Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
As stipulated under the Indian Drugs Price Control Order (DPCO), drug pricing regulator the National Pharmaceutical Pricing Authority (NPPA) has slashed the price of cancer drugs by up to 86% since a year ago, with several more cuts in the offing, reports The Pharma Letter’s India correspondent. 20 March 2017
Biotechnology
Results from two analyses of PCSK9 inhibitor rejection rates presented at the American College of Cardiology (ACC) meeting this weekend showed that around 80% of prescription claims in the USA are initially rejected. 20 March 2017
Pharmaceutical
Among the political news last week, perhaps the most controversial of which was US President Donald Trump’s budget blueprint – a wish list of spending priorities for legislators to consider, which included a proposal to double the use fee charge that drugmakers pay to get their products through the regulatory process and a much criticized 20% cut in the budget for the National Institutes of Health. 19 March 2017
Pharmaceutical
AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). 17 March 2017
Biotechnology
The UK’s medicines cost-effectiveness body, the National Institute for Health and Care Excellence (NICE) has released a consultation document saying it cannot recommend Darzalex (daratumumab) for routine use, based on the data submitted by Janssen. 17 March 2017
Pharmaceutical
US President Donald Trump has released a budget ‘blueprint’ for 2018 that could have a major impact on the pharmaceutical and healthcare industries in America. 17 March 2017
Pharmaceutical
The controllers of the purse strings for the National Health Service (NHS) in England made a statement on Wednesday that they are unwilling to continue to pay for patients to access innovative treatments to the extent that they do now. 17 March 2017
Pharmaceutical
Innocoll Holdings has confirmed it was in discussion which may or may not lead to an offer for the entire issued share capital of the company. 17 March 2017
Pharmaceutical
Morningstar, an independent Chicago-based investment research firm, has published its latest Healthcare Observer, “Despite PBM Scrutiny, Differentiated Drugs Provide Undervalued Stocks with Underappreciated US Pricing Power.” 17 March 2017
Pharmaceutical
Amid ongoing US public health concerns about the use of opioid-based painkillers because of the threat of addiction, the risk posed by a product sold by Ireland-incorporated Endo International is now seen as greater than the therapeutic benefit it offers. 16 March 2017
Generics
When one of the year’s major events in Japanese pharma returns next month, the issues of an aging population, growing healthcare costs and the government’s attempts to address them are certain to crop up. 16 March 2017
Pharmaceutical
The Chinese Food and Drug Administration (CFDA) to market its has approved oral Janus kinase (JAK) inhibitor, Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 16 March 2017
Pharmaceutical
The US Food and Drug Administration is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. 16 March 2017
Pharmaceutical
The European Commission (EC) has approved a label extension granting three new indications for Cinryze (C1 inhibitor [human]), broadening its use to children with Hereditary angiodema (HAE). 16 March 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending that Zinbryta (daclizumab) be made available on the UK’s National Health Service (NHS) for adult patients living with relapsing-remitting multiple sclerosis (RRMS). 15 March 2017
Pharmaceutical
The UK’s National Institute for Health and Clinical Excellence (NICE), in collaboration with NHS England, has decided to propose a dynamic upper-limit for costs per quality adjusted life year (QALY) above which they will not recommend funding for highly specialized technologies (HST) treatments. 15 March 2017
Pharmaceutical
With proposals being discussed for a replacement of the Affordable Care Act (ACA) – or Obamacare – Kent Holtorf, the medical director for The Holtorf Medical Group, and outspoken critic of the ACA, puts forward his model for change in an expert view piece. 15 March 2017
Pharmaceutical
US Health and Human Services Secretary Dr Tom Price is questioning the findings of the Congressional Budget Office (CBO) report on the American Health Care Act, which predicts that 24 million more Americans would be uninsured by 2026 under the House Republican health care bill than under Obamacare, including 14 million by next year. 15 March 2017
Biotechnology
The US Food and Drug Administration has extended the action date for the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), an anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. 15 March 2017
Generics
Indian drug major Sun Pharmaceutical Industries said yesterday that the US Food and Drug Administration will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. 15 March 2017
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