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
A large US study, reported in Nature Medicine, has found no evidence that taking drugs that include diabetes and weight-loss medication semaglutide is tied to an increase in suicidal thoughts. 6 January 2024
Paris, France-based cardiology specialist Corteria Pharmaceuticals has announced the appointment of Dr Mark Pruzanski, as chairman of its board of directors. 6 January 2024
Mersana Therapeutics today announced business updates, its expected milestones and its upcoming presentation at the 42nd Annual JP Morgan Healthcare Conference. 5 January 2024
Swiss pharma giant Roche has entered into a third licensing deal this week alone, signing an agreement with Cambridge, USA-based biotech MOMA Therapeutics. 5 January 2024
China and USA-based Allorion Therapeutics has announced a second licensing deal within a few days, this time entering an exclusive agreement with US clinical-state biotech Avenzo Therapeutics. 5 January 2024
US pharma major AbbVie and Umoja Biopharma have entered into two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVec platform. 5 January 2024
French rare disease company Innate Pharma has received good news from the US Food and Drug Administration, with a partial clinical hold being lifted from its lacutamab program. 5 January 2024
Dutch clinical-stage biotech NewAmsterdam Pharma yesterday provided an update on its clinical development programs and outlined its strategic priorities for 2024. 5 January 2024
Californian rare disease company Ultragenyx Pharmaceutical has received a positive reimbursement decision from the UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE). 5 January 2024
Swiss pharma giant Novartis announced today that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of Pluvicto at new plant. 5 January 2024
Boston, USA-based biotech start-up Kojin Therapeutics has announced the appointment of Harvey Berger as its new chairman, president and chief executive (CEO). 5 January 2024
In what was a hectic news day for the German pharm major, Boehringer Ingelheim announced it has entered into a new strategic collaboration and licensing agreement with California, USA-based 3T Biosciences. 4 January 2024
By Barbara Obstoj-Cardwell. Editor
In full year 2023, the total number of mergers and acquisitions (M&A) in the pharma and biotech sectors was 105, compared with 109 in 2022 and just 92 in 2021, according to tracking by The Pharma Letter (TPL). 4 January 2024
Further extending its reach beyond it core diabetes business, Denmark’s Novo Nordisk today revealed it has entered into separate research collaborations, one with Omega Therapeutics and the other with Cellarity, in the area of cardiometabolic diseases. 4 January 2024
Agios Pharmaceuticals’ shares rose 5.2% to $24.02 by close of trading yesterday on the news of positive trial results for its mitapivat. 4 January 2024
China’s Suzhou Ribo Life Science and its Ribocure unit have entered into collaboration with German family-owned pharma major Boehringer Ingelheim to develop novel treatments for non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). 4 January 2024