AstraZeneca’s Tagrisso (osimertinib) was the first drug to be approved for adjuvant treatment after complete tumor resection in adults with stage IB to IIIA non-small cell lung cancer (NSCLC). 4 October 2021
Enthera Pharmaceuticals, a privately-held autoimmune disease specialist based in Milan, has appointed Antonio Speziale as chief medical officer. 4 October 2021
UK cell-based therapeutics developer ReNeuron Group edged up 1.6% as it provided an update this morning on the company's Phase IIa clinical evaluations for the treatment of retinitis pigmentosa (RP), an inherited, degenerative eye disease. 1 October 2021
Merck & Co has entered into a settlement and license agreement with fellow US pharma giant Pfizer, resolving all worldwide patent infringement litigation related to the use of Merck’s investigational and licensed pneumococcal conjugate vaccine (PCV) products, including Vaxneuvance (pneumococcal 15-valent conjugate vaccine). 27 September 2021
In Greece, the government’s newly-appointed health secretary, Thanos Plevris, has met with the country’s leading trade group for the pharmaceutical industry. 27 September 2021
As widely expected following the recommendation last week of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the US Food and Drug Administration yesterday formerly amended the emergency use authorization (EUA) for Comirnaty, the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: 23 September 2021
US ophthalmic drugmaker Aerie Pharmaceuticals today announced that it is executing its succession plan for its chairman and chief executive and that effective September 17, 2021, Vicente Anido no longer serves in these positions, or as a director of the company. 21 September 2021
US pharma giant Pfizer is voluntarily recalling all lots of Chantix 0.5mg and 1mg tablets (varenicline), a medication used to help people stop smoking. 21 September 2021
Paris, France-based Jeito Capital, a rapidly growing, new, independent private equity firm dedicated to biotech and biopharma, today announced the final closing of its first fund, Jeito I, at 534 million euros ($630 million), exceeding its original target of 500 million euros. 20 September 2021
German active pharmaceutical ingredient (API) maker PharmaZell and France-based Novasep, a contract development and manufacturing organization (CDMO) have entered into exclusive negotiations to create a leading European platform in the attractive API manufacturing and CDMO space with a complementary set of differentiated technologies and highly diversified base of blue-chip pharma and biotech customers. 16 September 2021
US biotech Amylyx Pharmaceuticals is to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate/taurursodiol) for the treatment of amyotrophic lateral sclerosis (ALS) within months. 15 September 2021
Privately-held US biotech Skyhawk Therapeutics today announced that Fidelity Management & Research Company has led a $133 million oversubscribed investment round in Skyhawk, along with other major investors. 14 September 2021
Otsuka group company Taiho Pharmaceutical has submitted for Japanese approval for TAS-116 (pimitespib), as a treatment for people with gastrointestinal stromal tumor (GIST). 14 September 2021
USA-based RNA interference (RNAi) specialist Alnylam Pharmaceuticals has formally submitted for European approval to market vutrisiran for certain people with hereditary transthyretin-mediated (hATTR) amyloidosis. 13 September 2021
A biosimilar epilepsy treatment, CannEpil+, has been approved for import into the UK. The therapy will be made available for free on compassionate grounds to ten patients for six months, as part of the clinical trial process. 13 September 2021
Beijing-based BeiGene has announced the US regulator has accepted its submission to market the checkpoint blocker tislelizumab for certain people with esophageal squamous cell carcinoma (ESCC). 13 September 2021
Spanish drugmaker PharmaMar says that the World Health Organization (WHO) has confirmed the International Nonproprietary Name (INN) of its investigational anti-tumor compound PM14 as ecubectedin. 13 September 2021
The European Medicines Agency’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. 10 September 2021
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