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Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England and Wales, has issued a Final Appraisal Determination (FAD) which recommends US pharma major Bristol-Myers’ Opdivo (nivolumab), as monotherapy, for the treatment of advanced (unresectable or metastatic) melanoma in adult patients. 22 January 2016
Generics
At their joint executive meeting in Barcelona yesterday, the Spanish Generic Medicines Association (AESEG) and the European Generic and Biosimilar Medicines Association (EGA) confirmed their commitment to join forces and bring access to generic medicines to the Spanish market. 20 January 2016
Generics
The Medicines Patent Pool (MPP) has announced its first sub-licenses for the generic production of Bristol-Myers Squibb’s daclatasvir. 20 January 2016
Pharmaceutical
The Canadian federal government will join a drug-buying alliance that negotiates to lower the cost of brand name and generic drugs, it has been announced. 20 January 2016
Pharmaceutical
Gavi, the Vaccine Alliance, has signed an agreement with the MSD subsidiary of US pharma giant Merck & Co to support the provision of a vaccine to protect against future deadly Ebola outbreaks. 20 January 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined the added benefit of aclidinium bromide (trade names Eklira, Bretaris) under the Act on the Reform of the Market for Medicinal Products (AMNOG). 19 January 2016
Pharmaceutical
Prices for drugs in Russia will increase by 10%-15% this year, which, however will be significantly lower than in 2015, when the price hikes was equivalent to 22.8%, compared to the previous year, according to data of the Russian Federal State Statistics Service, reports The Pharma Letter’s local correspondent. 18 January 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) had examined the revised added benefit dossier from US pharma major Bristol-Myers Squibb for Opdivo (nivolumab), which has been approved since June 2015 for adults with advanced melanoma. 14 January 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has released its findings with regard to added benefit on two oncology treatments, coming to different conclusions. 13 January 2016
Generics
In response to a recent hearing of the US Senate Special Committee on Aging to examine factors contributing to “price spikes in off-patent drugs,” the Generic Pharmaceutical Association (GPhA) and 10 stakeholder groups representing pharmacists, chain drug stores, pharmacy benefit managers, public and private retirement systems, and others, sent a letter to the Committee calling for consideration of the Fair Access to Safe and Timely (FAST) Generics Act (HR 2841) to improve competition in the pharmaceutical marketplace. 7 January 2016
Pharmaceutical
January 1 marked the start of landmark competition reforms in the Australian medicines sector, whereby pharmacists are able to discount the cost of a prescription subsidized through the government’s Pharmaceutical Benefits Scheme (PBS) for the first time. 4 January 2016
Pharmaceutical
Australian Health Minister Sussan Ley says she has asked her Department to urgently alert the Australian Competition and Consumer Commission (ACCC) to plans by the maker of Panadol Osteo to increase its price by 50% on January 1, 2016. 31 December 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier to assess whether evolocumab offers an added benefit over the appropriate comparator therapy. 22 December 2015
Pharmaceutical
Spending on prescription drugs in the USA was up by 12% in 2014, faster than in any year since 2002, according to the Centers for Medicare & Medicaid Services (CMS), which is one of the largest purchasers of prescription drugs in the USA. 22 December 2015
Generics
Skyrocketing generic drug prices in the USA cost taxpayers an additional $1.4 billion over the last decade, according to a new report from the Department of Health and Human Services’ Inspector General, undertaken at the request of Senator Bernie Sanders (Independent, Vermont) and Representative Elijah Cummings (Democrat, Maryland), ranking member of the House Committee on Oversight and Government Reform. 22 December 2015
Biosimilars
A new report, “The Impact of Biosimilars Competition,” which was prepared by IMS Health for the European Commission services, together with the summary of the “Workshop on Access to and Uptake of Biosimilar Medicinal Products” of October 6, 2015, has now been published and is welcomed by the European pharmaceutical industry. 21 December 2015
Pharmaceutical
Canadian drug maker Valeant Pharmaceuticals has struck a deal with the biggest pharmacy chain in the US to sell its skin and eye medications at a discounted price. 16 December 2015
Pharmaceutical
A ‘promising’ new treatment for lung cancer cannot be recommended for use in the NHS because it is not cost effective, the UK's National Institute for Health and Care Excellence (NICE) has said. 16 December 2015
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), the medicines cost watchdog for England and Wales, this morning issued two sets of final guidance, one negative and one positive. 16 December 2015
Biotechnology
The biotechnology sector is expected to continue to outperform and generate returns for investors, said Carl Harald Janson, lead manager at SV Life Sciences Managers at the recently held annual general meeting of the International Biotechnology Trust (IBT). 14 December 2015
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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