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
Today's issue
Refine Search
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
The US Food and Drug Administration approved Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. 24 March 2017
Pharmaceutical
The International Society of Cellular Therapy (ISCT) believes that the massive and unprecedented budget cuts to US governmental scientific agencies including the (National Institutes of Health (NIH) and National Science Foundation (NSF) proposed by US President Donald Trump, if implemented, will have wide ranging and potentially life threaten in ramifications to science, clinical care and patients in the US and internationally. 24 March 2017
Pharmaceutical
The European Medicines agency is expected to complete its review of brexpiprazole for use in schizophrenia, according to the drug’s developers. 23 March 2017
Biotechnology
There was good news for US clinical-stage biotech Akashi Therapeutics yesterday, when it received permission to resume development of its Duchenne drug candidate. 23 March 2017
Biotechnology
Canada’s federal budget for 2017 has been welcomed by a biotech trade group for supporting the advancement of the industry. 23 March 2017
article
India’s Union Health Ministry plans to create a digital platform to track and regulate sale of quality drugs in the country, according to a posting on Brand India Pharma*. 23 March 2017
Biosimilars
Key authorities, eminent lawyers and industry leaders this week discussed in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. 23 March 2017
Biotechnology
US-based Boston Biomedical is making new senior appointments in oncology, as the company’s founder Chiang J. Li steps down from his role as chief executive. 23 March 2017
Pharmaceutical
The application of cost-effectiveness criteria is a hallmark of the UK’s approach to health technology assessment, differentiating it from many other European countries. It’s an approach which raises ethical considerations around access to medical technology; which drugs we should fund and which diseases, which patients, we should treat. 22 March 2017
Pharmaceutical
Ireland-headquartered Shire today announced that the US Food and Drug Administration has granted the company Fast Track designation for its rare disease candidate SHP655. 22 March 2017
Pharmaceutical
In a U-turn by the US agency, the Food and Drug Administration on Tuesday approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. 22 March 2017
Pharmaceutical
The Russian Federal Antimonopoly Service (FAS) is discussing with the government lifting of the "third extra" rule for public procurement of drugs, according to recent statements of Igor Artemyev, head of the FAS, reports The Pharma Letter’s local correspondent. 22 March 2017
Pharmaceutical
Up to 10 domestic and leading global drugmakers operating in the Russian market are considering reducing prices for their drugs, and in particular those intended for the treatment of the most serious diseases, including HIV/AIDS, hepatitis C, tuberculosis and some others, reports The Pharma Letter’s local correspondent. 21 March 2017
Pharmaceutical
Texan analgesia specialist Pain Therapeutics has announced positive regulatory guidance from a recent meeting with the US Food and Drug Administration, regarding lead candidate Remoxy (oxycodone). 21 March 2017
Generics
The US Food and Drug Administration under the US President's Emergency Plan for AIDS Relief (PEPFAR) has approved the New Drug Application for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400mg/300mg/300mg ("TLE400"). 21 March 2017
Pharmaceutical
The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017 for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%. 21 March 2017
Biotechnology
The Therapeutics Goods Administration (TGA) is investigating ways that it might provide support for small- and medium-enterprises (SMEs) in accessing regulatory guidance, and seeks feedback on the key themes that emerged in initial discussions with trade group AusBiotech and industry. 21 March 2017
Pharmaceutical
USA-based Rich Pharmaceuticals has reached agreement with I Tech Health Corp to form a subsidiary and launch CannCodex to serve the medicinal cannabis industry as well as provide data and services to pharmaceutical companies worldwide. 21 March 2017
Pharmaceutical
Multinational pharma companies have long been complaining that it takes too long to get their drugs into the Chinese market, reports The Pharma Letter’s local correspondent Wang Fangqing. 20 March 2017
Pharmaceutical
US lipid management firm Esperion Therapeutics leapt as much as 52% in morning trading today, after getting positive regulatory feedback on its cholesterol lowerer. 20 March 2017
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze