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.
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
Roche today released positive top-line results of the Phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. 19 September 2024
US contract development and manufacturing organization (CDMO) BioCentriq has appointed Syed Husain as its new chief executive (CEO), and as a member of the board of directors. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Upstream Bio, a clinical-stage biotechnology company, has filed for an initial public offering, listing on the Nasdaq under the ticker symbol "UPB." 19 September 2024
Denmark-based Bavarian Nordic and Gavi, the Vaccine Alliance yesterday announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN mpox vaccine (marketed as Jynneos or Imvanex) to be supplied to countries in Africa impacted by the mpox outbreak. 19 September 2024
California, USA-based rare disease company Reneo Pharmaceuticals saw its shares fall 12.2% to $1.59 yesterday, when it announced it has entered into a definitive merger agreement with privately-held OnKure to combine the companies in an all-stock transaction. 14 May 2024
French pharma major Sanofi has announced an investment of more than 1 billion euros ($1.08 billion) to create new bioproduction capacity at its sites in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime) and Lyon Gerland (Rhône). 14 May 2024
Diversified German drugmaker Bayer has reported group sales of 13.8 billion euros ($14.9 billion) for the first quarter of 2024, a fall of around 0.6%, meeting expectations. 14 May 2024
At a cool $1 billion, the venture round secured by AI group Xaira ranks as the second-biggest raise in biotech history. In the drug discovery space, this financing is dwarfed only by Altos Lab’s $3 billion, amassed back in 2021. 14 May 2024
German family-owned pharma major Boehringer Ingelheim has entered into an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer's biosimilar to AbbVie’s Humira (adalimumab), in the USA. 14 May 2024
Oncology companies including New York-based giant Pfizer and Japan’s Astellas Pharma have outlined details of data they intend to present at the USA’s leading cancer conference. 13 May 2024
US drugmaker AbbVie has become one of the first big pharma companies to place a major bet on neuroplastogens for the treatment of mental health problems. 13 May 2024
US rare diseases focused biotech Fulcrum Therapeutics has entered into a collaboration and license agreement with French pharma major Sanofi for the development and commercialization of losmapimod. 13 May 2024
USA-based biotech Ajax Therapeutics today announced the completion of an oversubscribed $95 million Series C financing, led by Goldman Sachs with participation from new investors, including Eli Lilly. 13 May 2024
Boston, USA-based genomic medicines company Ensoma has announced the appointment of Jim Burns as chief executive and a member of the board of directors. 13 May 2024
The Phase III study (SCORPIO-HR) with ensitrelvir did not meet its primary endpoint of a statistically-significant reduction in time to sustained resolution of 15 common COVID-19 related symptoms, said Japanese drugmaker Shionogi. 13 May 2024
Spanish dermatology company Almirall impressed investors with its financial results for the first quarter of 2024, which were presented on Monday. 13 May 2024
Immuno-oncology company iTeos Therapeutics has lofty ambitions, claiming to be pioneering the discovery and development of a new generation of highly differentiated therapeutics in the field. 13 May 2024
Indian biotech Biocon today announced the signing of a semi-exclusive distribution and supply agreement with Medix, a specialty pharmaceutical company in Mexico, for the commercialization of its vertically integrated drug product, Liraglutide (gSaxenda), used in the treatment of chronic weight management. 13 May 2024
Despite a lower dose, data from the Phase II stage of the TAMARACK study have raised concerns over the safety profile of MacroGenics’ antibody-drug conjugate (ADC), vobra duo. 13 May 2024