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
Yesterday, the US Food and Drug Administration (FDA) published the following guidances for Abbreviated New Drug Applications (ANDAs) for the generic medicines industry: 25 January 2024
Healthcare giant Johnson & Johnson has reportedly reached a tentative settlement to resolve probes by US states into whether it misled consumers about the safety of its talc products. 24 January 2024
The Serum Institute of India (SII), which claims to be the world’s largest vaccine manufacturer, is joining a growing Coalition for Epidemic Preparedness Innovation (CEPI) network of vaccine producers in the Global South to support more rapid, agile, and equitable responses to future public health disease outbreaks. 24 January 2024
Unnatural Products (UNP), a biotech company pairing AI with chemistry to enable the next generation of molecularly targeted therapeutics, has announced a collaboration with US pharma giant Merck & Co. 24 January 2024
Japanese drugmaker Otsuka Pharmaceutical revealed it has obtained approval in Japan for an additional indication for Rexulti (brexpiprazole) for the treatment of depression/depressive state. 24 January 2024
A new manufacturing plant will be built in Japan, at a cost of over $40 million, by Chinese contract development and manufacturing organization (CDMO) Jiuzhou Pharmaceutical. 24 January 2024
Scientists advising the US medicines regulator will convene to discuss a submission to move Carvykti (ciltacabtagene autoleucel) into an earlier line of treatment. 24 January 2024
Akouos, which Eli Lilly acquired in 2022, has released positive initial clinical results from the Phase I/II AK-OTOF-101 study, testing a gene therapy for the restoration of hearing loss. 24 January 2024
AI specialist BenevolentAI today announced the appointment of Dr Joerg Moeller as chief executive and executive board member with immediate effect. 24 January 2024
The US Court of Appeals for the Second Circuit yesterday affirmed a district court ruling which ordered “pharma bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry. 24 January 2024
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector. 24 January 2024
Accent Therapeutics, a US biopharma seeking to develop a new class of small molecule precision cancer therapies, has announced the completion of a $75 million Series C financing. 23 January 2024
As a market leader in obesity therapy and the largest European company by market cap, Danish diabetes care gain Novo Nordisk has entered into another accord to further solidify its dominance. 23 January 2024
Privately-held Boston, USA-based biotech Vivtex Corporation has entered a research collaboration with Japanese drug major Astellas Pharma. 23 January 2024
Shares of US radiopharmaceuticals-focussed Lantheus Holdings (Nasdaq: LNTH) were down 5.4% at $51.88 by late morning today, as it announced the appointment of Brian Markison, current board chairman and industry veteran, to the position of chief executive (CEO), effective as of March 1, 2024. 23 January 2024
German pharma major Bayer’s independently operated company BlueRock Therapeutics today revealed it has exercised its option to exclusively license OpCT-001 under a 2021 deal with FUJIFILM Cellular Dynamics and Opsis Therapeutics. 23 January 2024