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
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
MAIA Biotechnology, a US biopharmaceutical company developing targeted immunotherapies for cancer, has announced a positive update on its lead clinical candidate. 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Takeda announced that the European Commission (EC) has approved Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP). 8 August 2024
The US Food and Drug Administration (FDA) has granted accelerated approval for Novartis’ Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. 8 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
CytoReason’s $80 million venture round may not have been the biggest in July, but it is one of a growing number of investor bets on AI powered drug discovery this year. 7 August 2024
Finland-based Faron Pharmaceuticals, a biopharma reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has announced that its chief executive Markku Jalkanen is to retire. 7 August 2024
Denmark US oncology-based Pharmacosmos today revealed it has entered a definitive agreement to acquire US cancer-focused company G1 Therapeutics. 7 August 2024
Shares of US therapeutic gene editing company Sangamo Therapeutics leapt as much as 46% to $1.11 yesterday on the news of a licensing deal. 7 August 2024
Danish pharma major Novo Nordisk was trading nearly 4% lower on Wednesday afternoon after earlier presenting its latest quarterly financial results and guidance for the rest of 2024. 7 August 2024
The US Food and Drug Administration approved French privately-held drug major Servier’s vorasidenib, now trade named Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for certain types of brain tumors. 7 August 2024
Tuesday was a good day for Levicept, a UK biotech focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis and other pain indications. 7 August 2024
US biotech major Amgen reported second quarter 2024 financial results late yesterday, showing total revenues increased 20% to $8.4 billion in comparison to the like quarter of 2023. 7 August 2024
US clinical-stage biotech Equillium saw its shares rise 8% to $0.68 as it revealed progress with its first-in-class anti-CD6 monoclonal antibody. 6 August 2024
Life sciences venture capital company Apple Tree Partners (ATP) has unveiled Red Queen Therapeutics, a biotech developing antivirals for the general population and especially for immunocompromised patients at increased risk of serious illness or death from common and emerging viral pathogens. 6 August 2024
Daiichi Sankyo (and US pharma giant Merck & Co have expanded their existing global co-development and co-commercialization agreement to include Merck’s MK-6070. 6 August 2024
The US subsidiary of Swiss family-owned protein specialist Octapharma today revealed that the US Food and Drug Administration (FDA) has expanded the approval of fibryga, fibrinogen (human) lyophilized powder for reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). 6 August 2024