In Brief
Refine Search
Biotechnology
Yesterday, the US Food and Drug Administration issued a draft guidance for industry titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. 22 October 2021
Pharmaceutical
Horizon Therapeutics has published more data supporting the long-term efficacy of Tepezza (teprotumumab-trbw), for the treatment of thyroid eye disease (TED), in the journal Ophthalmology. 22 October 2021
Pharmaceutical
UK-based psychedelic-assisted therapy company Small Pharma has been granted an Innovation Passport designation from the British medicines regulator for lead candidate SPL026. 21 October 2021
Biotechnology
SpringWorks Therapeutics, a start-up set up by US pharma giant Pfizer to take forward a number of drug programs, today announced that it has entered into an exclusive worldwide license agreement with Dana-Farber Cancer Institute (Dana-Farber) and a sponsored research agreement (SRA) with Stanford Medicine for a portfolio of novel small molecule inhibitors of epidermal growth factor receptor (EGFR) designed for the treatment of EGFR-mutant lung cancers. 20 October 2021
Pharmaceutical
British drugmaker AstraZeneca has successfully defended an important patent for its diabetes med Farxiga (dapagliflozin), in litigation with India’s Zydus Cadila. 18 October 2021
Pharmaceutical
The European Union has exported over 1 billion COVID-19 vaccine doses worldwide, over the past 10 months, marking an important milestone, according to a statement today by President Ursula von der Leyen. 18 October 2021
Pharmaceutical
Chiesi Global Rare Diseases, a business unit of privately-held Italian drugmaker Chiesi Farmaceutici, announced today that Health Canada has approved Ferriprox (deferiprone) for the treatment of iron overload in patients with sickle cell disease (SCD) or other anemias. 15 October 2021
Biotechnology
Pfizer and German partner BioNTech today said they had submitted data supporting the vaccination of children aged five to 15 October 2021
Pharmaceutical
Exelixis and STORM Therapeutics have entered into an exclusive collaboration and license agreement to discover and develop novel ADAR1-targeting candidates. 14 October 2021
Pharmaceutical
US healthcare giant Johnson & Johnson has announced that Paul Stoffels, currently vice chairman of the executive committee and chief scientific officer of the company, will retire effective December 31, 2021. 13 October 2021
Pharmaceutical
In a series A financing, Singapore-based AUM Biosciences has raised $27 million, money which will be used to try to develop drugs for targets considered by some to be undruggable. 12 October 2021
Biotechnology
The Russian Ministry of Health has issued the 12th version of the Temporary guidelines for the prevention, diagnosis and treatment of COVID-19. 11 October 2021
Biotechnology
The European Medicines Agency said today it has started evaluating an application for marketing authorization for the monoclonal antibody combination Ronapreve (casirivimab/imdevimab) submitted by Swiss pharma giant is Roche. 11 October 2021
Biotechnology
The European Commission has approved, under the EU Merger Regulation, the acquisition of sole control of Swedish Orphan Biovitrum (Sobi) of Sweden by Advent International Corporation of the USA. 8 October 2021
Biotechnology
Pfizer and German partner BioNTech have filed with the US Food and Drug Administration emergency use authorization from for their Comirnaty COVID-19 vaccine for children ages 5 to 11. 8 October 2021
Biotechnology
A new non-viral gene therapy company, Intergalactic Therapeutics, has been launched with a $75 million series A financing round from venture capital firm ATP. 7 October 2021
Biotechnology
French drugmaker Sanofi has named Valeria Fantin its new global head of oncology research. 6 October 2021
Biotechnology
Privately-held US biotech Lumen Bioscience today announced new development funding from the US Army for its COVID-19 monoclonal antibody drug cocktail. 6 October 2021
Biotechnology
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a conditional Marketing Authorization (CMA) for Tepmetko (tepotinib) for advanced non-small cell lung cancer (NSCLC) patients with mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. 5 October 2021
Pharmaceutical
German drugmaker Bayer today announced an investment of 400 million euros ($465 million) in manufacturing facilities. 5 October 2021
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
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
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
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
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze