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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
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The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
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Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DFD-29 (minocycline hydrochloride modified release capsules, 40mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. 18 March 2024
Pharmaceutical
In the UK, research originating from Cambridge University has received a significant vote of confidence from investors banking on the therapeutic potential of mitochondria. 18 March 2024
Pharmaceutical
US speciality drugmaker Fennec Pharmaceuticals and Norgine today announced an exclusive licensing agreement under which Norgine will commercialize Pedmarqsi (sodium thiosulfate) in Europe, Australia and New Zealand. 18 March 2024
Pharmaceutical
Japanese drugmaker Sumitomo Pharma and its US subsidiary Sumitomo Pharma America have amended a collaboration with Otsuka Pharmaceuticals. 18 March 2024
Pharmaceutical
March is designated multiple system atrophy (MSA) awareness month, which we have taken as an opportunity to delve into advances in treatment for this rare disorder. 18 March 2024
Pharmaceutical
Global drugmakers will have an opportunity to increase sales of their drugs, particularly those for the treatment of rare diseases in the Russian market due to the recently announced plans of the state to establish a public fund for procurements of expensive innovative drugs for adults, reports The Pharma Letter’s local correspondent. 18 March 2024
Pharmaceutical
Privately-held ophthalmology company OcuTerra is facing an uncertain future after announcing a trial failure with its lead asset. 15 March 2024
Pharmaceutical
A US Food and Drug Administration (FDA) advisory panel has voted in favor of the clinical benefit/risk profile of imetelstat for transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). 15 March 2024
Pharmaceutical
More than 86% of the National Pharmaceutical Pricing Authority's (NPPA) total demand for overcharging remains unrecovered from drug majors operating in India. 15 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday approved Rezdiffra (resmetirom) for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). 15 March 2024
Pharmaceutical
New York-based neuroscience company Gilgamesh Pharmaceuticals has been awarded a multi-year $14 million grant from the National Institute on Drug Abuse (NIDA). 14 March 2024
Pharmaceutical
German firms Bayer and Aignostics have announced a strategic collaboration on several artificial intelligence (AI)-powered approaches with applications in precision oncology drug research and development. 14 March 2024
Pharmaceutical
US clinical-stage pharma company Spruse Biosciences announced disappointing top-line results from its CAHmelia-203 study of tildacerfont. 14 March 2024
Pharmaceutical
New real-world data show a positive safety profile for Xcopri (cenobamate), an anti-seizure medication which is offered in a tablet formulation. 14 March 2024
Pharmaceutical
US RNA-targeted drug developer Ionis Pharmaceuticals has announced positive results from a Phase II study of ION224, an investigational DGAT2 antisense inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). 14 March 2024
Pharmaceutical
US biopharma company Catalyst Pharmaceuticals has announced the US commercial launch of Agamree (vamorolone) oral suspension for the treatment of Duchenne muscular dystrophy (DMD) in patients aged two years and older. 14 March 2024
Pharmaceutical
Just a couple of months after launching its direct-to-consumer pharmacy service, Eli Lilly has announced plans to ramp things up significantly. 14 March 2024
Pharmaceutical
Germany-based AI-driven drug discovery company Partex Group has announced a collaboration with French pharma major Sanofi. 14 March 2024
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) released a Final Evidence Report assessing the comparative clinical effectiveness and value of Novartis’ iptacopan and AstraZeneca subsidiary Alexion’s danicopan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC). 14 March 2024
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