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
The US Food and Drug Administration on Friday approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. 6 May 2017
Biotechnology
The European Commission has approved Keytruda (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. 5 May 2017
Pharmaceutical
The new UK Health Services Medical Supplies Bill has now completed its path through Parliament and is now law. 5 May 2017
Biosimilars
A joint statement from bodies representing European pharmaceutical, biotech and biosimilar drugmakers has said that they welcome increased competition in the biologics markets. 5 May 2017
Biotechnology
US pharma giant Pfizer has said it will offer women in the UK its novel breast cancer therapy Ibrance for free, while the country’s reimbursement agency decides whether or not to fund the drug. 5 May 2017
Pharmaceutical
Denmark-based allergy specialist ALK Abello has received Canadian approval for its house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT), Acarizax. 5 May 2017
Pharmaceutical
The US House of Representatives, led by Republicans, has fulfilled its seven-year effort to undo the Affordable Care Act, commonly referred to as ‘Obamacare,’ voting to repeal and replace it by a narrow margin of 217-213 votes. 4 May 2017
Pharmaceutical
The Spanish pharmaceutical market is set to see a slight rise in value from $23.7 billion in 2016 to $25.1 billion by 2021, registering a compound annual growth rate approaching 1%, new research shows. 4 May 2017
Biotechnology
A trade group representing France’s biotech industry has issued a warning about the protectionist policies proposed by one of the candidates standing in Sunday’s French presidential election. 4 May 2017
Biotechnology
The president and chief executive of leading biotech trade group the Biotechnology Innovation Organization (BIO) has launched a scathing attack on a report which blames pharma companies for high drug prices. 4 May 2017
Biosimilars
The World Health Organization has announced that it will begin a pilot project this year for prequalifying biosimilar medicines to make some of the most expensive cancer treatments more widely available in low and middle-income countries. 4 May 2017
Generics
Generic drugmaker Perrigo lost 5% in its stock-market value on Wednesday, closing at $72.35, amid news of a raid on its corporate offices in relation to the US Department of Justice Antitrust Division investigation into price fixing. 4 May 2017
Pharmaceutical
Spending on pharmaceutical products in the USA saw growth during 2016, but at a much slower rate than in the previous two years, according to new research. 4 May 2017
Pharmaceutical
The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) have published their final version of a template for investigators to use when organizing clinical trial protocols. 3 May 2017
Pharmaceutical
China’s detailed pilot plan for the Marketing Authorization Holder (MAH) system, which is seen as a revolutionary process in the development of biopharmaceutical innovation in the country, will be discussed at CPhI & P-MEC China – organized by UBM EMEA and UBM SINOEXPO and set to take place June 20-22. 3 May 2017
Biotechnology
The China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir). 3 May 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has recommended Stelara (ustekinumab) in its Final Appraisal Determination (FAD) for adult patients with moderately to severely active Crohn’s disease. 2 May 2017
Biotechnology
The US Food and Drug Administration has granted accelerated approval to Imfinzi (durvalumab), the agency’s latest approval for a PD-L1 checkpoint inhibitor. 2 May 2017
Pharmaceutical
German pharma major Bayer and development partner, Janssen Research & Development, part of US healthcare giant Johnson & Johnson, have announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration to update the prescribing information for Xarelto (rivaroxaban). 2 May 2017
Pharmaceutical
The Independent Payment Advisory Board (IPAB), a US government agency created as part of Barack Obama’s Affordable Care Act, has come under further criticism from pressure groups which are asking for it to be repealed. 2 May 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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