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
APAC Biotech has been granted with a commercial license by India’s Central Drugs Standard Control Organization (CDSCO) to market product, Apcedene, a dendritic cell-based autologous Immuno-oncology product for four cancer indications. 5 April 2017
Biotechnology
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to extend the use of Opdivo (nivolumab). 5 April 2017
Biotechnology
Trade group AusBiotech has made a submission endorsing proposed changes to improved access options for unapproved therapeutic goods in Australia, which are intended to reduce time and administrative burden and greatly improve efficiencies for applicants. 5 April 2017
Pharmaceutical
The Commonwealth Scientific and Industrial Research Organisation (CSIRO), an Australian government agency responsible for scientific research, is calling for: “action now to establish an ecosystem that will support the growth and innovation of the MTP sector in Australia.” 4 April 2017
Biotechnology
Amgen has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for Xgeva (denosumab). 4 April 2017
Generics
Mallinckrodt has reached an agreement in principle with the US Drug Enforcement Administration (DEA) and the US Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York regarding controlled substances. 4 April 2017
Pharmaceutical
The US Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease, Teva Pharmaceutical has announced. 4 April 2017
Pharmaceutical
Sanofi Pasteur has agreed to pay $19,868,194 to resolve claims that it incorrectly calculated drug prices and thereby overcharged the US Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011, the Department of Justice revealed yesterday. 4 April 2017
Biotechnology
Ireland-headquartered Shire has announced that its partner in Japan, Shionogi , has received the approval of the Japanese Ministry of Health, Labor and Welfare to manufacture and market Intuniv (guanfacine hydrochloride prolonged release). 4 April 2017
Pharmaceutical
Global drugmakers operating in Russia will be obliged to transfer information on the price of their drugs to a single information system operated by the Russian Federal Tax Service, as part of the new state strategy for drugs’ labeling in the Russian pharmaceutical market, reports The Pharma Letter’s local correspondent. 4 April 2017
Pharmaceutical
Further lots have been added to the EpiPen (epinephrine) Auto-Injector devices being recalled because it is feared that they might not work. 3 April 2017
Pharmaceutical
Swiss pharma giant Novartis has received EU approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib) in non-small cell lung cancer (NSCLC). 3 April 2017
Biotechnology
A completed rolling submission has been filed with the US Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel. 3 April 2017
Biotechnology
Privately-held Swiss biotech AB2 Bio has received Breakthrough Therapy Designation from the US Food and Drug Administration for its autoinflammatory candidate IL-18BP (tadekinig alfa). 3 April 2017
Pharmaceutical
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib). 3 April 2017
Pharmaceutical
Most of the headline grabbing news last week focussed on approvals of new medicines and some exciting clinical trial results. Among these were the approvals of Roche’s Ocrevus for multiple sclerosis, Tesaro’s Zejula for treatment of recurrent ovarian cancer and Sanofi’s Dupixent for atopic dermatitis. Also stirring interest was clinical data on Vertex’ combination of tezacaftor and ivacaftor. 2 April 2017
Pharmaceutical
The chief executive for the UK and Ireland at German pharma major Bayer is spending 30% of his time working on issues related to Brexit, he said this week. 1 April 2017
Pharmaceutical
In a new snapshot survey of leading pharmaceutical businesses in the UK, companies have said that changes to the way the National Institute for Health and Care Excellence (NICE) and NHS England (NHSE) assess new medicines coming in to effect today (April 1, 2017), will decrease access to the latest treatments, with new medicines for cancer set to be impacted the most. 1 April 2017
Pharmaceutical
Jubilant Democrats may have to put the champagne cork back in the bottle - the Affordable Care Act (ACA) may not be out of the woods just yet. 31 March 2017
Pharmaceutical
Ahead of its Advisory Committee meeting to discuss the Biologics License Application for nonacog beta pegol, a long-acting factor IX for the treatment of hemophilia B, the US Food and Drug Administration has published briefing documents. 31 March 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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