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
Cambridge, Massachusetts-based Pinetree Therapeutics has entered into an exclusive option and global license agreement with Cambridge, UK-based AstraZeneca . 25 July 2024
“Circle of Goodness,” one of Russia’s largest public funds, specializing on procurements of drugs for children with rare diseases, will begin procurements of the US drug Vyjuvek (beremagen heperpavec), which is designed for patients with epidermolysis bullosa (butterfly syndrome), reports The Pharma Letter’s local correspondent. 25 July 2024
Californian drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) has announced that the US Food and Drug Administration has approved a label expansion for Brineura (cerliponase alfa). 25 July 2024
AstraZeneca (LSE: AZN) announced robust financial results for the second quarter of 2024, with a 13% increase in total revenue to $12.94 billion, driven by a strong performance across its key therapeutic areas. 25 July 2024
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
The Indian government has announced a full exemption from customs duties on three cancer medications: trastuzumab deruxtecan, osimertinib and durvalumab. 24 July 2024
Positive top-line results from the Phase III AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A, were released today by US pharma giant Pfizer. 24 July 2024
Sage Therapeutics’ shares plunged nearly 22% to $10.25 in pre-market activity, as it announced disappointing top-line results from the Phase II KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET). 24 July 2024
A report has been presented by the House Committee on Oversight and Accountability entitled The Role of Pharmacy Benefit Managers (PBMs) in Prescription Drug Markets. 24 July 2024
US pharma giant Merck & Co has released positive top-line results from its Phase IIb/III clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), 24 July 2024
The US medicines regulator has issued a warning letter to Indian contract development and manufacturing organization (CDMO) Brassica Pharma for severe data integrity violations at its manufacturing facility in Thane. 24 July 2024
Former executives at Johnson & Johnson (NYSE: JNJ) have teamed up to launch a new biotech company, Third Arc Bio, with significant backing from investors. 24 July 2024