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.
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
Danish drugmaker Novo Nordisk—a frontrunner in the obesity space with the GLP-1 receptor agonist Wegovy (semaglutide)—is now making swift progress in the field with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
Aligos Therapeutics (Nasdaq: ALGS) has announced positive top-line results from the Phase IIa HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. 20 September 2024
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
Sanofi has announced encouraging results from its Phase III HERCULES trial of tolebrutinib in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS). 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
Achilles Therapeutics has announced it will discontinue its tumor-infiltrating lymphocyte (TIL)-based clonal neoantigen T cell (cNeT) program and shut down its Phase I/IIa CHIRON and THETIS trials. 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
US companies Incyte and Syndax Pharmaceuticals today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), 19 September 2024
California, USA-based chimeric antigen receptor (CAR) T-cell therapies developer ImmPACT Bio has appointed Han Lee as president and chief financial officer (CFO). 1 November 2023
Danish biotech company Evaxion has announced initial results from a Phase II trial of the first five metastatic melanoma patients treated with EVX-01, a peptide-based personalized cancer vaccine. 31 October 2023
UK pharma major GSK and Arrowhead Pharmaceuticals today announced an agreement for GSK to obtain an exclusive license for JNJ-3989 (formerly ARO-HBV) for treatment of chronic hepatitis B. 31 October 2023
US pharma giant Pfizer was trading more than 1% lower during Tuesday morning’s trading in New York, following the release of financial results. 31 October 2023
US biotech Beam Therapeutics today announced that Eli Lilly has agreed to acquire certain rights under Beam’s amended collaboration and license agreement with Verve Therapeutics. 31 October 2023
UK drugmaker GSK has announced positive headline results from a planned analysis of part one of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial. 31 October 2023
In line with a provisional report issued in September, Boston, USA-based pricing watchdog the Institute for Clinical and Economic Review (ICER) has confirmed guidance on the cost-effectiveness of a new gene therapy. 31 October 2023
Shares Japanese drugmaker Sosei Heptares rose 4% to 1,390 yen today, after it announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the approval of daridorexant (ACT-541468). 31 October 2023
Gilead Sciences Kite unit has agreed a collaboration and research deal with Epicrispr Biotechnologies (Epic Bio), using the latter’s proprietary gene regulation platform to develop next-generation cancer cell therapies. 31 October 2023
Indian pharmaceutical companies are demonstrating a growing commitment to advancing cancer treatment through substantial investments in biologics. 31 October 2023
US biotech Sarepta Therapeutics unveiled mixed results late Monday for its gene therapy Elevidys (delandistrogene moxeparvovec-rokl) in patients with Duchenne muscular dystrophy between the ages of four through seven years. The stock was halted in late trading. 31 October 2023
Russian pharmaceutical manufacturers have increased the number of clinical trials that are conducted in the domestic market as part of their efforts of import substitution, The Pharma Letter’s local correspondent reports. 31 October 2023
The Coalition for Epidemic Preparedness Innovations (CEPI) is collaborating with US mRNA specialist Moderna, that will harness Moderna's platform to accelerate the development of vaccines against viral disease outbreaks that threaten global health. 30 October 2023
Indian drugmaker Intas Pharmaceuticals has inked an exclusive deal with Shanghai Henlius Biotech for the development and commercialization of serplulimab in Europe and India. 30 October 2023
Swiss pharma giant Novartis has announced positive top-line results from the interim analysis of the ongoing pivotal Phase III ALIGN study of atrasentan, an oral endothelin A receptor antagonist (ERA), in patients with IgA nephropathy (IgAN). 30 October 2023
The Food and Drug Administration (FDA) has approved Loqtorzi (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). 30 October 2023