US companies Incyte and Syndax Pharmaceuticals today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), 19 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
Roche today released positive top-line results of the Phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. 19 September 2024
US contract development and manufacturing organization (CDMO) BioCentriq has appointed Syed Husain as its new chief executive (CEO), and as a member of the board of directors. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Upstream Bio, a clinical-stage biotechnology company, has filed for an initial public offering, listing on the Nasdaq under the ticker symbol "UPB." 19 September 2024
Denmark-based Bavarian Nordic and Gavi, the Vaccine Alliance yesterday announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN mpox vaccine (marketed as Jynneos or Imvanex) to be supplied to countries in Africa impacted by the mpox outbreak. 19 September 2024
The atopic dermatitis (AD) market is on track to reach $16.7 billion across mature markets by 2030, according to data and analytics company GlobalData. 19 September 2024
TG Therapeutics yesterday shared new five-year data from the ULTIMATE I & II Phase III trials evaluating Briumvi (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
MAIA Biotechnology, a US biopharmaceutical company developing targeted immunotherapies for cancer, has announced a positive update on its lead clinical candidate. 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
US precision genetic medicines firm Sarepta Therapeutic saw its close up 5% and soar a further 36.5% to $168.55 in after-hours activity, as it revealed a welcome indication extension for its Duchenne muscular dystrophy (DMD) drug. 21 June 2024
New data analysis by University of Bath, UK, and Lund University, Sweden, academics reveals that public health in the UK could be undermined by a failing system of drug company self-regulation. 21 June 2024
The US Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics, replacing the June 2022 draft guidance on this topic. 21 June 2024
French vaccines major Sanofi and Biovac, a Cape Town-based biopharmaceutical company, have announced a partnership to produce inactivated polio vaccines in Africa. 20 June 2024
US biopharma company Vanda Pharmaceuticals on Wednesday revealed that it has rejected takeover offers from UK-based Cycle Pharmaceutical and a revised bid from contract manufacturer Future Pak, arguing that both offers undervalue the company. 20 June 2024
Sanofi today revealed that UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final draft guidance (FDG) not recommending Sarclisa (isatuximab) plus pomalidomide and dexamethasone (Isa-Pd), within its marketing authorization 20 June 2024
Spanish plasma-derived products specialist Grifols announced it has completed the sale of a 20% equity stake in Shanghai RAAS (SRAAS) to Haier Group Corp. 20 June 2024
As anticipated following a positive scientific opinion, British pharma major AstraZeneca's Truqap (capivasertib) has been approved by the European Union. 20 June 2024
USA and Japan based privately held company Aurion Biotech announced that the US Food and Drug Administration (FDA) has granted both Breakthrough Therapy designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) designation for AURN001, the company’s allogeneic cell therapy candidate for the treatment of corneal edema secondary to corneal endothelial disease. 20 June 2024
Midsize Japanese drugmaker Otsuka Pharmaceuticals says it has concluded an expanded licensing agreement for hereditary angioedema (HAE) drug candidate donidalorsen with Ionis Pharmaceuticals to cover the development and sales area to the Asia-Pacific region, including Japan. 20 June 2024
Kotak Alt, part of India's Kotak Mahindra Group, has invested $173 million in Matrix Pharma to facilitate its acquisition of Viatris’ (Nasdaq: VTRS) active pharmaceutical ingredient (API) business, a major US-based company. 19 June 2024
The European Commission has granted marketing authorization for Altuvoct (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A. 19 June 2024
Chicago, USA-based biopharma giant AbbVie has picked up a new nod for Skyrizi (risankizumab-rzaa), for adults with moderately to severely active ulcerative colitis. 19 June 2024