Pricing, reimbursement and access
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Biotechnology
Pressures felt in Japan as a result of the country's aging population, drug price revisions and patent expiries have compelled pharmaceutical industry leaders to rationalize their sourcing and distribution, and increase operational efficiency, according to a new report by GBI Research, which states that market competition has led to a monopoly being held by a few wholesalers, who effectively control the country's pharmaceutical distribution market. 19 July 2012
Generics
The USA's Alabama Supreme Court came out in favor of Sandoz, the generics subsidiary of Swiss drug major Novartis (NOVN: VX), overturning the earlier $78.4 Montgomery County Circuit Court's February 2009 jury verdict against the company, ruling on Friday that there was no evidence to support allegations that the company defrauded the Alabama Medicaid Agency. 16 July 2012
Generics
The Serbian Ministry of Health will raise the prices of more than 400 Drugs once a new government is formed. In doing so, the Ministry aims to overcome the long-standing problem of drug shortages in Serbia, writes Sebastian Gensior in the Europe-health-care.eu news service. 15 July 2012
Pharmaceutical
A decision by the Egyptian Health Ministry to peg local medicine prices to those of international markets is causing concern, according to IRIN, a service of the UN Office for the Coordination of Humanitarian Affairs. 13 July 2012
Pharmaceutical
Since the start of 2012, a new drug - rilpivirine from US health care giant Johnson & Johnson (NYSE: JNJ) - has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1), notes the German Institute for Quality and Efficiency in Health Care (IQWiG). 13 July 2012
Biotechnology
Cancer patients in the USA get faster access to more oncology drugs to treat their disease than patients in Europe, according to a newly-completed study by the Tufts Center for the Study of Drug Development. 11 July 2012
Pharmaceutical
Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin), a novel treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease, has received reimbursement approval from the French health authorities. 11 July 2012
Pharmaceutical
The growing elderly population and its associated disease burden add to the economic challenges faced by the Australian government, according to a new report by health care experts GlobalData, which notes that the Australian health care market is driven by universal health care coverage and good access to facilities such as government-subsidized medicines. However, the growing elderly population and its associated disease burden are set to challenge Australia's ability to maintain this level of care. 10 July 2012
Biotechnology
Government initiatives to cut health expenditure are likely to encourage sales of generic medications in Europe, according to a new report by health care experts GBI Research, which predicts an increase in revenue made by generics in the region during the next five years, as cost-containment policies strongly support the consumption of generic drugs over innovative drug use. 9 July 2012
Pharmaceutical
Final draft guidance published today (July 6) by the UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) does not recommend Swiss drug major Roche's (RGO: SIX) Avastin (bevacizumab), when used in combination with capecitabine (Xeloda, also from Roche), as a treatment for a particular set of people with metastatic breast cancer. This confirms an earlier negative draft guidance (The Pharma Letter April 18). 6 July 2012
Pharmaceutical
New Zealand's pharmaceutical management agency PHARMAC has approved the proposal to fund AstraZeneca's (LSE: AZN) Iressa (gefitinib) and to amend the Special Authority criteria applying to Roche's (ROG: SIX) Tarceva (erlotinib). This was the subject of a consultation letter dated May 31, 2012. 5 July 2012
Pharmaceutical
Exclusivity is everything in the pharmaceutical brand business. Without it, power over pricing disappears and sales evaporate, leaving drug makers helpless - but can this fate be avoided, asks a new report by health care experts GlobalData. 5 July 2012
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of Anglo-Swedish drug major AstraZeneca's Caprelsa (vandetanib) under the Act on the Reform of the Market for Medicinal Products (AMNOG), concluding that there is no proof of added benefit, because no data on patient-relevant outcomes for those patients for whom the drug is approved were presented by the drug manufacturer in its dossier. In view of these deficiencies, the IQWiG says it considered itself compelled to declare the contents of the dossier as "incomplete." 5 July 2012
Generics
Patent expiry of key blockbuster atypical antipsychotic drugs is likely to cause a decline in growth of the European bipolar disorder therapeutics market until 2013. However, approval of new drugs and improved depot formulations are expected to present growth opportunities from 2014 to 2018. 4 July 2012
Generics
The UK's total National Health Service (NHS) spending on medicines is well under control, whilst expenditure on innovative branded medicines is actually set to shrink in real terms and as a proportion of the health care budget over the next three years, according to a new forecast published by the Office of Health Economics, for the trade group the Association of the British Pharmaceutical Industry (ABPI). 2 July 2012
Biotechnology
US biotech firm Gilead Sciences (Nasdaq: GILD), world's largest maker of HIV drugs, has submitted a New Drug Application to the US Food and Drug Administration for approval of its elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. 29 June 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today published new technology appraisals, updating on its previous decisions announced earlier this year. 26 June 2012
Pharmaceutical
Europe's pharmaceutical industry is facing two huge problems: drug reference pricing and parallel trade (the re-exportation of pharmaceutical products from lower-priced to higher-priced countries), which represent a threat to orderly supply of medicines in the region, warned Sir Andrew Witty, president of the European Federation of Pharmaceutical Manufacturers and Associations (EFPIA) in a letter sent to European Union leaders, Commission President Jose Manuel Barroso and Council President Herman Van Rompuy ahead of the June 28-29 summit. 26 June 2012
Biotechnology
The listing of 11 prescription medicines on the Australian Pharmaceutical Benefits Scheme (PBS) has been announced by the Federal Minister for Health Tanya Plibersek, which will benefit some 45,000 patients through new, cheaper medicines, she said. 26 June 2012
Generics
In India, even after four months of receiving overcharging notices from the department of pharmaceuticals (DoP), not even one of the 500-odd pharma companies have responded to the charges, reports the local Hindustan Times. 25 June 2012
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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