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
Swiss contract development and manufacturing organization (CDMO) Lonza today announced that Wolfgang Wienand has been appointed chief executive (CEO). 2 April 2024
Pharmaceutical
Taiho Ventures unit has been selected as a certified venture capital of the Strengthening Program for Pharmaceutical Startup Ecosystem implemented by the Japan Agency for Medical Research and Development (AMED) and has entered into an agreement with AMED. 2 April 2024
Pharmaceutical
Marking a second regulatory authorization, Voydeya (danicopan) has now been approved in the USA as add-on therapy for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). 2 April 2024
Pharmaceutical
Joint Clinical Assessments (JCA) can support getting new innovative cancer medicines to patients faster, if the right balance in evidence generation and assessment to facilitate national decisions on access for these innovations can be found. 2 April 2024
Pharmaceutical
Viatris today announced the US commercial launch of Ryzumvi (phentolamine ophthalmic solution). 1 April 2024
Pharmaceutical
US pharma major Bristol Myers Squibb yesterday announced a disappointing update following the initial analysis of results from the first of two induction studies in the Phase III YELLOWSTONE. 29 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) as a treatment of classic galactosemia by three months. 29 March 2024
Pharmaceutical
Just as MDMA looked to be leading the charge of psychedelics and related compounds towards market for mental health conditions, a dose of jeopardy has been thrown into the mix. 28 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 28 March 2024
Pharmaceutical
US biopharma Altimmune has claimed that it could have something special on its hands in the highly lucrative obesity field. 28 March 2024
Pharmaceutical
Swedish biotech Oncopeptides yesterday announced a collaboration with Vector Pharma FZCO to commercialize its flagship drug Pepaxti (melphalan flufenamide in the Middle East and North Africa (MENA) region. 28 March 2024
Pharmaceutical
An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024
Pharmaceutical
A South Korean company, AriBio, has announced the signing of exclusive marketing rights for its investigational Alzheimer’s disease drug, AR1001. 27 March 2024
Pharmaceutical
In what is seen as an important win for Merck & Co, the US pharma giant late yesterday announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk injection (which will be marketed in the USA as Winrevair). 27 March 2024
Pharmaceutical
A $20 million series A fundraise will propel Edgewood Oncology out of stealth mode and through early stage research for BTX-A51. 27 March 2024
Pharmaceutical
Israel’s Teva Pharmaceutical Industries and Japanese drugmaker Daiichi Sankyo have been called out for breaches of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. 27 March 2024
Pharmaceutical
Building on positive Phase I/IIa data for its Dravet syndrome candidate, Stoke Therapeutics now hopes to jump towards pivotal research. 27 March 2024
Pharmaceutical
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical have secured European approval for a new formulation of Abilify Maintena (aripiprazole). 27 March 2024
Pharmaceutical
The European Medicines Agency (EMA) has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. 27 March 2024
Pharmaceutical
Veeda Clinical Research Limited, a full-service contract research organization (CRO) with a proven record of drug development success, announced that it has acquired Heads, a privately held European CRO, which specializes in conducting clinical trials in oncology. 27 March 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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