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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Pharmaceutical
Eli Lilly says that its previously-announced lower-priced Insulin Lispro Injection is now available for order in US pharmacies for people who use Lilly's rapid-acting insulin and need a lower-cost option. 22 May 2019
Pharmaceutical
US drugmaker Mallinckrodt today revealed that, through a subsidiary, it has filed suit in federal district court against the Health and Human Services (HHS) Department and Centers of Medicare and Medicaid Services (CMS). 21 May 2019
Pharmaceutical
Pharmaceutical companies guilty of overcharging have got a reprieve. The Indian government has offered to waive $190 million of interest on penalties of $692 million against several drugmakers in what it terms is a special one-time settlement scheme, reports The Pharma Letter’s India correspondent. 21 May 2019
Generics
The retail price of nine anti cancer drugs have been slashed by up to 87% in India by the National Pharmaceutical Pricing Authority. 20 May 2019
Pharmaceutical
Influential US pricing watchdog the Institute for Clinical and Economic Review (ICER) has announced the development of two new tools for payers, pharma firms and others to access its cost-effectiveness analyses. 20 May 2019
Pharmaceutical
The US trade group National Association of Specialty Pharmacy (NASP) today expressed its extreme disappointment that the administration did not initiate much needed reforms to ensure Medicare beneficiaries begin paying less at the pharmacy counter in 2020. 17 May 2019
Generics
Connecticut Attorney General William Tong has led a coalition of 44 US states in announcing a fresh lawsuit against Teva Pharmaceutical Industries and 19 other generic drugmakers. 15 May 2019
Pharmaceutical
Lithuania's new assessment procedure for reimbursable medicines: will there be any positive changes?
Lithuanian attorney Ruta Pumputiene provides an Expert View on amendments to the Lithuanian Pharmaceutical Law and the subsequent changes to the reimbursable medicines system. 15 May 2019
Generics
Shares of Indian pharmaceutical companies continued their downward slide on reports that a lawsuit has been filed against Teva Pharmaceuticals Industries and other generic companies in the USA, including many Indian drugmakers, by 44 US states. 15 May 2019
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Biogen’s Spinraza (nusinersen) to treat infants, children and adults with spinal muscular atrophy (SMA). 15 May 2019
Biotechnology
Chuikyo, Japan’s Central Social Insurance Medical Council, on May 15 approved the listing of Swiss pharma giant Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) on May 22, with a National Health Insurance (NHI) price tag of some 33.5 million yen ($305,800), according to media reports. 15 May 2019
Generics
Civica Rx has inked a supply deal with Danish firm Xellia Pharmaceuticals for the manufacture of essential generic antibiotics, including vancomycin and daptomycin, for Civica’s member health systems. 15 May 2019
Pharmaceutical
The US cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of Spravato (esketamine), a nasal spray approved by the Food and Drug Administration in March as a therapy for treatment-resistant depression (TRD). 10 May 2019
Pharmaceutical
Industry analyst IQVIA has released its 2019 Medicines Report on US Drug Consumption, showing that in 2018, spending on all US medicines increased 4.5% to $344 billion. 10 May 2019
Pharmaceutical
Edward Jones, policy and communications consultant at GK Strategy, provides an Expert View on how companies can take advantage of the UK National Health Service's policy initiatives to support market access and uptake. 10 May 2019
Biotechnology
An eight-month patient-led campaign to get the first ever treatment for early, inflammatory primary progressive multiple sclerosis (PPMS) paid for by the National Health Service (NHS) in England has ended in success. 9 May 2019
Pharmaceutical
Companies marketing expensive drugs in the USA will no longer just be able to tell TV viewers just the good news about their products’ therapeutic potential along with a mention of side-effects. 9 May 2019
Pharmaceutical
Right-wing think tank The Institute for Policy Innovation (IPI) has commented on the ongoing Congressional debate over “Medicare for all” proposals, condemning the idea as imposing: “socialist price controls on Medicare's prescription drugs.” 8 May 2019
Pharmaceutical
Top Russian pharmaceutical manufacturers and global drugmakers, operating in the local market have called on the government to provide additional guarantees for the safety of their business in the country and to create conditions for their comfortable development in the local market. 7 May 2019
Biotechnology
An Evidence Report assessing the comparative clinical effectiveness and value of Swiss pharma giant Novartis’ Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) was released on Thursday by the USA’s Institute for Clinical and Economic Review (ICER). 3 May 2019
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