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 segment of public procurement of medicines in Russia is facing a serious crisis due to the ever-growing number of failed tenders, caused by a low interest of suppliers and drugmakers for them, The Pharma Letter’s local correspondent reports. 10 April 2024
Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH). 9 April 2024
Nearly eight years after the UK voted to leave the European Union (EU), the government is still delaying on introducing certain new rules that impact the life sciences industry. 9 April 2024
Asklepios BioPharmaceutical, the wholly-owned but independently operated subsidiary of Bayer, has appointed a new chief scientific officer. 9 April 2024
The biopharmaceutical industry is currently facing pressure from expiring patents, which are expected to result in a $100 billion headwind for the industry over the next five years. 9 April 2024
The Russian drugmaker Geropharm says it plans to launch a generic copy of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide) for the treatment of obesity, reports The Pharma Letter’s local correspondent. 9 April 2024
Seaport Therapeutics has become the latest founded entity to be created by PureTech Health, the Boston-based biotech behind Karuna Therapeutics, which was recently acquired by Bristol Myers Squibb for $14 billion. 9 April 2024
Results from the Phase III clinical trial MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of Abrysvo versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD), were released today by Pfizer. 9 April 2024
Sino Biopharmaceutical revealed it has entered into a strategic partnership with Boehringer Ingelheim to bring the German family-owned company’s innovative cancer therapies to the market in mainland China. 9 April 2024
The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals to register its Parkinson’s disease candidate SPN-830. 9 April 2024
UK health technology assessor the National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending use of remdesivir for treating COVID-19 in eligible adults and children. 9 April 2024
Of the 46 cancer drugs for which the US Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study presented at the American Association for Cancer Research (AACR) 2024 annual meeting. 9 April 2024
The USA-based Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, has released a new analysis of IQVIA data revealing health plans and patients missed out on savings up to $6 billion as a result of rebate schemes by pharmacy benefit managers. 9 April 2024
An FXR agonist developed by Ascletis Pharma has not performed well in mid-stage trials, leading the Hangzhou, China-based firm to dial down its investment in the drug. 8 April 2024
Increasing interest in targeted therapies is driving demand in the antibody discovery market, finds industry analyst Future Market Insights. 8 April 2024
Family-controlled Spanish pharma company Esteve today announced the appointment of Jacob Tolstrup as chief business development officer, part of the executive management and reporting to Staffan Schüberg, chief executive of the company. 8 April 2024
Two frequent words that people often hear in recent China’s pharma industry comments are “Chu Hai” and “Nei Juan”. The former means “selling overseas,” while the latter means “cut throat competition.” 8 April 2024
South Korean drugmaker Samsung Bioepis today released its Second Quarter 2024 Biosimilars Market report, which includes the latest average sales price (ASP) information of all biosimilars and reference products available in the US market. 8 April 2024