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
French ophthalmic drug specialist Nicox has provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc Phase III clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting. 7 March 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Alyftrek (triple combination medicine deutivacaftor/tezacaftor/vanzacaftor. 7 March 2025
Pharmaceutical
Cardiorenal specialist scPharmaceuticals has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). 7 March 2025
Biotechnology
US clinical stage biotech Rapport Therapeutics has announced the appointment of Dr Jeffrey Sevigny as chief medical officer (CMO), effective immediately. 7 March 2025
Biotechnology
A recent study by TEConomy Partners, commissioned by industry group PhRMA, has revealed that biopharmaceutical company-sponsored trials generated over $62 billion in economic activity in the USA in 2023. 7 March 2025
Pharmaceutical
US healthcare giant Johnson & Johnson yesterday revealed that it has made the decision to discontinue the Phase III VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder (aMDD) due to insufficient efficacy in the target patient population. 7 March 2025
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lazcluze (lazertinib) for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). 7 March 2025
Biotechnology
A treatment combining AstraZeneca’s immunotherapy Imfinzi (durvalumab) with chemotherapy has significantly reduced the risk of cancer recurrence in patients with early-stage stomach and gastroesophageal junction cancers, according to results from the MATTERHORN Phase III trial. 7 March 2025
Biotechnology
Tenaya Therapeutics, a clinical-stage biotechnology company based in South San Francisco, has announced plans to raise approximately $52.5 million through a public offering. 6 March 2025
Pharmaceutical
Private equity firms acquiring assets were among the most eye-catching deals in pharma M&A during February. 6 March 2025
Pharmaceutical
China’s Enhua Pharma has announced a $3.5 million investment in NeuroThree Therapeutics, a biotech firm specializing in treatments for central nervous system disorders. The investment secures a 10.4% stake in the company as part of its Pre-A funding round. 6 March 2025
Pharmaceutical
Privately-held US drugmaker Tris Pharma today announced positive top-line results from its ALLEVIATE-2 Phase III pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. 6 March 2025
Pharmaceutical
USA-based Medicus Pharma has announced a positive-trending interim analysis for the SKNJCT-003 Phase II study, which aims to treat non-invasively basal cell carcinoma of the skin (BCC). 6 March 2025
Generics
Indian drugmaker Biocon’s Biocon Biologics unit and USA-based Civica Rx, a not-for-profit generic drug and pharmaceutical company, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the USA, with the news sending Biocon’s shares up nearly 4% to 333 rupees. 6 March 2025
Pharmaceutical
ARS Pharmaceuticals’ shares closed up 3.4% at $10.87 yesterday, after the company announced that the US Food and Drug Administration (FDA) had approved neffy 1mg (epinephrine nasal spray) for a new indication. 6 March 2025
Pharmaceutical
Germany’s Merck KGaA returned to profitable growth in 2024 and delivered on its guidance for the year. 6 March 2025
Pharmaceutical
As the new White House seeks to push ahead with swingeing cuts to government spending, a federal judge in Massachusetts has thrown a wrench in the works. 6 March 2025
Pharmaceutical
Polish drugmaker Celon Pharma has announced positive results from a Phase II trial of CPL’36, an experimental oral treatment for levodopa-induced dyskinesia (LID) in Parkinson’s disease. 6 March 2025
Biotechnology
The US Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two of Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing, according to media reports. 6 March 2025
Biotechnology
German biotech major BioNTech has suffered a blow as it seeks to add new revenue streams beyond its COVID-19 vaccine, Comirnaty. 6 March 2025
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