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
USA-based ophthalmic diseases specialist EyePoint Pharmaceuticals saw its shares leap as much as 212% yesterday, after it announced positive top-line results of its Phase II DAVIO 2 trial of EYP-1901. 5 December 2023
Shares of UK-based cancer and women’s health drug developer ValiRx were up 16.6% at 11.51 pence mid-afternoon, following the announcement that its joint venture company ValiSeek has entered a deal to license VAL401 to Ambrose Healthcare 5 December 2023
Johnson & Johnson’s TAR-200 has been granted Breakthrough Therapy designation (BTD) to potentially treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo radical cystectomy. 5 December 2023
French independent pharma major Servier today announced the appointment of Nicolas Garnier as chief patient officer, effective from December 4. 5 December 2023
Japan’s largest drugmaker Takeda has announced the signing of a three-year memorandum of understanding (MoU) with the Biotechnology Industry Research Assistance Council (BIRAC). 5 December 2023
Privately-held Californian company Alto Neuroscience has announced encouraging results from its Phase IIa study of ALTO-300 at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP). 5 December 2023
Industry has renewed its criticism of the UK government after the publication of new terms for the statutory scheme for branded medicines. 5 December 2023
Roche subsidiary Genentech has provided an update on its multiple sclerosis program, revealing a partial trial stoppage for the oral BTK inhibitor fenebrutinib. 5 December 2023
Spanish drugmaker PharmaMar has announced that its licensing partner, Luye Pharma Group, has received marketing approval for Zepzelca (lurbinectedin) in Macao. 5 December 2023
Russian drugmaker Basis-Metigreens together with the India’s Synmedic company plan to launch the production of an analogue of Ingavirin (pentandioici imidazolylaethanamidum), one of the most popular antiviral drugs in Russia, which is produced by the local Valenta Pharm, The Pharma Letter’s local correspondent reports. 5 December 2023
With demand for outsourcing continuing to increase, US financial services firm Morningstar has published a report into the industry landscape, outlining the increasingly central role that the sector plays in drug and biologic development. 5 December 2023
Hungarian drugmaker Gedeon Richter has expanded its partnership with Mithra Therapeutics with a deal to develop and commercialize the first estetrol-based combined oral contraceptive in China. 5 December 2023
In the latest move in the USA for rights to contraceptives and abortion drugs, on Monday, the Reproductive Rights Task Force (RRTF) provided a briefing to Attorney General Merrick Garland and Task Force Chair Associate Attorney General Vanita Gupta on the Department of Justice’s (DoJ) work to protect reproductive freedom under federal law. 5 December 2023
A new collaboration between Washington, USA-based Absci and UK-based AstraZeneca will see the firms working together to discover new cancer treatments. 4 December 2023
Inflammation and immunology (I&I) specialist Zenas BioPharma has named Jennifer Fox as its chief business officer and chief financial officer and Tanya Fischer as head of research and development and chief medical officer. 4 December 2023
Israeli biotech RedHill Biopharma has announced new funding of around $5 million, which will be directed towards evaluation of COVID-19 treatment RHB-107, also known as upamostat. 4 December 2023
The European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 4 December 2023