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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
Sino Biopharmaceutical revealed it has entered into a strategic partnership with Boehringer Ingelheim to bring the German family-owned company’s innovative cancer therapies to the market in mainland China. 9 April 2024
Pharmaceutical
The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals to register its Parkinson’s disease candidate SPN-830. 9 April 2024
Pharmaceutical
UK health technology assessor the National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending use of remdesivir for treating COVID-19 in eligible adults and children. 9 April 2024
Pharmaceutical
Of the 46 cancer drugs for which the US Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study presented at the American Association for Cancer Research (AACR) 2024 annual meeting. 9 April 2024
Pharmaceutical
An FXR agonist developed by Ascletis Pharma has not performed well in mid-stage trials, leading the Hangzhou, China-based firm to dial down its investment in the drug. 8 April 2024
Pharmaceutical
Family-controlled Spanish pharma company Esteve today announced the appointment of Jacob Tolstrup as chief business development officer, part of the executive management and reporting to Staffan Schüberg, chief executive of the company. 8 April 2024
Pharmaceutical
Providing continuing competition to market leader Gilead Sciences, ViiV Healthcare has achieved a new milestone in the HIV space. 8 April 2024
Pharmaceutical
British life sciences investor Medicxi is betting $40 million on a Shanghai-based company, D3 Bio, working in the areas of oncology and immunology. 8 April 2024
Pharmaceutical
The New England Journal of Medicine has published new data on Jardiance (empagliflozin) from a Phase III trial. 8 April 2024
Pharmaceutical
New interim results from the Phase III EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia were presented on Saturday at the Annual Congress of the Schizophrenia International Research Society (SIRS). 8 April 2024
Pharmaceutical
Denmark’s Pharmaceutical Industry Association (Lif) says that the first quarter of 2024 will be remembered as the quarter with the highest number of non-recommendations since the Medical Council introduced the new method for assessments. 8 April 2024
Pharmaceutical
San Diego, USA-based drugmaker Acadia Pharmaceuticals has appointed Dr Elizabeth Thompson as executive vice president, head of R&D. 6 April 2024
Pharmaceutical
An analysis of the investment activity of Novartis in recent years. 5 April 2024
Pharmaceutical
In the next decade, Japan’s largest drugmaker Takeda Pharma is hoping to bring more Chinese developed drugs to the global market by working with local partners in some key therapeutic areas, said its leaders at Takeda R&D China innovation forum held in Shanghai. 5 April 2024
Pharmaceutical
US healthcare giant Johnson & Johnson (NYSE: JNJ) has entered a definitive agreement to acquire all outstanding shares of Shockwave Medical, in a move aimed at boosting its MedTech business. 5 April 2024
Pharmaceutical
Following its initial investigation into the acquisition by Theramex of certain drug rights held by Viatris, the UK’s antitrust body has said the transaction: “could reduce competition and choice for hormone replacement therapy treatments.” 5 April 2024
Pharmaceutical
The pharmaceutical industry’s overall R&D pipeline size has again hit a new high, and the rate of expansion is on the up again. 5 April 2024
Pharmaceutical
A trial flop for eFFECTOR Therapeutics has prompted the Californian firm to drop development of its lead candidate, tomivosertib, in lung cancer. 5 April 2024
Pharmaceutical
Amylyx Pharmaceuticals’ shares were up 5.9% at $2.78 mid-morning, despite the company revealing that it was pulling its lead product from the market after the drug failed in a confirmatory trial that was announced last month. 4 April 2024
Pharmaceutical
The UK’ Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Exblifep, the combined antibiotic cefepime/enmetazobactam. 4 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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