Latest Pharma and Biotech News
Biotechnology
21 May 2025 A panel of experts convened by the US regulator has given a cautious nod to Johnson & Johnson’s Darzalex Faspro (daratumumab/hyaluronidase-fihj) for some multiple myeloma patients.
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Pharmaceutical
USA-based nonprofit CureDuchenne has announced the appointment of Brenda Wong as its new chief medical advisor (CMA), effective January 5, 2026. 22 May 2025
Biosimilars
South Korean Samsung Group’s biopharmaceutical business is being reorganized into two separate tracks: contract development and manufacturing organization (CDMO) and biosimilars. 22 May 2025
Pharmaceutical
The US Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. 22 May 2025
Biotechnology
Precision oncology start-up Fore Biotherapeutics, founded in 2011, today announced a $38 million Series D-2 financing. 22 May 2025
Biotechnology
Chinese drugmaker Jiangsu Hengrui Pharmaceuticals priced its Hong Kong stock offering at the top of the marketed range to raise HK$9.9 billion ($1.3 billion). 22 May 2025
Biotechnology
US clinical-stage biotech Vigil Neuroscience saw its share price skyrocket more than 240% to $7.89 pre-market, on the news that French pharma major Sanofi had made a takeover bid for the company. 22 May 2025
Pharmaceutical
USA-based UroGen Pharma, a biotech developing and commercializing innovative solutions that treat urothelial and specialty cancers, closed 45% lower Wednesday. 22 May 2025
Pharmaceutical
UK pharma major AstraZeneca is set to present data from more than 80 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Spanning across 20 approved and investigational medicines, the presentations include two plenary sessions and a special late-breaking abstract. 22 May 2025
Biosimilars
Swiss biosimilars specialist Sandoz has launched what it says is the first autoinjector presentation of a biosimilar to Stelara (ustekinumab) in Europe, bolstering its presence in the region’s rapidly expanding immunology market. 22 May 2025
Biotechnology
Privately-held US genome-scale drug discovery company Orionis Biosciences has announced a second multi-year collaboration with Genentech, a subsidiary of Roche , to discover small-molecule monovalent glue medicines for novel and challenging targets in oncology. 22 May 2025
Pharmaceutical
Merck KGaA plans to move its investigational lupus drug enpatoran into late-stage development, after new Phase II data showed clinically meaningful improvement in skin manifestations of the disease among treated patients. 22 May 2025
Generics
The share of generics in the Russian pharmaceutical market is steadily growing despite the efforts of the local state to create conditions for the production of original drugs, The Pharma Letter’s local correspondent reports. 22 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is set to sharply restrict vaccine availability to millions of Americans without a persuasive justification based in science. 22 May 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca reports that it will have a historic presence at this year’s American Society of Cancer Oncology (ASCO) meeting across its expansive cancer portfolio. 21 May 2025
Biotechnology
US biotech Moderna today announced that in consultation with the US Food and Drug Administration (FDA), the company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. 21 May 2025
Pharmaceutical
The Dementia Discovery Fund (DDF) - managed by healthcare fund manager SV Health Investors - has announced the final closing of its second fund, DDF-2, with $269 million in commitments. 21 May 2025
Pharmaceutical
Earlier this month, the US Department of Health and Human Services (HHS) said it would require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 21 May 2025
Pharmaceutical
Pharmasyntez, one of Russia’s leading drugmakers, plans a significant expansion of its portfolio of innovative drugs in the short-term, according to recent statements, made by representatives of the company, reports The Pharma Letter’s local correspondent. 21 May 2025
Pharmaceutical
Swiss reproductive and women’s health medicines specialist ReproNovo today announced the successful closing of a $65 million Series A financing round, which will be used to advance its pipeline of multiple Phase II programs. 21 May 2025
Pharmaceutical
North Carolina, USA-based vTv Therapeutics has announced that screening has been reinitiated in the company’s CATT1 Phase III trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes (T1D). 21 May 2025
All news
Pharmaceutical
With shortages of its blockbuster obesity now declared resolved in the USA, Denmark’s Novo Nordisk is moving to make the drug more widely available. 6 March 2025
Biotechnology
In what is seen as an unusual decision, the UK’s National Institute for Health and Care Excellence (NICE) says it will convene a third appraisal committee meeting as part of its ongoing evaluation of Leqembi (lecanemab), the drug’s developers, Eisai and Biogen announced today. 6 March 2025
Biotechnology
French biopharmaceutical Osivax, which is developing vaccines to provide broad-spectrum protection against highly mutating respiratory viruses, has announced the successful first close of its Series B financing, raising 10 million euros ($10.05 million) from new and existing investors. 6 March 2025
Biotechnology
CordenPharma has unveiled plans for a strategic investment exceeding 1 billion euros ($1.1 billion) to enhance its peptide development and manufacturing capabilities. 6 March 2025
Biotechnology
Israel-based Pluri, a biotech using its platform for cell-based solutions to create a collaborative network of ventures, was trading 4% higher Wednesday lunchtime. 5 March 2025
Biotechnology
UK-based Trimtech Therapeutics, a biotech harnessing targeted protein degradation (TPD) for neurodegenerative diseases, has announced the closing of its $31 million seed funding round. 5 March 2025
Pharmaceutical
Ireland-headquartered Jazz Pharmaceuticals has entered into a definitive agreement to acquire US biopharma company Chimerix for $8.55 per share in cash, representing a total consideration of around $935 million. The news sent Chimerix’ shares rocketing almost 70% to $8.40. 5 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis submitted by Swiss pharma giant Roche. 5 March 2025
Biotechnology
The board of directors at immunology-focused biopharma Acelyrin has found that an unsolicited takeover bid from Concentra Biosciences is an inferior proposal to the planned merger with Alumis. 5 March 2025
Pharmaceutical
Pliant Therapeutics has scrapped its Phase IIb Beacon-IPF trial for bexotegrast in idiopathic pulmonary fibrosis (IPF), after data monitors noted higher adverse events for the treatment group. 5 March 2025
Pharmaceutical
The Department of Government Efficiency (DOGE), led by Tesla chief executive Elon Musk, has terminated leases for 30 US Food and Drug Administration facilities across the USA. 5 March 2025
Biotechnology
IN8bio has unveiled a new T cell engager (TCE) platform, marking its first major push into autoimmune disease. 5 March 2025
Pharmaceutical
German life science giant Bayer has reported 2024 group revenue of 47.6 billion euros ($51.5 billion), down 2.2% from the previous year. Core earnings per share fell 21% to 5.05 euros, while EBITDA before special items declined 13.5% to 10.1 billion euros. 5 March 2025
Pharmaceutical
The combined use of two well-known active substances can fight leukemic cells and limit their spread. This is the result of a study conducted by the Karl Landsteiner University of Health Sciences (KL Krems) and recently published in the journal Cancer Letters. 5 March 2025
Pharmaceutical
Leading pharmaceutical associations in Russia have called on the government to postpone the introduction of new procurement rules that will give preference to drugs completely produced in Russia in state tenders. 5 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). 5 March 2025
Biosimilars
Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). 5 March 2025
Biotechnology
San Francisco-based 3T Biosciences, an immunotherapy company in the field of solid tumors and other immune-mediated diseases, has announced the promotion of Marvin Gee to chief research officer and the appointment of Barbara Sennino as senior vice president and head of early development. 4 March 2025
Pharmaceutical
Russia plans to increase procurements of drugs against rare diseases despite the current tough business environment and maintaining sanctions pressure, reports The Pharma Letter’s local correspondent. 4 March 2025
Generics
Czech Republic-based Zentiva Pharma, a generics and over-the-counter medicines company that is wholly-owned by private equity firm Advent International and was formerly a subsidiary of Sanofi , has announced a major UK launch. 4 March 2025
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