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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biotechnology
Japanese drugmaker Chugai Pharmaceutical said today it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 June 2023
Biotechnology
Israel-based NeuroSense Therapeutics announced in a Securities and Exchange Commission that it has entered into a collaborative evaluation agreement with a unit of US biotech major Biogen. 14 June 2023
Pharmaceutical
As a functional, practical and intelligent way to regulate medical products in today’s globalized world—especially with increasing public health needs, limited resources and demand for faster and better treatments—the use of regulatory decisions from other jurisdictions represents a powerful and effective alternative. 14 June 2023
Pharmaceutical
The Russian government plans to significantly increase public procurement of drugs against diabetes this year despite the existing shortage of funds, reports The Pharma Letter’s local correspondent. 14 June 2023
Generics
The UK subsidiary of Hungarian drugmaker Gedeon Richter today announced that full marketing and distribution rights to an oral contraceptive range of branded generics, acquired from Ireland-headquartered Consilient Health, have been transferred to the company. 14 June 2023
Pharmaceutical
India is to join an international system - the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) - that fosters cooperation between countries and regulatory authorities on good manufacturing practices (GMPs) in order to improve the quality of its medical products. 14 June 2023
Pharmaceutical
Just months after France’s Ipsen bought liver disease specialist Albireo (Nasdaq: ALBO), the company’s main product Bylvay (odevixibat) has won a new US nod. 14 June 2023
Pharmaceutical
Spanish dermatology-focused drugmaker Almirall has launched a non pre-emptive share capital increase for a total aggregate amount (including nominal value and share issue premium) of around 200 million euros, by issuing more than 24 million new ordinary shares at 8.20 euros. 14 June 2023
Pharmaceutical
French drugmaker Sanofi has placed a strong emphasis on the adoption of artificial intelligence capabilities to facilitate its internal operations. 13 June 2023
Biotechnology
Soliris (eculizumab), from the AstraZeneca subsidiary Alexion, has won a new approval in China. 13 June 2023
Biotechnology
UK-headquartered biotech Tiziana Life Sciences has announced the appointment of Dr Matthew Davis as its new chief operating officer (COO). 13 June 2023
Pharmaceutical
The Russian drug market grow may substantially this year due to the general stabilization of economic situation in the country and the existing stable demand for drugs from middle and high-priced segments of the market, The Pharma Letter’s local correspondent report. 13 June 2023
Biotechnology
Seagen has announced latest efficacy and safety results from Part C of a Phase II trial of Adcetris (brentuximab vedotin) alongside nivolumab and standard chemotherapy agents doxorubicin and dacarbazine as a frontline treatment for early-stage classical Hodgkin lymphoma (cHL). 13 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) late yesterday said it has approved Linzess (linaclotide) capsules to treat functional constipation in pediatric patients aged six to 17 years. 13 June 2023
Pharmaceutical
An initiative to regulate non-scheduled drug prices in India, which was under the Department of Pharmaceuticals (DoP) consideration, has been pushed to the back burner. 13 June 2023
Biotechnology
German radiopharmaceutical specialist ITM Isotope Technologies (ITM) has opened a new manufacturing facility for therapeutic radionuclides in its home town of Munich. 13 June 2023
Pharmaceutical
With UK pharma major GSK last month becoming the first to gain US Food and Drug Administration approval of a respiratory syncytial virus (RSV) vaccine with its Arexvy in May, following swiftly by the approval of US pharma giant Pfizer’s option Abrysvo, the battle ground is set for dominance in the sector. 13 June 2023
Biosimilars
Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines, says a leading European trade group. 13 June 2023
Pharmaceutical
The Biden administration has provided more evidence of its desire to follow rhetoric with action on lowering drug prices through the Inflation Reduction Act (IRA). 12 June 2023
Pharmaceutical
Spanish drugmaker PharmaMar and China-based Luye Pharma have revealed that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). 12 June 2023
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