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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
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
US RNAi therapeutics company Alnylam Pharmaceuticals took a hefty 10% hit in the stock market on Thursday. 16 February 2024
Biotechnology
The US Food and Drug Administration yesterday revealed it has granted traditional approval for Tepmetko (tepotinib,) from EMD Serono, a US subsidiary of Germany’s Merck KGaA. 16 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib). 16 February 2024
Biotechnology
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. 16 February 2024
Generics
The Indian Commerce Ministry confirmed has rejected of Switzerland's demand for data exclusivity for medicines in the India-EFTA trade deal, and emphasised the importance of protecting the country’s generic drug production and supply. 16 February 2024
Generics
Leading Russian patient associations have called on the state to expand the list of vital drugs and increase their procurements this year, reports The Pharma Letter’s local correspondent. 16 February 2024
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has issued a Final Draft Guidance (FDG) recommending GSK’s Omjjara (momelotinib) for myelofibrosis-related splenomegaly or symptoms in adults with moderate to severe anaemia who have not had a JAK-inhibitor or had Jakafi (ruxolitinib). 15 February 2024
Biotechnology
Positive Phase II clinical trial demonstrated frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS). 15 February 2024
Generics
Russia plans to consider issuing a compulsory license for dolutegravir, one of Russia’s most demanded anti-HIV drugs, reports The Pharma Letter’s local correspondent. 15 February 2024
Biotechnology
US biopharma Citius Pharmaceuticals has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 15 February 2024
Generics
The USA’s Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) yesterday jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups - group purchasing organizations (GPOs) and drug wholesalers - may be contributing to generic drug shortages. 15 February 2024
Biotechnology
US biotech Cogent Biosciences saw its shares close up a massive 59.3% at $8.70 yesterday, after it announced a securities purchase agreement for a private investment in public equity financing 15 February 2024
Biotechnology
Tesaro, a subsidiary of UK pharma major GSK, has come up on top in the latest stage of its legal battle with Anglo-Swedish drugmaker AstraZeneca regarding the ovarian cancer drug Zejula (niraparib). 15 February 2024
Pharmaceutical
San Diego, USA-based precision oncology company Erasca announced two clinical trial collaboration and supply agreements (CTCSAs) with Swiss pharma giant Novartis for the MEK inhibitor Mekinist (trametinib). 15 February 2024
Pharmaceutical
US biopharma Merrimack Pharmaceuticals has revealed plans to dissolve and hand out cash to shareholders from a newly-announced milestone payment that the company is to receive. 15 February 2024
Pharmaceutical
Cathal Friel, co-founder, substantial shareholder, and currently non-executive chairman of London-listed Poolbeg Pharma, is assuming the role of executive chairman at the company effective immediately. 15 February 2024
Biosimilars
India has achieved a notable milestone in the field of cancer treatment with its indigenously developed CAR-T cell therapy, resulting in the first patient being declared cancer-free post treatment. 15 February 2024
Biotechnology
Japan’s Ono Pharmaceutical yesterday revealed that it has entered into an option and collaboration agreement with Swiss biotech Numab Therapeutics. 15 February 2024
Pharmaceutical
Today, the US Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. 14 February 2024
Biotechnology
French pharma major Sanofi is angry that its interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab) has been recommended for the treatment of moderate-to-severe prurigo nodularis (PN) in Scotland but not in England and Wales. 14 February 2024
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