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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Pharmaceutical
An inquiry has been launched by the House of Lords into a strategy promised to make the UK the best place in the world to invest in life sciences. 21 July 2017
Biotechnology
US biotech Amgen has had its Biologics License Application (BLA) for the migraine treatment Aimovig (erenumab) accepted by the US Food and Drug Administration (FDA). 21 July 2017
Biotechnology
Privately-held Italian company Dompé has had its marketing authorization application of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis approved by the European Commission (EC). 21 July 2017
Pharmaceutical
Swiss pharma group Vifor Pharma has received European marketing authorization for Veltassa a sodium-free potassium binder for the treatment of hyperkalemia in adult patients. The company filed for approval in April 2016. 21 July 2017
Biosimilars
The US Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin in a pre-filled dosing device. 21 July 2017
Pharmaceutical
Yesterday’s announcement that the European Ombudsman Emily O’Reilly is instigating an inquiry into the European Medicines Agency’s pre-submission meetings with pharmaceutical companies regarding marketing authorization applications (MAAs) has prompted a response from trade group the European Federation of Pharmaceutical Industries and Associations (EFPIA). 21 July 2017
Pharmaceutical
The New Drug Application (NDA) for Yonsa (abiraterone acetate) ultramicrosize tablets has been accepted for filing by the US Food and Drug Administration, says privately-held company Churchill Pharmaceuticals. 20 July 2017
Biotechnology
Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy, has been granted full marketing authorization in all 28 EU member countries plus Iceland, Liechtenstein and Norway. 20 July 2017
Biotechnology
Israel’s Teva Pharmaceutical has received a positive recommendation for Cinqaero from the UK’s health technology assessor, the National Institute for Health and Care Excellence. 20 July 2017
Pharmaceutical
European Ombudsman Emily O’ Reilly has written to Guido Rasi, executive director of the European Medicines Agency (EMA), to notify him of her inquiry into the regulator’s meetings with drug companies before they have submitted marketing authorization applications (MAAs). 20 July 2017
Biotechnology
The pharmaceutical industry is one of the UK’s great success stories, writes Michael Jewell, healthcare partner at Cavendish Corporate Finance, in an Expert View piece on how the sector could see an increase in deal-making as Brexit looms. 20 July 2017
Biotechnology
The USA-based not-for-profit Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of chimeric antigen receptor T-cell (CAR-T) therapies for treatment of certain types of cancer. 20 July 2017
Pharmaceutical
A pilot program’s progress in streamlining drug approvals for the China market has been described as ‘only the beginning’ of a scheme designed to give Chinese patients access to more drugs, more quickly and more affordably. 19 July 2017
Pharmaceutical
The latest Republican attempts to replace or repeal the Affordable Care Act – former President Barack Obama’s signature policy that is nicknamed Obamacare – have gone the way of those before them, ending in failure. 19 July 2017
Pharmaceutical
The surge in international companies wanting to partner in Korea reflects a flourishing South Korean pharma economy, which, in recent years, has become the third largest pharma region in Asia. 19 July 2017
Pharmaceutical
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) today published its updated clinical guideline on Parkinson's disease. 19 July 2017
Biotechnology
The US Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of adults with chronic hepatitis C virus (HCV). 19 July 2017
Pharmaceutical
A white paper with input from a host of experts from big pharma has looked into the extent to which the US market is moving towards value-based contracts that reward manufacturers on outcomes rather than volume. 19 July 2017
Pharmaceutical
Gedeon Richter has been granted marketing authorization from the European Commission for Reagila (cariprazine), a novel antipsychotic for the treatment of schizophrenia in adult patients. 19 July 2017
Pharmaceutical
The launch of a new Russian-Nicaraguan vaccine production, which was recently established in the city of Managua with the aim of becoming one of the largest in Central and Latin America, will be postponed for the end of the current year, according to press-service of the Russian Ministry of Health. 19 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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