Gilead Sciences has announced that Cindy Perettie will join the firm as executive vice president of its subsidiary company Kite, overseeing the cell therapy business. 17 May 2023
Scientists at the US Food and Drug Administration have outlined a positive stance towards an RSV vaccine developed by Pfizer, ahead of a formal meeting to discuss the firm’s regulatory submission for the candidate. 17 May 2023
Some positive data from Coya Therapeutics lifted the US biotech’s shares 10% in normal trading and a further 6.4% to $6.20 in after-hours activity on Tuesday. 17 May 2023
Positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS) have been released by Swiss pharma giant Roche. 17 May 2023
New late-stage data from the FLAURA2 trial confirm the treatment potential for Tagrisso (osimertinib), while underscoring the value of targeted therapies for certain kinds of lung cancer. 17 May 2023
Boundless Bio, a US precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) for oncogene amplified cancers, has announced the closing of a $100 million Series C financing. 16 May 2023
As soon as US biotech giant Amgen announced that it is to acquire Horizon Therapeutics in a deal worth $27.8 billion, concerns were voiced that the US competition regulator would take a serious look at monopoly and anti-competitiveness implications. 16 May 2023
Much has been made of the sudden rise in sales of Wegovy (semaglutide) and the weight loss drug’s impact in driving rapid growth at Novo Nordisk. 16 May 2023
Dermavant Sciences, an immuno-dermatology-focused subsidiary of Switzerland-based Roivant Sciences, today announced positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase III studies to evaluate the efficacy and safety of topical Vtama (tapinarof) cream. 16 May 2023
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), under development by Dutch clinical-stage biotech Byondis. 16 May 2023
Medicines regulator Health Canada has accepted a New Drug Submission (NDS), submitted by Japan’s Eisai and US biotech Biogen, for Leqembi (lecanemab). 16 May 2023
India's pharmaceutical industry captains have voiced their plea to the government, urging an expansion of the bulk drugs park scheme beyond its current scope. 16 May 2023
Chinese biotech start-up LaNova Medicines revealed it has entered into an exclusive license agreement with UK pharma major AstraZeneca, for LM-305, a pre-clinical stage antibody drug conjugate (ADC) targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D). 15 May 2023
Californian companies Gilead Sciences and Arcus Biosciences have expanded a previously-announced research collaboration focused on oncology to include therapies for the treatment of inflammatory diseases. 15 May 2023
The UK's National Institute for Health and Care Excellence (NICE) has recommended the use of Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection on the National Health Service (NHS) in England. 15 May 2023
Adding to regulatory approvals in the USA and European Union, US pharma major Bristol Myers Squibb said today that its first drug in psoriasis, Sotyktu (deucravacitinib), has been granted Marketing Authorisation (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). 15 May 2023
UK-based RNA delivery and therapeutics company SiSaf has announced that SIS-101-ADO, its siRNA therapeutic for patients with autosomal dominant osteopetrosis type 2 (ADO2), has been granted orphan drug designation by the US Food and Drug Administration (FDA). 15 May 2023
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is preparing to publish an update on variable rates of access to new medicines in the region. 15 May 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