Latest Pharma and Biotech News
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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
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
Pharmaceutical
UK pharma major AstraZeneca has outlined plans to invest £650 million ($828 million) in the UK – helping boost the UK’s life sciences sector and grow the economy. 7 March 2024
Pharmaceutical
The UK’s leading pharmaceutical and biotechnology trade groups welcomed Chancellor Jeremy Hunt’s Spring Budget to unlock investment in medical research and manufacturing that was announced on Wednesday. 6 March 2024
Pharmaceutical
Melbourne-based Telix has entered into an agreement to acquire the Canadian radioisotope production technology firm ARTMS. 6 March 2024
Pharmaceutical
US drugmaker Vanda Pharmaceuticals saw its shares close down 3% yesterday and fall a further 2.2% to $4.04 pre-market on news of a setback for its Hetlioz (tasimelteon) 6 March 2024
Pharmaceutical
Sales of Gilead Sciences’ antiviral medication Veklury (remdesivir) decreased by 44% to $2.2 billion last year compared to 2022, primarily driven by lower rates of COVID-19 related hospitalizations in all regions. 6 March 2024
Pharmaceutical
Shares of Sweden-headquartered Calliditas Therapeutics were up 6.8% at 116.60 kronor by mid-morning after revealing a patent extension on its lead product. 6 March 2024
Pharmaceutical
French drugmaker Ipsen has appointed Ioana Parsons as general manager of the company’s UK & Ireland affiliate. 6 March 2024
Pharmaceutical
Nashville, USA-based biotech Revance Therapeutics has announced an underwritten public offering, with the goal of raising $100 million. 5 March 2024
Pharmaceutical
USA-based biopharma firm Paratek Pharmaceuticals has announced positive top-line efficacy data for Nuzyra (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. 5 March 2024
Pharmaceutical
Danish diabetes and obesity specialist Novo Nordisk today announced positive headline results from the kidney outcomes trial FLOW, but its shares dipped 1.1% to 865 kroner. 5 March 2024
Pharmaceutical
US biopharma Nocion Therapeutics has raised $62 million in Series B funding. 5 March 2024
Pharmaceutical
All manufacturers participating in the first cycle of the US Medicare drug price negotiations have responded with counter offers, according to the US Department of Health and Human Services’ (HHS) Centers for Medicare and Medicaid Services (CMS). 5 March 2024
Pharmaceutical
Announcing its financial results for 2023, diversified German drugmaker said it would delay a plan to break up the group for at least a couple of years. 5 March 2024
Pharmaceutical
Privately-held company GAIA has announced an update on klariva, an innovative digital therapeutic (DTx). 5 March 2024
Pharmaceutical
California’s BridgeBio Pharma and German life sciences company Bayer have announced a collaboration. 4 March 2024
Pharmaceutical
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
Pharmaceutical
Boston, USA-based Anagenex today announced the appointment of Adrian Schreyer as chief technology officer. 4 March 2024
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