Glenmark Pharmaceuticals has launched a novel diabetes med in India, a fixed-dose combination of the widely-used DPP4 inhibitor teneligliptin, together with pioglitazone. 25 April 2022
Health Canada has granted Marketing Authorization for the expanded use of Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages six through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 21 April 2022
US biotech Dragonfly Therapeutics has announced an expansion of its research collaboration with AbbVie to discover and develop Dragonfly's novel immunotherapies for new targets in autoimmune and fibrotic diseases. 21 April 2022
Regeneron Pharmaceuticals revealed on Friday that the US Food and Drug Administration has extended by three months its review of the Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. 15 April 2022
Nagoya, Japan-based RaQualia Pharma has received approval of its new drug application (NDA) in China for its acid-related gastrointestinal disease treatment tegoprazan, a potassium competitive acid blocker (P-CAB). 14 April 2022
Mitsubishi Tanabe Pharma Corporation and The Research Foundation for Microbial Diseases of Osaka University have announced the submission of an application for marketing authorization in Japan. 13 April 2022
Switzerland-based Myovant Sciences and US pharma giant Pfizer have announced an update on the Supplemental New Drug Application (sNDA) for Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) for the management of moderate to severe pain associated with endometriosis. 13 April 2022
Privately-owned pharma company Galen has acquired the rights to Provocholine 100mg Powder for nebuliser solution (methacholine chloride) - manufactured by Methapharm Specialty Pharmaceuticals of Canada - to exclusively distribute and commercialize in the UK. 12 April 2022
Swedish immunology company InDex Pharmaceuticals today announced that after more than seven years as chief executive, Peter Zerhouni has decided to leave his position. 11 April 2022
In a Stock Exchange filing on April 8 by the US biotech, Kaleido Biosciences said that its board of directors had voted to immediately wind-down and cease all of the company’s ongoing operations, sending the firm’s shares down 75% to $0.36. 8 April 2022
The European Commission (EC) has expanded the marketing authorization for French pharma major Sanofi’s Dupixent (dupilumab) in the European Union. 7 April 2022
US biotech major Gilead Sciences has announced the formal opening of an office focused on developing new pediatric formulations for its portfolio of medicines in Dublin, Ireland. 6 April 2022
The European Medicines Agency has announced that general, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorization holders are increasing by 0.3% and 5.3% as of April 1, 2022, to reflect the inflation rate adjustments of 2020 and 2021, respectively. 5 April 2022
Vifor Pharma has announced full results from its Phase-IIIb DIAMOND trial showing that Veltassa (patiromer) allowed patients to achieve long-term potassium control, reduced the risk of recurrent hyperkalemia and prolonged optimized and guideline recommended renin-angiotensin aldosterone system inhibitor (RAASi) therapy. 4 April 2022
A New Jersey federal judge has tossed a qui tam lawsuit accusing Bayer Corp. and Johnson & Johnson of defrauding federal insurance programs through antibiotic labeling shortfalls, ruling that the complaints need more specifics in order to advance, according to Law360. 4 April 2022
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
US biotech Paragon Therapeutics yesterday revealed that biotech industry veteran Susanna High has been appointed as chief executive (CEO). In this newly-created role, Ms High will lead the team’s continued efforts to propel the development of a pipeline of transformative therapies and accelerate their potential impact. 22 November 2024
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 2024
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
California-based venture capital firm Versant Ventures yesterday announced the launch of Pep2Tango Therapeutics, a start-up focused on innovative, next-generation weight loss therapies. Proceeds from the significant, undisclosed round will support development of the company’s novel unimolecular tetra-receptor agonist peptides to treat obesity and related conditions. 22 November 2024
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024