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 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
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
A new formulation of Xgeva (denosumab) is the first product to be authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) via the regulator’s new International Recognition Procedure (IRP). 1 March 2024
San Diego-based BlossomHill Therapeutics, a company focused on the design and development of small molecules for cancer and autoimmune diseases, has announced the closing of a $100 million Series B financing round. 1 March 2024
More positive data for Abrysvo (respiratory syncytial virus vaccine) will support Pfizer’s position in an important new market for products targeting RSV infections. 1 March 2024
Privately-held Danish dermatology specialist LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and earnings before interest, tax, depreciation and amortization for 2023. 1 March 2024
In December 2023, the US Food and Drug Administration (FDA) released a 25-page draft guidance on Potency Assurance for Cellular and Genetic Therapy Products.1 1 March 2024
Russia is experiencing, shortage of a unique drug against repeated heart attacks - Effient (prasugrel) from the American pharma major Eli Lilly representative of the Russian Ministry of Health told the business newspaper Vedomosti, the Pharma Letter’s local correspondent reports. 1 March 2024
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
British pharma major AstraZeneca has chosen Shanghai as the location for what will become its fifth global strategic center for research and development. 29 February 2024
US gastroenterology specialist Ironwood Pharmaceuticals saw its shares plunge more than 30% to $10.50 in pre-market activity today, after it announced what it called ‘positive’ top-line results from its pivotal Phase III STARS trial. 29 February 2024
Avidity Biosciences has announced an oversubscribed $400 million private placement, with the news sending the US RNA-focussed biotech firm’s shares up 21.8% to $18.58 by mid-morning. 29 February 2024
San Diego, USA-based Kenai Therapeutics, a biotech leveraging induced pluripotent stem cell (iPSC) tech to discover and develop a platform of allogeneic neuron replacement cell therapies for neurological disorders, has raised $82 million in a Series A financing. 29 February 2024
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
Denmark-based life sciences investor Novo Holdings today announced it had launched Orbis Medicines, a leader in macrocycle drug discovery, to advance the development of next-generation oral macrocycle drugs. 29 February 2024
Swiss generics and biosimilars drugmaker Sandoz today announced that its US subsidiaries – Sandoz Inc and Fougera Pharmaceuticals - have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. 29 February 2024
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
The tides are shifting. As multinational entities such as Novartis, AstraZeneca and Sanofi recalibrate their strategies in India, spurred by intensified local competition and patent expiries, domestic pharma players like Cipla, Torrent Pharma, Eris Lifesciences, and JB Chemicals are asserting their prominence. 29 February 2024
Shares in New Jersey, USA-based Palatin Technologies fell over a third on Wednesday, after a key Phase III trial missed its efficacy goals. 29 February 2024
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions. 29 February 2024