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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: 609

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 April 2025: Merck KGaA buys SpringWorks for US$ 3.9 bn; Swiss giants lead pharma migration to US soil
April witnessed considerable volatility in pharmaceutical stocks as the US President Donald Trump’s administration signaled major shifts in drug pricing policies and import regulations. These include Trump’s proposed international reference pricing to align US drug prices with lower costs in other developed countries, a national security investigation into pharmaceutical imports that could lead to tariffs of 25 percent or more on foreign-made drugs and, a sweeping executive order to reshape Medicare drug pricing. However, as the month drew to a close, key pharmaceutical indices rebounded and were back in the black. The Nasdaq Biotechnology Index (NBI) rose 0.44 percent from 4,241.91 to 4,260.42. The SPDR S&P Biotech ETF (XBI) rose 2.58 percent — from 80.86 to 82.95. And the S&P Biotechnology Select Industry Index (SPSIBI) increased 0.91 percent — from 6,319.47 to 6,376.95. However, stocks of most drugmakers ended the month in the red.  Access the Pipeline Prospector Dashboard for April 2025 Newsmakers (Free Excel) Trump’s tariff threats prompt drug majors to announce investments in US The unrest created by Trump’s tariff threat on drug imports was palpable across the world. In Europe, CEOs of nearly three dozen global drugmakers, including Pfizer, Eli Lilly, and AstraZeneca, warned European Commission President Ursula von der Leyen that without "rapid, radical policy change", over US$ 100 billion in pharma R&D and manufacturing could leave the European Union. These drugmakers are pushing for abandonment of price controls to match US pricing levels.  Global players are also rapidly reorienting their manufacturing strategies towards the US soil in order to avoid imminent tariffs on imported medicines. For instance, Swiss pharmaceutical giant Roche has announced a massive US$ 50 billion investment in the US over the next five years. Another Swiss drugmaker, Novartis, has committed US$ 23 billion to expand its US operations over the next five years. Meanwhile, AstraZeneca has said it will be shifting the production of some drugs sold in America from Europe to the US in order to avoid Trump’s tariffs. Even American drugmaker AbbVie plans to invest US$ 10 billion in US manufacturing over the next decade to avoid tariffs. Regeneron Pharmaceuticals has taken a different approach by announcing an investment exceeding US$ 3 billion through a 10-year strategic partnership with Fujifilm Diosynth Biotechnologies. This collaboration aims to nearly double Regeneron’s US production capacity for biologic medicines.  Access the Pipeline Prospector Dashboard for April 2025 Newsmakers (Free Excel)  Merck buys SpringWorks for US$ 3.9 bn; GSK inks US$ 2.7 bn deal with ABL Bio This was going to be a year of mergers and acquisitions. But with the imminent policy changes in America’s healthcare sector, M&A activity appears to have slowed down. However, the last days of April saw two M&A announcements — Merck KGaA entered into a deal to buy US biotech company SpringWorks Therapeutics for US$ 3.9 billion, and Novartis announced the acquisition of Regulus Therapeutics for up to US$ 1.7 billion. The month saw several licensing deals. GSK signed a licensing agreement valued at approximately £ 2.08 billion (US$ 2.66 billion) with South Korea’s ABL Bio for exclusive access to ABL’s innovative Grabody-B brain delivery platform, a technology designed to enhance the penetration of therapeutic antibodies across the notoriously selective blood-brain barrier (BBB). The BBB acts as the body’s natural defense to protect the brain from toxins and pathogens. Similarly, Eli Lilly inked a US$ 1.4 billion licensing agreement with Sangamo Therapeutics to gain access to Sangamo’s proprietary neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, which has shown remarkable potential in crossing the BBB. In the autoimmune and immunology space, Sanofi signed an exclusive licensing agreement with US biotech Earendil Labs valued at up to US$ 1.8 billion. The agreement centers on two next-generation bispecific antibodies, HXN-1002 and HXN-1003, discovered through Earendil's AI-driven high-throughput protein modeling platform.  Access the Pipeline Prospector Dashboard for April 2025 Newsmakers (Free Excel)  Lilly’s obesity pill matches Ozempic in trial; Novo seeks FDA nod for semaglutide pill In the market for obesity meds, Eli Lilly’s experimental weight-loss pill, orforglipron, demonstrated efficacy that was comparable to its rival Novo Nordisk’s injectable Ozempic. Analysts view orforglipron pill as a potential game-changer in obesity treatment. Meanwhile, Novo Nordisk has sought FDA approval for a 25-mg pill version of its weight loss medication semaglutide. And Rhythm Pharmaceuticals’ drug, Imcivree (setmelanotide), achieved primary endpoint in a late-stage trial for acquired hypothalamic obesity, a rare condition resulting from damage to the brain’s hypothalamus. Meanwhile, in a high profile trial failure, Pfizer discontinued development of its experimental oral weight-loss pill, danuglipron, following a case of potential drug-induced liver injury in a clinical trial participant. Another significant disappointment came from BMS’ investigational schizophrenia drug, Cobenfy (xanomeline and trospium chloride) — it failed to meet the primary endpoint in a pivotal late-stage trial evaluating its use as an adjunctive treatment for patients who no longer respond to standard antipsychotics. Adding to the month’s disappointments, FDA declined to approve Aldeyra Therapeutics’ dry eye disease treatment, reproxalap, for the second time.  Access the Pipeline Prospector Dashboard for April 2025 Newsmakers (Free Excel)  Amgen’s Uplizna, Sanofi’s Dupixent among noteworthy FDA approvals Amgen received a groundbreaking approval for Uplizna (inebilizumab-cdon) as the first and only treatment for immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition. Analysts estimate that Uplizna could generate global annual sales of US$ 1.3 billion by 2030 for the IgG4-RD indication alone.  Sanofi and Regeneron received FDA approval for Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in patients aged 12 and older who remain symptomatic despite antihistamine therapy. Sanofi’s bestselling drug is now FDA-approved for seven indications. As the month drew to a close, FDA approved Abeona Therapeutics’ gene therapy — Zevaskyn (prademagene zamikeracel) — for a rare skin disorder known as recessive dystrophic epidermolysis bullosa. It also approved Johnson & Johnson’s Imaavy (nipocalimab-aahu), a drug that treats patients aged 12 years and older with a form of generalized myasthenia gravis (gMG) — an immunity-related disorder that weakens the skeletal muscles, especially those in the eyes, mouth, throat and limbs.  Access the Pipeline Prospector Dashboard for April 2025 Newsmakers (Free Excel)  Our view The US economy contracted by 0.3 percent during the first quarter of 2025, as businesses panicked and imported goods to avoid higher costs. The US dollar has been weakening, and has hit a fresh low against the euro, Japanese yen and the Swiss franc. This will reduce the profit of foreign companies from their US divisions once they remit their earnings back to their home country. A study undertaken by Ernst & Young has predicted that a 25 percent US tariff on drug imports would increase drug cost by nearly US$ 51 billion annually, thereby boosting drug prices in America by 12.9 percent. These and other cues only point to the fact that Trump administration’s policies will hurt the US. As of today, a rollback or a softening of stand looks like a distant possibility. Access the Pipeline Prospector Dashboard for April 2025 Newsmakers (Free Excel)  

Impressions: 3916

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-april-2025-merck-kgaa-buys-springwork-for-us-3-9-bn-swiss-giants-lead-pharma-migration-to-us-soil

#PharmaFlow by PHARMACOMPASS
01 May 2025

NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2025/04/06/3056373/0/en/Rhythm-Pharmaceuticals-to-Announce-Topline-Results-from-Pivotal-Phase-3-TRANSCEND-Trial-Evaluating-Setmelanotide-in-Patients-with-Acquired-Hypothalamic-Obesity.html

GLOBENEWSWIRE
07 Apr 2025

https://www.globenewswire.com/news-release/2025/04/07/3056552/0/en/Rhythm-Pharmaceuticals-Announces-Pivotal-Phase-3-TRANSCEND-Trial-Meets-Primary-Endpoint-with-19-8-Placebo-adjusted-BMI-Reduction-in-Patients-N-120-with-Acquired-Hypothalamic-Obesit.html

GLOBENEWSWIRE
07 Apr 2025

https://www.globenewswire.com/news-release/2025/03/20/3046692/0/en/Rhythm-Pharmaceuticals-Reacquires-Licensing-Rights-to-IMCIVREE-setmelanotide-in-China-with-Termination-of-Agreement-with-RareStone-Ltd.html

GLOBENEWSWIRE
21 Mar 2025

https://www.globenewswire.com/news-release/2025/01/10/3007577/0/en/Rhythm-Pharmaceuticals-Announces-Preliminary-Fourth-Quarter-and-Full-Year-2024-Net-Product-Revenues-Pipeline-Advancements-and-Upcoming-Milestones.html

GLOBENEWSWIRE
10 Jan 2025

https://www.globenewswire.com/news-release/2024/12/20/3000811/0/en/Rhythm-Pharmaceuticals-Announces-FDA-Approval-of-IMCIVREE-setmelanotide-for-Patients-as-Young-as-2-Years-Old.html

GLOBENEWSWIRE
20 Dec 2024

https://www.globenewswire.com/news-release/2024/12/03/2990395/0/en/Rhythm-Pharmaceuticals-Announces-IMCIVREE-setmelanotide-Receives-Expanded-Marketing-Authorization-in-the-United-Kingdom-for-Treatment-of-Obesity-and-Control-of-Hunger-in-Patients-w.html

GLOBENEWSWIRE
03 Dec 2024