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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Rybrevant (amivantamab-vmjw), from Janssen Biotech, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). 2 March 2024
Pharmaceutical
Cambridge, USA-based clinical-stage cancer drug developer FogPharma on Friday announced the successful closing of a $145 million Series E financing round. 2 March 2024
Biotechnology
OncoNano Medicine, a biotech company that develops pH-activated compounds that digitalize and exploit the variability of pH in disease, has named Kartik Krishnan its new chief executive and member of the board of directors. 1 March 2024
Pharmaceutical
Kinnate Biopharma saw its shares gain 6% to $2.21 by mid-morning on news of an assets sale. 1 March 2024
Pharmaceutical
A new report has provided an overview of the state of healthcare in Latin America and its nations, reports The Pharma Letter's local correspondent. 1 March 2024
Biotechnology
China-headquartered oncology specialist BeiGene has announced a new matching adjusted indirect comparison (MAIC) of the efficacy of Brukinsa (zanubrutinib) versus acalabrutinib in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) based on data from the Phase III ALPINE and Phase III ASCEND trials. 1 March 2024
Biotechnology
There is a ray of hope for sickle cell disease (SCD) patients in the UK, after the British health technology assessor re-opened its review into Oxbryta (voxelotor). 1 March 2024
Biotechnology
New regulatory guidance will be of interest for the increasing number of drugmakers investing ever more R&D capital into antibody-drug conjugates (ADC). 1 March 2024
Pharmaceutical
Matching January's explosive start to 2024 in pharmaceutical M&A was always going to be difficult during February, and by deal volume, the month fell short of its predecessor. 1 March 2024
Biotechnology
At a meeting with the investment community yesterday, US pharma giant Pfizer laid out its new oncology strategy following the $43 billion acquisition of antibody-drug conjugate specialist Seagen. 1 March 2024
Biotechnology
Biocon Biologics has signed a settlement and license agreement with Janssen Biotech that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab) in the USA. 1 March 2024
Pharmaceutical
Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka, is to collaborate with Shanghai-based Haihe Biopharma on a new cancer med. 1 March 2024
Biotechnology
A new formulation of Xgeva (denosumab) is the first product to be authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) via the regulator’s new International Recognition Procedure (IRP). 1 March 2024
Pharmaceutical
San Diego-based BlossomHill Therapeutics, a company focused on the design and development of small molecules for cancer and autoimmune diseases, has announced the closing of a $100 million Series B financing round. 1 March 2024
Biotechnology
More positive data for Abrysvo (respiratory syncytial virus vaccine) will support Pfizer’s position in an important new market for products targeting RSV infections. 1 March 2024
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and earnings before interest, tax, depreciation and amortization for 2023. 1 March 2024
Biotechnology
In December 2023, the US Food and Drug Administration (FDA) released a 25-page draft guidance on Potency Assurance for Cellular and Genetic Therapy Products.1 1 March 2024
Pharmaceutical
Russia is experiencing, shortage of a unique drug against repeated heart attacks - Effient (prasugrel) from the American pharma major Eli Lilly representative of the Russian Ministry of Health told the business newspaper Vedomosti, the Pharma Letter’s local correspondent reports. 1 March 2024
Pharmaceutical
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
Pharmaceutical
Fore Biotherapeutics, a precision oncology start-up founded in 2011, has selected William Hinshaw as its new chief executive. 29 February 2024
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