Latest Pharma and Biotech News
Pharmaceutical
7 January 2025 Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all.
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Pharmaceutical
Calico Life Sciences, a biotech founded by Alphabet and Arthur Levinson focused on the biology of aging and age-related diseases, has announced a setback. 8 January 2025
Pharmaceutical
Denmark’s Novo Nordisk and Valo Health today announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). 8 January 2025
Pharmaceutical
Antag Therapeutics, a Denmark-based biopharma developing novel treatments for obesity, has announced the appointment of Joerg Moeller as chief executive officer, effective immediately. 8 January 2025
Pharmaceutical
The US Food and Drug Administration has imposed a label change for two new respiratory syncytial virus (RSV) vaccine rivals. 8 January 2025
Pharmaceutical
Metsera today announced positive data from a 12-week Phase IIa clinical trial of MET-097i, its potential once-monthly, ultra-long acting, subcutaneously injectable, fully-biased, GLP-1 receptor agonist (RA). 7 January 2025
Pharmaceutical
Central nervous system (CNS) specialist Neuraxpharm Group has acquired Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. 7 January 2025
Pharmaceutical
Japan-based FUSO Pharmaceutical Industries and Australia’s Dimerix Limited have entered into an exclusive development and license agreement for the development and commercialization of Dimerix’ Phase III drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan. 7 January 2025
Pharmaceutical
The heart failure market is projected to grow at a compound annual growth rate of 9.6% over the next decade, increasing from $13.5 billion in 2022 to $33.7 billion in 2032 across seven major markets, according to a report from analytics firm GlobalData. 7 January 2025
Pharmaceutical
A late-stage trial failure has dented Denali Therapeutics stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. 7 January 2025
Pharmaceutical
Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all. 7 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. 7 January 2025
Pharmaceutical
Sentynl Therapeutics, wholly owned by Zydus Lifesciences, has announced that the US Food and Drug Administration has accepted its New Drug Application for CUTX-101, a potential first treatment for Menkes disease. The application has been granted priority review, with a target action date set for June 30, 2025. 7 January 2025
Pharmaceutical
rug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical revealed in a Security and Exchange Commission (SEC) notice. 7 January 2025
Pharmaceutical
A team of Chinese researchers has identified a promising candidate for glaucoma treatment using artificial intelligence tools. 6 January 2025
Pharmaceutical
Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market. 6 January 2025
Pharmaceutical
Immedica Pharma, a Swedish company specializing in rare diseases, has announced its acquisition of Marinus Pharmaceuticals in a deal valued at $151 million. The agreement, finalized through a cash tender offer, marks a significant expansion of Immedica’s presence in the US market. 6 January 2025
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca has announced that new, positive, long-term results from the pivotal ALPHA Phase III trial have appeared in the journal Blood, which is published by the American Society of Hematology. 6 January 2025
Pharmaceutical
Alon Natanson, a business leader and alumnus of the Hebrew University of Jerusalem, has been appointed chief executive officer (CEO) of Yissum, the Israeli Hebrew University Tech Transfer company. 6 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
Pharmaceutical
Switzerland’s Santhera Pharmaceuticals has entered an exclusive deal with Clinigen Group to manage the supply and distribution of Agamree (vamorolone) in regions where the drug is not yet commercially available. 6 January 2025
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Pharmaceutical
Drugmakers, patient advocate groups, policymakers and others have come together for Rare Disease Day, which took place at the end of February, to both celebrate progress and call for more action in this therapy area. 4 March 2024
Pharmaceutical
Innovative approaches are poised to revolutionize the treatment of amyotrophic lateral sclerosis (ALS), a challenging and rare disease. 4 March 2024
Pharmaceutical
The 2024 Importance Study underlines the outstanding importance of the pharmaceutical industry for Switzerland, said the country’s pharma trade group Interpharma. 4 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
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
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
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
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
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
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
Pharmaceutical
US gastroenterology specialist Ironwood Pharmaceuticals saw its shares plunge more than 30% to $10.50 in pre-market activity today, after it announced what it called ‘positive’ top-line results from its pivotal Phase III STARS trial. 29 February 2024
Pharmaceutical
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
Pharmaceutical
Cannabinoid and psychedelic medicine company Incannex Healthcare closed 49% higher after Wednesday’s trading. 29 February 2024
Pharmaceutical
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
Pharmaceutical
Shares in New Jersey, USA-based Palatin Technologies fell over a third on Wednesday, after a key Phase III trial missed its efficacy goals. 29 February 2024
Pharmaceutical
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions. 29 February 2024
Pharmaceutical
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024. 29 February 2024
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