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
Joe Jimenez, the chief executive of Swiss pharma giant Novartis and chairman-elect of US trade group PhRMA, has said that he expects Donald Trump’s administration to come back with proposals on making prescription drugs more affordable for Americans within three months. 1 June 2017
Biotechnology
Breakthrough Therapy designation has been granted by the US Food and Drug Administration for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the prophylaxis of attacks in patients with acute hepatic porphyria (AHP). 1 June 2017
Pharmaceutical
Ohio is to become the second US state to sue the pharmaceutical industry over its role in the opioid epidemic currently facing America, after Mississippi. 1 June 2017
Pharmaceutical
The US Food and Drug Administration has approved the Biologics License Application for Rebinyn (nonacog beta pegol; N9-GP) for the treatment of adults and children with hemophilia B. 1 June 2017
Biotechnology
French biotech firm Nicox saw its shares rise 18% to 12.55 euros by late-afternoon trading today, after the company announced it has received its first drug approval from the US Food and Drug Administration. 31 May 2017
Biotechnology
The National Institute of Health and Care Excellence (NICE) has issued a positive Final Evaluation Determination (FED) recommending Cerdelga (eliglustat) as a first-line treatment for adult patients with type 1 Gaucher disease, a very rare and inherited genetic condition which can be life-threatening in severe cases. 31 May 2017
Pharmaceutical
The Cystic Fibrosis Engagement Network, a project of the Alliance for Patient Access, today released a new white paper, “Making Treatment Accessible for Cystic Fibrosis Patients.” 31 May 2017
Pharmaceutical
The European Commission has granted approval for Trumenba (meningococcal group B vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. 31 May 2017
Biosimilars
Sandoz, a division of Swiss pharma giant Novartis, has had its proposed adalimumab and infliximab biosimilars accepted for regulatory review by the European Medicines Agency (EMA). 31 May 2017
Generics
Several drugmakers have simultaneously received US Food and Drug Administration approval for copycat versions of Strattera (atomoxetine), a treatment for attention-deficit/hyperactivity disorder in pediatric and adult patients. 31 May 2017
Pharmaceutical
In a report likely to please French and Scandinavian readers and have the opposite effect on Italians and Spaniards, the cities hoping to host the new headquarters of the European Medicines Agency (EMA) have been ranked by the financial services firm KPMG. 30 May 2017
Pharmaceutical
Partnerships between UK and European Union medical researchers have increased the value of research, benefiting patients across Europe, according to a report published today (May 30). 30 May 2017
Generics
Women’s health specialist Mithra has received a Marketing Authorization (MA) for the commercialization of Tibelia (tibolone), a generic version of Livial, in France. 30 May 2017
Biotechnology
TaiGen Biotechnology has submitted a new drug application (NDA) for the intravenous formulation of Taigexyn (nemonoxacin) to the China Food and Drug Administration (CFDA). 30 May 2017
Pharmaceutical
Switzerland’s medicines regulator has released its annual report, noting that regulatory approval was granted for more than 40 innovative medicinal products last year, with 99% of applications completed on schedule. 30 May 2017
Generics
Indian drugmaker Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic nebivolol product. 30 May 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended Keytruda (pembrolizumab) for inclusion in the UK’s Cancer Drugs Fund (CDF) as the first immunotherapy for a specific population of previously untreated metastatic non-small-cell lung cancer (NSCLC). 30 May 2017
Generics
The USA’s new Food and Drug Administration Commissioner Scott Gottlieb was in the hot seat last week to defend President Donald Trump's budget plan to the House of Representatives appropriations subcommittee. 30 May 2017
Pharmaceutical
South Africa’s Aspen Pharmacare has entered into a memorandum of understanding (MoU) has been concluded between Aspen’s Russian business and the Vladivostok Far Eastern Federal University (FEFU). 30 May 2017
Generics
On May 30, 2017 (tomorrow), trade talks will resume for the India-EFTA (European Free Trade Association) free trade agreement (FTA) in Liechtenstein, between India and the EFTA countries of Switzerland, Norway, Iceland and Liechtenstein. 29 May 2017
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