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Biotechnology
The European Commission (EC) has approved South Korean firm Celltrion Healthcare’s Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorization from the European Medicines Agency. 15 November 2021
Pharmaceutical
An anxiously awaited nomination for the future Commissioner of the US Food and Drug Administration was announced in Friday by US President Joe Biden, who named former head of the regulatory agency, Dr Robert Califf, as his choice for the post. 13 November 2021
Biotechnology
Swiss pharma giant Roche today announced that the European Commission has granted a marketing authorization for Ronapreve (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis). 12 November 2021
Biotechnology
Global instant logistics company Zipline has partnered with Pfizer and BioNTech to successfully complete the first long-range drone delivery of both authorized mRNA COVID-19 vaccines requiring ultra-cold-chain in Ghana. 12 November 2021
Biotechnology
Two new program designations have been agreed as part of an ongoing neuroscience collaboration between Hamburg’s Evotec and New York’s Bristol Myers Squibb, triggering payments of $40 million to the German firm. 10 November 2021
Biotechnology
German biotech BioNTech, which sprung into the limelight with the first launch of a COVID-19 vaccine in partnership with US pharma giant Pfizer, today reported financial results, sending its New York-listed shares up 12%. 9 November 2021
Biotechnology
Biotech incubator Flagship Pioneering has launched a new company in Cambridge, USA, focused on a novel RNA-based technology with potential to treat both rare and common diseases. 9 November 2021
Biotechnology
A new immuno-oncology company has launched in Cambridge, USA. 8 November 2021
Pharmaceutical
Portugal’s largest drugmaker BIAL has announced the appointment of Joerg Holenz as R&D general manager, a role that he will assume alongside as a member of the board of directors. 8 November 2021
Pharmaceutical
Germany’s Bayer has appointed Christoph Koenen as the new global head of clinical development and operations within research and development at its Pharmaceuticals Division, effective January 1, 2022. 5 November 2021
Pharmaceutical
The European Commission has approved, under the EU Merger Regulation, the acquisition of joint control of clinical research organization (CRO) Parexel by Goldman Sachs Group, both of the USA, and EQT Fund Management of Luxembourg. 5 November 2021
Biotechnology
Life sciences investment trust Syncona has committed $30.0 million (£21.7 million) to Cambridge, Massachusetts-based biotech Clade Therapeutics, in a $87 million Series A financing. 3 November 2021
Pharmaceutical
Switzerland’s Lonza today announced it is to acquire and operate Codiak BioSciences' Lexington, MA (US) facility and become the strategic manufacturing partner for Codiak’s pipeline. 2 November 2021
Biotechnology
Japanese drugmaker Daiichi Sankyo has launched Delytact (teserpaturev/G47∆) in its home country to treat a type of brain cancer. 1 November 2021
Biotechnology
The US Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. 30 October 2021
Biotechnology
Shares of USA-based RNA interference (RNAi) specialist Alnylam Pharmaceuticals plunged more than 14% to $168.98 today as the company revealed that its long-time chief executive was leaving the company. 28 October 2021
Biotechnology
The US government has purchased 50 million more doses of Comirnaty, the COVID-19 vaccine developed and marketed by Pfizer and BioNTech. 28 October 2021
Biotechnology
USA-based biotech Geron Corporation says that imetelstat, the company’s first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit. 26 October 2021
Pharmaceutical
The Serum Institute of India (SII), which bagged the go-ahead last month to start Covovax trials on children above seven years old, could export 30 million COVID-19 vaccine doses to WHO-backed COVAX by December. 25 October 2021
Biotechnology
Adding another string to the bow of the mega-blockbuster checkpoint inhibitor, the European Commission (EC) has approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease. 22 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
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