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 Hellenic Association of Pharmaceutical Companies (SFEE) is strongly against and rejects in principle the new method for calculating the claw-back in Greece, as it is an unfair measure. 10 July 2017
Pharmaceutical
Events in the pharma sector hitting the headlines last week included a hitch for Merck & Co’s Keytruda, mixed results for Cara Therapeutics’ pain drug candidate CR848, Celgene’s deal with China’s BeiGene and an overview on the sluggish first-half 2017 M&A activity. 9 July 2017
Pharmaceutical
US Health and Human Services Secretary Dr Tom Price has named Dr Brenda Fitzgerald, as the 17th Director of the Centers for Disease Control and Prevention (CDC) and Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). 8 July 2017
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Endari (L-glutamine oral powder) for sickle cell disease to reduce severe complications associated with the blood disorder. 7 July 2017
Pharmaceutical
Some of the most senior figures in UK pharma have applauded a commitment made by government ministers to seek a collaborative post-Brexit relationship between the UK and the European Union (EU). 7 July 2017
Biotechnology
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC),at its meetings over July 3-6, said it is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab)
. 7 July 2017
Pharmaceutical
Japan, with an aging population and increasing healthcare costs, is looking to reform parts of its regulatory system and introduce a larger role for value-based medicine. 7 July 2017
Pharmaceutical
Under pressure from the US Food and Drug Administration, Ireland-incorporated Endo International has agreed to voluntarily withdraw its opioid pain drug Opana ER (oxymorphone hydrochloride extended release) from the US market. 7 July 2017
Biotechnology
Germany’s health technology assessor, the Federal Joint Committee, has determined that Cinqaero provides “minor additional benefit” in certain asthma cases. 7 July 2017
Biotechnology
Bristol-Myers Squibb’s Orencia (abatacept) received US Food and Drug Administration (FDA) approval to treat adults with active psoriatic arthritis (PsA), the company announced on Thursday. 6 July 2017
Biotechnology
Japan’s medicines regulator has ordered that the gastroenterological condition primary sclerosing cholangitis (PCS) be added as a potential side effect of Opdivo. 6 July 2017
Pharmaceutical
National Health Service trusts in England reported a £791 million ($1 billion) deficit last year, despite receiving an additional £1.8 billion from government through a reform program. 5 July 2017
Biotechnology
Colorado-based Array BioPharma has submitted two applications to the US Food and Drug Administration, for binimetinib and encorafenib as treatments for BRAF-mutant advanced, unresectable or metastatic melanoma. 5 July 2017
Pharmaceutical
Members of the European Parliament (MEPs) today urged the Commission to address the increase in HIV/AIDS, tuberculosis and viral hepatitis cases in the EU and to develop long-term programs. 5 July 2017
Biotechnology
The antiviral drug tenofovir alafenamide (TAF) has been used since 2015 in different combinations for the treatment of HIV and has already been subject to three early benefit assessments for this therapeutic indication by the German Institute for Quality and Efficiency in Health Care (IQWiG). 5 July 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) today published final draft guidance recommending asfotase alpha for people with pediatric-onset hypophosphatasia – a very rare inherited condition affecting between one and seven babies each year in England. 5 July 2017
Biotechnology
Biopharmaceutical research draws from a diffuse range of highly specialized technologies, and the traditional wisdom is that pharmaceutical firms, even very large companies, have little choice but to collaborate with others if they are to succeed. 4 July 2017
Biotechnology
Although the Canadian regulatory agency has approved the use of three important new drugs for the treatment of multiple myeloma since the start of 2016, none of them is being funded by the government, bemoans the charity Myeloma Canada. 4 July 2017
Pharmaceutical
Dr Nicola Davies looks at how real world evidence carries ever greater importance in an industry where often regulatory approval alone is no longer enough. 4 July 2017
Pharmaceutical
After a year of uncertainty, a letter written by two senior government ministers has finally sought to clear up what the UK’s relationship with the European Medicines Agency (EMA) might look like after Brexit. 4 July 2017
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