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
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
Pharmaceutical
The European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. 19 December 2016
Generics
Bangladeshi generic drugs company Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a generic equivalent of Glucophage XR tablets (metformin hydrochloride). 19 December 2016
Pharmaceutical
Based on a US Food and Drug Administration review of a large clinical trial that FDA required the drug companies to conduct, the agency has determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. 19 December 2016
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. 19 December 2016
Pharmaceutical
The proposed new measures of the Ministry of Health prove to be disastrous for both the right of Greek patients to unhindered and fair access to the necessary treatments and for public health and the viability of the pharmaceutical industry. 19 December 2016
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
Pharmaceutical
Agios Pharmaceuticals saw its shares drop 20% to $44.74 today, after it announced that development of its second pyruvate kinase-R (PKR) activator, AG-519, was to be discontinued. 16 December 2016
Pharmaceutical
The publication of a second draft recommendation not recommending use of Takeda’s Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma (R/R HL) on the National Health Service (NHS), has prompted fresh criticism from the Japanese drugmaker. 16 December 2016
Pharmaceutical
Grünenthal says that the US Food and Drug Administration has granted Breakthrough Therapy designation to neridronic acid. 16 December 2016
Generics
Mylan on Friday announced the US launch of the authorized generic for EpiPen (epinephrine injection, USP) Auto-Injector at a wholesale acquisition cost (WAC) of $300 per epinephrine injection, USP two-pack. 16 December 2016
Generics
The UK’s Competition and Markets Authority (CMA) has accused generic drugmaker Actavis UK of breaking competition law by raising the price for hydrocortisone tablets paid by the National Health Service. 16 December 2016
Pharmaceutical
The prices of prescription branded drugs widely used by older Americans rose by an average of 15.5% in 2015, some 130 times above inflation, according to a new report. 15 December 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Japanese drugmaker Takeda’s Adcetris (brentuximab vedotin) to treat some patients with Hodgkin’s lymphoma on the National Health Service (NHS). 15 December 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC consulted on a proposal to list ranibizumab (Lucentis) and aflibercept (Eylea) in Section H of the Pharmaceutical Schedule from November 1, 2016 for the second and third line treatment (respectively) of wet age-related macular degeneration (wAMD). 15 December 2016
Generics
The US Department of Justice (DoJ) has announced two former senior generic pharmaceutical executives have been charged over price-fixing of generic medicines. 15 December 2016
Biotechnology
GlaxoSmithKline has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy. 15 December 2016
Biotechnology
New York Mayor Bill de Blasio has announced $500 million in funding in a bid to establish the city as a leader in life sciences innovation and research and development (R&D). 14 December 2016
Pharmaceutical
USA-based Intercept Pharmaceuticals has won conditional marketing authorization from the European Commission for its liver disease drug Ocaliva (obeticholic acid). 14 December 2016
Biosimilars
The 2017 Finance Bill, recently approved by the Republic of Italy's Senate, includes important provisions favoring biosimilar medicines, a significant landmark that will increase competition among biotech drug companies. 14 December 2016
Pharmaceutical
Swissmedic has published amendments to regulations for drug manufacturers when highlighting changes to manuscripts of medicinal product information relating to their products. 14 December 2016
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