22 October 2024 The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM).
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 23 October 2024
Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Melbourne, Australia-based Telix Pharmaceuticals has announced the launch of Rhine Pharma, a subsidiary aimed at increasing global access to radiopharmaceuticals for cancer treatment and imaging. 22 October 2024
Berlin, Germany-based Ariceum Therapeutics has presented data at the European Association of Nuclear Medicine 2024 conference on its first-in-class radiopharmaceutical drug, 225Ac-satoreotide. 22 October 2024
Philadelphia, USA-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn (iloprost), the only FDA-approved treatment for severe frostbite in the USA. 22 October 2024
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Sweden-based OncoZenge has announced the intention to partner with UK-based specialty pharma Pharmanovia to secure exclusive rights to commercialize BupiZenge in Europe, the Middle East, and Northern Africa (EMENA). 21 October 2024
Gilead Sciences and Merck & Co have announced new results from a Phase II clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor. 21 October 2024
Trade group the Association of the British Pharmaceutical Industry (ABPI) has had its say on UK government plans to overhaul the National Health Service (NHS). 21 October 2024
Vertex Pharmaceuticals on Sunday presented its pivotal Phase III data on suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor for the treatment of moderate-to-severe acute pain. 21 October 2024
French pharma major Sanofi has opened negotiations to sell a 50% controlling stake in its consumer health business Opella to US private equity firm Clayton Dubilier & Rice (CD&R). 21 October 2024
Angelini Pharma, part of Italy’s Angelini Industries, has entered into an exclusive option agreement with South Korea-based Cureverse for the global development and commercialization of a clinical-stage brain health asset. 21 October 2024
Generic drugmakers Actavis and Mylan have prevailed in a patent dispute against Warner-Lambert, part of the Pfizer group of companies. 14 November 2018
German science and tech company Merck KGaA was trading nearly 4% higher late on Wednesday as markets digested its third-quarter financial results. 14 November 2018
The European Medicines Agency has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the pediatric population. 14 November 2018
Research from industry analyst GlobalData highlights progress in developing new therapies for diabetes, while identifying significant areas of unmet need. 14 November 2018
Continuing its prolific deal-making, German family-owned drugmaker Grünenthal says it has acquired the USA-based pharmaceutical company Averitas Pharma, thereby extending its commercial footprint to the USA. 14 November 2018
The USA’s leading pharmacy benefit manager (PBM) has announced that it is introducing a new formulary to provide employers and health plans a better opportunity to leverage changing dynamics to help lower their members' out-of-pocket costs. 14 November 2018
Bayer’s Stivarga (regorafenib) will be subject to a new trial run by The Global Coalition for Adaptive Research (GCAR), called GBM AGILE. 14 November 2018
AbbVie has released new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, Mavyret (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. 14 November 2018
French drugmaker Sanofi has signalled its intention to introduce six innovative drugs and vaccines to the Chinese market “as early as possible.” 14 November 2018
The US Food and Drug Administration yesterday proposed amending its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. 14 November 2018
Rare disease specialist Shire has filed to extend the label for Gattex (teduglutide) in the USA to include pediatric patients with short bowel syndrome (SBS) who are dependent on parenteral support. 13 November 2018
Continuing its divestment program for non-core products, AstraZeneca has announced a second deal within less than a week, with the news lifting its shares 0.89% to 6,306.50 pence. 13 November 2018
Findings presented by Japan’s largest drugmaker Takeda at ISPOR 2018 report that where standards of care are not clearly defined in terms of cost or outcomes, the ability of payers to accurately estimate the cost effectiveness of new therapeutic options can be hindered. 13 November 2018
Germany’s Bayer has provided an upbeat third quarter financial results statement, showing sales of pharmaceuticals rose by 4.8% to 4.2 billion euros ($4.7 billion). 13 November 2018
Novartis has released new data on its already marketed Entresto (sacubitril and valsartan), which so far has failed to reach sales expectations, that will give it a positive edge in the treatment of heart failure patients, pushing the firm’s shares up 0.76% to 89.76 Swiss francs in early trading. 13 November 2018
The global market for drugs to treat myeloproliferative disorders is expected to be valued at $9.26 billion by 2023, expanding at a compound annual growth rate (CAGR) of 3.4% during the forecast period. 13 November 2018
Prices for drugs in Russia may rise significantly as soon as the beginning of 2019, according to recent statements by an official spokesman of the Russian Pharmacy Guild, a public association, which unites Russian leading pharmacies and some local drugmakers, reports The Pharma Letter’s local correspondent. 12 November 2018
Amarin has announced primary results from a trial of Vascepa (icosapent ethyl) which show a 25% relative risk reduction (RRR), including 20% reduction in cardiovascular death. 12 November 2018
Top-line results from the first two cohorts of its Phase IIa trial evaluating investigational treatment CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss, have been released today. 12 November 2018
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Dewpoint is a biotech company pioneering the application of biomolecular condensate biology – the science studying the organization of biomolecules within membrane-less compartments – towards the development of a new generation of therapeutics to address diseases of high unmet need.