Pricing, reimbursement and access
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Pharmaceutical
German pharma major Bayer is set to receive a positive reimbursement decision from the UK’s National Institute for Health and Care Excellence (NICE) for Xarelto (rivaroxaban). 1 August 2019
Pharmaceutical
The National List of Essential Medicines (NLEM) in India, which determines the basis of drug price regulation, is set to add new medicines for the treatment of cardiac diseases and cancer along with certain antibiotics to its list. This would result in a massive slash in prices for these drugs, reports The Pharma Letter’s India correspondent. 1 August 2019
Pharmaceutical
The US Department of Health and Human Services (HHS) and the country’s Food and Drug Administration (FDA) have announced a plan to import certain prescription drugs in order to lower prices for patients. 31 July 2019
Pharmaceutical
In Australia, newly-diagnosed patients aged 18 years and over with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) will now have affordable access to Sprycel (dasatinib) as a first line oral therapy, when this is integrated with chemotherapy. 29 July 2019
Pharmaceutical
Last week’s news included a setback for Biohaven Pharmaceuticals, with the US Food and Drug Administration issuing a CRL for its amyotrophic lateral sclerosis drug Nurtec. Research news of note was Acadia presenting new Phase III data on its schizophrenia candidate Nuplazid (pimavanserin) that failed to impress, and Intec Pharma last Monday releasing Phase III data in its Accordion-Pill-Carbidopa/Levodopa showing that it was not superior to Sinemet. On the government affairs front, last Tuesday saw the US Senate Finance Committee release details of the long-awaited proposed legislation on pharma pricing which has come in for much scrutiny. 28 July 2019
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) for Lokelma (sodium zirconium cyclosilicate) for hyperkalemia. 26 July 2019
Generics
The UK’s Competition and Marketing Authority (CMA) has provisionally found that sellers of the antibiotic nitrofurantoin broke competition law by arranging to carve up the market between them. 26 July 2019
Biotechnology
British drugmaker AstraZeneca has won a positive reimbursement recommendation for its PARP blocker Lynparza (olaparib), through the Cancer Drugs Fund (CDF). 26 July 2019
Biotechnology
US biotech Celgene has agreed to pay $55 million to settle a class action lawsuit over alleged attempts by the drugmaker to block generic competition. 24 July 2019
Pharmaceutical
Melonie Warfel, vice president and general manager for life sciences at software company Model N, provides an Expert View column on pharma's hottest topic. 24 July 2019
Pharmaceutical
The leading members of the USA’s Senate Finance Committee on Tuesday unveiled a long-awaited bipartisan bill to ease drug prices by increasing drugmaker rebates and demanding more scrutiny of price hikes, which is projected to save the federal government $85 billion on drug spending over the next decade. 24 July 2019
Biosimilars
Swiss pharma giant Roche lost 2.5% of its market value on Friday morning with the arrival of competition to two of its biggest-selling cancer drugs in their largest market. 19 July 2019
Biotechnology
The global advanced therapy medicinal product (ATMP) sector is growing rapidly, with more than 900 developers active in this space, sponsoring 1,060 clinical trials, including 93 Phase III studies. 18 July 2019
Biotechnology
There was positive news for Swiss pharma giant Novartis, with the UK medicines cost-effectiveness watchdog reversing an earlier negative decision and agreeing wider National Health Service use for its cancer drug Kisqali (ribociclib). 17 July 2019
Biotechnology
British medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Document (FAD), confirming that Skyrizi (risankizumab) is recommended for the treatment of severe psoriasis in adult patients who have failed conventional systemic therapies. 15 July 2019
Biotechnology
A new report from Boston, USA-based cost-effectiveness watchdog The Institute for Clinical and Economic Review (ICER) will make difficult reading for Duchenne muscular dystrophy (DMD) therapy manufacturers. 12 July 2019
Pharmaceutical
Medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) for Forxiga (dapagliflozin) 5mg with insulin as an option for treating type 1 diabetes in England and Wales. 12 July 2019
Pharmaceutical
Shares in major pharmaceutical companies fell on Thursday, after the US government said it would abandon a proposal to require health insurers to pass significant rebates on to Medicare patients. 12 July 2019
Pharmaceutical
The US medicines cost-effectiveness watchdog Institute for Clinical and Economic Review (ICER) has released its preliminary list of potential assessment topics for 2020. 10 July 2019
Pharmaceutical
The UK Government has unveiled a new subscription-type trial that pays pharmaceutical companies upfront for access to certain antibiotics, based on their usefulness to the country’s national healthcare provider, the NHS. 9 July 2019
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
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