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
Ophthalmic drug developer NicOx has resubmitted its application to the US Food and Drug Administration for Zerviate (cetirizine ophthalmic solution) the company’s novel cetirizine eye drop formulation. 9 March 2017
Pharmaceutical
Leading UK research body the Institute for Cancer Research (ICR) is calling on European regulators to close a “cancer loophole” that it says allows drugmakers to focus cancer research on larger, more lucrative adult populations, while neglecting younger patients. 9 March 2017
Pharmaceutical
The 505(b)(2) approval pathway for new drug applications (NDAs) in the USA is not shortening approval times, according to an analysis conducted by research group the Tufts Center for the Study of Drug Development (CSDD). 8 March 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending Parsabiv (etelcalcetide) recommending the drug as an option for treating secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis on the National Health Service. 8 March 2017
Pharmaceutical
House committees in the US capital plan to begin voting on the replacement of the Affordable Care Act (ACA) on Wednesday. 8 March 2017
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report and Meeting Summary on the comparative clinical effectiveness and value of disease-modifying therapies (DMTs) for treatment of relapsing-remitting and primary progressive multiple sclerosis (RRMS and PPMS). 8 March 2017
Pharmaceutical
The Russian government is ready to allow the production of anti-HIV drugs bypassing patents of their right-holders, reports The Pharma Letter’s local correspondent. 8 March 2017
Pharmaceutical
Access to medicinal cannabis has taken another major step forward today with first license being granted for an Australian company to grow and harvest medicinal cannabis, the Department of Health and Ageing announced today. 8 March 2017
Pharmaceutical
For more than a decade, analysts and industry insiders have discussed the potential impact of data in healthcare, but what has actually changed, and what changes are yet to come? 7 March 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Vectibix (panitumumab) as an option for patients with previously untreated, RAS wild-type metastatic colorectal cancer (MCC) in adults in combination with the FOLFOX or FOLFIRI chemotherapy regimes. 7 March 2017
Biotechnology
Switzerland-based Actelion announced today that the European Commission has granted marketing authorization for the use of Ledaga (chlormethine gel) 160 micrograms/g for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). 7 March 2017
Pharmaceutical
The US Food and Drug Administration has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes. 7 March 2017
Pharmaceutical
Though India makes up 16% of the world's population and 20% of the world's disease burden, less than 1.4% of global clinical trials are carried out in the country. 6 March 2017
Biotechnology
TiGenix say it has received a Day 180 List of Outstanding Issues (LoOI) notice from the European Medicine Agency for its experimental gastroenterology candidate Cx601. 6 March 2017
Pharmaceutical
The average productivity of life sciences employees in the UK, expressed as Gross Value Added (GVA), is £104,000 ($128,000), compared to the GVA average of £49,000, according to a new report. 6 March 2017
Pharmaceutical
Dublin, Ireland-headquartered Allergan and American specialty pharmaceutical company Serenity Pharmaceuticals have received approval from the US Food and Drug Administration for Noctiva (desmopressin acetate). 6 March 2017
Biosimilars
The Russian Ministry of Health has awarded domestic biotech firm Biocad marketing authorization for its interferon beta-1a biosimilar, a knockoff of Rebif. 6 March 2017
Pharmaceutical
Trade group Medicines Australia does not accept the findings of the latest Grattan Institute report on medicine prices, calling it “inaccurate, selective and misleading.” 6 March 2017
Pharmaceutical
The introduction in the USA of legislation to encourage the importation of cheaper prescription drugs from Canada and elsewhere could have serious impact on drugmakers. Last week also saw focus on the decline of the hepatitis C market as a result of the success of new drugs to treat the condition. Additionally, there was excitement around potential new drugs from La Jolla, Kite Pharma and Chi-Med. 5 March 2017
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has said that, in an early benefit assessment investigating whether palbociclib offers advantages for patients over the appropriate comparator therapies in advanced breast cancer, the drug’s disadvantages predominate in certain patients. 4 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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