25 November 2024 In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards.
The World Health Organization (WHO) has prequalified the meningococcal meningitis vaccine developed by the Serum Institute of India (SII) and PATH, a global non-profit. 13 July 2023
The Journal of the American Medical Association (JAMA) has published key data on cytisinicline, from US specialty pharma Achieve Life Sciences. 12 July 2023
Japan’s largest drugmaker Takeda announced that it has voluntarily withdrawn the US Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003. 12 July 2023
ADC Therapeutics has announced a pause in patient enrollment in the Phase II LOTIS-9 trial of Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously-untreated diffuse large B-cell lymphoma. 12 July 2023
The recent full approval of Leqembi (lecanemab-irmb) has upped the stakes for what promises to be a particularly intriguing congress of the Alzheimer’s Association next week. 12 July 2023
US gene therapy company Avrobio today announced that it has completed a review of its business, including the status of its programs, resources, and capabilities, joining a growing list of biotechs that have recently announced similar actions. 12 July 2023
Global drugmakers continue to defend the rights for their original drugs in Russia by participating in legal disputes with local generics’ producers, The Pharma Letter’s local correspondent reports. 12 July 2023
The Swiss subsidiary of Sino-American biotech BeiGene and Swiss pharma giant Novartis on Tuesday entered into a mutual termination and release agreement to mutually terminate the option agreement, effective immediately. 12 July 2023
Boston, USA-based Crossbow Therapeutics, a biotech developing a new class of potent and precise antibody therapies to treat a broad range of cancers, has announced an $80 million Series A funding round. 12 July 2023
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the global sector trade body, today announced a new line up for its chief executive (CEO) leadership team for the coming two years. 12 July 2023
South Korean biosimilars company Samsung Bioepis has now released the second edition of its Biosimilar Market Report, which explores latest market trends for all biosimilars commercially available in the USA. 12 July 2023
Replicate Bioscience, a company pioneering self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease and other therapy areas, has appointed Rachael Lester as its chief business officer. 11 July 2023
Dermatology specialist Journey Medical has announced positive top-line results from two Phase III trials of its rosacea candidate, DFD-29, a formulation of minocycline hydrochloride. 11 July 2023
Yesterday after market close, US genetic medicines company 4D Molecular Therapeutics announced a license agreement with Japanese drug major Astellas Pharma. 11 July 2023
Sino-American biotech BeiGene has entered an agreement with Duality Biologic (DualityBio) to acquire an exclusive option for a global clinical and commercial license to an investigational, pre-clinical antibody-drug conjugate (ADC) therapy for patients with select solid tumors. 11 July 2023
US pharma major Bristol Myers Squibb has exercised its option to enter into an exclusive global license agreement with German drug discovery company Evotec. 11 July 2023
China-based Brii Biosciences says that it has entered into license agreements with US firm VBI Vaccines, expanding the companies’ collaboration in the hepatitis B virus (HBV) field. 11 July 2023
Adding to US regulatory approval last month for its dual action antibody, Swiss pharma giant Roche today announced that the European Commission (EC) has granted conditional marketing authorization for Columvi (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. 11 July 2023
The safety monitoring committee of the European Medicines Agency is to investigate a potential connection between the use of certain Novo Nordisk products and suicidal thoughts. 11 July 2023
Dublin, Ireland-headquartered protein specialist Prothena revealed that US pharma major Bristol Myers Squibb has exercised its option under the global neuroscience research and development collaboration to obtain the exclusive worldwide commercial rights for PRX005. 11 July 2023
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