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Biotechnology
California, USA-based 3T Biosciences (3T), an immunotherapy company changing the future of treatment for solid tumors and other immune-mediated diseases, today announced its launch from stealth backed by $40 million Series A financing led by Westlake Village BioPartners with participation from Lightspeed Venture Partners. 25 August 2022
Biotechnology
US biotech Tessera Therapeutics, which is backed by Flagship Pioneering, has appointed Anne-Virginie “AV” Eggimann, as chief regulatory officer responsible for leading US and global regulatory science and program and portfolio management for the company’s GENE WRITING development programs. 24 August 2022
Biotechnology
Japanese drugmaker Daiichi Sankyo today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive. 23 August 2022
Pharmaceutical
Relief Therapeutics and NRx Pharmaceuticals have agreed to a tentative settlement of their pending litigation. 22 August 2022
Biotechnology
AstraZeneca India has received a Drugs Controller General of India (DCGI) approval to market Lynparza (olaparib) as a monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2-negative high-risk early breast cancer. 19 August 2022
Biotechnology
Polish drugmaker Ryvu Therapeutics plans to raise an additional $66.5 million through equity fundraising and partnering as part of its future development plan, covering the period up to 2024. 19 August 2022
Generics
The US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware’s decision that US drugmaker Eagle Pharmaceuticals’ vasopressin product does not infringe on any of the patents asserted by Par Pharmaceutical, a subsidiary of Endo International. 19 August 2022
Pharmaceutical
Rentschler, a leading global contract development and manufacturing organization for biopharmaceuticals, has announced the appointment of Mark Caswell as vice president, site head. 18 August 2022
Pharmaceutical
The UK's National Institute for Health and Care Excellence (NICE) has recommended CSL Vifor's Tavneos (avacopan), in combination with a rituximab or cyclophosphamide regimen, for the treatment of adults with the two main forms of ANCA-associated vasculitis. 18 August 2022
Biotechnology
US messenger RNA therapeutics and vaccines company Moderna says that James Mock has been appointed as its new chief financial officer (CFO). 17 August 2022
Pharmaceutical
The Swiss biopharmaceutical company Relief Therapeutics has announced the appointment of David McCullough as senior director and the newly created position head of US market access. 17 August 2022
Pharmaceutical
Anglo-American firm Aspire Pharma has in-licensed Retinolx (vitamin A) from Orphanix, an Austrian biopharma focussed on the development of novel therapeutic orphan drugs across a range of pediatric therapy areas. 16 August 2022
Biotechnology
California-based Nuvig Therapeutics, a private biotech company developing novel therapeutics to restore immune homeostasis and treat chronic autoimmune diseases, has announced the appointment of Joanne Quan as chief medical officer (CMO). 16 August 2022
Biotechnology
Rubraca (rucaparib camsylate) should no longer be used as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA-mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. 15 August 2022
Pharmaceutical
The US House of Representatives passed President Joe Biden’s sweeping $370 billion Inflation Reduction Act on Friday.
The vote was along party lines, with 220 Democrats for the legislation and 207 Republicans opposed. 13 August 2022
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The UK’s Medicine and Health products Regulatory Agency (MHRA) has issued a Conditional Marketing Authorization (CMA) for Paxlovid (nirmatrelvir and ritonavir tablets) in Great Britain and a temporary Regulation 174 authorization for Northern Ireland to ensure supply across all of the UK. 12 August 2022
Biotechnology
The Alliance for Regenerative Medicine (ARM), the international advocacy group representing the cell and gene therapy sector, has appointed Timothy Hunt as it's next chief executive. 11 August 2022
Pharmaceutical
Northern Ireland's Almac Group has announces a $65 million, 100,000 ft2 expansion of its clinical supply operations at the company’s North American headquarters in Pennsylvania, USA. 11 August 2022
Biotechnology
Karolinska Development has announced that the board of directors of portfolio company Umecrine Cognition has recruited Anders Karlsson to be its new chief executive. 11 August 2022
Biotechnology
Ferring Pharmaceuticals has announced that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (FDA) will hold a meeting to review data supporting the biologics license application (BLA) for RBX2660, the company's microbiota-based live biotherapeutic. 10 August 2022
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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The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
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