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.
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
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 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. 25 November 2024
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Shares in Stoke Therapeutics have fallen by a third after the company announced what it described as “positive new safety and efficacy data” from its early stage trial program for STK-001. 26 July 2023
Barcelona, Spain-based plasma-derived medicine specialist Grifols revealed that its recently concluded Phase IV trial (evaluating a biweekly dosing of Xembify has met its primary endpoint. 26 July 2023
In a change of stance from its earlier proposal, India's Health Ministry has proposed that either the state or central authorities be empowered to regulate drugs and cosmetic manufacture, instead of only the Central Drugs Standard Control Organization (CDSCO). 26 July 2023
Kodiak Sciences lost 47% of its stock market value on Monday after presenting top-line results from three Phase III studies of tarcocimab tedromer, an antibody biopolymer conjugate. 25 July 2023
The SGLT2 inhibitor drug Jardiance (empagliflozin), developed and marketed by family-owned German pharma major Boehringer Ingelheim and the USA’s Eli Lilly, has won approval from the European Commission for the new indication of chronic kidney disease (CKD). 25 July 2023
US biotech major Biogen today reported solid second quarter 2023 financial results, with top-line revenues of $2.46 billion that were down 5% (-3% at constant exchange rates) that beat consensus expectations of $2.38 billion. 25 July 2023
Shares in BioCardia, a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, closed nearly 50% lower on Monday. 25 July 2023
Japanese pharma major Astellas Pharma today announced a research collaboration and license agreement with Kanagawa-based biotech firm PeptiDream to discover novel protein degraders for two targets selected by Astellas. 25 July 2023
Germany-based STADA Arzneimittel and Sweden’s Xbrane Biopharma are considering options, including out-licensing, for their co-developed ranibizumab biosimilar candidate in North America. 25 July 2023
Shares of Denmark-based vaccine developer Bavarian Nordic plummeted 21% to 148.80 Danish kroner yesterday, after it said it was discontinuing its RSV program. 25 July 2023
The US Food and Drug Administration (FDA) has approved Ycanth (cantharidin), a drug/device for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. 25 July 2023
Ahead of its second quarter financials due to be released on August 8, Germany’s Bayer adjusted its full-year outlook for 2023 downward on Monday, mainly due to a significant further decline in sales of glyphosate-based products (broad-spectrum herbicides). 25 July 2023
Ireland-headquartered Horizon Therapeutics’ shares were barely changed in morning trading today, despite the company announcing after hours on Friday that its Phase II clinical trial evaluating daxdilimab for the treatment of systemic lupus erythematosus (SLE) did not show a statistically-significant separation between daxdilimab and placebo on the primary endpoint. 24 July 2023
Bicara Therapeutics, a biotech start-up founded in 2021 with the goal of developing dual-action biologics, has appointed David Raben as chief medical officer. 24 July 2023
California, USA-bas biotech Quince Therapeutics today announced that it has entered into an agreement to acquire EryDel SpA, a privately-held, late-stage biotech company, in a stock-for-stock upfront exchange and potential downstream milestone cash payments. 24 July 2023
US antibody-drug conjugates (ADCs) developer ImmunoGen today announced a multi-target license and option agreement to research novel, first-in-class ADCs with Canadian privately-held firm ImmunoBiochem Corp. 24 July 2023
The US Food and Drug Administration (FDA) is working closely with Pfizer to assess the impact of the damage at its facility at Rocky Mount, North Carolina. 24 July 2023