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
US radiopharmaceuticals company Lantheus Holdings has appointed Dr Jeffrey Humphrey as chief medical officer (CMO) and Dr Jean-Claude Provost as chief science officer (CSO), effective May 28, 2024. 16 May 2024
Israeli generics giant Teva Pharmaceutical Industries has appointed Matthew Shields as executive vice president of Teva Global Operations (TGO), the company’s manufacturing and supply division, effective June 3, 2024. 15 May 2024
Shares in Merck KGaA rose by around 5% in Wednesday’s trading after the Germany-based company presented its first quarter financial results and latest forecast for 2024. 15 May 2024
May 15, 2024
Texas, USA-based drugmaker Lexicon Pharmaceuticals saw its shares edge up 2.7% to by close of trading yesterday and a further 2% to $1.96 pre-market as its announced new research results on its heart failure drug. 15 May 2024
Sands Capital, an active, long-term investor in leading innovative businesses globally, today announced the close of its third life sciences fund, Sands Capital Life Sciences Pulse Fund III (Pulse II”), raising $555 million. 15 May 2024
A US Food and Drug Administration (FDA) panel will consider Lykos Therapeutics’ filing for midomafetamine capsules (MDMA) as a therapy-assisted treatment for post-traumatic stress disorder (PTSD) in early June. 15 May 2024
Japanese drugmaker Eisai has started the rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Leqembi (lecanemab-irmb) subcutaneous (SC) autoinjector for weekly maintenance dosing. 15 May 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for Heplisav-B vaccine, said US immunotherapy specialist Dynavax Technologies. 15 May 2024
More leading oncology companies have outlined their planned highlights for the upcoming annual meeting of the American Society of Clinical Oncology (ASCO). 15 May 2024
Four-year data from the SELECT trial will significantly bolster Novo Nordisk’s bid to become the GLP-1 company of choice for payers and prescribers. 15 May 2024
Danish CNS specialist Lundbeck today reported first-quarter 2024 financials, showing that revenues grew 7% at constant exchange rates (CER) and 5% in kroner terms to 5,288 million kroner ($766 million). 15 May 2024
Norwich Pharmaceuticals has submitted to the US regulator for approval to market a generic version of Xifaxan (rifaximin), a treatment for irritable bowel syndrome. 15 May 2024
Russia has faced with the shortage of oncology drug Uromitexan (mercapto ethane sulphonacid; mesna), for which last deliveries to the country were in the spring of 2023, reports The Pharma Letter’s local correspondent. 15 May 2024
Mergers and acquisitions (M&As) in biopharma have rebounded with a $76.9 billion increase in total deal value seen from 2022 to 2023, according to GlobalData. 14 May 2024
Precision oncology platform company Tavros Therapeutics has achieved two milestone payments in its collaboration with the Bayer subsidiary Vividion Therapeutics. 14 May 2024
The Russian Ministry of Health has registered domestic generic of Spinraza (nusinersen), an expensive drug used for the treatment of all types of spinal muscular atrophy (SMA) in children and adults, reports The Pharma Letter’s local correspondent. 14 May 2024
With the annual meeting of the American Society of Clinical Oncology (ASCO) now only weeks away, more drugmakers and research groups are lifting the lid on data they intend to present at the event. 14 May 2024
Chinese biopharma company Everest Medicines announced that Nefecon, a delayed release capsule of budesonide, has been successfully launched in China with the first prescription issued. 14 May 2024
A new study by diabetes awareness website Diabetes Strong reveals that “How to get Ozempic” is the most googled question about the medication. 14 May 2024