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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
British biopharmaceutical companies have welcomed an announcement from the UK’s Chancellor, Jeremy Hunt, of a new enhanced R&D tax relief rate for certain innovators. 15 March 2023
article
Shares of Texas, USA-based Bellicum Pharmaceuticals tanked almost 50% to $0.46 this morning after it said it has decided to discontinue its ongoing Phase I/II clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. 15 March 2023
Biotechnology
Servier, a French pharma major governed by a non-profit foundation, today revealed that the Phase III INDIGO clinical trial investigating vorasidenib in monotherapy for patients with residual or recurrent IDH mutant low-grade glioma met its primary endpoint of progression free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). 15 March 2023
Pharmaceutical
An Expert View from the global consulting firm CRA's Steve Kelly, Mike Hodder and Owen Jones. 15 March 2023
Biotechnology
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals yesterday announced that its Qinlock (ripretinib) has been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for second-line gastrointestinal stromal tumor (GIST) patients intolerant to sunitinib. 15 March 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday announced it has amended the emergency use authorization (EUA) for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, co-developed by US pharma giant Pfizer and Germany’s BioNTech. 15 March 2023
Biotechnology
UK-based company that uses artificial intelligence (AI) in drug discovery Exscientia saw its shares edge up 2.8% to $6.86 in morning trading today, despite announcing that US pharma major Bristol Myers Squibb would not be taking up an option under an agreement with Celgene. 15 March 2023
Pharmaceutical
US healthcare giant Johnson & Johnson has recently presented positive results from A DUE analyses of Opsynvi (macitentan and tadalafil), providing insight into the drug’s ability to reduce pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH). 15 March 2023
Pharmaceutical
In a major change towards placing all drug manufacturing responsibilities in the hands of a single licensing authority, the Indian government has proposed that the country's apex drug regulatory body, the CDSCO, (Central Drugs Standard Control Organization), be empowered to regulate the manufacture of drugs and medical devices, instead of state drug regulators as is the current practice. 14 March 2023
Generics
Attempts to curb drug shortages in Germany may not be sufficient to prevent a crisis, the government has been warned. 14 March 2023
Pharmaceutical
Russia may face a shortage of rare disease drug Cuprenil (penicillamine), according to government procurement statistics data and the statistics of the commercial retail, reports The Pharma Letter’s local correspondent. 14 March 2023
Pharmaceutical
Sales of Russian drugs grew in 2022 due to an increase of advertising budgets and a decline of the share of foreign drugs, reports The Pharma Letter’s local correspondent. 14 March 2023
Pharmaceutical
To achieve its goal of being a leader in medical dermatology, Denmark’s LEO Pharm today announced – in early 2023 - a significant shift in R&D to a research model, which aims at driving the early-stage pipeline with externally sourced innovation. 14 March 2023
Pharmaceutical
UK pharma major GSK has announced positive headline results from a Phase III trial of its MenABCWY combination vaccine candidate. 14 March 2023
Pharmaceutical
Japan’s largest drugmaker Takeda has revealed that its dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; TAK-003), is now approved by Brazil’s National Health Surveillance Agency (ANVISA) for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from four to 60 years of age. 14 March 2023
Biotechnology
Given the large market potential and high unmet need for new respiratory syncytial virus (RSV) therapies, drug developers have been focused on new vaccine and monoclonal antibody (MAb) development. 14 March 2023
Pharmaceutical
The Lancet has published detailed results from the Phase III SKYLIGHT 1 study of fezolinetant. 14 March 2023
Pharmaceutical
In June 2021, the US Food and Drug Administration (FDA) approved Novo Nordisk’s (NOV: N) type 2 diabetes drug Wegovy (semaglutide) injection for chronic weight management in overweight or obese adults with at least one weight-related condition.1 This is just one example of the potential for existing drugs to offer new uses – also known as drug repurposing. 14 March 2023
Biotechnology
US biotech Moderna has failed to dodge a patent lawsuit relating to its COVID-19 vaccine. 13 March 2023
Biotechnology
The Phase I trial of XMT-2056 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, US clinical-stage biotech Mersana Therapeutics, whose shares fell over 2% to $4.6 in pre-market trading today 13 March 2023
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