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Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Pharmaceutical
The US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) today launched new advertisements urging Congress to make sure savings on medicines go to patients, not middlemen. 11 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
UK pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2 polyneuropathy across England and Wales. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Pharmaceutical
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved US pharma major Eli Lilly’s (NYSE: LLY) Kisunla (donanemab) for people in Britain with mild cognitive impairment or those in the early stages of Alzheimer’s disease. 23 October 2024
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
“The new key figures from the NZa show that Dutch expenditure on expensive medicines remains stable,” says Mark Kramer, chairman of the Association of Innovative Medicines (VIG), adding: “That is good news from a social perspective.” 21 October 2024
Pharmaceutical
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Pharmaceutical
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Biotechnology
US pharma major Eli Lilly has announced that the National Institute for Health and Care Excellence (NICE) has recommended Emgality (galcanezumab) as an option for the prevention of migraine in adults with episodic and chronic migraine in England and Wales. 18 November 2020
Pharmaceutical
Two weeks after Americans voted in the presidential election, the losing candidate, Donald Trump, remains in denial over the outcome of the poll. 18 November 2020
Biotechnology
US pharma major Eli Lilly’s monoclonal antibody (MAb) bamlanivimab is unlikely to face payer pushback, despite its broad label, after recent Food and Drug Administration emergency use authorization (EUA), experts told Manasi Vaidya, pharma writer for the investigative news team at data and analytics company GlobalData. 17 November 2020
Biotechnology
While much of the world’s focus is on what pharma can do to end the coronavirus pandemic, the rest of the industry is continuing its work ensuring innovative medicines reach those most in need. 17 November 2020
Pharmaceutical
The high and rising cost of prescription drugs in the United States remains a concern for patients, physicians, payers, and policy makers. It is also a key priority for the US Food and Drug Administration, the Trump administration, and the Department of Health and Human Services (HHS). 16 November 2020
Biotechnology
The UK National Institute of Health and Care Excellence (NICE) has issued a positive final appraisal document (FAD) for the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 12 November 2020
Biotechnology
French pharma major Sanofi has announced that the UK National Institute for Health and Care Excellence (NICE) has recommended Cablivi (caplacizumab) with plasma exchange and immunosuppression, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults and in young people aged from 12 years who weigh at least 40 kg. 12 November 2020
Biotechnology
The UK's National Institute of Health and Care Excellence (NICE) has published guidance recommending Venclyxto (venetoclax) plus obinutuzumab for all front-line English patients with chronic lymphocytic leukemia (CLL). 12 November 2020
Generics
Pharmasynthez, one of Russia’s leading drugmakers, has asked for permission to begin production of a generic of remdesivir, an original drug from US antivirals giant Gilead Sciences, reports The Pharma Letter’s local correspondent. 10 November 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) has weighed up the comparative clinical effectiveness and value of two drugs in development for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guerin (BCG) intravesical therapy. 6 November 2020
Pharmaceutical
In response to the Request for Input on Modernizing the 340B Drug Pricing Program issued by Representative Greg Walden and Senator Lamar Alexander, trade body Pharmaceutical Research and Manufacturers of America (PhRMA) has outlined a number of commonsense ways policymakers can get the 340B program back on track and refocused on patients. 3 November 2020
Pharmaceutical
The UK would gain from more fully recognizing the long-term value of better therapies for cancers and other severe illnesses. 2 November 2020
Pharmaceutical
Drug sales in Russia reached more than 800 billion roubles (~$10 billion) during the January-September 2020 period, which set a new record for the country and the local pharmaceutical market, according to a recent report published by local pharma analytics agency the DSM Group. 2 November 2020
Biotechnology
BioCryst Pharmaceuticals revealed on Friday that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). 31 October 2020
Biotechnology
A positive reimbursement decision in the UK means that Novo Nordisk’s Saxenda (liraglutide) will be available through the country’s national healthcare provider as a weight management treatment. 30 October 2020
Pharmaceutical
Research from the University of Leeds, UK, highlights the cost-effectiveness of direct oral anticoagulants (DOACs) within the British healthcare system. 29 October 2020
Biotechnology
Leverkusen-based Bayer has won a positive reimbursement decision in the UK for Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) in prostate cancer. 23 October 2020
Pharmaceutical
Flublok, a flu (influenza) vaccine for adults who are 18 years of age and older, will be used as part of the UK’s 2020/21 seasonal flu program from December, the Medicines & Healthcare products Regulatory Agency (MHRA) announced today. 23 October 2020
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has reversed a draft rejection of Keytruda (pembrolizumab) and now recommends the monotherapy for the first-line treatment of adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). 23 October 2020
Biotechnology
US pharma major Bristol Myers Squibb’s blockbuster combination of Opdivo (nivolumab) and Yervoy (ipilimumab) is facing increasing scrutiny in various oncology indications as to whether the financial burden and clinical toxicity added by Yervoy is worth it. 22 October 2020
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