9 October 2024 US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company.
Geneva-based cell-line company Selexis and NexImmune, a T cell specialist, has signed a service agreement to develop cell lines targeting rare cancers and autoimmune diseases. 9 September 2022
SpringWorks Therapeutics shares were up 8% to $27.97 after the US biotech announced that it has entered into an expanded global, non-exclusive license and collaboration agreement with UK pharma major GSK. 9 September 2022
A less cumbersome dosing schedule for Eylea (aflibercept) has been shown safe and effective in late-stage trials, boosting its developers' chances of defending market share. 9 September 2022
German drugmaker STADA Arzneimittel is broadening its offering to patients, pharmacists and physicians in Europe by introducing abiraterone acetate 500mg film-coated tablets in 21 European countries. 9 September 2022
Spanish dermatology company Almirall has provided some detail on the results from a Phase III atopic dermatitis (AD) trial of lebrikizumab. 8 September 2022
Privately-held Danish dermatology specialist LEO Pharma has presented new safety data on Adtralza (tralokinumab) at the European Academy of Dermatology and Venereology (EADV) Congress. 8 September 2022
French vaccines developer Valneva and USA-based VBI Vaccines today announced a partnership in select European markets for the marketing and distribution of PreHevbri [hepatitis B vaccine (recombinant, adsorbed)], the only 3-antigen hepatitis B vaccine approved in Europe. 8 September 2022
US biotech Vertex Pharmaceuticals today announced that Jonathan Biller has been appointed chief legal officer, effective September 19, 2022. 8 September 2022
Shares of Amylyx Pharmaceuticals rocketed up 74% in pre-market trading today on positive news from a regulatory advisory committee on its amyotrophic lateral sclerosis (ALS) drug candidate, having suffered earlier following the release of downbeat briefing papers from the US Food and Drug Administration’s (FDA) last Friday. 8 September 2022
Indian drugmaker Dr Reddy’s Laboratories has launched a generic version of Bristol Myers Squibb’s cancer drug Revlimid (lenalidomide). 8 September 2022
Positive Phase III results have been presented on eplontersen, a ligand-conjugated antisense therapy from US RNA-targeted drug developer Ionis Pharmaceuticals and Anglo-Swedish pharma major AstraZeneca. 8 September 2022
LifeArc revealed that its portfolio company Ducentis BioTherapeutics, a pre-clinical-stage UK biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases, has been acquired by Arcutis Biotherapeutics. 8 September 2022
Industry analyst GlobalData has presented context on recently-approved inhalable coronavirus vaccines, indicating that the method of administration could be key to combating the spread of infections. 8 September 2022
Nodus Oncology has announced the completion of an asset purchase agreement (APA) for Basilea Pharmaceutica's novel poly (ADP-ribose) glycohydrolase (PARG) inhibitor discovery program. 8 September 2022
India's drug regulator has stepped up efforts to stop the sale of unapproved antibiotic cocktail combinations over the counter. The regulator has warned that certain fixed-dose combinations (FDCs) will be banned unless scientific trials are conducted to verify their regularisation before they can be distributed, reports The Pharma Letter’s India correspondent. 8 September 2022
It is no secret that last year was a generally a positive one for the world’s largest biopharmaceutical companies, particularly those with COVID-19 vaccines. 7 September 2022
Health authorities in Europe have urged countries to use newly-authorized adapted COVID-19 vaccines as part of autumn and winter vaccination campaigns. 7 September 2022
Privately-held Seattle, USA-based drug developer Good Therapeutics says it has entered into a definitive agreement to be acquired by Swiss pharma giant Roche. 7 September 2022
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024