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
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The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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
Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
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Pharmaceutical
In a new report, The World Health Organization (WHO) has warned of growing resistance to certain HIV medications, while the overall picture on combating the disease remains positive. 11 March 2024
Pharmaceutical
Privately-held German firm Boehringer Ingelheim and Japan’s Sosei Group Corporation have entered into a global collaboration and exclusive option-to-license agreement. 11 March 2024
Pharmaceutical
Data protection is in the spotlight in Europe, as lawmakers gather to decide on an important set of rules on intellectual property, the Regulatory Data Protection (RDP) law. 11 March 2024
Pharmaceutical
Germany’s Bayer has entered into deal with USA-based BridgeBio Pharma to commercialize its cardiovascular candidate acoramidis worth $310 million in upfront and milestone payments. Research news last week included Denmark’s Novo Nordisk releasing positive new data on its semaglutide, showing it cut kidney-disease related events in diabetes patients by 24%. Also, Singapore-based TauRx Pharma released new data on its Alzheimer’s candidate hydromethylthionine mesylate (HMTM). US President Joe Biden is moving further with his intent to bring down drug prices in the USA, with plans not to limit Medicare negotiations to just 20 drugs a year. 10 March 2024
Pharmaceutical
In another win for Denmark’s Novo Nordisk, the US Food and Drug Administration approved a new indication for use for its Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. 9 March 2024
Pharmaceutical
With demand for GLP-1 agonists outstripping supply, Zepbound (tirzepatide) developer Eli Lilly has issued a warning against resorting to counterfeits. 8 March 2024
Pharmaceutical
Massachusetts, USA-based Amylyx Pharmaceuticals has announced topline results from the Phase III PHOENIX study. 8 March 2024
Pharmaceutical
Research undertaken by Californian antiviral specialist Gilead Sciences and fellow American company Merck & Co is moving in the right direction, new data show. 8 March 2024
Pharmaceutical
An analysis of recent pharma activity in the metabolic diseases field and why obesity is a hot topic amongst investors. 8 March 2024
Pharmaceutical
USA-based ophthalmic diseases specialist EyePoint Pharmaceuticals has appointed Ramiro Ribeiro as its new chief medical officer. 8 March 2024
Pharmaceutical
Singapore-based TauRx Pharmaceuticals, which is seeking treatments for Alzheimer’s and related neurodegenerative diseases, presented the 24-month data from its Phase III LUCIDITY trial of hydromethylthionine mesylate (HMTM). 8 March 2024
Pharmaceutical
Novo Nordisk’s investments in GLP-1 agonism and related approaches to weight loss are continuing to bear fruit, as shown by striking headline data from the STEP-1 trial. 8 March 2024
Pharmaceutical
India's drug manufacturers are lobbying for a one-time exemption from a price control regulation linked to the Wholesale Price Index (WPI). 8 March 2024
Pharmaceutical
Shares in Mind Medicine were nearly 52% higher following Thursday's trading. 7 March 2024
Pharmaceutical
Germany’s Merck KGaA will hope to draw a line under a challenging year as it predicts a return to growth in 2024—albeit when adjusted for currency headwinds. 7 March 2024
Pharmaceutical
French drugmaker Ipsen has secured a positive reimbursement decision from the UK’s National Institute for Health and Care Excellence (NICE). 7 March 2024
Pharmaceutical
Staying true to her values is not a secondary consideration for Dr Dennise Broderick in her career and leadership of Galen, but rather is front and central to every action she takes. 7 March 2024
Pharmaceutical
The US subsidiary of Germany’s family-owned drug major Boehringer Ingelheim today said it will cap out-of-pocket costs at $35 per month for eligible patients for all the company’s inhaler products. 7 March 2024
Pharmaceutical
President Joe Biden’s actions to cut prescription drug prices through the Inflation Reduction Act (IRA) and other means have been far from popular with big pharma and its lobbyists. 7 March 2024
Pharmaceutical
South Korean vaccine maker SK bioscience today announced that it has broken ground on a major expansion of its vaccine manufacturing plant, L HOUSE, located in Andong, Gyeongsangbuk-do. 7 March 2024
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