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
The Russian government will launch a project aimed at creating generic copies of patented original drugs, according to recent statements made by the deputy head of the Ministry of Industry and Trade, Ekaterina Priezzheva. 4 April 2024
Oruka Therapeutics, a US biotech focused on developing biologics designed to set a new standard for the treatment of chronic skin diseases, including plaque psoriasis, has entered into a merger agreement with ARCA biopharma. 3 April 2024
Russian patients with diabetes have been faced with serious difficulties in obtaining ultra-fast insulin aspart Fiasp from Denmark’s Novo Nordisk, reports The Pharma Letter’s local correspondent 3 April 2024
The landscape of biosimilars has rapidly evolved over the past decade, with the US Food and Drug Administration (FDA) spearheading efforts to enhance their approval and utilization. 3 April 2024
Having already signed up licensing deals in the ever-growing interest in the antibody-conjugates (ADCs) arena, Danish biotech Genmab is now going further with an outright company acquisition. 3 April 2024
Shares in Gritstone bio, a US biotech that claims to be developing the world’s most potent vaccines, closed Tuesday’s trading nearly 49% lower. 3 April 2024
French drugmaker Ipsen and US drug developer Sutro Biopharma have entered into an exclusive global licensing agreement for the antibody-drug conjugate (ADC) STRO-003. 3 April 2024
A major public-private research initiative in the UK, Our Future Health, has added a new partner from industry, Swiss pharma giant Novartis. 3 April 2024
Adding to recent setbacks in the development of Leqembi (lecanemab), US firm Biogen (Nasdaq: BIIB) has revealed a filing for a subcutaneous formulation will be delayed. 3 April 2024
Shares of US neurological drug specialist Acorda Therapeutics fell more than 81% to $2.50 by close on Monday after the company said it had filed for bankruptcy protection. 3 April 2024
A start-up focused on neurology, Neurosterix, has launched with a $63 million series A financing led by Perceptive Xontogeny Venture Fund II. 3 April 2024
The US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) has released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. 3 April 2024
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” 3 April 2024