Latest Pharma and Biotech News
Pharmaceutical
12 December 2025 New York, USA-based rare disease firm Applied Therapeutics has announced a definitive agreement to be acquired by privately-held UK-based Cycle Pharmaceuticals.
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Biotechnology
One of the biggest challenges to the cell and gene therapy (CGT) landscape over the last couple of years has been the reduction in venture financing from $7.5 billion in 2021 to $3.3 billion in 2024. 15 December 2025
Biotechnology
California-based Tenaya Therapeutics, a biotech seeking to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, has announced the pricing of a $60 million public offering. 15 December 2025
Pharmaceutical
Results from the PERSEUS Phase III study showed that tolebrutinib did not meet its primary endpoint in delaying time to 6-month composite confirmed disability progression (cCDP) in participants with primary progressive multiple sclerosis (PPMS), which represents 10% of the overall multiple sclerosis patient population. 15 December 2025
Biotechnology
US biopharma Arcus Biosciences has announced the discontinuation of the Phase III STAR-221 study, being conducted in partnership with Gilead Sciences (Nasdaq: GILD), due to futility. 15 December 2025
Pharmaceutical
Japan’s Mochida Pharmaceutical and Canada-based Duchesnay have entered into a license agreement to provide access to Bonjesta, a combination of two active ingredients: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). 15 December 2025
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, has entered into a definitive agreement to acquire San Diego, USA-based biotech Arthrosi Therapeutics, a private late-stage biotechnology company focused on developing a next-generation treatment for gout. 15 December 2025
Biotechnology
Swedish rare disease specialist Hansa Biopharma announced a reorganization of its European and International Commercial and Medical Affairs operations. 15 December 2025
Pharmaceutical
Japan’s Tanabe Pharma, formerly known as Mitsubishi Tanabe and now owned by Bain Capital, has obtained approval from the Ministry of Food and Drug Safety in South Korea to Radicut Suspension for the indication of amyotrophic lateral sclerosis. 15 December 2025
Biotechnology
M&A news last week featured Mirum Pharmaceuticals announcing plans to acquire fellow USA-based Bluejay Therapeutics and its kidney disease candidate brelovitug. The US Advisory Committee on Immunization Practices (ACIP) revealed changes to guidance on hepatitis B vaccination for newborns. On the research front, Swiss pharma giant Roche presented strong new data on its giredestrant in early breast cancer, while Rezolute released disappointing Phase III data on its congenital hyperinsulinism candidate ersodetug. 14 December 2025
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its December 2025 meeting. 13 December 2025
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday announced it has approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea. 13 December 2025
Pharmaceutical
British pharma major AstraZeneca has joined a near-$100 million series A and A+ financing round for Syneron Bio, a biotechnology startup focused on macrocyclic peptide therapies for oncology and chronic diseases. 12 December 2025
Pharmaceutical
Danish biotech Sidera Bio has raised about 700 million kroner ($109 million) in a series A financing, one of the largest early-stage biotech rounds ever completed in Denmark. Investors include Novo Holdings, Forbion, RA Capital Healthcare Fund and Gilde Healthcare. 12 December 2025
Pharmaceutical
New York, USA-based rare disease firm Applied Therapeutics has announced a definitive agreement to be acquired by privately-held UK-based Cycle Pharmaceuticals. 12 December 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. 12 December 2025
Biotechnology
US late-stage rare disease focused pharma Rezolute announced disappointing top-line results from its Phase III sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI) with news sending its shares crashing 87% to $1.40 by close of trading yesterday. 12 December 2025
Pharmaceutical
Medra, a US company developing the first platform for physical AI scientists, has announced a $52 million Series A financing. 12 December 2025
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ezmekly (mirdametinib) for the treatment of plexiform neurofibromas in adults and adolescents. 12 December 2025
Pharmaceutical
Eli Lilly has shown the strength of its obesity pipeline beyond its on-market blockbuster Mounjaro (tirzepatide) 12 December 2025
Biotechnology
California, USA-based biotech Prolynx, which is developing a next-generation portfolio of ultra-long-acting medicines for obesity and related metabolic conditions, has announced the closing of a $70 million Series A financing and the appointment of industry veteran Chris Boulton as chief executive (CEO). 12 December 2025
All news
Biotechnology
Among last week’s significant news, US biotech Veridian Therapeutics announced it has entered into a royalty financing agreement and updated progress on its veligrotug and VRDN-003. Belgian drugmaker Galapagos announced that, having failed to get any significant bids for its cell therapy business it will wind these operations down. On the M&A front, Alkermes revealed a potentially $2.1 billion takeover bid for fellow Ireland based Avadel and its already approved Lumryz treatment for excessive sleepiness. Also of note, Tango Therapeutics released mixed early data on its cancer candidate vopimetostat. 26 October 2025
Biotechnology
US pharma major Eli Lilly shares closed up 2.8%, while those of Adverum Biotechnologies dropped 2.4% to $4.28, on news of a takeover. 25 October 2025
Pharmaceutical
Indian drugmaker Cipla Limited has entered into a strategic marketing and distribution agreement with US pharma major Eli Lilly to promote tirzepatide under the brand name Yurpeak in India. 25 October 2025
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine Alhemo (concizumab) to prevent or reduce the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with hemophilia A or B with inhibitors. Concizumab is injected subcutaneously daily. 25 October 2025
Pharmaceutical
UK regulators have dismantled a major illicit operation producing unlicensed weight loss medicines, following a raid on a Northampton warehouse. The Medicines and Healthcare products Regulatory Agency (MHRA) said the site marks the first illegal production facility for such products found in the country. 24 October 2025
Biotechnology
US healthcare giant Johnson & Johnson today announced that the European Commission (EC) has approved the expansion for the marketing authorization for Tremfya (guselkumab) to include a subcutaneous (SC) induction option for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). 24 October 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of German drugmaker Bayer’s Nubeqa (darolutamide) in combination with ADT as an option for treating adult patients with mHSPC who are unsuitable for chemotherapy (docetaxel). 24 October 2025
Biotechnology
US biotech major Biogen and Chicago, Canada-based Vanqua Bio today announced a license agreement granting Biogen exclusive worldwide rights to Vanqua’s pre-clinical, oral C5aR1 antagonist. 24 October 2025
Biotechnology
San Diego-based inflammatory diseases specialist Ventyx Biosciences announced positive results from its Phase II study of oral, once-daily VTX3232 in patients with obesity and cardiovascular risk factors. 24 October 2025
Biotechnology
US clinical-stage biotech Tango Therapeutics has announced the pricing of an underwritten offering of 21,023,337 shares of its common stock and pre-funded warrants to purchase up to 3,226,458 shares of its common stock. 24 October 2025
Pharmaceutical
French pharma major Sanofi reported third-quarter 2025 revenue of 12.4 billion euros ($13.2 billion), up 7% at constant exchange rates, with business earnings per share rising 13% to 2.91 euros ($3.09). The company said continued strength in its immunology and rare disease portfolios offset weaker vaccine sales. 24 October 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Blenrep belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma. 24 October 2025
Pharmaceutical
Japan’s Mitsubishi Tanabe Pharma (MTPC) yesterday announced that the US Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of its investigational ND0612. 24 October 2025
Generics
The Association for Accessible Medicines (AAM) has filed for a federal injunction to prevent Connecticut from enforcing a new price-control law that it says threatens patient access to low-cost drugs and violates the US Constitution. The request was submitted October 23 in the US District Court for the District of Connecticut. 24 October 2025
Pharmaceutical
French biotech Abolis Biotechnologies has signed a strategic partnership with EUROAPI to develop microbial strains and bioprocesses for the production of corticosteroids and related active ingredients. The collaboration is part of the Important Project of Common European Interest (IPCEI) Med4Cure program, backed by up to 140 million euros ($150 million) in public funding under France 2030. 24 October 2025
Pharmaceutical
Research from GlobalData highlights the strength of Novartis' position in IgA nephropathy (IgAN), following strong data for Fabhalta (iptacopan). 23 October 2025
Biotechnology
Elixion Biotech has emerged from stealth with a breakthrough that it claims could reshape early-stage drug discovery. 23 October 2025
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) today released its new “Launch Price and Access Report,” finding that drug launch prices continue to rise at a rate that exceeds inflation, gross domestic product (GDP) growth, and overall healthcare costs. 23 October 2025
Biosimilars
South Korea’s Samsung Bioepis today released its Fourth Quarter 2025 Biosimilar Market Report, marking the eleventh edition of the Quarterly Biosimilar Market Report in the United States (US). 23 October 2025
Biotechnology
GlobalData’s Venture Capital Investment Trends In Pharma – Q3 2025 report reveals that the biotech industry witnessed a 70.9% increase in total venture financing deal value from $1.8 billion in second-quarter 2025 to $3.1 billion in third-quarter 2025. 23 October 2025
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