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
Novartis has successfully extended the marketable use of Zykadia in Europe, to include the first-line treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC). 30 June 2017
Biotechnology
The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Vectibix (panitumumab). 30 June 2017
Pharmaceutical
Against a backdrop of ever-increasing requests for Orphan Drug designation in the USA, the Food and Drug Administration today unveiled a strategic plan to eliminate the agency’s existing backlog of requests and ensure continued timely response to all new requests for designation with firm deadlines. 29 June 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending Eli Lilly’s Olumiant (baricitinib) for some people with rheumatoid arthritis (RA). 29 June 2017
Pharmaceutical
The European Commission today launched its new European Union action plan to tackle antimicrobial resistance (AMR) – a growing threat that is responsible for 25,000 deaths in the EU every year. 29 June 2017
Biotechnology
UK pharma major GlaxoSmithKline has filed for US approval for an expanded indication of its an interleukin-5 (IL-5) antagonist for the treatment of a rare disease. 29 June 2017
Pharmaceutical
Netherlands-headquartered independent drugmaker Norgine says the US Food and Drug Administration has accepted and will review the company’s regulatory submission for Plenvu. 29 June 2017
Pharmaceutical
The US Federal Trade Commission is currently accepting public comments on an application by Grifols, a Spain-based manufacturer of plasma-derived drugs, to amend the terms of a manufacturing agreement that was part of a 2011 FTC-ordered divestiture. 29 June 2017
Pharmaceutical
Eisai has temporarily withdrawn its new drug application for its anticancer agent Halaven (eribulin mesylate) in China. 28 June 2017
Biotechnology
The European Medicines Agency has given PRIME designation to Global Blood Therapeutics’ sickle cell disease candidate GBT440. 28 June 2017
Pharmaceutical
The UK’s health technology assessor has provided a positive recommendation on Afinitor, from Novartis, and Sutent, from Pfizer. 28 June 2017
Pharmaceutical
The US Institute for Clinical and Economic Review (ICER) has agreed to work closely with the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services office (PBM) to support its use of ICER drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry. 28 June 2017
Generics
The US Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. 28 June 2017
Biosimilars
The US Food and Drug Administration anticipates that interchangeable biosimilars will be available in the USA within two years. 28 June 2017
Pharmaceutical
US Republican attempts to rush through US President Donald Trump’s beleaguered Obamacare replacement look likely to fail, as the Congressional Budget Office found the bill would deny millions of Americans coverage. 27 June 2017
Biosimilars
The European Commission has approved Erelzi (biosimilar etanercept) for use in Europe for the treatment of multiple inflammatory diseases. 27 June 2017
Pharmaceutical
Spain’s leading drugmaker Almirall has received European clearance to market Skilarence (dimethyl fumarate), a new oral formulation of a type of fumaric acid ester, for the treatment of patients with moderate-to-severe chronic plaque psoriasis. 27 June 2017
Pharmaceutical
Health economists have given the UK an “amber warning” on the potential consequences of leaving the European Medicines Agency, in a new research paper. 27 June 2017
Biotechnology
The European Commission has granted marketing authorization for Kevzara (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis. 27 June 2017
Biotechnology
A New Drug Application (NDA) for Jatenzo (formerly Rextoro), US biotech firm Clarus Therapeutics’ oral testosterone (T) replacement product for the treatment of low testosterone in hypogonadal men, has been re-submitted, to the US Food and Drug Administration. 27 June 2017
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