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Pharmaceutical
The US Department of Health and Human Services (HHS) Office of the General Counsel this week released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. 31 December 2020
Pharmaceutical
Two US district courts – Maryland and the Northern District of California - recently dealt what may become fatal blows to the Trump administration’s Most Favored Nation (MFN) rule for Medicare Part B drug payment on procedural grounds, according to a posting on Hyman, Phelps & McNamara’s (HP&M) FDA Law Blog. 31 December 2020
Pharmaceutical
Representatives of the Association of Cancer Patients, Zdravstvy, one of Russia’s leading public associations representing the interests of patients, has called on the national government to resume procurements of some high-priced original drugs, which are used to treat cancer and for which purchases are not planned for 2021. 29 December 2020
Biotechnology
China's National Health Security Administration (NHSA) has announced the annual results from the National Reimbursement Drug List (NRDL) negotiations in 2020, according to a client noted from SVB Leerink Research analyst Andrew Berens. 28 December 2020
Biotechnology
UK government officials confirmed on Sunday that the Medicines and Healthcare products Regulatory Agency (MHRA) would imminently approve the Oxford COVID-19 vaccine, adding that the announcement could come as soon as Tuesday, according to the Financial Times. 28 December 2020
Pharmaceutical
The demand for foreign drugs designed for cancer treatment in Russia remains stable, despite the ever-growing number of generics in the local market, according to recent statements by some leading Russian pharma analysts and local media, reports The Pharma Letter’s local correspondent. 22 December 2020
Pharmaceutical
Shionogi has been included in an innovative pilot program in the UK, designed to support the production of novel antibiotics and boost defences against antimicrobial resistance (AMR). 21 December 2020
Pharmaceutical
The year 2020 has brought unprecedented scientific challenges for the US Food and Drug Administration as it joined the global battle against the COVID-19 pandemic. Despite the challenges faced, the FDA stands in a strong position, with robust scientific and regulatory processes in place to evaluate potential COVID-19 vaccines and drugs. 17 December 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) has published its final recommendations on two drugs in development for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guerin (BCG) intravesical therapy. 17 December 2020
Biotechnology
Takeda’s Alunbrig (brigatinib) has been recommended for use on the National Health Service (NHS) for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor. 10 December 2020
Biosimilars
Biosimilar medicines have multiple long-term benefits, but policymakers need to act immediately to maximize these, according to new IQVIA data. 9 December 2020
Biotechnology
US biopharma Global Blood Therapeutics has announced the initiation of an early access program for voxelotor in Europe and other regions outside the USA, for the treatment of hemolytic anemia in sickle cell disease (SCD) patients aged 12 years and older. 2 December 2020
Biotechnology
Thousands of Australians with debilitating back and joint pain will have access to a life changing treatment option through the Pharmaceutical Benefits Scheme (PBS) which would otherwise cost tens of thousands of dollars. 30 November 2020
Pharmaceutical
An intense debate is going on in India on whether patented drugs should be selected and identified for inclusion in the National List of Essential Medicines (NLEM) 2020, which is being finalized by the Expert Committee constituted by the Ministry of Health. 27 November 2020
Generics
The European Commission has fined the pharmaceutical companies Israel-based Teva Pharmaceutical Industries 60.5 million euros ($72 million) for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon's drug for sleep disorders, modafinil, after Cephalon's main patents had expired. 26 November 2020
Pharmaceutical
The UK Competition and Markets Authority (CMA) launched a competition law investigation into Essential Pharma last month because of suspicions that the firm may have abused its dominant position by proposing to withdraw the supply of bipolar drug, lithium-based Priadel, to UK patients. 26 November 2020
Pharmaceutical
A much awaited Pharmaceutical Strategy for Europe was adopted today by the European Commission. 25 November 2020
Pharmaceutical
Not to be left behind in the race to prove the value of vaccines to deal with the novel coronavirus pandemic, the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund), today announced positive results obtained during the second interim data analysis of the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers evaluating the country’s already approved COVID-19 vaccine. 24 November 2020
Pharmaceutical
In support of US President Donald Trump's historic commitment to lowering drug prices for patients, Health and Human Services (HHS) Secretary Alex Azar announced a drug payment model through the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services. 23 November 2020
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Braftovi (encorafenib) plus cetuximab, within its marketing authorization, as an option for treating BRAFV600E mutation-positive metastatic colorectal cancer (mCRC), in adults who have had previous systemic treatment. 20 November 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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