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Biotechnology
The European Commission (EC) has approved US pharma giant Pfizer’s Xeljanz (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). 21 August 2021
Pharmaceutical
Bristol Myers Squibb stalwart Scott Cooke has been named the company’s general manager for the UK and Ireland, replacing Lynelle Hoch who has been promoted into a new role at the group’s corporate headquarters in the USA. 18 August 2021
Biotechnology
Just eight months after launching with a $50 million Series A, Cambridge, USA-based Vigil Neuroscience has announced a $90 million Series B financing led by Vida Ventures to further advance its pipeline of microglia targeted medicines for the treatment neurodegenerative diseases. 18 August 2021
Biotechnology
An extension to the current UK approval of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) from US mRNA-based biotech Moderna, that allows its use in 12- to 17-year-olds has today been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). 18 August 2021
Pharmaceutical
Following a public consultation, the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) is making Nuromol, which ontains 200mg of ibuprofen and 500mg of paracetamol per tablet, available as a General Sales medicine, meaning it can be bought without the need to visit a pharmacy. 17 August 2021
Biotechnology
UK biotech Freeline Therapeutics, which is developing transformative AAV-mediated gene therapies for patients suffering from inherited systemic debilitating diseases, today announced the appointment of Michael Parini as chief executive and executive director of the company. 16 August 2021
Pharmaceutical
The Brazilian research institute Fiocruz has announced the signing of an agreement with the regional government and State University of Ceará for the development and production of the HH-120-Defenser vaccine against COVID-19. 16 August 2021
Generics
US trade group the Association for Accessible Medicines has appointed Joe Russo as senior director, federal government affairs, in order to help develop the association’s strategy and implement the initiatives of AAM’s government affairs department. 13 August 2021
Generics
Heraeus Pharmaceutical Ingredients’ additional production line for platinum-based highly potent active pharmaceutical ingredients (Pt hAPIs) is now fully operational at the company’s headquarters in Hanau, Germany. 10 August 2021
article
Ono Pharmaceutical has entered into a drug discovery collaboration agreement with MiraBiologics. 10 August 2021
Biotechnology
The UK’s Medicines and Health Regulatory Agency (MHRA) has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable malignant pleural mesothelioma. 6 August 2021
Generics
Germany’s Bayer entered a strategic partnership with the Chinese major online pharmacy 111. 5 August 2021
Biotechnology
Korean company GC Pharma and Japan’s Tottori University have announced a worldwide licensing and collaboration agreement for the orally administrable chaperone drug of GM1 gangliosidosis (GM1). 2 August 2021
Biotechnology
Pfizer has raised the price of Comirnaty, its COVID-19 vaccine, by more than a quarter and Moderna by more than a tenth in the latest EU supply contracts, the Financial Times reported today. 2 August 2021
Biotechnology
The US Food and Drug Administration has updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV (casirivimab and imdevimab). 31 July 2021
Generics
The US Food and Drug Administration (FDA) has published a revision to its Manual of Policies and Procedures (MAPP), Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic (FD&C) Act. 27 July 2021
Pharmaceutical
Bayer today announced Prof Dr Dominik Ruettinger as the new head of research and early development for oncology at its Pharmaceuticals Division, effective October 1, 2021. 26 July 2021
Biotechnology
AgeX Therapeutics closed 7.3% higher at $1.50 on Friday, after the US biotech said that its previously-announced merger with privately-held peer LyGenesis has been called off. 24 July 2021
Biotechnology
Novo Holdings has co-led a $55 million series A financing round funding Hemab, a company focused on next generation therapeutics for serious bleeding and thrombosis disorders. 22 July 2021
Pharmaceutical
Johnson & Johnson has confirmed the finalization of a settlement agreement to resolve opioid-related claims and litigation in the USA. 22 July 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
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