp provides primary and secondary packaging services for oral thin films and transdermal patches. Sharp specializes in die-cutting and pouching sublingual and oral dissolvable films, and transdermal drug delivery systems, and offers specialized pharmaceutical packaging services through quality procedures. It utilizes the most up-to-date solid dose packaging solutions and processes to safely package and safeguard specialty drug products. Sharp’s oral thin film and transdermal patch capabilities include highly accurate dosing by die-cutting laminated products to any size and shape, in-line printing of drug info, bar codes, lot number, expiration date, serialization with optical character verification (OCV), etc. Therefore, Sharp is a pharmaceutical contract packaging organization that offers clinical services, cold chain packaging, clinical packaging and labeling, and commercial packaging. Its pharmaceutical contract packaging service also encompasses primary and secondary clinical and commercial packaging. 

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    #LearnMore by PharmaCompass
    04 Mar 2024