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Pharmaceutical
Bernstein analyst Tim Anderson and team wonder if Pfizer winning the bidding war for Medivation with its $14 billion offer (announced last Monday) is “something to be proud of,” reported Barron’s magazine. 28 August 2016
Pharmaceutical
The Russian Federal Anti-Monopoly Service (FAS) has started investigations regarding the recent detection of a cartel in the Russian pharmaceutical market, which was created by some leading local drugmakers and global majors operating in the Russian market, according to press-service of the FAS, reports The Pharma Letter’s local correspondent. 26 August 2016
Pharmaceutical
NICE, the medicines cost-effectiveness watchdog for England and Wales, has issued an updated guideline recommending the use of Esmya (ulipristal acetate 5mg), up to four courses, as first-line treatment for patients presenting with heavy menstrual bleeding and uterine fibroids 3cm or more in diameter. 26 August 2016
Pharmaceutical
Mylan today announced it is taking immediate action to further enhance access to EpiPen (epinephrine) Auto-Injector by expanding already existing programs in recognition of those patients who are facing the burden of higher out-of-pocket costs. 25 August 2016
Pharmaceutical
Republican Iowa Senator Chuck Grassley has asked the manufacturer of the EpiPen, used for emergency treatment for life-threatening allergic reactions, to explain a steep price increase in the product in recent years. 24 August 2016
Pharmaceutical
Final guidance from the UK's National Institute for Health and Care Excellence (NICE) has recommended Lonsurf (trifluridine/tipiracil), within its marketing authorization, as an option for treating metastatic colorectal cancer, in adults who have had previous treatment. 24 August 2016
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today issued final guidance recommending two drugs for routine use within the National Health Service, both of which were previously available on the now being reformed Cancer Drugs Fund (CDF). 24 August 2016
Biotechnology
German pharma major Bayer has announced that its drug Eylea (aflibercept) has been recommended as a cost-effective treatment by the National Institute for Health and Care Excellence (NICE) for visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO). 24 August 2016
Biotechnology
The August 17 article “PCSK9 inhibitors are not cost-effective, concludes JAMA article,” highlights a cost-effectiveness model published in JAMA that threatens to make it even more difficult for patients with high cholesterol to access new medicines called PCSK9 inhibitors. 22 August 2016
Generics
The local operations in China’s Guangdong province of nine departments and ministries, including the CFDA, the Ministry of Finance and the National Health and Family Planning Commission (NHFPC), jointly issued five new policies for public hospitals in the region on drug procurement, which is done at a medicine exchange in Guangzhou, a pilot project launched in 2013 aiming to lower drug prices through online auction, reports The Pharma Letter’s local correspondent Wang Fangqing. 19 August 2016
Pharmaceutical
US trade group PhRMA has said that new government data on the cost of prescription drugs paints a ‘misleading picture’ about the Medicare Part D program because it fails to include discounts and rebates negotiated directly with manufacturers. 19 August 2016
Pharmaceutical
Many orphan drugs on the US market today are used to treat common, non-orphan conditions, and that’s making them more expensive for patients and the health care system, according to a new report from America’s Health Insurance Plans (AHIP). 19 August 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has said in draft guidance published today that German pharma major Bayer’s liver cancer drug Nexavar (sorafenib) – which is currently available on the Cancer Drugs Fund (CDF) – is not value for money. 19 August 2016
Biotechnology
The makers of two cholesterol-lowering drugs have responded to a report which said that their products were not cost-effective and called for their US price to be cut by at least 68%. 18 August 2016
Pharmaceutical
Removing cancer drug Afinitor (everolimus) from the UK’s revamped Cancer Drugs Fund (CDF) will prevent women with advanced breast cancer from accessing medicine that could significantly slow the progression of their disease, Swiss pharma giant Novartix has said. 18 August 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued second draft guidance which recommends US pharma giant Pfizer’s Xalkori (crizotinib) for some people with lung cancer. 18 August 2016
Pharmaceutical
A ‘huge blow to patients’ and the realization of ‘our worst fears' about the re-launched Cancer Drugs Fund (CDF) is how one charity has reacted to the recommended discontinuation of oncology treatments in England. 18 August 2016
Biotechnology
At a time when the inability of UK patients to access certain potentially lifesaving cancer drugs has come under fire, one company executive has praised the stance taken by the British government on a treatment of advanced renal cell carcinoma (RCC). 17 August 2016
Biotechnology
The price of a new group of cholesterol-lowering drugs is too high and should be cut by at least 68% to represent good value for the US health care system, according to a new article published in the Journal of the American Medical Association (JAMA). 17 August 2016
Pharmaceutical
A report on why UK cancer patients are missing out on drugs available elsewhere is ‘too simplistic’ in attributing the problem to failed negotiations with pharma companies, according to the Association of the British Pharmaceuticals Industry (ABPI). 15 August 2016
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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