Latest Pharma and Biotech News
Pharmaceutical
9 July 2025 US pharma giant Merck & Co today revealed it has made a bid to acquire UK-based lung therapy company Verona Pharma, sending the latter’s shares up 20.4% to $104.61 in pre-market activity.
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Pharmaceutical
The US Food and Drug Administration (FDA) has taken the radical move of publishing more than 200 decision letters, known as complete response letters (CRLs). 10 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review Merck & Co’s New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. 10 July 2025
Biotechnology
US late-stage oncology-focused Revolution Medicines and Iambic Therapeutics, which is developing novel medicines using its AI-driven discovery and development platform, today announced a technology and research collaboration to pursue novel drug candidates using Iambic’s leading AI models. 10 July 2025
Biotechnology
The European Commission has approved Tevimbra (tislelizumab), alongside gemcitabine and cisplatin, for the first-line treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. 10 July 2025
Biotechnology
US pharma major AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation today announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, developed using IGI's proprietary BEAT protein platform, for oncology and autoimmune diseases. 10 July 2025
Biotechnology
BeOne Medicines - the Sino-American oncology specialist formerly known as BeiGene - has announced that the National Institute for Health and Care Excellence (NICE) has recommended Brukinsa (zanubrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL) after one line of treatment. 10 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for Inqovi (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. 10 July 2025
Pharmaceutical
Secarna Pharmaceuticals has formed a strategic collaboration with Vect-Horus aimed at advancing RNA-targeted therapies capable of crossing the blood-brain barrier, a key hurdle in treating central nervous system disorders. 10 July 2025
Pharmaceutical
The US Supreme Court has aided President Donald Trump in his mission to plough on with a major workforce reduction and agency overhaul impacting the US Department of Health and Human Services (HHS). 10 July 2025
Biotechnology
Japanese authorities are putting Eisai under pressure to reconsider the price of its Alzheimer’s disease therapy Leqembi (lecanemab), after a government-backed review found that the drug significantly exceeds accepted cost-effectiveness thresholds in the country. 10 July 2025
Pharmaceutical
French biotech Inventiva has changed up its executive team as it continues to bet on experimental MASH therapy lanifibranor, bringing in new leadership to steer the drug through its late-stage development and potential regulatory filings. 10 July 2025
Pharmaceutical
US pharma major Eli Lilly’s C is emerging as a promising oral glucagon-like peptide (GLP)-1 therapy, with upcoming clinical milestones in obesity and diabetes set to shape its market trajectory. 10 July 2025
Pharmaceutical
The USA’s Federal Trade Commission is sending payments totaling more than $409,000 to consumers who bought products from weight-loss supplement marketer Roca Labs. 10 July 2025
Pharmaceutical
Singapore-based market expansion services provider DKSH Business Unit Healthcare announced a partnership with Germany’s Bayer. 10 July 2025
Biotechnology
Radiant Biotherapeutics, a Canadian biotech advancing multi-specific, multi-affinity antibody (Multabody) therapeutics in cancer and autoimmune diseases, has announced the appointment of Deborah Geraghty as president and chief executive. 9 July 2025
Biotechnology
Dutch privately held Amarna Therapeutics, which specializes in transformative gene therapies announced the formalization of an agreement with biologics manufacturing partner, Sweden’s NorthX Biologics, to accelerate the development of Nimivec, Amarna’s next-generation gene therapy platform targeting immune-mediated diseases. 9 July 2025
Pharmaceutical
Shares of US biopharma Rhythm Pharmaceuticals rose 27.4% to $82.96 in early trading today, as it announced positive top-line results from its Phase II trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity. 9 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Eli Lilly's once-monthly amyloid-targeting therapy for early symptomatic Alzheimer's disease (AD), including patients with mild cognitive impairment (MCI) and the mild dementia stage of AD, with confirmed amyloid pathology. 9 July 2025
Biotechnology
US clinical-stage biotech ProKidney reported statistically-significant and clinically-meaningful positive top-line results from the full Group 1 modified intent-to-treat (mITT) population of the Phase II REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes. 9 July 2025
Pharmaceutical
US antivirals specialist Gilead Sciences today announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir - Gilead's twice-yearly injectable HIV-1 capsid inhibitor - for the prevention of HIV as pre-exposure prophylaxis (PrEP). 9 July 2025
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Pharmaceutical
French independent pharma major Servier is ramping up its industrial development with the inauguration of a new production unit for the active ingredient of one of its venous medicines. 26 March 2025
Pharmaceutical
US pharma giant Merck & Co today announced that the European Commission (EC) has approved Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for a new indication, marking the fourth nod for the product from the regulator. 26 March 2025
Pharmaceutical
Spain-based drugmaker REIG JOFRE has signed a commercial agreement with LEO Pharma, a privately-held Danish firm specializing in medical dermatology and thrombosis. 26 March 2025
Pharmaceutical
Pharma major GSK on Tuesday said its urinary tract infection treatment gepotidacin, under the brand name Blujepa, has been approved in the USA. 26 March 2025
Biotechnology
Polygenic diseases company Character Biosciences has announced an oversubscribed $93 million Series B financing round to accelerate the advancement of its pipeline of precision therapies to treat degenerative eye diseases, starting with age-related macular degeneration (AMD). 26 March 2025
Biotechnology
The global central nervous system (CNS) market is projected grow to over $80 billion in sales in 2025 for the first time since 2013, making a significant resurgence after a decade of stagnation. 26 March 2025
Biotechnology
Theratechnologies has received approval from the US Food and Drug Administration for Egrifta WR (tesamorelin), a new formulation for injection. The treatment is indicated for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. 26 March 2025
Pharmaceutical
US biotech Cassava Sciences will shut down development of its lead Alzheimer’s disease candidate, simufilam, after the treatment failed a second late-stage trial. 26 March 2025
Biotechnology
Asgard Therapeutics, a privately-held biotech working in in vivo direct cell reprogramming for cancer immunotherapy, has named experienced immunology drug development specialist Shane Olwill its chief development officer (CDO). 26 March 2025
Pharmaceutical
The NHS Business Services Authority (NHSBSA) has released an exploratory analysis estimating that patients could have faced prescription charges totaling approximately £837 million ($1.1 billion) in the 2023/24 period without the use of prescription prepayment certificates. 26 March 2025
Pharmaceutical
Norwegian bladder cancer specialist Photocure has appointed Jane Healy as vice president and general manager EMEA. 26 March 2025
Generics
Russian drug manufacturers are eliminating global players from the domestic insulin market, as their sales are steadily growing, The Pharma Letter’s local correspondent reports. 26 March 2025
Pharmaceutical
A new report by the Wall Street Journal (WSJ) reveals abuse of the 340B hospital markup program is getting worse as hospitals and middlemen find new ways to profit off the program, according to a website posting by trade group Pharmaceutical Research and Manufacturers of America (PhRMA). 26 March 2025
Pharmaceutical
California-based clinical stage biotech Alumis today announced a collaboration and licensing agreement with Japan’s Kaken Pharmaceutical to develop, manufacture and commercialize ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases. 25 March 2025
Pharmaceutical
A newly-published randomized controlled trial (RCT) has demonstrated that Deprexis, a digital therapeutic for depression with already extensive clinical validation, shows enhanced effectiveness when used alongside transcranial infrared laser stimulation (TILS). 25 March 2025
Biotechnology
US clinical-stage biotech Syncromune today announced the appointment of Zhihong Li as chief regulatory affairs officer. 25 March 2025
Biotechnology
Newly-launched Hillstar Bio, a US biotech developing precision immunology therapies for autoimmune diseases, has announced the successful closing of a $67 million Series A financing round. 25 March 2025
Pharmaceutical
US pharma giant Merck & Co and China’s Jiangsu Hengrui Pharmaceuticals have entered into an exclusive license agreement for HRS-5346. 25 March 2025
Pharmaceutical
UK pharma major GSK today announced a major new research collaboration with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to advance understanding of neurodegeneration with a first-of-its-kind dementia study. 25 March 2025
Biotechnology
California, USA-based UNITY Biotechnology has announced top-line results from the Phase IIb ASPIRE clinical trial of intravitreal UBX1325 (foselutoclax) in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment. 25 March 2025
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