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DATA COMPILATION #PharmaFlow

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DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions
The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.

Impressions: 945

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-surge-44-in-q1-2025-india-tops-list-with-51-rise-in-year-on-year-submissions

#PharmaFlow by PHARMACOMPASS
15 May 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: 6866

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.globenewswire.com/news-release/2025/05/19/3083968/0/en/SONATA-HCM-Study-Design-Presented-at-Heart-Failure-2025-the-Annual-Congress-of-the-Heart-Failure-Association-of-the-European-Society-of-Cardiology.html

GLOBENEWSWIRE
19 May 2025

https://www.globenewswire.com/news-release/2025/02/18/3027794/0/en/Published-Data-in-The-Lancet-Diabetes-Endocrinology-Highlights-Unique-Efficacy-Benefits-of-Sotagliflozin-to-Reduce-Major-Adverse-Cardiovascular-Events-MACE.html

GLOBENEWSWIRE
18 Feb 2025

https://www.globenewswire.com/news-release/2024/12/20/3000869/0/en/Lexicon-Announces-Receipt-of-Complete-Response-Letter-for-Zynquista-sotagliflozin.html

GLOBENEWSWIRE
20 Dec 2024

https://www.globenewswire.com/news-release/2024/11/14/2981121/0/en/Post-Hoc-Analysis-Demonstrating-Sotagliflozin-Benefits-Across-Broad-Spectrum-of-Heart-Failure-Patient-Populations-is-Among-Four-Lexicon-Supported-Presentations-at-the-American-Hear.html

GLOBENEWSWIRE
14 Nov 2024

https://www.globenewswire.com/news-release/2024/11/05/2975211/0/en/Published-Data-in-Journal-of-American-Society-of-Nephrology-Highlights-Findings-on-Efficacy-and-Safety-of-Sotagliflozin-for-People-With-Type-1-Diabetes-and-Chronic-Kidney-Disease.html

GLOBENEWSWIRE
05 Nov 2024

https://www.globenewswire.com/news-release/2024/10/31/2973110/0/en/Lexicon-Announces-Outcome-of-FDA-Advisory-Committee-for-Zynquista-sotagliflozin-as-an-Adjunct-to-Insulin-Therapy-for-Glycemic-Control-in-Adults-with-Type-1-Diabetes-and-Chronic-Kid.html

GLOBENEWSWIRE
31 Oct 2024