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 US Food and Drug Administration (FDA) yesterday approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. 26 July 2023
The US Food and Drug Administration (FDA) has granted approval of Balfaxar (prothrombin complex concentrate, human-lans) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. 26 July 2023
Sales and profits at GSK beat expectations in the second quarter, with the firm reporting respectively a 4% and 8% increase from the same period of last year. 26 July 2023
Swiss clinical-stage biotech AC Immune today announced the appointment of Nuno Mendonca as its new chief medical officer of the neurodegenerative diseases specialist. 26 July 2023
US cell therapy developer SQZ Biotechnologies saw its shares close down almost 6% at $0.10 yesterday, after it revealed that Swiss pharma giant Roche has decided not to excercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program. 26 July 2023
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
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