Pricing, reimbursement and access
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Biosimilars
Certain targeted therapies enjoy extensive but incomplete coverage in Brazil and Mexico through complex mechanisms, according to research by Decision Resources Group. 10 June 2014
Generics
The Canadian subsidiary of USA-based injectable generic drugs specialist Hospira has refuted press reports regarding its supply and pricing strategy with regard to the cancer drug paclitaxel. 8 June 2014
Pharmaceutical
The head of the US trade group Pharmaceutical Research and Manufacturers of America has issued a strong defence of the country’s drug costs, which comes in the wake of criticism of the high price of Gilead Sciences' new hepatitis C treatment Sovaldi (sofosbuvir). 30 May 2014
Biotechnology
The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Genzyme’s Lemtrada (alemtuzumab) be reimbursed on the National Health Service for treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. 28 May 2014
Pharmaceutical
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that Viiv Healthcare’s HIV treatment Tivicay (dolutegravir) provided added benefit over comparator therapy. 27 May 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline has said it will freeze the prices of its vaccines for a period of five years for developing countries that graduate from GAVI Alliance support. 22 May 2014
Pharmaceutical
Japanese pharma company Eisai has launched its Fycompa (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), in France. 21 May 2014
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) said it has found no added benefit for Anglo-Swedish drug major AstraZeneca’s Xigduo (dapagliflozin and metformin 16 May 2014
Pharmaceutical
Janssen, a subsidiary of US health care giant Johnson & Johnson, said today that it welcomes the publication of the Final Appraisal Determination from UK drugs watchdog the National Institute for Health and Care Excellence (NICE), for Invokana (canagliflozin), a new treatment option indicated for reducing blood glucose levels in people for whom diet and lifestyle measures or treatment with other blood glucose-lowering medicines, do not provide adequate control. 16 May 2014
Pharmaceutical
In draft guidance published this morning, the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has not recommended US health care giant Johnson & Johnson subsidiary Janssen’s Zytiga (abiraterone) for prostate cancer which has spread in people whose first treatment has failed, have no or mild symptoms and for whom chemotherapy is not yet clinically indicated. 14 May 2014
Pharmaceutical
Following the announcement of Australia’s 2014-15 Budget today, the pharma Industry trade group Medicines Australia says it welcomes the government’s recognition of the importance of the Pharmaceutical Benefits Scheme (PBS). 13 May 2014
Pharmaceutical
Japanese drug major Eisai has exercised its option to jointly develop and commercialize its clinical candidates for Alzheimer's disease with US biotech firm Biogen Idec in Japan. 12 May 2014
Pharmaceutical
Last week’s meeting of the Greek Pharmaceutical Pricing Committee of the Ministry of Health, which was expected to issue a Corrective Price Bulletin, took the representatives of the pharmaceutical industry by surprise, as once again the Ministry refused to act on the Committee’s recommendation on a correction of all pricing errors, says the Hellenic Association of Pharmaceutical Companies (SfEE). 12 May 2014
Pharmaceutical
The Philippines’ pharmaceutical market value will increase from a value of $4.3 billion in 2013 to $8 billion by 2020, expanding at a compound annual growth rate (CAGR) of 9.4%, largely as a result of the country’s high medicine prices. 8 May 2014
Pharmaceutical
In a major crackdown, India's drug price regulator, the National Pharmaceutical Pricing Authority (NPPA) has issued notices to 89 pharmaceutical companies for overcharging their medicines, taking the total number of cases since its inception to 1,018, for a whopping $563 million, reports The Pharma Letter's India correspondent. 6 May 2014
Biotechnology
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether US biotech firm Gilead Sciences’ new controversially high-prices hepatitis C drug Sovaldi (sofosbuvir) offers added benefit in comparison with the appropriate comparator therapy. 3 May 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has today issued preliminary guidance rejecting Swiss drug major Roche’s Kadcyla (ado-trastuzumab emtansine or T-DM1), for women with advanced HER2-positive breast cancer who have previously received Roche’s Herceptin (trastuzumab) and a taxane chemotherapy, separately or in combination. 23 April 2014
Pharmaceutical
People in England and Wales with lung cancer whose tumors test positive for a mutation will now have access to a third targeted treatment, says the UK’s drugs watchdog the National Institute for Health and Care Excellence (NICE), which has given the go ahead for German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) to be paid for by the National Health Service (NHS). 23 April 2014
Pharmaceutical
Vietnam is currently one of the fastest growing pharmaceutical markets in Southeast Asia, recording a growth rate of nearly 17% and exceeding $3 billion in size in 2013. 22 April 2014
Pharmaceutical
Price revisions are being considered this month in Japan, as part of the biennial alterations, but the world’s second largest pharmaceutical market still holds great opportunity for global pharma, according to analysis from Datamonitor Healthcare. 14 April 2014
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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