The US Food and |Drug Administration (FDA) has released briefing documents for the April 28, 2023, Advisory Committee Meeting (AdCom) discussing the supplemental new drug application (sNDA) for UK AstraZeneca’s Lynparza (olaparib) in first-line (1L) metastatic castration-resistant prostate cancer (mCRPC). 27 April 2023
A new antibody therapy targeting coronavirus has “demonstrated benefit” in a Phase III trial, according to a statement from SAB Biotherapeutics, while markets reacted negatively to the top-line results. 27 April 2023
The International Council for Harmonization (ICH) has initiated the process for a new guideline on bioequivalence requirements for the approval of medicines, which is an important milestone for global convergence. 26 April 2023
With another set of strong data under its belt, Swiss pharma giant Novartis is now looking to filing regulatory applications for its investigational oral monotherapy iptacopan. 26 April 2023
The US Food and Drug Administration (FDA) yesterday approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). 26 April 2023
UK-based company Epsilogen is even more confident in its claim to be a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer following three new senior hires. 26 April 2023
Shares of Morphic Therapeutics experienced volatility yesterday, after the US biotech reported positive top-line data from the main cohort of the open-label EMERALD-1 Phase IIa study of MORF-057, an oral small molecule inhibitor of the α4β7 integrin, in adults with moderate to severe ulcerative colitis (UC). 26 April 2023
Kidney disease specialist Akebia Therapeutics saw its shares lifted over 6% on Monday, following a European approval for Vafseo (vadadustat). 26 April 2023
Post-marketing research into Vabysmo (faricimab) shows superior performance to aflibercept in wet age-related macular degeneration (nAMD). 26 April 2023
Swiss pharma giant Roche says that, in the first three months of 2023, group sales declined by 3% (-7% in Swiss franc term) to 15.3 billion francs ($17.2 billion). 26 April 2023
German family-owned drugmaker Grünenthal says it has successfully placed its 300 million-euro ($329 million) aggregate principal amount of 6.75% senior secured notes due 2030. 26 April 2023
It has been a challenging first quarter for biotech financing, but a company founded by British clinical-stage biopharma firm PureTech Health has secured over $100 million for its work on the microbiome. 25 April 2023
US biotech company Biogen beat analysts’ expectations with its first-quarter 2023 financial results, exceeding forecasts with both sales and earnings figures. 25 April 2023
Specialty pharma firm Assertio Holdings has entered into a definitive agreement to acquire fellow USA-based Spectrum Pharmaceuticals in an all-stock and contingent value rights (CVR) transaction. 25 April 2023
Idorsia’s shares were down more than 9% at 8.76 Swiss francs by early afternoon, as the Switzerland-based biotech announced its financial results for the first quarter of 2023. 25 April 2023
Swiss pharma giant Novartis was trading 3% higher on Tuesday afternoon after presenting its first-quarter 2023 financial results and latest full-year guidance. 25 April 2023
Californian specialty drugmaker Amphastar Pharmaceuticals has bought Baqsimi (glucagon) from Eli Lilly, in a deal worth over a billion dollars. 25 April 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