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
German pharma major Bayer has secured a positive reimbursement decision from the UK’s health technology assessor for Nubeqa (darolutamide). 19 May 2023
The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access. 19 May 2023
French pharma major Sanofi has successfully completed the Phase I trial for its von Willebrand disease (vWD) therapy, efanesoctocog alfa (BIV001), a novel antihemophilic factor recombinant fusion protein that acts as a coagulation factor VIII therapy. 19 May 2023
Famed as a great success story of the generics sector in previous decades, Israel’s Teva Pharmaceutical Industries has seen its growth and share price tail off since the mid-2010s. 18 May 2023
As part of its ongoing inquiry into pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs, the USA’s Federal Trade Commission (FTC) has issued compulsory orders to two group purchasing organizations (GPOs) that negotiate drug rebates on behalf of other PBMs. 18 May 2023
The US Food and Drug Administration (FDA) has eased the partial clinical hold on AOC 1001, allowing Avidity Biosciences, the drug’s developer, to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001. 18 May 2023
New guidance has been developed by the European Medicines Agency to help the pharmaceutical industry maintain continuity of supply and prevent shortages. 18 May 2023
Today’s announcement that the UK’s National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance (FDG) recommending dapagliflozin for adult patients with symptomatic chronic heart failure (HF) with preserved or mildly reduced ejection fraction (LVEF of more than 40%) in England and Wales is a significant day for patients and the wider cardiology community. 18 May 2023
UK-based Senisca, a biotech company developing RNA-based therapeutics to reverse cellular senescence and target age-related disease, has announced an expansion of its leadership team. 18 May 2023
USA-based ophthalmic diseases specialist EyePoint Pharmaceuticals saw its share leap 15.4% to $7.40 in pre-market trading today, as it announced a definitive agreement for the sale of Yutiq (fluocinolone acetonide intravitreal implant) 0.18mg to Alimera Sciences. 18 May 2023
Shares of US drug developer Intercept Pharmaceuticals closed down 14.7% at $13.83 yesterday, after the US Food and Drug Administration released briefing document ahead of the FDA’s Gastrointestinal Drugs Advisory Committee. 18 May 2023
US biotech Novavax’ COVID-influenza combination (CIC) vaccine reflects a wider industry trend for increased usage of artificial intelligence (AI) in clinical trial design, says data and analytics company GlobalData. 18 May 2023
Not-for-profit UK medical research organization LifeArc and techbio company PrecisionLife have announced a strategic R&D collaboration to accelerate the discovery and development of targeted treatments for amyotrophic lateral sclerosis (ALS), a disease also known as motor neurone disease. 17 May 2023
The US Food and Drug Administration (FDA) has accepted Japanese pharma major Takeda’s Biologics License Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder, for priority review. 17 May 2023