Latest Pharma and Biotech News
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8 January 2025 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.
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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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Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of KarXT (xanomeline tartrate/trospium chloride) drug KarXT, from Karuna Therapeutics for the treatment of schizophrenia. 26 January 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has provided an update on its review of the New Drug Application (NDA) for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 26 January 2024
Pharmaceutical
In early December, the USA’s Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. 26 January 2024
Pharmaceutical
The UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved a four-dose version (covering a month’s treatment) of the diabetes and weight management medicine Mounjaro (tirzepatide) - Mounjaro KwikPen. 26 January 2024
Pharmaceutical
The European regulatory filing for Acarizax (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation 25 January 2024
Pharmaceutical
UK-based dermatology company SkinBioTherapeutics is to acquire the issued share capital of Dermatonics, a specialist in innovative topical and dermatological products in the skincare and woundcare space. 25 January 2024
Pharmaceutical
Biopharma company Indian Immunologicals Ltd (IIL) has launched India's first indigenously developed hepatitis A vaccine. 24 January 2024
Pharmaceutical
Healthcare giant Johnson & Johnson has reportedly reached a tentative settlement to resolve probes by US states into whether it misled consumers about the safety of its talc products. 24 January 2024
Pharmaceutical
The Serum Institute of India (SII), which claims to be the world’s largest vaccine manufacturer, is joining a growing Coalition for Epidemic Preparedness Innovation (CEPI) network of vaccine producers in the Global South to support more rapid, agile, and equitable responses to future public health disease outbreaks. 24 January 2024
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical revealed it has obtained approval in Japan for an additional indication for Rexulti (brexpiprazole) for the treatment of depression/depressive state. 24 January 2024
Pharmaceutical
A new manufacturing plant will be built in Japan, at a cost of over $40 million, by Chinese contract development and manufacturing organization (CDMO) Jiuzhou Pharmaceutical. 24 January 2024
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has announced positive results from the DELTA FORCE trial. 24 January 2024
Pharmaceutical
AI specialist BenevolentAI today announced the appointment of Dr Joerg Moeller as chief executive and executive board member with immediate effect. 24 January 2024
Pharmaceutical
The US Court of Appeals for the Second Circuit yesterday affirmed a district court ruling which ordered “pharma bro” Martin Shkreli to face a lifetime ban from participating in the pharmaceutical industry. 24 January 2024
Pharmaceutical
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector. 24 January 2024
Pharmaceutical
Accent Therapeutics, a US biopharma seeking to develop a new class of small molecule precision cancer therapies, has announced the completion of a $75 million Series C financing. 23 January 2024
Pharmaceutical
As a market leader in obesity therapy and the largest European company by market cap, Danish diabetes care gain Novo Nordisk has entered into another accord to further solidify its dominance. 23 January 2024
Pharmaceutical
US healthcare giant Johnson & Johnson announced its fourth-quarter and annual financial results for 2023 on Tuesday. 23 January 2024
Pharmaceutical
Shares of US radiopharmaceuticals-focussed Lantheus Holdings (Nasdaq: LNTH) were down 5.4% at $51.88 by late morning today, as it announced the appointment of Brian Markison, current board chairman and industry veteran, to the position of chief executive (CEO), effective as of March 1, 2024. 23 January 2024
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma says it has finalized the acquisition of the strategic asset TMB-001 as well as certain other assets from Timber Pharmaceuticals following the US firm’s Chapter 11 bankruptcy filing. 23 January 2024
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