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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Generics
The total number of Abbreviated New Drug Applications (ANDAs) from the US Food and Drug Administration for Indian pharma firms rose to 129 this year, an increase of 45% from the number of 89 for the period of January-July of 2015. 31 July 2017
Biotechnology
The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 12 to 1 that the safety data for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]) support licensure for immunization against hepatitis B infection in adults 18 years of age and older. 29 July 2017
Pharmaceutical
Drugs will be the subject for total labeling in the Russian pharmaceutical market according to a recent draft law, which was submitted for the consideration of the national Parliament (State Duma) by the Russian national government, reports The Pharma Letter’s local correspondent. 29 July 2017
Biotechnology
The European Commission has granted Maviret (glecaprevir/pibrentasvir) marketing authorization for chronic hepatitis C virus (HCV) in all major genotypes. 28 July 2017
Pharmaceutical
Danish CNS specialist Lundbeck and Japan’s Otsuka Pharmaceutical have announced that Abilify Maintena (aripiprazole) for extended-release injectable suspension has been approved by the US Food and Drug Administration (FDA) for the maintenance monotherapy treatment of bipolar I disorder in adults. 28 July 2017
Biotechnology
US biotech Gilead Sciences has received Marketing Authorization from the European Commission for a triple-combination therapy which could cure hepatitis C virus (HCV) patients who do not respond to direct-acting antiviral (DAA)-containing regimens. 28 July 2017
Pharmaceutical
Donald Trump has suffered arguably his biggest setback as US President yet, with a humiliating defeat in his attempts to repeal Obamacare. 28 July 2017
Biotechnology
The Australian government today announced another significant step to eliminate hepatitis C from Australia by subsidizing a new drug which can treat all forms of the disease with an expected success rate of 90%. 28 July 2017
Biotechnology
The US non-profit Institute for Clinical and Economic Review (ICER) has released its preliminary list of prescription drug review topics for 2018. 28 July 2017
Pharmaceutical
The European Commission has approved an update to the Victoza (liraglutide) label in the European Union that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events as integral parts of type 2 diabetes treatment. 28 July 2017
Pharmaceutical
In an increasingly attritional attempt to stay true to his campaign pledge of repealing and replacing his predecessor Barack Obama’s signature health policy, US President Donald Trump has suffered another setback. 27 July 2017
Pharmaceutical
Ireland-incorporated Allergan said today that the National Institute of Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD), recommending that Truberzi (eluxadoline) be made available on the National Health Service for adults living with irritable bowel syndrome with diarrhea (IBS-D). 27 July 2017
Pharmaceutical
The European Commission (EC) has approved Orencia (abatacept) alone or in combination with methotrexate for the treatment of active psoriatic arthritis (PsA) adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required. 27 July 2017
Pharmaceutical
The US Food and Drug Administration has approved Japanese pharma major Eisai’s supplemental New Drug Application (sNDA) for Fycompa (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. 27 July 2017
Pharmaceutical
AstraZeneca’s failure to meet a primary endpoint in the Mystic trial in lung cancer is grabbing the headlines and impacting financial markets today, but in breast cancer the company has had better news. 27 July 2017
Generics
Netherlands-incorporated generic drugmaker Mylan has received approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) for its application for sofosbuvir tablets, 400mg, a generic version of Gilead Sciences' Sovaldi. 26 July 2017
Biotechnology
In a setback for the company’s blockbuster immuno-oncology therapy, America’s Merck & Co announced the pivotal KEYNOTE-040 Keytruda trial did not meet its primary endpoint of overall survival. 26 July 2017
Pharmaceutical
The Republicans finally took a step towards achieving President Donald Trump’s key campaign pledge of replacing the Affordable Care Act (ACA) on Tuesday evening, though only by convincing Senators to debate the issue. 26 July 2017
Pharmaceutical
The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants. 26 July 2017
Biotechnology
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) final draft guidance recommends the use of blood cancer drug Gazyvaro (obinutuzumab) with bendamustine for use within the Cancer Drugs Fund (CDF). 26 July 2017
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
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