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.
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
The atopic dermatitis (AD) market is on track to reach $16.7 billion across mature markets by 2030, according to data and analytics company GlobalData. 19 September 2024
TG Therapeutics yesterday shared new five-year data from the ULTIMATE I & II Phase III trials evaluating Briumvi (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). 19 September 2024
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
Indian biotech major Biocon has signed an exclusive licensing and supply agreement with South Korea’s Handok, for the commercialization of its vertically integrated, complex drug product, synthetic liraglutide. 24 May 2024
US pharma major Eli Lilly today revealed that it has more than doubled its investment in its Lebanon, Indiana, manufacturing site with a new $5.3 billion commitment, increasing the company's total investment in this site from $3.7 billion to $9 billion. 24 May 2024
Oncology-focused biotech company Tango Therapeutics is to discontinue development of its TNG348 program due toxicity observed in the initial study cohorts. 24 May 2024
Californian company Cytokinetics closed Thursday’s trading down 17% after announcing a couple of updates that will add $1 billion to its cash pile. 24 May 2024
Sweden-based metabolic disorders company Atrogi, has announced a publication in the Journal of Molecular Metabolism of a research paper that validates the mechanism of action of the company’s first-in-class, small molecule, ATR-127, in combating obesity and metabolic complications. 24 May 2024
The European Commission (EC) has approved the label update of both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolaemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. 24 May 2024
On Thursday, the US Food and Drug Administration’s (FDA0 Center for Drug Evaluation and Research published its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Report. 24 May 2024
The European Commission has presented European Union (EU) guidance on public procurement of medicines which is critical to improve the security of supply for patients and health systems. 24 May 2024
SynaptixBio, a UK biotech that claims to be the world’s only company developing a therapy for TUBB4A-related leukodystrophies, has appointed Uwe Meya as chief medical officer (CMO). 23 May 2024
Privately-held Chinese developer of molecular glue degraders for cancer treatment Degron Therapeutics has entered into a collaboration and exclusive license agreement with Japan’s largest drugmaker Takeda Pharma. 23 May 2024
Basel, Switzerland-based SixPeaks Bio emerged from stealth mode yesterday, with a pipeline of therapies for healthy weight loss, including a potentially best-in-class dual-specific antibody targeting activin type IIA and B receptors. 23 May 2024
MilliporeSigma, the US and Canada Life Science business of Germany’s Merck KGaA, has signed a definitive agreement to acquire USA-based Mirus Bio, a specialist in the development and commercialization of transfection reagents. 23 May 2024
The US National Institutes of Health (NIH) has issued a first-of-its-kind draft policy proposal to promote equal access to products stemming from NIH-owned inventions. 23 May 2024
hares of French immunotherapy company OSE Immunotherapeutics were up almost 15% at 8.33 euros mid-morning on news of an expand partnership with German family-owned pharma major Boehringer Ingelheim. 23 May 2024
Roche’s Japan-based majority-owned company Chugai has launched PiaSky for injection 340 mg (crovalimab), a pH-dependent binding humanized anti-complement (C5) monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), in the Asian country. 23 May 2024