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 accepted for regulatory review Astellas Pharma’s marketing authorization application (MAA) for zolbetuximab. 14 July 2023
US cell and gene therapy biotech Frequency Therapeutics saw its share leap more than 62% to $0.65 pre-market Friday, after announcing an agreement with RNA editing company Korro Bio to merge in an all-stock transaction. 14 July 2023
Shares of First Wave BioPharma closed down more than 32% at $0.90 on Thursday, after the company said a Phase II study of an enhanced formulation of its adrulipase drug candidate seems likely to have missed its primary efficacy endpoint. 14 July 2023
Privately-held US biotech KSQ Therapeutics, a developer cancer therapies using its proprietary CRISPRomics discovery platform, has entered into a worldwide license agreement with Swiss pharma giant Roche. 14 July 2023
Dutch healthcare investor BioGeneration Ventures has closed BVG V, its latest investment fund, securing 150 million euros ($168 million) to support innovative early-stage ventures. 14 July 2023
Colombia, which is home to a $4.8 billion pharma market, will soon decide whether to authorize price-cutting generic competition with a critical patented AIDS drug, directly challenging pharmaceutical industry power under a new health ministry resolution in one of the hemisphere’s most influential states. 14 July 2023
A stronger focus on oncology, and in particular well known targets such as the HER2 and HER3 proteins, marks a change in strategy for Hillstream BioPharma. 13 July 2023
The latest Life Sciences Competitiveness Indicators published by the UK government suggests that international investors are abandoning the country’s life sciences sector as excessive revenue clawback rates start to bite. 13 July 2023
Today, the US Food and Drug Administration (FDA) approved Opill (norgestrel) tablet for non-prescription use to prevent pregnancy - the first daily oral contraceptive approved for use in the USA without a prescription. 13 July 2023
The USA’s health technology assessor the Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of two sickle cell disease gene therapies. 13 July 2023
Roche has announced that the Phase III OCARINA II trial evaluating OCREVUS (ocrelizumab) as a twice-yearly 10-minute subcutaneous (SC) injection met its primary and secondary endpoints in relapsing forms of MS or primary progressive MS (RMS or PPMS). 13 July 2023
US drug developer TheracosBio today announced that Brenzavvy (bexagliflozin), an approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, is now available by prescription through the Mark Cuban Cost Plus Drug Company, a pharmacy benefit manager (PBM). 13 July 2023
Recursion, a tech-bio firm seeking to decode biology to industrialize drug discovery, has announced a $50 million investment by US tech firm NVIDIA (Nasdaq: NVDA), which was executed as a private investment in public equity (PIPE). 13 July 2023
French ophthalmology biotech company Nicox has provided details of a US market survey evaluating the commercial potential of its investigational drug NCX 470, a nitric oxide (NO)-donating bimatoprost aimed at treating angle ocular or ocular hypertension. 13 July 2023
As interest in advanced therapies continues to surge, a new ophthalmic specialist focused on cell-based medicines has been launched with $70 million in series A financing. 13 July 2023
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