Pricing, reimbursement and access
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Pharmaceutical
In response to a sharp price increase in the domestic market caused by the spread of the novel coronavirus (COVID-19), the Russian government and the national Parliament (State Duma) are considering introducing state regulation over prices for drugs and medical devices in the domestic market 10 March 2020
Biotechnology
New data has demonstrated that using Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] to treat patients with intracranial hemorrhage (ICH) associated with the oral Factor Xa inhibitors apixaban or rivaroxaban is projected to provide a net reduction in costs to an acute care hospital. 5 March 2020
Biotechnology
NHS England said on Saturday that it will fund a life-changing treatment for people with rare conditions causing repeated bouts of fever, joint pain and swelling. 2 March 2020
Biotechnology
US biotech firm Clovis Oncology today announced that Rubraca (rucaparib) is now available and reimbursed in Spain following the Spanish Interministerial Commission on Prices of Medicines and Health Products approval of the drug for reimbursement. 2 March 2020
Pharmaceutical
The American Pharmacists Association (APhA) says it has submitted comments to the Federal Trade Commission (FTC) and the US Department of Justice (DoJ) Antitrust Division addressing the impact vertical mergers are having on the pharmacy supply chain, medication pricing and patient access and choice. 28 February 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine. 26 February 2020
Biotechnology
US biotech Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that Kalydeco (ivacaftor) will be available to eligible patients with cystic fibrosis (CF) in New Zealand from March 1. 26 February 2020
Biotechnology
US health technology assessor the Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the comparative clinical effectiveness and value of treatments for cystic fibrosis. 21 February 2020
Pharmaceutical
The Council for Healthcare and Pharma, headquartered in New Delhi, on Saturday cited the urgent need to strengthen the system for the treatment of cancers in children, in India. 17 February 2020
Biotechnology
As high drug prices continue to incite public outcry and US legislation, it is nonetheless possible that Regeneron Pharmaceuticals’ (Nasdaq: REGN) drug for a rare cholesterol condition could lock in as much as $500,000 annually. 14 February 2020
Pharmaceutical
In its submission for the 2020 Special 301 Report, the Pharmaceutical Research and Manufacturers of America has singled out the same four priority countries as it calls for urgent action to address market access and intellectual property (IP) barriers. 13 February 2020
Generics
Israeli generics giant Teva Pharmaceutical Industries today released a new economic impact report detailing the billions of dollars saved by Teva’s generic medicines and the company’s impact on the US and global economies in 2018. 12 February 2020
Pharmaceutical
The Coalition for Preparedness for Treatment, a public association in Russia which protects the interests of local patients, has sent an official request to the UK’s GlaxoSmithKline, asking the drugmaker to lower the price for its dolutegravir anti-HIV drug, which is sold under Tivikai brand name in the local market (Tivicay elsewhere), according to recent statements by representatives of the Association, reports The Pharma Letter’s local correspondent. 11 February 2020
Pharmaceutical
Conservative pressure group the Pioneer Institute has released a report challenging the work of the Institute for Clinical and Economic Review (ICER). 10 February 2020
Biotechnology
The Indian National Pharmaceutical Pricing Authority (NPPA) has sought clarification on US biotech Gilead Sciences' (Nasdaq: GILD) drug pricing plea for its Vemlidy (tenofovir alafenamide tablet to treat chronic hepatitis B. The apex regulator has observed in a detailed document that the submission by Gilead would amount to ever-greening. 7 February 2020
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) says that patients in Ireland are waiting three times longer than in comparable European countries to access new medicines. 6 February 2020
Pharmaceutical
In US President Donald Trump’s State of the Union address on Tuesday, he again called for further bipartisan legislation to lower drug prices. 5 February 2020
Pharmaceutical
Leading Russian pharmaceutical companies, along with global drugmakers operating in the local market, have promised not to raise prices for their drugs that could potentially be used for the treatment of the new Chinese coronavirus, according to recent statements by representatives of producers. 4 February 2020
Biotechnology
A new Sanofi survey has found that only 6% of cardiologists are currently prescribing PCSK9 blockers, while 97% say they are satisfied with outcomes from these treatments. 3 February 2020
Pharmaceutical
The Hellenic Association of Pharmaceutical Companies (SFEE) hosted its annual New Year’s reception last week, at which its president, Olympios Papadimitriou, outlined some of the progress made in the past year. 3 February 2020
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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