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
Australian radiopharma developer Telix Pharmaceuticals Limited has launched an offering of A$600 million ($405 million) of convertible notes due 2029. 24 July 2024
The US Food and Drug Administration (FDA) announced it has approved Millicent’s Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. 24 July 2024
Brenig Therapeutics, a neurology-focused drug development company using an AI-based discovery platform, has closed a $65 million series A financing. 24 July 2024
Tuesday was not a good day for shareholders in US biopharma Cellectar Biosciences—a US biopharma focused on the discovery, development and commercialization of drugs for the treatment of cancer. 23 July 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved a new indication for Wegovy (semaglutide) to reduce the risk of overweight and obese adults suffering serious heart problems or strokes. 23 July 2024
Cambridge, USA-based biotech incubator Flagship Pioneering today unveiled Abiologics, a company reimagining biologics with the creation of a new class of supranatural and programmable medicines, called Synteins. 23 July 2024
Swiss pharma giant Roche and US biotech Regeneron are on the cusp of transforming the vascular endothelial growth factor A (VEGF-A) therapy market with their revolutionary treatments, Vabysmo (faricimab), and Eylea HD (aflibercept). 23 July 2024
UK-based Touchlight, a CDMO advancing enzymatic DNA production to enable the genetic medicine revolution, has announced a license agreement with London-based pharma major GSK (LSE: GSK). 23 July 2024
HIV specialist ViiV Healthcare, which is majority owned by UK pharma major GSK, today announced 48-week findings from PASO DOBLE (GeSIDA 11720 study). 23 July 2024
Latigo Biotherapeutics, a privately-held US biotech focused on developing non-opioid pain medicines, has appointed Nima Farzan as chief executive. 23 July 2024
Beijing, China-based Gan & Lee Pharmaceuticals announced that its independently developed long-acting GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved positive results in a clinical trial for adults with obesity/overweight in China. 23 July 2024
In San Francisco, RAPT Therapeutics (Nasdaq: RAPT) has announced a substantial workforce reduction as part of its cash conservation strategy. 23 July 2024
SIGA Technologies (Nasdaq: SIGA) has announced a significant procurement option exercised by the US health authorities, an order for $113 million worth of oral Tpoxx (tecovirimat). 23 July 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
California-based liver and viral disease specialist Aligos Therapeutics (Nasdaq: ALGS) has announced a clinical trial collaboration with Amoytop Biotech. 23 July 2024
Agilent Technologies has signed a definitive agreement to acquire Biovectra, a leading specialized contract development and manufacturing organization (CDMO), for $925 million. 23 July 2024
Chugai today announced it will transfer to Maruishi Pharmaceuticals the business in Japan concerning the physiological intestinal function improving and hyperammonemia drug Monilac 22 July 2024
The Organization of Pharmaceutical Producers of India (OPPI) has urged the government to exempt patented and orphan drugs from price control. 22 July 2024