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
Biotechnology
Swiss pharma giant Roche has received US Food and Drug Administration approval for Actemra (tocilizumab), the first ever treatment for adult patients with the autoimmune condition giant cell arteritis (GCA). 23 May 2017
Biotechnology
Taking in and making use of key findings from conferences can be a difficult task but industry veteran Shawn Manning, managing director of investment banking firm Outcome Capital, came away from this month’s BioTrinity 2017 in the UK with some important learnings on the life sciences sector at present. 22 May 2017
Pharmaceutical
The policy of putting Russian drug manufacturers before foreign firms was one of many issues discussed during the Adam Smith Institute’s Russian Pharmaceutical Forum last week. 22 May 2017
Pharmaceutical
Positive top-line results from an additional Phase III clinical trial of tolvaptan in adult patients with autosomal dominant polycystic kidney disease (ADPKD) have been released. 22 May 2017
Pharmaceutical
The European Medicines Agency has recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria. 22 May 2017
Pharmaceutical
Among major pharmaceutical news stories last week were Johnson & Johnson’s upbeat presentation on its R&D pipeline at an investors review day, as well as the announcement that Amgen was filing a Biological License application for its new migraine drug, more data on Shire’s rare disease candidate lanadelumab and Ionis’ inotersen. 21 May 2017
Biosimilars
Following the May meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) it was announced that three new marketing authorizations could not be recommended. 20 May 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive recommendations for six new medicines at its May meeting. 19 May 2017
Biotechnology
Swedish biotech firm Hansa Medical has been accepted onto the European Medicines Agency’s Priority Medicines (PRIME) scheme for lead candidate IdeS, an enzyme being developed to facilitate successful kidney transplantation. 19 May 2017
Pharmaceutical
Astellas Pharma says its partner, MSD KK, the Japanese subsidiary of US pharma giant Merck & Co, has submitted an application for marketing approval of a combination drug of the DPP-4 inhibitor Januvia (sitagliptin) phosphate hydrate and the SGLT2 inhibitor Suglat (ipragliflozin L-proline) for the treatment of type-2 diabetes in Japan. 19 May 2017
Biotechnology
Biotech giant Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab, a treatment designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor. 19 May 2017
Biotechnology
America’s Merck has received approval from US regulators for two new indications for its immuno-oncology drug Keytruda (pembrolizumab). 19 May 2017
Biotechnology
Santhera Pharmaceuticals says its bid to broaden the European label of Raxone (idebenone) has been delayed. 19 May 2017
Generics
Prices for drugs from low and middle-priced segments of the Russian market may increase significantly this year, due to plans of the government to change the scheme of pricing for such categories of drugs, starting from January 1, 2018, reports The Pharma Letter’s local correspondent. 19 May 2017
Biotechnology
Typically, when the US Food and Drug Administration approves an expansion of the indication for a drug, it means that additional clinical data have shown the drug can safely and effectively treat patient populations other than those for which it was originally intended. 19 May 2017
Pharmaceutical
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent. 18 May 2017
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI), the trade group representing the UK’s pharma sector, has praised parts of the manifestos proposed by Labour, the Liberal Democrats and the Conservatives. 18 May 2017
Pharmaceutical
Russia may be faced with a shortage of drugs in the future, due to the forthcoming transition to a new system of drug labeling that may lead to huge interruption in medicines supplies to the country. 18 May 2017
Biotechnology
Shares in USA-based Concert Pharmaceuticals dropped 10% before rallying slightly, as stockholders learned the company’s clinical trial into hair loss candidate CTP-543 has been put on hold by the US Food and Drug Administration. 18 May 2017
Pharmaceutical
Some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. 18 May 2017
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