Pricing, reimbursement and access
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Pharmaceutical
In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Swiss drug major Roche’s new cancer drug Erivedge (vismodegib) offers an added benefit over the current standard therapy. However, no added benefit can be derived from the data presented in the company's dossier, the IQWiG concluded. 18 November 2013
Pharmaceutical
Humanitarian medical organization Medecins Sans Frontieres is calling for four key policy changes to reduce the number of children missing out on vaccinations globally from 22.6 million in 2012. 29 October 2013
Biosimilars
The US drug channel is likely to exhibit a higher acceptance of biosimilars, copy versions of biological drugs, over time than Europe, according to Fitch Ratings, which expects that acceptance of biosimilars will be stronger in the USA, although uptake may be fairly slow at first. 10 October 2013
Pharmaceutical
The government of Ukraine is considering fixing the prices of the drugs sold in the country, according to Ukraine’s Deputy Prime Minister Konstantin Grishchenko. 5 October 2013
Pharmaceutical
A German unit of Spain’s largest drugmaker Almirall, Hermal GmbH and Germany’s National Association of Statutory Health Insurance Funds agreed this week on a reimbursement amount for the medicine cannabis-based prescription multiple sclerosis spasticity drug Sativex. 25 September 2013
Generics
By year-end, the government of Romania will draw up new legislation that changes the clawback taxation mechanism for generic drugs, in an effort to promote their usage in the face of a tight budget, according to Health Minister Eugen Nicolaescu, reported by Balkans.com Business News. 16 September 2013
Generics
Ireland Health Service Executive's (HSE) Medicines Management Program (MMP) has identified two new preferred drugs as part of the second phase of the "Preferred Drugs Initiative." This is the first time the MMP has identified preferred drugs in the angiotensin-converting-enzyme (ACE) inhibitor and angiotensin II receptor blocker (ARB) drug category. 6 September 2013
Pharmaceutical
More than half of surveyed neurologists consider US biotech firm Biogen Idec's (Nasdaq: BIIB) Tecfidera (dimethyl fumarate) to be a breakthrough in the treatment of multiple sclerosis (MS), slightly greater than those who feel the same about Swiss drug major Novartis' (NOVN: VX) Gilenya (fingolimod) and nearly twice as many as for Sanofi (Euronext: SAN) subsidiary Genzyme's Aubagio (teriflunomide). 3 September 2013
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined nine biotechnologically produced drugs for the treatment of adults with rheumatoid arthritis in whom prior pharmacological treatment had failed. According to the findings, for each drug the data provide proof, an indication, or at least a hint of a benefit in relation to at least one outcome criterion, the IQWiG concluded in its final report. 30 August 2013
Pharmaceutical
New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list two brands of influenza vaccine in the Pharmaceutical Schedule for the 2014, 2015, and 2016 influenza seasons. In summary, this proposal would result in: 21 August 2013
Pharmaceutical
US pharma behemoth Pfizer (NYSE: PFE) has today (August 16) expressed concern and disappointment that the final appraisal determination (FAD) from the UK's National Institute of Health and Care Excellence (NICE) does not recommend Xalkori (crizotinib) for previously-treated, ALK positive advanced non small cell lung cancer (NSCLC). 20 August 2013
Pharmaceutical
As the US Food and Drug Administration approved the new HIV drug Tivicay (dolutegravir) late Monday (The Pharma Letter August 13), international medical humanitarian organization Medecins Sans Frontieres (MSF) questioned when people in developing countries would be able to access this promising new drug. 13 August 2013
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Constella (linaclotide), from Spain's largest drugmaker Almirall (ALM: MC) and partner USA-based Ironwood Pharmaceuticals (Nasdaq: IRWD) offered no added benefit over the current standard therapy for the treatment of adults with moderate to severe irritable bowel syndrome (IBS) with constipation. 7 August 2013
Pharmaceutical
The price that the GAVI Alliance, a public/private partnership, pays for lifesaving pneumococcal vaccines for children in the world's poorest countries is set to be reduced under new agreements between GAVI, UNICEF, The World Bank, GlaxoSmithKline and Pfizer. 30 July 2013
Pharmaceutical
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information for two studies comparing Japanese drug major Astellas' (TYO: 4503) antibiotic Dificlir (fidaxomicin), which is used for diarrhea caused by Clostridium difficile infections, with vancomycin. 16 July 2013
Pharmaceutical
New Zealand's Pharmaceutical Management Agency, PHARMAC, is seeking feedback on a proposal to list a new brand of fentanyl patches, Fentanyl Sandoz, under a sole supply arrangement with the local subsidiary of Swiss drug major Novartis (NOVN: VX). 8 July 2013
Pharmaceutical
Following years of austerity-induced health care spending cuts and falling revenues, the Spanish pharmaceutical sector will soon turn a corner, with market value expected to demonstrate steady growth by the end of the decade, says research and consulting firm GlobalData. 27 June 2013
Pharmaceutical
In a new benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) Caprelsa (vandetanib) for the treatment of adult patients with a particular form of aggressive thyroid cancer, under the Act on the Reform of the Market for Medicinal Products (AMNOG). Caprelsa is the first approved treatment for advanced medullary thyroid cancer in Europe (The Pharma Letter February 21, 2012). 26 June 2013
Biotechnology
An approval of US drug major Eli Lilly (NYSE: LLY) and Incyte Pharmaceuticals'(Nasdaq: INCY) drug baricitinib is predicted to prove paramount to the autoimmune community, but the recent rise of biosimilars threatens the long-term future of pharma giants' rheumatoid arthritis (RA) blockbuster hopefuls, according to GlobalData analysts. 26 June 2013
Pharmaceutical
The UK Department of Health yesterday (June 20) announced further steps in what it says is "its commitment to making sure patients get the medicines they need whilst ensuring what the National Health Service pays for medicines is fair and better value for taxpayers." 21 June 2013
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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