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 European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
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
Despite the current Bruton tyrosine kinase (BTK) inhibitor market being valued at around $6 billion, sales specifically for chronic lymphocytic leukemia (CLL) are predicted to be nearly $5 billion by 2032 in the seven major markets (USA, France, Germany, Italy, Spain, UK, and Japan). 19 January 2024
Sun Pharmaceutical Industries of India announced its intention to acquire all outstanding shares of US generics drugmaker Taro Pharmaceutical Industries at a price of $43 per share in cash, the companies announced. 19 January 2024
USA–based heart disease specialist Windtree Therapeutics has entered into a license agreement with Lee's Pharmaceutical, related to its candidate istaroxime. 18 January 2024
The Cell and Gene Therapy Catapult (CGT Catapult), a government-funded body encouraging the development of the advanced therapy sector, has published a report into trial activity in the UK. 18 January 2024
US clinical stage developer Immunitas Therapeutics today announced the appointment of Annalisa D’Andrea as its chief scientific officer (CSO). 18 January 2024
California, USA-based biotech BridgeBio Pharma (Nasdaq: BBIO) today announced strategic financing from Blue Owl Capital and Canada Pension Plan Investment Board (CPP Investments), bringing in capital of up to $1.25 billion. 18 January 2024
The Medicines Control Authority of Zimbabwe (MCAZ) has signed a Memorandum of Understanding (MoU) with the South African Health Products Regulatory Authority (SAHPRA). 18 January 2024
Following recent approvals in Europe and the USA, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now also granted marketing authorization for Zilbrysq (zilucoplan). 18 January 2024
Stimulants, amphetamines and methylphenidates are the first-line treatment for moderate to severe attention-deficit/hyperactivity disorder (ADHD) across the seven major markets (7MM), notes GlobalData in a forecast on the future of the field. 18 January 2024
While 2023 saw the approval of many notable new drugs by the US Food and Drug Administration (FDA), the past year also featured many holds being imposed on clinical trials. 18 January 2024
Dutch immunology specialist argenx has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyvdura (efgartigimod alfa and hyaluronidase-qvfc; also marketed under the Vyvgart brand name) injection subcutaneous (SC). 18 January 2024
Boston, USA-based Ratio Therapeutics has completed a $50 million series B financing, bringing the total raised by the company so far to over $90 million. 18 January 2024
Japanese drugmaker Daiichi Sankyo yesterday announced that the US Patent and Trademark Office (US PTO) rendered a Final Written Decision invalidating all claims of Seagen’s US patent 10,808,039 (the ’039 patent) that were challenged by Daiichi Sankyo in a post-grant review proceeding (PGR). 18 January 2024
German pharma and crop sciences major Bayer is introducing a new operating model called “Dynamic Shared Ownership” (DSO) worldwide, which will reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes. 18 January 2024
Two new initial public offerings (IPO) are set to go ahead in the USA, raising hopes of a thaw in what has been a long winter for biotech companies going public. 17 January 2024
Washington University in Missouri, USA, has joined forces with the life sciences investment company Deerfield Management to launch a new R&D venture. 17 January 2024
Global spending and demand for medicines will increase over the next five years to approximately $2.3 trillion by 2028 as more patients get access to new and better medicines, according to a new report from the IQVIA Institute for Human Data Science titled, “The Global Use of Medicines 2024 – Outlook through 2028.” 17 January 2024
Belgian clinical-stage biotech PDC*line Pharma today announced the selection of the PDC*neo+ project for funding by the Walloon region and BioWin, the health cluster for Wallonia. 17 January 2024
With the aim of boosting is leadership team, clinical-stage biotech Zura Bio today announced the appointments of Robert Lisicki as president and chief operating officer, and Kiran Nistala as executive vice president development and chief medical officer, to the executive leadership team. 17 January 2024