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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
A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex. 4 April 2024
Pharmaceutical
The US Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection), developed by Swiss drugmaker Basilea Pharmaceutica. 4 April 2024
Pharmaceutical
In San Diego, USA, an oncology start-up focused on next-generation targeted therapies has raised $132 million in a series B financing. 4 April 2024
Pharmaceutical
LENZ Therapeutics, a biopharma focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, is a step closer to realizing its ambition. 4 April 2024
Pharmaceutical
First approved in 2009 as a treatment for schizophrenia, Vanda Pharmaceuticals’ Fanapt (iloperidone) has now won US regulatory approval for a new indication, with the news sending the US drugmaker’s shares up 33% to $5.23. 4 April 2024
Pharmaceutical
Russian patients with diabetes have been faced with serious difficulties in obtaining ultra-fast insulin aspart Fiasp from Denmark’s Novo Nordisk, reports The Pharma Letter’s local correspondent 3 April 2024
Pharmaceutical
A start-up company focused on digital health has launched with a series A financing round worth $20 million. 3 April 2024
Pharmaceutical
A major public-private research initiative in the UK, Our Future Health, has added a new partner from industry, Swiss pharma giant Novartis. 3 April 2024
Pharmaceutical
Shares of US neurological drug specialist Acorda Therapeutics fell more than 81% to $2.50 by close on Monday after the company said it had filed for bankruptcy protection. 3 April 2024
Pharmaceutical
A start-up focused on neurology, Neurosterix, has launched with a $63 million series A financing led by Perceptive Xontogeny Venture Fund II. 3 April 2024
Pharmaceutical
The US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) has released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. 3 April 2024
Pharmaceutical
A new licensing deal has been agreed between American firm Incyte and Hong Kong-based China Medical System Holdings (CMS). 2 April 2024
Pharmaceutical
Deal flow was heavy in pharmaceutical M&A during March. 2 April 2024
Pharmaceutical
The US regulator has lifted a partial clinical hold affecting research undertaken by New York-based firm ProJenX. 2 April 2024
Pharmaceutical
UK-based specialty CNS-focused pharma company CNX Therapeutics today announce that it has successfully completed the acquisition of two CNS products from the French sales subsidiary of Japan’s Eisai. 2 April 2024
Pharmaceutical
A report released by the non-profit group No Patient Left Behind has claimed that it has found critical flaws in a key metric used by US insurance companies and foreign governments to determine whether to cover prescribed treatments at low out-of-pocket costs. 2 April 2024
Pharmaceutical
The pharma company known as Sosei Group or Sosei Heptares will now go by the name Nxera Pharma. 2 April 2024
Pharmaceutical
Danish pharma trade group Lif has expressed concerns over a new bill that will make it mandatory for companies to set up safety stocks of critical medicines. 2 April 2024
Pharmaceutical
With new legislation on data protection in the offing, The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on negotiators to take more time to make sure the law is drafted optimally. 2 April 2024
Pharmaceutical
A new collaboration has been agreed between Israel’s Teva Pharmaceutical and Launch Therapeutics, related to the candidate TEV-248, which combines fluticasone and albuterol. 2 April 2024
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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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