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Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
  • A company that focuses on development and manufacturing of various injectable finished formulations is looking for suppliers of Injectable Grade Oxaliplatin (120 g) API for commercial purposes. The suppliers must support this enquiry with CoA.
    15 Jul 2024
    A company that focuses on development and manufacturing of various injectable finished formulations is looking for suppliers of Injectable Grade Bendamustine HCl (450 g) API for commercial purposes. The suppliers must support this enquiry with CoA.
    15 Jul 2024

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  • A CMO that focuses on solid & liquid finished formulations in various therapeutic areas is looking for suppliers of IP Grade Chlorzoxazone (1 MT) API for commercial purposes. The suppliers must support this enquiry with CoA.
    15 Jul 2024
    A company that focuses on development, manufacturing and distribution of both various finished dosage formulations and active pharmaceutical ingredients is looking for suppliers of USP Grade Potassium Dihydrogen Phosphate API for both development & commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    15 Jul 2024

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  • A company that focuses on development, manufacturing and distribution of both various finished dosage formulations and active pharmaceutical ingredients is looking for suppliers of USP Grade Disodium Phosphate API for both development & commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    15 Jul 2024

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    A company that focuses on development, manufacturing and distribution of both various finished dosage formulations and active pharmaceutical ingredients is looking for suppliers of USP Grade Monosodium Phosphate API for both development & commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    15 Jul 2024

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  • A company that focus on development and manufacturing of various tablets, capsules, ointments and dry powder finished dosage forms is looking for suppliers of Ph. Eur. Grade Water for injection (10 ml) Ampoules for commercial purpose. The required quantity is 1 lakh units.
    08 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 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 development and manufacturing of various Rx, generics & OTC finished formulations is looking for suppliers of Microcrystalline cellulose 101 Excipient. The required quantity is 50 MT. The supplier must support this enquiry with CoA.
    15 Jul 2024
    A company that focuses on manufacturing and distribution of various excipients, APIs & intermediates is looking for suppliers of BP/ USP Grade Isopropyl Alcohol Solvent for commercial purposes. The required quantity is 40 ft FCL. The supplier must support this enquiry with CoA.
    15 Jul 2024

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  • A leading pharmaceutical company with 25 years of experience that focuses on the development & manufacturing of prescription drugs, generics, OTC products, intravenous infusion and bulk actives is looking for suppliers of Various Excipients for commercial purposes. The required quantity is 500 kg. The supplier must support this enquiry with CoA.
    1. BP/ EP Grade Maize Starch Excipient
    2. BP/ EP Grade Acetone Excipient
    3. BP/ EP Grade Titanium Dioxide Excipient
    10 Jul 2024
    A company that focuses on development and manufacturing of various intermediates and active pharmaceutical ingredients is looking for suppliers of Various Excipients for commercial purposes. The supplier must support this enquiry with CoA.
    1. Cetyl Alcohol (1.8 MT) Excipient
    2. Stearic Acid (850 kg) Excipient
    3. Glycerin (383 kg) Excipient
    4. Squalane (1.3 MT) Excipient
    09 Jul 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: 2105

    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’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments
    This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA`s June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA`s June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  

    Impressions: 886

    https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

    #PharmaFlow by PharmaCompass
    11 Jul 2024

Monthly Stock Recap #PipelineProspector

  • Pipeline Prospector June 2024: FDA approves Merck’s next-gen pneumococcal vaccine, Verona’s COPD therapy
    The pharma indices were back in the black in May, and the good streak continued through June with the Nasdaq Biotechnology Index (NBI) gaining 3 percent, the SPDR S&P Biotech ETF (XBI) index up over 3.1 percent and the S&P Biotechnology Select Industry Index (SPSIBI) rising 4.25 percent.The two summer months were similar in more ways than one. In May, Eli Lilly had announced an investment of US$ 5.3 billion to boost the supply of Zepbound and Mounjaro. In June, Novo Nordisk followed suit, investing US$ 4.1 billion to develop a new manufacturing facility to boost the supply of Ozempic and Wegovy.Similarly, the US Food and Drug Administration (FDA) continued to grant vaccine approvals in June after okaying Moderna’s mRNA respiratory syncytial virus (RSV) vaccine in May. Last month, Merck’s next-generation pneumococcal vaccine won an FDA nod, and the agency expanded the use of GSK’s respiratory syncytial virus (RSV) vaccine to include adults aged 50 to 59.However, June was a lackluster month for mergers and acquisitions. The month had to be content with some tie-ups. For instance, Roche signed an up to US$ 1.8 billion deal with Boston-based startup Ascidian Therapeutics to discover and develop novel gene therapies for difficult-to-treat neurological diseases. AbbVie inked a US$ 1.7 billion agreement with China’s FutureGen to bring the latter’s next-generation treatment (FG-M701) for inflammatory bowel disease to market. Takeda signed an option agreement with China’s Ascentage Pharma for an exclusive license to a promising drug for chronic myeloid leukemia and other blood cancers. And Day One Biopharmaceuticals struck a licensing deal with MabCare for a novel antibody drug conjugate (ADC) to treat multiple cancers. The deal’s potential value is US$ 1.2 billion.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel)Merck’s pneumococcal jab wins FDA nod; Moderna’s combo vaccine scores trial winVaccines took centerstage in June. FDA approved Merck’s Capvaxive, a next-generation pneumococcal vaccine designed to protect adults from a broader range of pneumococcus bacteria strains that cause serious illnesses and pneumonia. Capvaxive targets 21 bacterial variations responsible for about 85 percent of invasive pneumococcal disease cases in older adults. Similarly, GSK secured FDA approval for its RSV vaccine for adults aged 50 to 59 years. This makes Arexvy the only RSV shot endorsed for that age group.In a late-stage trial, Moderna’s mRNA-1083, an investigational combination vaccine against influenza and Covid, elicited a higher immune response compared to separate shots in people aged 50 and over. The combo jab generated more antibodies than currently marketed flu vaccines and Moderna’s Spikevax. And the world’s first personalized mRNA cancer vaccine from Moderna has raised hopes for patients with skin cancer, as three-year data from a mid-stage trial showed some benefits on patients who took the vaccine in combination with Merck’s Keytruda.Despite these developments, Moderna’s stock dropped 19 percent in June after it said the efficacy of its RSV vaccine mRESVIA had vaned substantially to 50 percent after 18 months.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Verona, Geron score maiden FDA approvals; BMS’ Augtyro bags tumor-agnostic nodTwo companies obtained their first FDA approvals last month. The first one was Verona Pharma (stock up 15 percent) — it received its maiden FDA approval for Ohtuvayre for treating chronic obstructive pulmonary disease (COPD). This is also the first inhaled COPD treatment with a novel mechanism of action.The second company to get its maiden FDA approval was Geron, a commercial-stage biopharmaceutical company. FDA signed off on Geron’s Rytelo for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers.In June, FDA granted accelerated approvals to at least three drugs. BMS’ Augtyro was granted FDA’s accelerated approval for treating adult and pediatric patients (over 12 years) with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, regardless of where they occur in the body.Ipsen received FDA’s accelerated approval for Iqirvo, a first-in-class, once-daily oral medication for treating primary biliary cholangitis (PBC), a progressive liver disease affecting mostly women.Sarepta Therapeutics’ (stock up 24 percent) Elevidys received accelerated approval for Duchenne muscular dystrophy (DMD) despite failing its primary endpoint in a late-stage trial.Amongst other approvals, Argenx’s Vyvgart Hytrulo was approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP). This is a novel treatment option for this rare and debilitating neuromuscular disorder. And BMS’ Krazati got its second approval for treating colorectal cancer with a specific KRAS mutation.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) GSK’s failed cancer drug posts trial win; Gilead’s HIV prophylaxis shows efficacyIn late-stage trials, GSK’s multiple myeloma therapy Blenrep cut the risk of disease progression or death by almost half compared to standard-of-care treatments. The once-failed ADC was pulled from the lucrative US market in 2022, but the results could signal a comeback for Blenrep.Intra-Cellular’s antipsychotic drug Caplyta scored another remarkable late-stage win for treating major depressive disorder (MDD). In another late-stage trial, Gilead’s (stock up 6 percent) long-acting injection proved to be more effective in preventing HIV infection in women compared to the daily pill Truvada. 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, Sunlenca could be a game-changer in HIV prevention. Analysts estimate that PrEP-related sales could be over US$ 1.7 billion.In a blow to millions affected by long Covid, Pfizer’s Paxlovid did not appear to improve the symptoms as was hoped. Pfizer’s stock fell 7 percent in June.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Our view This was the second month when pharma indices showed an upward trend. It’s been a good first half for the US stock markets. But there are mixed reports on how markets will perform in the second half, given the uncertainties around interest rate cuts and the outcome of the presidential elections in the US slated to be held in November. Though for those tracking biopharma news, there are enough interesting developments to fret over the markets.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) 

    Impressions: 1549

    https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-june-2024-fda-approves-merck-s-next-gen-pneumococcal-vaccine-verona-s-copd-therapy

    #PipelineProspector by PharmaCompass
    04 Jul 2024

Weekly News Recap #Phispers

  • Lilly to acquire IBD drug developer Morphic for US$ 3.2 bn; Pfizer’s R&D chief to step down
    This week saw Eli Lilly strike yet another deal as it announced the acquisition of Morphic Holding for about US$ 3.2 billion, thereby bolstering its position in the market for inflammatory bowel disease (IBD) drugs.Pfizer announced that its Chief Scientific Officer (CSO) Mikael Dolsten, a key figure behind the development of its Covid vaccine Comirnaty, will be stepping down after over 15 years with the drugmaker.A study found that Lilly’s glucagon-like peptide 1 (GLP-1) drug tirzepatide, used in its diabetes and weight-loss drugs Mounjaro and Zepbound, was more effective than its rival semaglutide, used in Novo Nordisk’s Ozempic and Wegovy, at shedding extra pounds.Another study found that GLP-1 drugs may have a role in preventing cancer. Meanwhile, a study undertaken by an American pharmacy found that only one in four patients in the US who were prescribed Novo Nordisk’s Wegovy or Ozempic for weight loss were still taking the popular medications after two years.Spain’s Grifols said it has received a takeover offer from its founding family and Brookfield Corporation to go private. The deal could potentially be worth about US$ 6 billion.Roche scrapped a trial testing its new immunotherapy tiragolumab in non-small cell lung cancer (NSCLC) patients after it failed to significantly improve survival more than a Keytruda-chemo combination. The Swiss drugmaker is reintroducing its eye therapy Susvimo in the US after voluntarily recalling it in October 2022.UniQure released promising 24-month data for its investigational gene therapy that showed AMT-130 significantly decreased disease progression in patients with Huntington’s disease.Lilly to acquire bowel disease drug developer Morphic for US$ 3.2 billionEli Lilly said it is acquiring Massachusetts-based Morphic Holding for approximately US$ 3.2 billion in cash, bolstering its presence in the US$ 26.65 billion IBD market. The Indiana drugmaker gains an investigational oral IBD therapy — MORF-057 — which will offer a more convenient dosing option compared to current injectable drugs, including Lilly’s Omvoh (mirikizumab). MORF-057 is being tested in three mid-stage studies to treat ulcerative colitis and Crohn’s disease, the two conditions that fall under IBD. Lilly sees the IBD space as a way to diversify beyond obesity.Pfizer’s R&D chief Mikael Dolsten, architect behind Comirnaty, to step downPfizer’s CSO Mikael Dolsten is stepping down after a 15-year career at the New York drugmaker. Under Dolsten, Pfizer won approvals for over 35 drugs and vaccines including for blockbuster drugs like its blood thinner Eliquis (apixaban), breast cancer med Ibrance (palbociclib), and heart disease treatment Vyndaqel (tafamidis meglumine). However, what stands out most is its Covid vaccine Comirnaty under Dolsten’s tenure. Jointly developed with BioNTech, the mRNA vaccine became the first Covid shot approved in the US. Comirnaty catapulted Pfizer’s sales to over US$ 100 billion in 2022.Lilly’s Mounjaro outperforms Novo’s Ozempic in weight loss studyElectronic records of over 18,000 obese or overweight US adults showed Lilly’s tirzepatide helped patients shed more weight than its rival Novo’s semaglutide, with the effect increasing over time. The study found that 82 percent of patients taking tirzepatide lost 5 percent of their starting body weight compared to 67 percent of those taking semaglutide, after a year. Novo pointed out that the analysis did not include its weight-loss drug Wegovy and said a head-to-head clinical trial is the best way to compare the two weight-loss drugs. Such a trial on tirzepatide and semaglutide is yet to conclude.GLP-1 drugs linked to lower cancer risk: Type 2 diabetes patients taking GLP-1 treatments “had a significant risk reduction” in developing 10 common types of cancers closely associated with obesity compared to those on insulin, according to a study published in JAMA Network Open. The study concluded that the “findings provide preliminary evidence of the potential benefit” of GLP-1 drugs for cancer prevention in high-risk populations.Few continue weight loss drugs after two years: Only one in four patients in the US who were prescribed Novo Nordisk’s Wegovy or Ozempic for weight loss were still taking the popular medications two years later, a Reuters report said. The analysis, undertaken by an American pharmacy, does not include details about why patients quit. Another news report said only about 15 percent of people who began taking GLP-1 drugs such as Wegovy stuck with them after two years.Grifols gets US$ 6 billion takeover offer from founding family, BrookfieldSpanish multinational pharmaceutical company Grifols said it is evaluating a takeover offer from its founding family and the Canadian investment management company Brookfield that would delist the company from the Spanish and Nasdaq stock markets. Based on the company’s current market value, the deal is potentially worth around US$ 6 billion. The Grifols family holds a stake of about 30 percent, which they don’t plan to sell. Brookfield is mulling investing over € 5 billion (US$ 5.41 billion), part of which will be to refinance and restructure the company’s debt. The beleaguered drugmaker was rocked by allegations of fraud earlier this year over manipulation of its debt.FDA rejects Novo’s weekly insulin, seeks manufacturing informationFDA has issued Novo Nordisk a complete response letter (CRL), declining to approve the Danish drugmaker’s weekly insulin Awiqli (insulin icodec). The agency has requested information related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed, a company statement said. In May, an FDA panel had voted seven to four against the benefits of Awiqli outweighing its risks.Roche scraps trial after new immunotherapy loses to Keytruda-chemo comboRoche is putting an end to a trial testing its new immunotherapy tiragolumab in non-small cell lung cancer (NSCLC) patients. Tiragolumab is part of a new class of drugs called anti-TIGIT antibodies. The study involving 524 patients with NSCLC tested tiragolumab in combination with Roche’s Tecentriq (atezolizumab) in the first line setting. It failed to best Merck’s Keytruda (pembrolizumab) plus chemotherapy as a first line of treatment in the phase 2/3 study.Meanwhile, Roche is reintroducing Susvimo (ranibizumab injection) in the US after voluntarily recalling it in October 2022. The implant used to treat patients with neovascular age-related macular degeneration (wet AMD) requires a one-time surgery to be inserted into the eye.UniQure posts strong data on gene therapy for Huntington’s diseaseUniQure released promising 24-month data for its investigational gene therapy that showed AMT-130 significantly decreased disease progression in patients with Huntington’s disease. The early-mid stage data showed that among 29 US and European patients, those given the higher dose showed an 80 percent reduction of the neurodegenerative disease progressing, while those given the lower dose saw a 30 percent reduction of the same.  

    Impressions: 605

    https://www.pharmacompass.com/radio-compass-phisper/lilly-to-acquire-ibd-drug-developer-morphic-for-us-3-2-bn-pfizer-s-r-d-chief-to-step-down

    #Phispers by PharmaCompass
    11 Jul 2024

Content #LearnMore

  • View Sharp
    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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    04 Mar 2024