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 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 contract research organization (CRO) IRBM has signed a new agreement with Merck & Co to continue their collaboration in the peptide therapeutics area. 23 June 2023
Spikevax developer Moderna has submitted data to the US Food and Drug Administration with the aim of securing approval for the latest monovalent version of its jab. 23 June 2023
Switzerland-headquartered Roivant Sciences saw its shares rise 17% in pre-market trading yesterday, after it announced positive results from the chronic period of the TUSCANY-2 Phase IIb study of RVT-3101, a once-monthly subcutaneously administered anti-TL1A antibody. 23 June 2023
The US Food and Drug Administration (FDA) yesterday approved Elevidys (delandistrogene moxeparvovec-rokl), the first gene therapy for the treatment of pediatric patients aged four through five years of age with Duchenne muscular dystrophy (DMD). 23 June 2023
A few days after the World Health Organization (WHO) flagged seven India-made syrups during a global investigation into contaminated medicines, India's Health Minister Mansukh Mandaviya has asserted that India follows a zero-tolerance policy on spurious medicines. 23 June 2023
In the USA, people with the most severe form of hepatitis have reason to cheer as Gilead Sciences announces new positive data at the annual congress of the European Association for the Study of the Liver (EASL). 23 June 2023
San Diego, USA-based Solve Therapeutics (SolveTx) has announced the acquisition of privately-held radiotherapeutics and radiodiagnostics company Cereius. 23 June 2023
India has made it clear that it will not compromise on intellectual property, regulatory data protection, and patent extension as part of ongoing trade negotiations with the UK and the European Union. 22 June 2023
Shares of US cell therapy developer Talaris Therapeutics leapt 26% to $2.77 this morning, as the company announced a proposed reverse merger. 22 June 2023
Aeglea BioTherapeutics has acquired Spyre Therapeutics, a privately-held biotech advancing antibody therapeutics aimed at transforming the treatment of inflammatory bowel disease (IBD). 22 June 2023
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review, said the drug’s developer, bluebird bio. 22 June 2023
Having just last month become the first company to get US approval in the therapy class, UK pharma major GSK revealed that US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of it Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making. 22 June 2023
Boston Pharmaceuticals has released positive Phase IIa results for BOS-580, its investigational, proprietary, long-acting fibroblast growth factor 21 (FGF21) analog for the treatment of non-alcoholic steatohepatitis (NASH). 22 June 2023
Four companies in the Asia Pacific region have taken out licenses with The Medicines Patent Pool (MPP) to manufacture generic versions of Tasigna (nilotinib). 22 June 2023
The US drug industry is not happy with the Inflation Reduction Act (IRA) and is pursuing broad legal action in an attempt to limit its impact. 22 June 2023
Promising clinical results from the 12-week portion of the PIVOT-HD Phase II study of PTC518 in Huntington's disease (HD) lifted US pharma group PTC Therapeutics. 22 June 2023
Belgo-Dutch autoimmune diseases specialist argenx can now boast that it has the first subcutaneous (SC) injectable for generalized myasthenia gravis (gMG) to be approved by the US Food and Drug Administration (FDA). 21 June 2023
The US Food and Drug Administration (FDA) yesterday approved US pharma giant Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). 21 June 2023