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
Ono Pharmaceuticalannounced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib. 19 July 2024
Boston, USA-based AVEO Oncology, a subsidiary of LG Chem (KRX: 051910), has announced that the TiNivo-2 Phase III trial did not meet its primary efficacy endpoint. 19 July 2024
The US Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10 mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD). 18 July 2024
German family-owned pharma major Boehringer Ingelheim today reported significant progress in its pipeline across key therapeutic areas as it reached major milestones in the first half of the year. 18 July 2024
Swedish firm Enzymatica (STO: ENZY) will conduct a rights issue to raise approximately $12 million, with existing shareholders being given preferential rights. 18 July 2024
Privately-held German drugmaker Boehringer Ingelheim has inked a deal with GoodRx (Nasdaq: GDRX), in a bid to boost US penetration of its biosimilar to Humira (adalimumab). 18 July 2024
60% of listed Indian pharmaceutical companies have experienced an uptick in new business inquiries from US pharma companies due to the discussions around the US Biosecure Act. 18 July 2024
A new research paper concluding that the use of Inpefa (sotagliflozin) for the treatment of patients hospitalized for heart failure (HF) and suffering from co- morbid diabetes leads to significant positive impact on provider health system financial outcomes. 18 July 2024
Boehringer Ingelheim has entered partnership with AI company Brainomix for a collaborative program of activity to improve the care of patients with fibrosing lung disease in the USA. 18 July 2024
The show is over for Aslan Pharmaceuticals, the immunology-focused biopharmaceutical company, as its financial troubles have led it to file for voluntary liquidation. 18 July 2024
French pharma major Sanofi announced that full results from the XTEND-Kids Phase III study have been published in The New England Journal of Medicine (NEJM). 18 July 2024
Swiss pharma giant Novartis (NOVN: VX) has reported an impressive second quarter, with net sales increasing by 11% and core operating income rising by 19% to reach $5 billion. 18 July 2024
Russian drugmaker Promomed is aiming to accelerate expansion in both domestic and foreign markets in the coming years, reports The Pharma Letter’s local correspondent. 18 July 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday announced it has approved two new medicines for use in Great Britain. 18 July 2024
Basel, Switzerland-based Roche has announced promising new, four-year data from the RHONE-X extension study, the largest long-term study on diabetic macular edema (DME). 18 July 2024