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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
The Medicines for Malaria Venture (MMV) and Shin Poong Pharm have welcomed the formal inclusion of Pyramax (pyronaridine-artesunate), developed by the South Korean company, in the World Health Organization’s (WHO) Guidelines for Malaria following an extensive review process. 25 November 2022
Biotechnology
Privately-held Italian drugmaker Chiesi announced that its new center of excellence for the development and production of biologic drugs, currently under construction, will be built in Parma in the area of the production plant where the company is headquartered. 24 November 2022
Pharmaceutical
Privately-held German drugmaker Grünenthal and Japanese speciality pharma company Kyowa Kirin have announced an agreement. 24 November 2022
Pharmaceutical
The European Organization for Research and Treatment of Cancer (EORTC) has entered into a collaboration aimed at bringing treatment and research in the oncology sector to patients in the Middle East. 24 November 2022
Pharmaceutical
Johnson & Johnson’s subsidiary Janssen has presented further findings on its approved depression drug Spravato (esketamine). 24 November 2022
Biotechnology
In another boost for AbbVie (NYSE: ABBV), the European Commission (EC) has granted a third approval of Skyrizi (risankizumab, 600mg intravenous [IV] induction and 360mg subcutaneous [SC] for maintenance therapy). 24 November 2022
Biotechnology
California, USA-based BioMarin Pharmaceutical saw its shares leap 10.7% to $98.49 yesterday, after it announced that the US Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of Roctavian (valoctocogene roxaparvovec AAV gene therapy) for adults with severe hemophilia A would not, after all, be submitted for review by the agency’s advisory panel. 24 November 2022
Pharmaceutical
New UK Health Security Agency (HAS) evidence indicates that a single MVA-BN vaccine dose provides around 78% protection against monkeypox 14 days after being vaccinated. 23 November 2022
Generics
STADA Arzneimittel has replaced the departing Carsten Cron with Stéphane Jacqmin as head of emerging markets at the German firm. 23 November 2022
Pharmaceutical
Japanese drugmaker Shionogi (TYO: 4507) said yesterday that its Xocova (ensitrelvir fumaric acid, Code No.: S-217622), a novel anti-SARS-CoV-2 drug for COVID-19 obtained emergency regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the indication of SARS-CoV-2 infection. 23 November 2022
Biotechnology
US biotech Arvinas closed 16% lower after Monday’s trading. 23 November 2022
Biotechnology
In a landmark regulatory first, Dutch gene therapy company uniQure (Nasdaq: QURE) has secured US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb). 23 November 2022
Biotechnology
A new dengue vaccine, first approved in Indonesia, is to be evaluated by the US Food and Drug Administration under its Priority Review scheme. 23 November 2022
Pharmaceutical
As US federal funding for COVID-19 vaccines and treatments dwindles and cases decline, the Biden administration is planning to stop paying for these products and transition to a more standard purchasing process through different health care system channels, including commercial insurers and pharmacy benefit managers (PBMs) next year. 23 November 2022
Biotechnology
Belgium’s largest drugmaker UCB said yesterday it has resubmitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. 23 November 2022
Generics
Leading Indian and Chinese drugmakers are considering accelerating their expansion into the Russian market – in a move to fill vacant niches that appeared after the reduction of presence of Western pharmaceutical companies in recent months following the invasion of Ukraine. 23 November 2022
Biotechnology
UK pharma major GSK has started the process of withdrawing the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf). 22 November 2022
Biotechnology
The US Food and Drug Administration (FDA) today revealed it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). 22 November 2022
Pharmaceutical
Novo Nordisk has announced plans to spend 5.4 billion Danish kroner ($750 million) on the expansion of existing facilities and the addition of a new plant in Bagsværd, Denmark. 22 November 2022
Pharmaceutical
Representatives of the Russian patient community have warned about the shortage of the antiretroviral drug Eviplera (rilpivirine/tenofovir/emtricitabine), the most popular and most expensive combination drug for the treatment of HIV on the domestic market, reports The Pharma Letter’s local correspondent. 22 November 2022
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