Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Pharmaceutical
Shares in US biotech major Amgen were 11% lower early on Tuesday. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Biotechnology
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Pharmaceutical
Spanish HIV focused immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa, has announced the acquisition of its investigational assets related to the HTI therapeutic HIV vaccine by US antiviral specialist Gilead Sciences. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Pharmaceutical
Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co. 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
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Generics
Russia will allow domestic drugmakers to develop generics of original foreign drugs under patent protection only in case of exodus of their producers from the Russian market. 29 March 2023
Biotechnology
Bristol Myers Squibb’s Sotyktu (deucravacitinib) is continuing to vindicate the company’s decision to favor the drug’s development over Otezla (apremilast). 28 March 2023
Biotechnology
Having won approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in September last year, Astra-Zeneca’s biologic Tezspire (tezepelumab) has now received backing from the health technology assessor. 28 March 2023
Biotechnology
US regulatory T cell-focused Sonoma Biotherapeutics and Regeneron have joined forces to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases. 28 March 2023
Biotechnology
Tuesday was a strange day for Hong Kong-based YS Biopharma. 28 March 2023
Biotechnology
Health Canada has scored a regulatory first, granting approval to Roche’s new blood cancer med, Columvi (glofitamab). 28 March 2023
Biotechnology
Shares of USA/Israel-based biotech BrainStorm Cell Therapeutics rose as much as 13% yesterday on more positive news from the US regulator, which in February issued a refusal-to-file (RTF) letter regarding the submission for its cell therapy NurOwn (autologous MSC-NTF cells). 28 March 2023
Biotechnology
Netherlands-based iOnctura today announced that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, a potential treatment for metastatic uveal melanoma by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA). 28 March 2023
Pharmaceutical
New Zealand-based AFT Pharmaceuticals has announced it has signed further new licence agreements for the intravenous dose form of its Maxigesic pain relief medicine as it continues to build momentum in its international business. 28 March 2023
Biosimilars
Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, welcomes the announcement by the government of Newfoundland and Labrador that it is implementing a “switching” or transitioning policy to expand the use of biosimilar biologic medicines for its public drug program. 28 March 2023
Biotechnology
Cancer immunotherapies and predictive biomarkers company Jounce Therapeutics has agreed to be acquired by Concentra Biosciences for $1.85 in cash per share plus a non-tradeable contingent value right (CVR). 27 March 2023
Biotechnology
US rare diseases focused biotech Amicus Therapeutics today announced that the European Commission (EC) has granted approval for Pombiliti (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD). 27 March 2023
Pharmaceutical
German pain specialist Grünenthal is continuing its upwards trajectory, with its 2022 full-year results showing record revenue and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA). 27 March 2023
Biotechnology
Having gained US approval with much fanfare in December 2022 and in Europe in February this year, Hemgenix (etranacogene dezaparvovec), from Australian biotech CSL Limited, has now received regulatory clearance in the UK 27 March 2023
Biotechnology
Germany’s Merck KGaA has regained exclusive worldwide rights to develop, manufacture, and commercialize its checkpoint blocker Bavencio (avelumab). 27 March 2023
Biotechnology
Shares of German mRNA technologies pioneer BioNTech were down 4.3% at $128.20 pre-market today as it revealed financial results for the fourth quarter and full year 2022. 27 March 2023
Biotechnology
PTC Therapeutics announced on Friday day that Stuart Peltz, chief executive (CEO) of the US biopharma company, is stepping down after 25 years. 27 March 2023
Pharmaceutical
Bayer has announced a move away from women’s health in early research as a priority area of focus for its pharmaceuticals division. 27 March 2023
Pharmaceutical
Shares in UK pharma major GSK closed 3% lower on Friday. 27 March 2023
Pharmaceutical
Britain’s AstraZeneca has reported positive high-level results from the Phase III NEURO-TTRansform study of eplontersen. 27 March 2023
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