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
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines for approval at its July 2024 meeting. 26 July 2024
In the UK, the health technology assessor has ruled in favor of reimbursing a new use for Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab). 26 July 2024
EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab). 26 July 2024
The biopharmaceutical supply chain plays a pivotal role in ensuring the seamless delivery of therapeutics to patients. However, pharmaceutical supply chains face several challenges, including regulatory complexities, global competition, and the need for innovation. 26 July 2024
Belgian clinical-stage G-protein coupled receptor (GPCR) company Confo Therapeutics today announced the closing of a 60 million euros Series B financing 26 July 2024
US clinical-stage biotech Immunome has announced exclusive license agreement with Israel-based Nectin Therapeutics for rights to a panel of antibodies targeting an undisclosed target. 26 July 2024
India’s Mankind Pharma has entered into a definitive agreement to acquire a 100% stake in Bharat Serums and Vaccines (BSV) from Advent International. 26 July 2024
An advisory panel of the US Food and Drug Administration has questioned the design of a trial for AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab), while confirming that it met the primary efficacy goal. 26 July 2024
Zymeworks has appointed Leone Patterson as executive vice president, and chief business and financial officer, effective September 1, 2024. 26 July 2024
The European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), from US pharma giant Pfizer 25 July 2024
Mid-size French drugmaker Ipsen and California’s Day One Biopharmaceuticals have announced a global partnership, outside the USA, for tovorafenib. 25 July 2024
The appointment of Dr Sicard comes at a time when the company has selected its lead candidate, DGX-01, a first-in-class recombinant protein that aims to replicate insulin-producing beta cells in t 25 July 2024
Shares of Swiss pharma giant Roche (ROG: SIX) edged up 2.4% in morning trading after the Swiss pharma giant posted a strong set of first-half 2024 financials. 25 July 2024