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DATA COMPILATION #PharmaFlow

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FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff
A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.

Impressions: 1869

https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

#PharmaFlow by PHARMACOMPASS
20 Feb 2025

STOCK RECAP #PipelineProspector

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Pipeline Prospector Nov 2024: Trump’s HHS pick drags down jab makers’ stocks; Novartis, Merck, Roche ink billion-dollar deals
In November, the markets responded to US President-elect Donald Trump’s picks, particularly the choice of Robert F. Kennedy Jr. to lead the Department of Health and Human Services (HHS). Given that RFK Jr. is known as an anti-vaccine activist, stocks of Pfizer, Novavax, and Moderna dipped by 10 percent, 10 percent and 20 percent respectively during the month. Vaccine makers in Europe, such as GSK and Bavarian Nordic, also met a similar fate, and their stocks were down by 11 percent and 9 percent respectively for the month.Overall, the Nasdaq Biotechnology Index (NBI) fell by 0.11 percent — from 4,650.07 to 4,644.81 in November. The SPDR S&P Biotech ETF (XBI) rebounded 2.67 percent from 97.03 to 99.62, while the S&P Biotechnology Select Industry Index (SPSIBI) ended higher by 2.68 percent — from 7,561.3 to 7,763.7. Access the Pipeline Prospector Dashboard for November 2024 Newsmakers (Free Excel)Pharma giants Novartis, Merck, Roche spark November’s billion-dollar deal bonanzaSwiss drugmakers — Novartis and Roche — dominated this month’s dealmaking landscape. Novartis acquired Kate Therapeutics for up to US$ 1.1 billion, targeting Duchenne muscular dystrophy and other neuromuscular diseases.Novartis also committed US$ 150 million upfront to computational drug discovery firm Schrödinger (stock up 21 percent) in a research collaboration and license deal that has the potential to reach US$ 2.45 billion.In yet another deal, Novartis committed US$ 745 million to Ratio Therapeutics for a radiotherapeutic candidate being developed to cure cancer. The company CEO Vas Narasimhan plans to keep pursuing strategic acquisitions under US$ 5 billion. Over the last five years, the company has spent approximately US$ 19.4 billion in deals.Roche entered into a US$ 1.8 billion deal with Flare Therapeutics to target previously undrugged cancer transcription factors (i.e. proteins that regulate the transcription of genes). It also acquired Poseida Therapeutics for up to US$ 1.5 billion. The acquisition of Poseida (stock up 350 percent) brings innovative CAR-T programs for solid tumors and autoimmune diseases within its fold.American drugmaker Sarepta Therapeutics (stock up 9 percent) signed a landmark deal with Arrowhead Pharmaceuticals (stock up 35 percent), valued at up to US$ 11.4 billion. It includes an  upfront payment of US$ 500 million, an equity investment of US$ 325 million, and worldwide rights to seven RNA-based programs (four clinical, three preclinical). Milestone payments and royalties make up for US$ 10 billion. The collaboration “affords multiple potential blockbuster opportunities” across skeletal muscle, cardiac, and central nervous system disorders.BioNTech (stock up 5 percent) is buying Chinese biotech firm Biotheus for up to US$ 950 million. And Merck signed a US$ 3.3 billion deal with China’s LaNova Medicines for LM-299, a bispecific antibody. Both these deals manifest growing interest in PD-(L)1xVEGF bispecific antibodies, intended for treating solid tumors. Access the Pipeline Prospector Dashboard for November 2024 Newsmakers (Free Excel) Journey Medical, UCB secure FDA nods for skin treatments; BridgeBio’s Attruby to take on Pfizer’s VyndaqelBridgeBio Pharma (stock up 8 percent) made an "improbable comeback" after a disastrous trial failure and two rounds of layoffs. It clinched FDA’s nod for Attruby, the first new treatment for transthyretin amyloid cardiomyopathy (a rare heart disease) in over five years. With this potentially transforming treatment option, BridgeBio gains a foothold in a lucrative market dominated by Pfizer’s blockbuster Vyndaqel. Attruby is expected to bring in US$ 2.5 billion in peak sales by 2035.In dermatology, Journey Medical secured approval for Emrosi, an innovative oral antibiotic developed along with Dr. Reddy’s Laboratories for treating rosacea (an inflammatory skin condition). UCB’s Bimzelx received its fifth FDA approval in just over a year, becoming the first therapy to selectively inhibit two proteins —  IL-17A and IL-17F — to treat hidradenitis suppurativa, a painful skin condition. And Johnson & Johnson’s oral drug icotrokinra achieved successful phase 3 results in moderate-to-severe plaque psoriasis (a skin condition where inflamed and scaly plaques appear on the skin).In oncology and hematology, Syndax Pharmaceuticals’ Revuforj became the first menin inhibitor approved for relapsed or refractory acute leukemia. And Azurity Pharmaceuticals bagged an FDA nod for Danziten (nilotinib), a formulation of Novartis’ blockbuster drug Tasigna that allows patients with chronic myeloid leukemia (a blood cancer that begins with the bone marrow) to take their medication without fasting.Autolus Therapeutics achieved its first FDA approval. Its med Aucatzyl for relapsed or refractory B-cell precursor acute lymphoblastic leukemia became the first FDA-approved CAR-T therapy without the agency’s drug safety program requirement, known as Risk Evaluation and Mitigation Strategies (REMS). Its REMS-free status could simplify its administration and increase its adoption among treatment centers.Other significant nods include PTC Therapeutics’ Kebilidi – the first-ever FDA approval for a gene therapy directly administered to the brain and, Jazz Pharmaceuticals’ Ziihera for HER2-positive biliary tract cancer. Access the Pipeline Prospector Dashboard for November 2024 Newsmakers (Free Excel) Novo, AbbVie, Cassava face trial failures; FDA rejects Lexicon, Applied Therapeutics’ drugsThe US Food and Drug Administration’s advisory committee rejected Lexicon Pharmaceuticals’ diabetes drug Zynquista, citing diabetic ketoacidosis risks for type 1 diabetes patients with chronic kidney disease. In 2023, the drug had been approved for heart failure.Applied Therapeutics saw the FDA reject its galactosemia drug, govorestat, dampening hopes for its first commercial product. Cassava Sciences’ Alzheimer’s drug simufilam, once hailed as a potential breakthrough, missed pivotal trial endpoints amid ongoing fraud investigations involving neuroscientist Hoau-Yan Wang. Critics questioned the validity of the preclinical and early clinical data, suggesting that the promising results may have been overstated or fabricated.Lexicon, Cassava, and Applied Therapeutics’ stocks plummeted 40 percent, 85 percent, and 78 percent, respectively.AbbVie (stock down 10 percent) faced a significant blow as emraclidine, the centerpiece of its US$ 8.7 billion Cerevel acquisition, failed to meet primary endpoints in two pivotal phase 2 schizophrenia trials.Novo Nordisk (stock down 5 percent) decided to discontinue kidney disease drug ocedurenone after a phase 3 trial failure, resulting in an impairment loss of approximately US$ 816.5 million. Access the Pipeline Prospector Dashboard for November 2024 Newsmakers (Free Excel) Our viewIn the third quarter of 2024, Pfizer recorded a 32 percent increase in its year-on-year sales, ending a six-quarter streak where either Eli Lilly or Novo Nordisk were leading in revenue growth. Despite this feat, Pfizer’s stock took a beating on the bourses due to RFK Jr’s nomination to head the HHS.Trump has nominated another controversial personality — Johns Hopkins’ surgeon Martin Makary — to head the FDA. Makary has been a critic of Covid-19 mandates such as masking and vaccines. While the markets didn’t react to his nomination, going forward, we foresee political headwinds causing some turbulence in the biopharma industry. Access the Pipeline Prospector Dashboard for November 2024 Newsmakers (Free Excel) 

Impressions: 6595

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-nov-2024-trump-s-hhs-pick-drags-down-jab-makers-stocks-novartis-merck-roche-ink-billion-dollar-deals

#PharmaFlow by PHARMACOMPASS
05 Dec 2024

NEWS #PharmaBuzz

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https://www.fiercepharma.com/pharma/fda-nod-azuritys-danziten-allows-patients-take-leukemia-med-without-fasting

FIERCE PHARMA
16 Nov 2024

https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-danziten-nilotinib-tablets-the-first-and-only-nilotinib-with-no-mealtime-restrictions-302306329.html

PR NEWSWIRE
14 Nov 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218544

FDA
02 Oct 2024

https://www.businesswire.com/news/home/20240709122699/en

BUSINESSWIRE
09 Jul 2024

https://www.pharmabiz.com/NewsDetails.aspx?aid=169532&sid=2

PHARMABIZ
03 Jun 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203640

FDA
05 Jan 2024