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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
Just-Evotec Biologics and Alpine Immune Sciences have announced a multi-year partnership for the development of ALPN-303, an engineered TACI domain for the treatment of systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases. 10 August 2022
Pharmaceutical
Danish CNS specialist Lundbeck has announced that its financial guidance range for 2022 has been raised. 9 August 2022
Pharmaceutical
US healthcare giant Johnson & Johnson said yesterday that Dr Mathai Mammen has decided to leave his position as executive vice president, Pharmaceuticals, R&D, and pursue other opportunities outside of the company. 9 August 2022
Pharmaceutical
The Wall Street Journal (link) reported that Pfizer could be in advanced talks to acquire Global Blood Therapeutics (GBT) for about $5 billion. 6 August 2022
Pharmaceutical
Germany’s Bayer announced on Friday that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). 6 August 2022
Pharmaceutical
AstraZeneca’s new tablet formulation of Calquence has been approved by the US Food and Drug Administration (FDA) for all current indications. 5 August 2022
Pharmaceutical
Takeda UK and Ireland has announced Seyda Atadan Memis as its new general manager. 4 August 2022
Biotechnology
JCR Pharma's Hunter syndrome treatment pabinafusp alfa (JR141) failed to get the manufacturing and marketing approval in Brazil, according to a statement. 4 August 2022
Biotechnology
Austrian drug discovery company Quantro Therapeutics has announced that it has entered a three-year collaboration, option and license agreement with German pharma major Boehringer Ingelheim for the identification and development of inhibitors for up to three cancer-associated transcription factors. 3 August 2022
Pharmaceutical
USA-based Marius Pharmaceuticals has announced the approval of Kyzatrex (testosterone undecanoate), an oral testosterone replacement therapy, by the US Food and Drug Administration. 3 August 2022
Biotechnology
A Seventh Circuit panel on Monday refused to revive landmark private antitrust claims from Humira (adalimumab) buyers accusing pharmaceutical firm AbbVie of using a "patent thicket" to illegally shield the blockbuster immunosuppressant from competition, ruling that there's nothing wrong with AbbVie's high volume of patents, LAW360 reported. 2 August 2022
Biotechnology
Gracell Biotechnologies, a clinical-stage biopharmaceutical company, has announced the appointment of Wendy Li , as its chief medical officer (CMO). 1 August 2022
Biotechnology
GreenLight Biosciences has announced a collaboration with the National Institutes of Health (NIH) to develop COVID-19 vaccines that are more broadly protective against new variants and with longer-lasting effects. 1 August 2022
Biotechnology
Nicox, a French ophthalmology company, has appointed Jean-Francois Labbé as chairman. 29 July 2022
Biotechnology
Vicinitas Therapeutics, a biotechnology company advancing a proprietary targeted protein stabilization platform to develop novel therapeutics in cancer and genetic disorders, has announced its launch and a $65 million Series A financing. 29 July 2022
Biotechnology
GSK has announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of children aged five to 17 with active lupus nephritis (LN) who are receiving standard therapy. 28 July 2022
Biotechnology
LFB, a French biopharma that develops, manufactures and markets plasma-derived products and recombinant proteins, has announced that its Cevenfacta (eptacog beta) has been granted marketing authorization in Europe. 26 July 2022
Pharmaceutical
Avadel CNS Pharmaceuticals, a subsidiary of Avadel Pharmaceuticals, has filed an Administrative Procedure Act suit against the US Food and Drug Administration (FDA), the US Department of Health and Human Services, the Secretary of Health and Human Services and the Commissioner of Food and Drugs in the US District Court for the District of Columbia related to the New Drug Application (NDA) for Lumryz (sodium oxybate; formerly known as FT218), the company revealed in a filing with the Securities and Exchange Commission. 26 July 2022
Pharmaceutical
Veru has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) regards the currently available safety and efficacy data as sufficient to support an expedited review of the marketing authorization application for using sabizabulin in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) when the application is submitted. 25 July 2022
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
article
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
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