Pricing, reimbursement and access
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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Generics
The US subsidiary of India’s Glenmark Pharmaceuticals has been charged for conspiring to fix prices for generic drugs, the US Department of Justice announced on Monday. 1 July 2020
Generics
Chinese inventory costs for Indian drug companies have soared by 10% compared to the pre-COVID-19 days. Indian companies are dependent on China for all the key ingredients made using the fermentation process, where China has achieved global dominance and capacities 1 July 2020
Biotechnology
The long-running feud between US biopharma Vertex Pharmaceuticals and budget holders for the National Health Service (NHS) in England seems well and truly over. 30 June 2020
Biotechnology
Russian President Vladimir Putin has approved the proposal of the Ministry of Health to establish a special state fund that will focus on the purchases of some of the most expensive drugs for the needs of Russian patents, primarily children for years to come, according to recent statements by the press-service of the Russian Presidential Administration. 30 June 2020
Pharmaceutical
Gilead Sciences is to set the price of the antiviral remdesivir at $390 per vial for governments in developed countries, and $520 per vial for private insurers. 29 June 2020
Pharmaceutical
Earlier this month, the Greek trade body Hellenic Association of Pharmaceutical Companies (SFEE) and the Foundation of Economic & Industrial Research (IOBE) held a special conference to launch a publication, The pharmaceutical market in Greece: Facts & Figures 2019, where the sector’s contribution to the country’s economy was discussed. 29 June 2020
Pharmaceutical
The UK’s reimbursement agency has provided a positive decision on funding for Rozlytrek (entrectinib), making it the second histology-independent treatment available through the country’s National Health Service (NHS). 26 June 2020
Pharmaceutical
Unlike in Scotland, where abiraterone acetate was recommended earlier this year, men in England and Wales with newly-diagnosed high-risk, metastatic hormone-sensitive prostate cancer (mHSPC) denied access to a life-extending treatment option. 26 June 2020
Pharmaceutical
The UK’s reimbursement agency has recommended against using the novel multiple sclerosis (MS) therapy Mayzent (siponimod), in draft guidance. 25 June 2020
Pharmaceutical
The Institute for Clinical and Economic Review (ICER), a Boston, USA-based cost effectiveness watchdog, has updated its pricing model for remdesivir in COVID-19. 25 June 2020
Pharmaceutical
A new Irish government program leaves unresolved the funding crisis for new medicines, according to the Irish Pharmaceutical Healthcare Association (IPHA). 22 June 2020
Generics
India is set to impose anti-dumping duty on Chinese antibacterial drug ciprofloxacin hydrochloride in order to guard its domestic industry from cheap imports from the Asian neighbor. 17 June 2020
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has granted a positive final appraisal document (FAD) for the use of Rozlytrek (entrectinib) in adults with ROS1-positive non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 15 June 2020
Generics
51 states and territories in the USA have banded together to accuse 26 drugmakers of drug price fixing. 11 June 2020
Pharmaceutical
One of the announcements made by Gavi, The Vaccine Alliance, around Thursday’s Global Vaccine Summit, has been around its donation to the Serum Institute of India. 4 June 2020
Pharmaceutical
A survey has shown what 389 patient groups think of the 33 leading pharma companies in the cancer space. 28 May 2020
Biotechnology
Reversing a previous negative decision, the UK’s reimbursement agency has provided final guidance in favor of immunotherapy Tecentriq (atezolizumab), plus chemo, for triple negative breast cancer. 22 May 2020
Biotechnology
Contrary to conventional wisdom that says the coronavirus pandemic will generally benefit biopharmaceutical companies, a new Pioneer Institute study finds that many companies will emerge from the pandemic commercially weaker, dealing with delays in new product launches and with fewer resources to invest in research and development. 21 May 2020
Generics
Higher sales of generic drugs and India's Jan Aushadhi initiative, that makes available quality drugs at affordable prices through dedicated stores selling generic medicines, are eating into volumes of branded generics players. As the buying capacity of consumers has reduced in light of the COVID-19 lockdown, there is a growing preference for generics and lower-priced medications, reports The Pharma Letter’s India correspondent. 20 May 2020
Biotechnology
AveXis today announced the European Commission (EC) granted conditional approval for Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene. 19 May 2020
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