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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
Biotechnology
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Pharmaceutical
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Pharmaceutical
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
Biosimilars
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Pharmaceutical
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
Biotechnology
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
Biotechnology
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
Biotechnology
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
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Biotechnology
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
Biotechnology
Japanese drugmaker Ono Pharmaceutical has entered into a license agreement with South Korea’s LigaChem Biosciences. 10 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Biotechnology
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
Biotechnology
Biogen revealed that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy designation. 9 October 2024
Biotechnology
German pharma major Bayer has announced the opening of its new life science incubator, Bayer Co.Lab Shanghai. 9 October 2024
Biotechnology
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
Pharmaceutical
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 9 October 2024
Biotechnology
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
Pharmaceutical
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
Pharmaceutical
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
Biotechnology
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Pharmaceutical
Some two-and-a-half years after buying the Novo Holdings portfolio company ReViral and its respiratory syncytial virus (RSV) candidate sisunatovir in a deal worth up to $525 million, US pharma giant Pfizer may have signalled an early end to the pricey project. 9 October 2024
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