10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Austrian immuno-oncology firm Apeiron Biologics today announced that it has received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19. 2 April 2020
The US Food and Drug Administration on Wednesday approved Sevenfact (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). 2 April 2020
Gilead Sciences company Kite has entered into a license and collaboration agreement with Teneobio, gaining exclusive rights to certain anti-BCMA antibodies under development. 2 April 2020
A new strategic partnership aimed at scaling up COVID-19 antigen production has been formed between UK-based Native Antigen Company (NAC) and Oxford Genetics (OXGENE). 2 April 2020
Since the first reports of coronavirus (COVID-19) in Wuhan, China in December 2019 there have been more than 823,000 confirmed cases and over 45,000 deaths in 206 countries worldwide. 1 April 2020
Japanese companies Eisai and Seikagaku Corporation have entered into an agreement for the co-development and marketing alliance in China for SI-613 (diclofenac conjugated sodium hyaluronate). 1 April 2020
Japan’s Daiichi Sankyo has entered into a strategic partnership for the non-exclusive use of Ultragenyx Pharmaceutical’s proprietary adeno associated virus (AAV) based gene therapy manufacturing technology. 1 April 2020
Japan’s SanBio and Ocumension (Hong Kong) Ltd have entered into a business alliance for the research, development and commercialization of innovative stem cell therapies for ophthalmic diseases. 1 April 2020
Chicago, USA-based ophthalmic specialist Horizon Therapeutics has revealed positive data from a new pooled analysis of Tepezza (teprotumumab-trbw). 1 April 2020
US biotech Regenxbio announced a new exclusive, worldwide license agreement with Ultragenyx Pharmaceutical, extending the companies’ existing gene therapy partnership announced in October 2018. 1 April 2020
The US Food and Drug Administration has dropped an investigation into Novartis company AveXis, related to the novel spinal muscular atrophy (SMA) Zolgensma (onasemnogene abeparvovec-xioi). 1 April 2020
The share price of Californian biotech company Akero Therapeutics was 22% higher by lunchtime on Tuesday after its presentation of data from a NASH study. 31 March 2020
UK-based biopharmaceutical company Sitryx, focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation, has signed an exclusive global licensing and research collaboration with US pharma major Eli Lilly. 31 March 2020
A New Drug Application (NDA) has been submitted to Japan’s Ministry of Health, Labor and Welfare for the CAR-T therapy axicabtagene ciloleucel to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and related lymphomas. 31 March 2020
It is predominantly in the USA, Europe and parts of Asia, where advanced new treatments such as cell and gene therapies are being developed, offering hope for better outcomes for patients with diseases like cancer. 31 March 2020
China-based WuXi Biologics, a contract development and manufacturing organization (CDMO), will focus on overseas development as well as efficiency improvement in 2020, said the firm’s chief executive Chris Chen at a press meeting in Shanghai on Friday, reports The Pharma Letter’s correspondent Wang Fangqing. 31 March 2020
Bristol-Myers Squibb and bluebird bio have submitted for US approval for idecabtagene vicleucel, a CAR-T cell immunotherapy, in multiple myeloma. 31 March 2020
USA-based CNS specialist biotech Axsome Therapeutics fell almost 15% after it revealed that its depression drug candidate AXS-05 had failed to achieve its primary endpoint in a Phase III study. 31 March 2020
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024