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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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Australia’s Starpharma has announced that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel BV (SPL7013/astodrimer sodium). 20 February 2024
Pharmaceutical
German pharma and crop sciences major Bayer plans to amend its dividend policy to pay out the legally required minimum for three years. 20 February 2024
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Velsipity (etrasimod) to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC). 19 February 2024
Pharmaceutical
Spanish dermatology company Almirall has announced its annual 2023 financial results. 19 February 2024
Pharmaceutical
Japan’s Ono Pharmaceutical today announced that it has entered into a research collaboration agreement with USA-based artificial intelligence (AI) company to identify novel therapeutic targets by leveraging cutting-edge InveniAI’s AI and machine learning (ML). 19 February 2024
Pharmaceutical
Japanese drugmaker Kyowa Kirin announced that Phozevel Tablets (tenapanor hydrochloride, development code: KHK7791) will be launched in Japan on February 20 for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. 19 February 2024
Pharmaceutical
Pharma giant Novartis has announced a strategic review of its listed entity in India. 19 February 2024
Pharmaceutical
UK pharma major AstraZeneca’s shares were up 2.7% at 10,094 pence Friday, after it revealed that its Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the USA for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 19 February 2024
Pharmaceutical
Autoimmune diseases specialist Aurinia Pharmaceuticals lost 24% of its market value on Thursday after presenting an update on the firm’s future. 16 February 2024
Pharmaceutical
US RNAi therapeutics company Alnylam Pharmaceuticals took a hefty 10% hit in the stock market on Thursday. 16 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib). 16 February 2024
Pharmaceutical
San Diego, USA-based precision oncology company Erasca announced two clinical trial collaboration and supply agreements (CTCSAs) with Swiss pharma giant Novartis for the MEK inhibitor Mekinist (trametinib). 15 February 2024
Pharmaceutical
US biopharma Merrimack Pharmaceuticals has revealed plans to dissolve and hand out cash to shareholders from a newly-announced milestone payment that the company is to receive. 15 February 2024
Pharmaceutical
Cathal Friel, co-founder, substantial shareholder, and currently non-executive chairman of London-listed Poolbeg Pharma, is assuming the role of executive chairman at the company effective immediately. 15 February 2024
Pharmaceutical
Today, the US Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. 14 February 2024
Pharmaceutical
Spanish plasma-derived products specialist Grifols has announced positive, top-line Phase III data for BT524, a fibrinogen concentrate being studied to treat patients with acquired fibrinogen deficiency, a bleeding disorder. 14 February 2024
Pharmaceutical
Shares in AN2 Therapeutics, a US biopharma focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, closed 74% lower on Monday. 14 February 2024
Pharmaceutical
US oncology company G1 Therapeutics was hoping for a positive interim analysis in its pivotal Phase III of trilaciclib alongside gemcitabine and carboplatin for the first-line treatment of metastatic triple negative breast cancer (mTNBC). 14 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome), from French drugmaker, in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX regime), for the first-line treatment of metastatic pancreatic adenocarcinoma (mPDAC). 14 February 2024
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
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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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