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
Russian President Vladimir Putin was told on a visit to Biocad, one of the country’s leading biotech companies, that the quality of Russia's research and development (R&D) and manufacturing meant it could “absolutely compete with foreign counterparts” in the pharmaceutical industry. 28 December 2016
Biotechnology
Seattle Genetics has revealed receipt of a notice from the US Food and Drug Administration that a clinical hold or partial clinical hold has been placed on several early stage trials. 28 December 2016
Pharmaceutical
The US Food and Drug Administration has approved Adynovate (antihemophilic Factor [recombinant], PEGylated), an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. 28 December 2016
Biotechnology
The US Food and Drug Administration has approved Spinraza (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. 27 December 2016
Biotechnology
China-based vaccines developer Sinovac Biotech (Nasdaq: SVA) responded to a recent report regarding the allegations raised in a research report by Geoinvesting. 23 December 2016
Pharmaceutical
Following the Colombian Ministry of Health’s recent decision to lower the price of its cancer drug Glivec/Gleevec (imatinib), Swiss pharma giant Novartis has advised The Pharma Letter that it proposes to take action. 23 December 2016
Pharmaceutical
Aerie Pharmaceuticals today revealed that the manufacturing line related to its glaucoma treatment Rhopressa (netarsudil ophthalmic solution) will not be ready in time for pre-approval inspection by the Food and Drug Administration. 23 December 2016
Pharmaceutical
Medical practitioner and politician Andrew Southcott will chair the new Australian Advisory Council on the Medicinal Use of Cannabis. 23 December 2016
Biotechnology
Belgian biopharma firm TiGenix has submitted its responses to the European Medicines Agency's (EMA) day 120 list of questions for Cx601, its lead product candidate being developed for complex perianal fistulas in Crohn's disease. 23 December 2016
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of Otezla (apremilast). 22 December 2016
Pharmaceutical
The price of Swiss pharma giant Novartis’ cancer drug Glivec/Gleevec (imatinib) will now be 44% lower in Colombia than previously, the country’s health authorities have decided. 22 December 2016
Pharmaceutical
The US Senate’s Special Committee on Aging has published a damning report on pharma companies’ manipulation of loopholes in the system so they can raise prices of off-patent drugs massively. 22 December 2016
Pharmaceutical
Fresh from its decision to intervene over the price of the multi-indication cancer drug Opdivo (nivolumab), the Japanese government has unveiled new plans to reduce the cost of health care. 21 December 2016
Pharmaceutical
Translating bold campaign trail claims of “repeal and replace” into legislative action can often be challenging with any established bill, let alone one as complex as the Affordable Care Act (ACA). 21 December 2016
Pharmaceutical
Sweeping changes are afoot at India's Health Ministry to encourage innovation in the pharmaceutical sector and to ensure speedier approvals for conducting medical research, reports The Pharma Letter's India correspondent. 21 December 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to investigational drug JCAR017. 21 December 2016
Pharmaceutical
The European Commission (EC) has authorized the extension of the label for all metformin-containing products for all metformin-containing products for the treatment of type 2 diabetes. 21 December 2016
Pharmaceutical
What more does pharma and biotech know now about the implications of Brexit six months after the UK population voted to leave the European Union? 19 December 2016
Biotechnology
The US Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. 19 December 2016
Biotechnology
Merck & Co has received approval in Japan for its immuno-oncology drug Keytruda (pembrolizumab) to treat certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first and second-line treatment settings. 19 December 2016
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