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Pharmaceutical
UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024
Biotechnology
Germany’s Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024
Biotechnology
Colorado, USA-based OncoVerity announced the closing of a series A extension led by existing investors, argenX and RefinedScience. The value was not disclosed, but this extension follows a $30 million Series A fundraiser in March 2023. 22 November 2024
Biotechnology
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi (lecanemab) for the 2024 fiscal year (FY), which runs from April 2024 through March 2025. 11 November 2024
Biotechnology
Danish biotech Gubra announces that Germany’s Boehringer Ingelheim has decided to discontinue the development of the long-acting neuropeptide Y receptor type 2 (NPY2R) agonist BI 1820237 in obesity. 4 November 2024
Biotechnology
Japanese drugmaker Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (US brand name Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. 1 November 2024
Pharmaceutical
GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024
Pharmaceutical
Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
Pharmaceutical
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Pharmaceutical
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Pharmaceutical
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
Pharmaceutical
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
Biotechnology
Sirnaomics, a firm specializing in RNAi therapeutics, has entered into a subscription agreement with biotech specialist Poon Hung Fai. 4 October 2024
Biotechnology
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Biotechnology
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Pharmaceutical
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
article
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair. 19 September 2024
Pharmaceutical
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Biotechnology
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
Pharmaceutical
Shares of Denmark’s Lundbeck were up more than 9% this morning, after the CNS specialist released its 2022 financial results, showing that growth of its strategic brands accelerated further with an increase of 31% (+20% in local currencies) in 2022, reaching 12.1 billion kroner ($1.76 billion), and representing 67% of overall revenue. 7 February 2023
Biotechnology
US pharma major Bristol Myers Squibb has pulled put of a license and collaboration deal with privately-held USA-based biotech Dragonfly Therapeutics. 7 February 2023
Biosimilars
The American business of South Korea's Celltrion Healthcare has appointed Thomas Nusbickel as chief commercial officer. 7 February 2023
Biotechnology
When Johnson & Johnson’s Janssen unit acquired nipocalimab in its $6.5 billion buy of Momenta Pharmaceuticals in 2020, the opportunity in myasthenia gravis appeared most compelling.
But the importance of another indication is becoming clear after Janssen’s presentation of positive Phase II results from the UNITY trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). 7 February 2023
Biotechnology
Roche’s (ROG: SIX) ambition to muscle in on the paroxysmal nocturnal hemoglobinuria (PNH) sector has received another boost, as the Swiss pharma giant today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with PNH who have not been previously treated with complement inhibitors. 7 February 2023
Pharmaceutical
Pharma lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) says it welcomes the opportunity to provide feedback on the European Commission proposal for a revised European Medicines Agency (EMA) Fees regulation. 7 February 2023
Biotechnology
US pairing Biogen and Sage Therapeutics have announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). 6 February 2023
Biotechnology
Genetic medicines company 4D Molecular Therapeutics has announced that its Fabry disease gene therapy program has been placed on clinical hold by the US Food and Drug Administration (FDA). 6 February 2023
Biotechnology
US pharma giant Merck & Co has announced the results of its Phase III NRG-GY018 trial evaluating Keytruda (pembrolizumab) alongside standard-of-care chemotherapy (carboplatin and paclitaxel). 6 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 6 February 2023
Biosimilars
Privately-held Advanz Pharma has announced that it has entered into an exclusive agreement with Alvotech, an Icelandic biosimilars company, for the exclusive license and supply rights for a proposed copy of Xolair (omalizumab). 6 February 2023
Biotechnology
A steady rise in the number of agents approved to treat inflammatory bowel diseases (IBD) has provided physicians with an increasing number of options to treat Crohn’s disease (CD). 6 February 2023
Pharmaceutical
Japanese drug major Astellas Pharma says it has been working on its Corporate Strategic Plan 2018 and Corporate Strategic Plan 2021 (CSP2021) since fiscal year 2018, when Kenji Yasukawa was appointed as president and chief executive, to realize its VISION “On the forefront of healthcare change to turn innovative science into VALUE for patients. 6 February 2023
Pharmaceutical
Shares of US drug developer Context Therapeutics were up more than 7% at $0.97 pre-market, after it announced that two patients enrolled in the Phase II OATH trial of ONA-XR plus anastrozole in advanced endometrial cancer) have achieved partial response (tumor shrinkage) to the treatment. 6 February 2023
Biosimilars
Sandoz, the generics and biosimilars business unit of Swiss pharma giant Novartis that is soon to be spun out, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. 6 February 2023
Pharmaceutical
Swiss pharma company Idorsia was trading 10% lower at lunchtime on Monday. 6 February 2023
Biotechnology
In order to spur research and innovation in the pharmaceutical industry, the Narendra Modi government in India is developing a new policy that will cater to a range of therapies - from gene therapy to precision medicine. 6 February 2023
Pharmaceutical
Hyderabad, India-based vaccine manufacturer Indian Immunologicals Limited (IIL) is all ready to launch vaccines for hepatitis A (Hep A) and for measles and rubella (MR) in 2023. 6 February 2023
Pharmaceutical
Pinder Sahota, who is the UK country manager of Danish diabetes care giant Novo Nordisk (NOV: N), has made the decision to resign as president of the trade body Association of British Pharmaceutical Industries (ABPI). 6 February 2023
Pharmaceutical
The European Medicines Agency (EMA), along with the Heads of Medicines Agencies (HMA) and the European Commission (EC) announced on Friday that they are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). 6 February 2023
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