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.
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
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
The European Medicines Agency (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. 19 July 2023
The US Federal Trade Commission (FTC) is again flexing its muscles in the pharma sector, with the aim of blocking IQVIA Holdings, the world’s largest health care data provider, from acquiring Propel Media (PMI). 19 July 2023
Massachusetts, USA-based biotech incubator Flagship Pioneering and US pharma giant Pfizer have announced a novel agreement to create a new pipeline of innovative medicines. 19 July 2023
UK biotech start-up Bloomsbury Genetic Therapies says that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation (RPDD) for BGT-OTCD, the company’s investigational liver-targeted gene therapy for the treatment of Ornithine transcarbamylase deficiency (OTCD). 19 July 2023
Right now, the biosimilars market is at a major inflection point, with momentum building in the US Congress for new drug pricing legislation while new biosimilars of America’s bestselling biologic medicine have come to market. 19 July 2023
Shares in Novartis closed 5% higher on Tuesday after the Swiss pharma major announced its second-quarter 2023 financial results and other updates for shareholders. 18 July 2023
Boston, USA-based clinical-stage biotech Pieris Pharmaceuticals saw its shares surge as much as 70%, and still up 27% at $0.24 mid-morning, after it provided a strategic update following recent events that have impacted its inhaled respiratory franchise. 18 July 2023
Privately held, venture-funded biotech Revolo Biotherapeutics today announced additional data from its proof of concept, two-week, three-dose, Phase IIa clinical trial evaluating the efficacy, safety, and tolerability of the company’s immune-resetting drug, ‘1104, in adults with active eosinophilic esophagitis (EoE). 18 July 2023
The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants. 18 July 2023
Shares of Swedish Orphan Biovitrum, also known as Sobi, edged up 3% to 212.00 kronor today, after it posted financial results for the second quarter of 2023. 18 July 2023
The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB. 18 July 2023
Over the last few days, attendees of the ongoing annual meeting of the Alzheimer’s Association have been arriving in Amsterdam for what has turned out to be a particularly exciting congress. 18 July 2023
Drug price controls in non-US Organization for Economic Cooperation and Development (OECD) nations reduce biopharmaceutical research and development (R&D) by more than $56 billion per year, depriving the world of 25 new drugs annually, according to a new study by the Information Technology and Innovation Foundation (ITIF), the leading think tank for science and technology policy. 18 July 2023
UK-based CAR-T therapies specialist Leucid Bio today announced the appointment of Filippo Petti as its chief executive (CEO), with immediate effect. 18 July 2023
While targeted protein-busting antibodies are revolutionizing the treatment of Alzheimer’s disease, a damaging side effect - amyloid-related imaging abnormalities (ARIA) - has emerged as a differentiator among the growing number of options. 17 July 2023
Mirum Pharmaceuticals, a US biopharma dedicated to transforming the treatment of rare liver diseases, is to buy Travere Therapeutics’ bile acid product portfolio. 17 July 2023