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
Dr Nicola Davies reports on what the US Food and Drug Administration (FDA) is doing to promote female participation in clinical trials. 19 January 2017
Biosimilars
The opportunities created, and necessary standards needed, by biosimilar drugs in order to deliver sustainable cancer care are outlined in a position paper from the European Society for Medical Oncology (ESMO). 18 January 2017
Pharmaceutical
The boss of one of the world’s biggest pharma companies has defended the industry after President-elect Donald Trump’s share-denting comments in a press conference last week. 18 January 2017
Biosimilars
Boehringer Ingelheim is the latest to announce that its biosimilar to AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab), BI 695501, has been accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration. 18 January 2017
Pharmaceutical
French pharma major Sanofi has received marketing authorization in Europe for its diabetes therapy Suliqua, known as Soliqua in the USA. 18 January 2017
Biotechnology
The US Food and Drug Administration has granted a Rare Pediatric Disease (RPD) designation for TXA127 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder. 18 January 2017
Pharmaceutical
The US Food and Drug Administration today announced the issue of new draft guidance on medical product communications, with FDA Commissioner Robert Califf saying that the agency is aware of a high level of interest about its views on such matters. 18 January 2017
Generics
A drug that's commonly used to treat high blood pressure is being repurposed for a rare tissue cancer in Europe. The medication, named propranolol, was recently granted Orphan Drug Designation by the European Commission (EC). 18 January 2017
Pharmaceutical
More than 20 pharma companies have given their backing to C/Can 2025: City Cancer Challenge, a new initiative launched at the World Economic Forum’s (WEC) Annual Meeting in Davos, Switzerland, on Tuesday. 17 January 2017
Pharmaceutical
Collaborations with other companies, academia and catapults are increasingly central to the discovery and development of new medicines, says a new report on UK pharma. 17 January 2017
Pharmaceutical
Dr Sam Samaratunga, a GP and life sciences lawyer with Keystone Law, looks at the proposed changes to arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s Technology Appraisal (TA) and Highly Specialized Technologies (HST) programs. 17 January 2017
Biosimilars
The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the USA. 16 January 2017
Generics
The US Food and Drug Administration has published draft guidance relating to the 180-day exclusivity for generic drug product provisions as the agency seeks to establish its current approach to this topic. 16 January 2017
Pharmaceutical
A new report published by the Organization for Economic Cooperation and Development has warned of pressures in public health spending, blaming pricing policies in the pharmaceutical and medical device industries. 16 January 2017
Pharmaceutical
An independent report has underlined just how important the contribution is of some of the pharmaceutical industry’s biggest companies to Europe’s economy. 16 January 2017
Biotechnology
US Biotechnology Innovation Organization (BIO) president and chief executive Jim Greenwood participated in economic development meetings with top Indian government officials, including Prime Minister Narendra Modi, while attending the Vibrant Gujarat Global Summit 2017 last week. 16 January 2017
Biotechnology
As the pace picks up after the festive break and the realities of our respective New Year’s resolutions settle on us, Australian trade group AusBiotech says it is starting the year with a renewed focus on leadership in policy and a resolution to continue committed advocacy for innovation in life sciences. 16 January 2017
Pharmaceutical
US pharmaceutical companies Eli Lilly and Incyte have announced that the US Food and Drug Administration has extended by three months the action date for its review of their rheumatoid arthritis candidate baricitinib. 16 January 2017
Pharmaceutical
On January 17, Health Ministers from Organization for Economic Cooperation and Development (OECD) countries will gather in Paris to discuss how healthcare systems can reform to better deal with the challenges and to realize the opportunities of tomorrow. 16 January 2017
Pharmaceutical
Biogen courted controversy after announcing a price for its newest approved rare disease drug that would make it one of the most expensive in history, but trial data released by the Cambridge biotech on Friday indicates that the treatment is effective. 15 January 2017
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