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
US-based AcelRx believes that its lead investigational compound ARX-04 has the potential to produce over $1 billion in revenue in the US. 9 January 2017
Pharmaceutical
Last week, the Spanish trade group Farmaindustria, the Ministry of Finance and Public Function and Health and the Ministry of Social Services and Equality signed the Agreement that renews, for 2017, the Protocol of Collaboration agreed back in November 2015 with the common objective to ensure the sustainability of the National Health System (NHS) and the access of citizens to pharmaceutical innovations. 9 January 2017
Pharmaceutical
The biopharmaceutical industry's desire for inorganic growth is expected to intensify an already heated mergers and acquisitions (M&A) environment in 2017. 9 January 2017
Pharmaceutical
Shares of biotech Innocoll Holdings tumbled as much as 65% on December 30, after the US Food and Drug Administration issued a refusal to file letter for the company's product candidate for a treatment for post-surgical pain Xaracoll. 8 January 2017
Pharmaceutical
The US Office of Congressional Ethics (OCE) and the US Securities and Exchange Commission (SEC) should look more closely at the stock trading activity of US Representatives Tom Price (Republican, Georgia.) and Chris Collins (Republican, New York) for conflicts of interest and possible insider trading, consumer advocacy Public Citizen said in a letter yesterday. 6 January 2017
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which concludes that an additional benefit for Kisplyx (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC, or kidney cancer) versus the established comparator therapy. 5 January 2017
Generics
Wockhardt on Wednesday revealed that it had received another US Food and Drug Administration warning letter for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat. 5 January 2017
Pharmaceutical
Pharmaceutical companies are increasingly using social media as a platform for their communications and advertising, enabling them to engage more actively with consumers and healthcare professionals, notes Dr Nicola Davies in her exclusive monthly FDA Blog for The Pharma Letter. 5 January 2017
Biotechnology
Ocular Therapeutix will submit a New Drug Application (NDA) to the US Food and Drug Administration for Dextenza (dexamethasone) in the first quarter of 2017. 5 January 2017
Pharmaceutical
Bayer has announced that its Supplemental New Drug Application (sNDA) for Stivarga (regorafenib) will be reviewed under the US Food and Drug Administration’s priority review scheme. 4 January 2017
Biotechnology
Swedish Orphan Biovitrum has received approval from Health Canada for its Orfadin (nitisinone) capsules for hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 4 January 2017
Pharmaceutical
Ireland-incorporated drugmaker Allergan finished Tuesday’s trading 3% up at $216.19 as markets and analysts reacted to drug price rises which the company limited to single figures – but only just. 4 January 2017
Generics
Russian drugmakers will be allowed to produce one drug under different brand names, which should help to accelerate the process of import substitution in the industry, according to a recent decision of the Russian government. 3 January 2017
Biotechnology
The US Food and Drug Administration approved a total of 22 new chemical entities during 2016, a disappointing six-year low. 3 January 2017
Biotechnology
China's first oral antiviral drug, dubbed danoprevir (ASC08), for treating hepatitis C virus (HCV) has been accepted for review by the Chinese Food and Drug Administration (CFDA). 1 January 2017
Pharmaceutical
The US Food and Drug Administration has issued a Refusal to File letter for Xaracoll (bupivacaine HCl collagen-matrix implants), a product candidate for the treatment of postsurgical pain. 30 December 2016
Pharmaceutical
The UK’s system for assessing the cost-effectiveness of medicines has long been criticized and the latest to slam the negations between drugmakers and the National Health Service (NHS) is AstraZeneca chief executive Pascal Soriot. 30 December 2016
Biotechnology
Shares of US antibiotics developer Cempra (Nasdaq: CEMP) slumped 53.4% to $2.85 in early trading this morning, following news late Thursday of a significant delay in the development of its pneumonia drug candidate. 29 December 2016
Pharmaceutical
Our quarterly Special Report from experts at QuintilesIMS provides scientific and practical insights on Post Authorization Safety Studies based on the first three years since implementation of the new European Union legislation, offering forecasts for likely advances in 2017. 29 December 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Kadcyla (trastuzumab emtansine), a breast cancer drug currently available through the UK’s Cancer Drugs Fund (CDF). 29 December 2016
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