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
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has submitted comments to the Office of the United States Trade Representative (USTR) to inform the agency’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. 21 October 2024
The Office of the US Trade Representative (USTR)’s 2019 Special 301 Report – scheduled to be released this spring – brings critical attention to overseas intellectual property (IP) and market access challenges that harm American innovators, patients and workers. 15 March 2019
At the Annual Meeting of the Global Chagas Disease Coalition in Barcelona, Spain, Swiss pharma giant Novartis said that it is joining the Coalition as a member contributor. 15 March 2019
Daiichi Sankyo’s European subsidiary and Esperion Therapeutics announced that positive results from the 2,230 patient, 52-week, Phase III long-term safety study of bempedoic acid were published in NEJM. 14 March 2019
In a change of policy, Italian children have been told not to turn up to school unless they can prove they have been properly vaccinated. The decision follows months of national debate over compulsory vaccination. 14 March 2019
Reflecting its growing standing as an opinion leader on all things drug price-related, the Institute for Clinical and Economic Review (ICER)—in collaboration with the Office of Health Economics (OHE) —has published a white paper looking at alternative models for pharmaceutical rebates in the USA. 13 March 2019
As the UK government struggles to retain some semblance of an orderly Brexit, the city that houses the headquarters of the European Union (EU) has offered British-based businesses a route to allow them to operate seamlessly across the UK and European Union (EU) post-Brexit. 13 March 2019
Researchers have warned that counterfeit and substandard medicines are associated with tens of thousands of deaths, with young children in poorer countries being particularly affected. 13 March 2019
Even if the UK parliament votes against ‘no deal’ on Wednesday, in the wacky world of Brexit, this cliff-edge scenario is still possible – so Stevens & Bolton partner Charlotte Tillett and senior associate Paula Harris, consider the potential implications for pharma in an Expert View piece. 13 March 2019
Following the unexpected resignation of incumbent Dr Scott Gottlieb earlier this month, the Trump administration on Tuesday announced that National Cancer Institute (NCI) Director Norman (Ned) Sharpless will serve as acting Commissioner of the US Food and Drug Administration. 13 March 2019
More positive Phase III data for Eli Lilly’s Cyramza (ramucirumab) will support a mid-2019 regulatory push into non-small cell lung cancer (NSCLC). 13 March 2019
Smith & Nephew has agreed to acquire Osiris Therapeutics,, a fast growing company delivering regenerative medicine products, including skin, bone graft and articular cartilage substitutes. 12 March 2019
Medical products and generic drugmaker Covidien has agreed to pay just under $17.5 million to resolve allegations that it violated the False Claims Act by providing free or discounted practice development and market development support to physicians located in California and Florida to induce purchases of Covidien’s vein ablation products, the US Department of Justice announced on Monday. 12 March 2019
As lawmakers in the UK Parliament prepare to vote, again, on the Prime Minister’s EU withdrawal deal, the impact of Brexit is already being felt in the pharmaceutical industry. 12 March 2019
Johnson & Johnson has announced new results from a real-world meta-analysis of therapies, including Xarelto (rivaroxaban), for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). 12 March 2019
Johnson & Johnson has won a positive reimbursement decision in the UK with regards to the triple combo therapy Darzalex (daratumumab) plus Velcade (bortezomib) and dexamethasone, a corticosteroid medication. 12 March 2019
Heron Therapeutics has announced results of a multi-center postoperative pain management study in which 31 patients undergoing bunionectomy surgery received the investigational agent, HTX-011, together with a regimen of generic over-the-counter (OTC) oral analgesics (acetaminophen and ibuprofen). 11 March 2019
Shares in AMAG Pharmaceuticals slipped by nearly 18% on Friday after a drug that was approved by the US Food and Drug Administration (FDA) in 2011, failed in a confirmatory study. 11 March 2019
Following swiftly on a Japanese filing, now the US Food and Drug Administration has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. 11 March 2019
In a move that is not totally surprising, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave a mixed reaction following its review of Sanofi’s dengue fever vaccine. 11 March 2019
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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.