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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Pharmaceutical
The European Commission has granted conditional marketing authorization for Lytgobi (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA). 6 July 2023
Pharmaceutical
The European Medicines Agency (EMA) is among the regulators to have endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA). 5 July 2023
Biotechnology
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 5 July 2023
Biotechnology
UK and USA-based biotech F-star Therapeutics, an invoX company, has entered into another collaboration with Japan’s largest drugmaker Takeda. 5 July 2023
Biotechnology
The Johnson & Johnson subsidiary Janssen has announced positive top-line results from its Phase IIb FRONTIER 1 trial of the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide, JNJ-2113, in moderate-to-severe plaque psoriasis. 5 July 2023
Pharmaceutical
Shares of Amneal Pharmaceuticals fell 13.1% to $2.70 in choppy post-market trading, after the US drugmaker revealed that the US drugmaker revealed that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the New Drug Application (NDA) for IPX203 in the treatment of Parkinson’s disease. 5 July 2023
Pharmaceutical
Chinese rare disease drug developer RareStone Group has received approval from the National Medical Products Administration (NMPA) for Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. 5 July 2023
Biotechnology
The European Commission has granted approval for the label extension of Orkambi (lumacaftor/ivacaftor), from US biopharma firm Vertex Pharmaceuticals, for the treatment of children with cystic fibrosis (CF) ages 1 to 5 July 2023
Pharmaceutical
South Korean firm SK bioscience today revealed it has signed a Memorandum of Understanding (MOU) with the Government Pharmaceutical Organization (GPO), a state pharmaceutical enterprise in Thailand, to strengthen Thailand’s vaccine infrastructure. 5 July 2023
Biotechnology
German multi-modal biotech Evotec has agreed terms for a $74 million project, building on work it has been undertaking on behalf of the US Department of Defense (DoD). 5 July 2023
Biosimilars
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today provided an update on the deal it announced last month with US pharma major Pfizer. 4 July 2023
Biosimilars
Pharmsynthez, one of Russia's leading drugmakers, is accelerating its expansion in the domestic market by investing more than 20 billion roubles ($223 million) in the building of one of Russia’s largest complexes for the production of active ingredients and finished dosage forms within the territory of the Vorotynsk Industrial Park in the Kaluga region. 4 July 2023
Pharmaceutical
Political and health leaders have signed and adopted the Nagasaki Outcomes Statement, calling for accelerated R&D, access, and delivery for neglected tropical diseases (NTDs). 4 July 2023
Generics
The Russian Ministry of Health has called on domestic drugmakers to accelerate efforts for the development and production of cheaper analogues of expensive drugs, particularly those that are used for the treatment of socially significant diseases, according to recent statements made by Sergey Glagolev, deputy head of the Ministry. 4 July 2023
Biotechnology
For many years, Britain’s pharma largest company AstraZeneca has maintained a strong presence in China, and this approach looks set to pay off. 4 July 2023
Pharmaceutical
Developing new drugs is a complex and expensive process with a high failure rate. In fact, only about one out of 250 preclinical compounds make it to FDA approval. With an average cost of $40,000 per patient in a phase three clinical trial, the financial impact of failure is staggering. 4 July 2023
Generics
Mumbai, India-based generic drugmaker Lupin Limited saw US regulatory approval for two of its copy medicines in the space of two days. 4 July 2023
Biosimilars
A life-changing treatment to prevent blindness in premature babies is to be routinely available on England’s National Health Service (NHS), it was revealed today. 4 July 2023
Biotechnology
German family-owned pharma major Boehringer Ingelheim today presented new late-breaking data from the EFFISAYIL trial showing that patients receiving the highest dose of spesolimab experienced significantly reduced generalized pustular psoriasis (GPP) flares by 84% over 48 weeks compared to placebo (hazard ratio 0.157; 95% confidence interval 0.05–0.54; p=0.0005). 4 July 2023
Pharmaceutical
Japanese drugmaker Maruho has entered into an exclusive license agreement to develop and commercialize Alchemedicine's aldehyde dehydrogenase 2 (ALDH2) activator following Maruho's exercise of the option right included in the exclusive negotiation and evaluation agreement that had already been executed between the companies. 4 July 2023
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