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
Engimmune Therapeutics, a biotech developing novel T-cell receptor (TCR)-based therapies, has announced the appointment of Lars Nieba as chief executive. 19 April 2023
Nektar Therapeutics has reacted to recent setbacks by taking actions expected to significantly reduce future operating expenses and extend its cash runway into the middle of 2026. 19 April 2023
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for Lonsurf (trifluridine/tipiracil), Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings, have revealed. 19 April 2023
While the US regulator’s scientists have given a positive opinion for Innoviva’s (Nasdaq: INVA) new antibiotic, the details appear not to have impressed investors, with shares falling 5% on Tuesday. 19 April 2023
Bold investments in the multiple sclerosis space are set to generate revenues of close to $30 billion per year by 2030, according to research from GlobalData. 19 April 2023
The US Department of Health ad Human Services (HHS) has announced the HHS Bridge Access Program for COVID-19 vaccines and treatment, which is aimed at maintaining broad access to COVID-19 vaccines for millions of uninsured Americans. 19 April 2023
Chicago-USA-based drugmaker AbbVie has announced that the US Food and Drug Administration (FDA) has approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. 18 April 2023
India's first mRNA-based Omicron-specific COVID-19 booster shot from Gennova Biopharmaceuticals, a needle-free vaccine, is under scrutiny by the subject experts' committee (SEC) under the drug regulatory authority 18 April 2023
Long-term incumbent Dr Roy Vagelos will retire from his role as chairman of US biotech Regeneron Pharmaceuticals’ board of directors and will not stand for re-election. 18 April 2023
Californian vaccine firm Vaxcyte has announced positive results from a Phase II study of VAX-24, its broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate. 18 April 2023
The European Commission (EC) has approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 18 April 2023
Shares of Canadian biopharma Bellus Health, a company developing therapeutics for the treatment of refractory chronic cough (RCC), nearly doubled to $14.39 in pre-market activity, on the news of a takeover bid. 18 April 2023
Research from industry analyst GlobalData highlights the significance of the pediatric treatment opportunity for Novartis’ Entresto (sacubitril/valsartan). 18 April 2023
The US Food and Drug Administration yesterday approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. 18 April 2023
For EC Awareness month, The Pharma Letter examines the treatment landscape of esophageal cancer (EC), a rare but deadly malignancy that is the sixth most common cause of cancer-related deaths in the world.1 18 April 2023
South Korean biosimilars company Samsung Bioepis has released the first edition of its Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the USA. 18 April 2023