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9 January 2025 Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare.
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Swiss pharma giant Novartis announced today that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of Pluvicto at new plant. 5 January 2024
Pharmaceutical
Global pharmaceutical giants are lobbying for simultaneous drug launches in India, the USA, and Europe. 5 January 2024
Pharmaceutical
Germany’s Merck KGaA has announced a licensing agreement with New York-based small molecule developer Inspirna. 4 January 2024
Pharmaceutical
Further extending its reach beyond it core diabetes business, Denmark’s Novo Nordisk today revealed it has entered into separate research collaborations, one with Omega Therapeutics and the other with Cellarity, in the area of cardiometabolic diseases. 4 January 2024
Pharmaceutical
Dublin-headquartered Alkermes has announced new long-term data from a Phase III trial of Lybalvi (olanzapine/samidorphan). 4 January 2024
Pharmaceutical
China’s Suzhou Ribo Life Science and its Ribocure unit have entered into collaboration with German family-owned pharma major Boehringer Ingelheim to develop novel treatments for non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). 4 January 2024
Pharmaceutical
Not long after the first home-grown GLP-1 agonist was approved in China, the country’s thriving biotech sector looks set to progress another novel candidate in this class with strong potential. 4 January 2024
Pharmaceutical
US pharma company Esperion Therapeutics on Wednesday announced a $125 million deal with Japanese drugmaker Daiichi Sankyo’s European subsidiary (DSE) to resolve Esperion's demand for $300 million from the company over Esperion's cholesterol reduction drugs. 4 January 2024
Pharmaceutical
Privately-held British drugmaker Mundipharma has secured European approval for Rezzayo (rezafungin), for the treatment of invasive candidiasis in adults. 3 January 2024
Pharmaceutical
Gannex Pharma has presented positive interim results from a Phase II trial of its thyroid hormone receptor β (THRβ) agonist ASC41. 3 January 2024
Pharmaceutical
Shares in Longboard Pharmaceuticals have shot up following positive data from the PACIFIC study evaluating bexicaserin. 3 January 2024
Pharmaceutical
UK-based Arecor Therapeutics has announced the appointment of Dr Helen Parris as senior vice president, commercial and general manager of Tetris Pharma. 3 January 2024
Pharmaceutical
China and USA-based Allorion Therapeutics has entered into an exclusive option and global license agreement with UK pharma major AstraZeneca. 3 January 2024
Pharmaceutical
Shares of Denmark-based Zealand Pharma dipped 4.9% to 355.00 kroner by late afternoon, on negative news from the US medicines regulator. 2 January 2024
Pharmaceutical
From January 1, 2024, developers of new medicines can now submit applications via the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new, International Recognition procedure (IRP). 2 January 2024
Pharmaceutical
Privately-held Italian drugmaker Alfasigma has signed an agreement with Belgium’s Galapagos to acquire the Jyseleca (filgotinib) business. 2 January 2024
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Japanese pharma major Takeda’s antiviral drug Livtencity (maribavir). 29 December 2023
Pharmaceutical
Russia may be faced with a shortage of some important antibiotics next year due to the recent decision of some global drugmakers to withdraw them from the market, The Pharma Letter’s local correspondent reports. 29 December 2023
Pharmaceutical
Californian biotech Amgen has announced that the US Food and Drug Administration has rejected its bid for full approval of Lumakras (sotorasib). 28 December 2023
Pharmaceutical
The market for Gaucher disease is set to experience a compound annual growth rate (CAGR) of 0.79% across the seven major markets from $1.2 billion in 2022 to $1.3 billion in 2032. 28 December 2023
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Pharmaceutical
German pharma major Bayer today announced top-line results of the Phase III study OASIS 4 investigating elinzanetant as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in women at high risk of developing breast cancer. 9 January 2025
Pharmaceutical
Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare. 9 January 2025
Pharmaceutical
UK headquartered Verdiva Bio Limited today announced its launch as a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and other cardiometabolic disorders. 9 January 2025
Pharmaceutical
Italy-based Newron Pharmaceuticals (SIX: NWRN, XETRA: NP5), a biopharma developing therapies for diseases of the central and peripheral nervous system, has announced a deal with South Korea’s Myung In Pharm. 9 January 2025
Pharmaceutical
British pharma major AstraZeneca has received positive news from the reimbursement from the UK’s health technology assessor. 9 January 2025
Pharmaceutical
German family-owned pain focused drugmaker Grünenthal announced today that Prof Dr Uli Brödl will assume the role of chief scientific officer (CSO) and a member of the corporate executive board, effective February 1, 2025. 9 January 2025
Pharmaceutical
Insilico Medicine, a biotechnology firm specializing in artificial intelligence-powered drug discovery, has raised over $100 million in a series E funding round. 8 January 2025
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
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