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
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
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
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
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
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
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
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
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
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
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
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
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
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Specialist pre-clinical contract research organization (CRO) and ion channel screening company Metrion Biosciences has announced the appointment of Lee Patterson as its new chief executive. 25 November 2024
Levothyroxine, a widely prescribed treatment for hypothyroidism, may contribute to bone loss in older adults, according to new research presented at the Radiological Society of North America’s (RSNA) annual meeting. 25 November 2024
The UK’s BioIndustry Association (BIA) has published research suggesting that the country’s medicines evaluation body is basing its methods and processes for evaluating drugs for rare diseases on outdated evidence. 6 April 2023
US biotechnology company Bicycle Therapeutics , which pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, has announced the appointment of Dr Santiago Arroyo as chief development officer, effective March 31. 6 April 2023
French clinical-stage biotech Abivax has appointed Marc de Garidel as chief executive (CEO) and interim board chairman of the company, effective May 5, 2023. 6 April 2023
There have been huge changes in the way highly regulated markets operate in recent years – caused by new regulations, technologies and demands. 6 April 2023
Having received accelerated approval from US Food and Drug Administration (FDA) in January this year for their Alzheimer’s disease drug Leqembi (lecanemab), Japan’s Eisai and US biotech Biogen are now awaiting authorizations in the important markets of the European Union and Japan to solidify the drug’s position as the top-selling drug for Alzheimer's in the upcoming years. 6 April 2023
In what is being seen as a double blow to UK pharma major AstraZeneca's non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib mesylate), the Indian Patent Office has granted a patent to the National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, for its nano-formulation of drug osimertinib mesylate. 6 April 2023
TheUK's National Institute for Health and Care Excellence (NICE) has recommended the provision of Lynparza (olaparib) for National Health Service (NHS) patients with forms of early-stage breast cancer and prostate cancer in England and Wales. 6 April 2023
Vienna, Austria-based start-up Proxygen today revealed entering a multi-year research collaboration and license agreement with US pharma giant Merck & Co, known as MSD outside the USA and Canada, to jointly identify and develop molecular glue degraders against multiple undisclosed therapeutic targets. 5 April 2023
US immunology focussed biotech Immunic saw its shares soar more than 23% to $1.80 in early trading today, as it reported positive data from the maintenance phase of its Phase IIb CALDOSE-1 trial of its lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC). 5 April 2023
A number of changes in how the US Food and Drug Administration (FDA) perceives rigorous trial design have been noted in a report on the evolving FDA approval processes for biotech companies in Asia Pacific, Europe, and the USA, including typical impediments to success. 5 April 2023
UK-based iron deficiency specialist Shield Therapeutics today revealed that Andy Hurley will be joining the firm’s executive team as chief commercial officer (CCO), effective April 10, 2023. 5 April 2023
American antiviral specialist Arbutus Biopharma and Genevant Sciences have filed a patent infringement case against the developers of Comirnaty, in the US District Court for New Jersey. 5 April 2023
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the use of Germany-headquartered clinical-stage biotech InflaRx Gohibic (vilobelimab) injection. 5 April 2023
Positive high-level results from a planned interim analysis of the DUO-O Phase III trial have been presented by Anglo-Swedish drugmaker AstraZeneca, which was subsequently trading 2% higher by lunchtime Wednesday. 5 April 2023
US biotech major Biogen has appointed Adam Keeney as executive vice president, head of corporate development effective April 17, 2023, adding a new face to its business development team. 5 April 2023
The value of treatments for obesity is set to grow considerably in the next decade, with industry analyst GlobalData forecasting a market value of around $37 billion by 2031. 5 April 2023
A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023
The US Food and Drug Administration (FDA) has placed a partial clinical hold on all trials of Gossamer Bio’s GB5121, in response to serious adverse events that have been observed in the Phase Ib/II STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. 5 April 2023