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
Days after the US Food and Drug Administration (FDA) and privately-held Marathon Pharmaceuticals heralded the approval of the company’s Emflaza (deflazacort) tablets, an oral suspension for Duchenne muscular dystrophy (DMD), its launch has been held back by a major backlash over the proposed price of the treatment. 14 February 2017
Pharmaceutical
A bill to enable regulatory reform measures in Australia stemming from the review of Medicines and Medical Devices Regulation (MMDR) has been delayed. 14 February 2017
Biotechnology
The European Commission has granted marketing authorization for Olumiant (baricitinib) in Europe for the treatment of moderate-to-severe active rheumatoid arthritis. 14 February 2017
Biosimilars
Dr Nicola Davies explores how pharma companies can secure the future of biobetters in the presence of biosimilars and increased payer scrutiny on high prices. 14 February 2017
Generics
Prices for drugs under public procurements in Russia may significantly increase in the event of the implementation of the latest initiative of the Russian Ministry of Health. 14 February 2017
Biotechnology
Draft guidance has been published recommending the routine use of the cancer drug Iclusig (ponatinib) on the UK’s National Health Service (NHS). 13 February 2017
Pharmaceutical
On Friday, Dr Tom Price was sworn in as the new US Secretary of Health and Human Services. 12 February 2017
Pharmaceutical
At its meeting this week, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency concluded a safety review and started two new ones. 10 February 2017
Biotechnology
US pharma major Bristol-Myers Squibb has reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for Opdivo (nivolumab). 10 February 2017
Pharmaceutical
The US Food and Drug Administration yesterday approved Emflaza (deflazacort) tablets and oral suspension to treat patients age five years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. 10 February 2017
Pharmaceutical
Warnings that patients could face delays in accessing new drugs if the UK withdraws from the European Medicines Agency (EMA) as part of the Brexit process have been issued by senior figures in British healthcare. 10 February 2017
Biosimilars
This week, Medicines for Europe engaged alongside its Irish national association Health Enterprise Alliance (HEA) in illustrating the benefits of stimulating competition in the biologic medicines market in Ireland. 10 February 2017
Pharmaceutical
Denmark has a high-profile supporter in its bid to become the new home of the European Medicines Agency (EMA) – the diabetes giant Novo Nordisk. 9 February 2017
Pharmaceutical
An update to its label means US pharma major Eli Lilly’s diabetes drug Trulicity (dulaglutide) is the first and only glucagon-like peptide-1 (GLP-1) receptor agonist that can be used in combination with mealtime insulin or basal insulin. 9 February 2017
Pharmaceutical
Carole Longson spent eight years developing novel pharmaceuticals at GlaxoSmithKline, before crossing the floor to join the UK’s national health watchdog, the National Centre for Health and Care Excellence (NICE). The Pharma Letter speaks with her about the importance of cost-effectiveness, the value of the revised Cancer Drugs Fund, the growing role played by real-world evidence, and her hopes for a positive decision on Kadcyla (trastuzumab emtansine). 8 February 2017
Biotechnology
Amgen yesterday revealed that the US Food and Drug Administration has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. 8 February 2017
Pharmaceutical
US drugmaker Alexion Pharmaceuticals has again criticized the National Institute for Health and Care Excellence (NICE) after the body chose to exclude a certain patient group in its recommendation of Strensiq (asfotase alfa) for pediatric-onset hypophosphatasia (HPP) in England. 7 February 2017
Biotechnology
Biogen boss Michel Vounatsos and his predecessor George Scangos, Bluebird Bio chief executive Nick Leschly and John Maraganore, the man at the helm of Alnylam Pharmaceuticals, are just a few of the 166 biotech leaders who have opposed an executive order signed by US President Donald Trump barring the entry of citizens from seven predominantly-Muslim countries into the USA. 7 February 2017
Pharmaceutical
Flexion Therapeutics today announced that the US Food and Drug Administration has accepted for filing the company’s New Drug Application for its lead investigational product candidate Zilretta (also known as FX006). 7 February 2017
Pharmaceutical
From today (February 7), children aged two to five in Australia will have immediate and free access to Kalydeco (ivacaftor) – a life-changing drug that addresses the causes of cystic fibrosis rather than just the symptoms. 7 February 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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