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Biotechnology
Japanese drugmaker Eisai today that the humanized antisoluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) has been launched in South Korea. 28 November 2024
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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biotech major Gilead Sciences has entered an exclusive option and collaboration agreement with fellow USA-based Macrogenics to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART platform, and two additional bispecific research programs. 17 October 2022
Pharmaceutical
Since the outbreak of the COVID-19 pandemic, the Egyptian government has offered tremendous opportunities for the localization of the vaccine and biologics’ industry in Egypt, writes The Pharma Letter's local correspondent. 17 October 2022
Pharmaceutical
The challenges of tackling international crime with national law enforcement are legion, writes John Binns, partner in the Financial Crime team at BCL Solicitors, in an Expert View piece. He considers how Interpol’s Operation Pangea illustrates how they can be overcome in the context of the global fight against illicit medicines. 17 October 2022
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for tofersen by three months. 17 October 2022
Biotechnology
Among important research news last week, US pharma giant Merck & Co released positive Phase III results for the pulmonary arterial hypertension (PAH) candidate sotatercept, validating its $11.5 billion acquisition of Acceleron last year. Also, Sino-American biotech BeiGene announced new Phase III showing that its blood cancers drug Brukinsa scored superiority to Johnson & Johnson’s Imbruvica in chronic lymphocytic leukemia (CLL). After several delays, the US Food and Drug Administration (FDA) has at last approved scPharmaceuticals at-home heart failure treatment Furosix. Last week Merck & Co also excercised its option to jointly develop Moderna’s personalized cancer vaccine mRNA-4157. 17 October 2022
Pharmaceutical
Canadian drug developer Milestone Pharmaceuticals today announced positive top-line efficacy and safety data from the Phase III RAPID clinical trial of etripamil, sending the firm’s shares up almost 30% $8.49 in pre-market trading in New York. 17 October 2022
Biosimilars
India’s largest biotech firm Biocon has entered into a strategic out-licensing agreement with Japanese drugmaker Yoshindo for the commercializing of two of its pipeline biosimilar assets, bUstekinumab and bDenosumab, in the Japanese market. 17 October 2022
Biosimilars
US biotech major Amgen, which also has a significant presence in the biosimilar medicines sector, has released the 9th edition of its Biosimilar Trends Report, which examines the current and future state of the US marketplace with biosimilars. 17 October 2022
Pharmaceutical
A new partnership between Unimed Procurement Services and International Health Partners (IHP) will seek to boost access to life-saving medical supplies around the world. 17 October 2022
Generics
Mumbai, India-based generic drugmaker Lupin Limited revealed that it has reached an agreement with Unitaid, the Aurum Institute, the Clinton Health Access Initiative (CHAI), and other global procurement agencies to support tuberculosis (TB) prevention treatment that will be rolled out to 138 countries, including many low-and middle-income countries with a large burden of TB. 17 October 2022
Generics
With the US Generic Drug User Fee Amendments (GDUFA) reauthorized by Congress on September 30, 2022, known as GDUFA III, these provisions are in effect October 1, 2022, through September 30, 2027. 17 October 2022
Biotechnology
Confirming that there are still plenty of investors ready to wager on attractive biotechnology prospects, France’s Mablink Biosciences today announced it has raised a 31 million-euro ($30 million) Series A funding round to advance its lead candidate to the clinic and to build a pipeline of antibody-drug conjugates (ADCs) using its proprietary platform technology. 14 October 2022
Biotechnology
The European Medicines Agency (EMA) today announced recommendations made by its human medicines committee (CHMP) following its October 2022 meeting. 14 October 2022
Pharmaceutical
US clinical-stage firm Reata Pharmaceuticals edged up 2.6% to $25.05 yesterday, when it puzzled investors with the news that the US Food and Drug Administration (FDA) has decided not to hold an advisory committee (AdCom) meeting in connection with its review of the company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. 14 October 2022
Biotechnology
After just a year in the role of chief medical officer and head of global clinical development at Californian biotech BioMarin, Harold Bernstein has taken a new job elsewhere. 14 October 2022
Biotechnology
US neurology company Otonomy saw its shares plunge nearly 54% to $0.12, a far cry from its height of more than $39 in mid-2015, after releasing disappointing data for its hearing loss candidate OTO-413. 14 October 2022
Biotechnology
Troubled Boston, USA-based rare disease specialist Imara saw its shares rise 4.4% yesterday and a further 17% to $3.01 pre-market today, after a planned merger with fellow USA-based Enliven Therapeutics was revealed. 14 October 2022
Biotechnology
New data from Pfizer and BioNTech’s Comirnaty program show the firms’ updated jab produces antibodies against the latest variants of the coronavirus. 14 October 2022
Pharmaceutical
The Russian pharmaceutical sector is steadily developing despite the ongoing military conflict in Ukraine and the ever-tightening sanctions pressure against the country, according to recent statements by some leading local pharma analysts and Russian media, reports The Pharma Letter’s local correspondent. 14 October 2022
Biotechnology
Russia has been faced with a shortage of Oncaspar (pegaspargase), a drug from French independent pharma major Servier, which is designed for the treatment of leukemia in children. 14 October 2022
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