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 New York Times published an analysis of a draft Trump executive order on prescription pricing and innovation. US advocacy group consumer rights Public Citizen reviewed portions of the order text in cooperation with the Times. 22 June 2017
Pharmaceutical
Anthem is pulling out of health insurance exchanges in Wisconsin and Indiana, a decision cheered by Republicans as another harbinger of doom for Obamacare. 22 June 2017
Pharmaceutical
One interesting corollary of Amazon’s recent acquisition of Whole Foods was the effect on pharmacies, which shed about $10 billion in share price value, according to UBS. 22 June 2017
Generics
Citing the saving of $1.67 trillion that competition from generics has brought to the US health care system in the last decade, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has voiced his support for more of these copycat drugs to reach market sooner. 21 June 2017
Pharmaceutical
Shares in Ireland-headquartered Shire are up more than 2% in London, on news that the rare disease specialist has finally received US Food and Drug Administration approval for its long-acting attention deficit hyperactivity disorder (ADHD) therapy. 21 June 2017
Pharmaceutical
A group of the three biggest state rheumatology organizations have joined a new coalition of provider and patient groups concerned about the role of pharmacy benefit managers (PBMs) in driving up drug costs. 21 June 2017
Pharmaceutical
Ten leading pharmaceutical companies in Canada have agreed to disclose payments made in exchange for services or to fund charitable, educational and scientific activities. 21 June 2017
Pharmaceutical
Brexit, political instability, economic uncertainty, an aging population increasingly suffering from chronic conditions, a cost-effectiveness watchdog looking to save every penny possible when paying for new medicines and a National Health Service (NHS) reportedly facing its worst crisis in generations – the challenges facing the UK health sector appear almost insurmountable. 21 June 2017
Pharmaceutical
The US Food and Drug Administration’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) has invited PharmaMar (MC: PHM) to participate in this ODAC, giving a presentation to provide background information on Zepsyre. 20 June 2017
Pharmaceutical
Increased scrutiny around the pricing of medicines is starting to have an impact on drug sales growth, according to Evaluate’s latest World Preview report. 20 June 2017
Biotechnology
The US Food and Drug Administration will review an application from biotech major Amgen to extend the label for Xgeva. 20 June 2017
Biosimilars
Under a coruscating Spanish sun, the 17th Annual European Congress of Rheumatology, EULAR, has at last drawn to a close in Madrid. 20 June 2017
Biotechnology
US biotech Amgen closed 1.6% up on Monday at $165.09 after news of further progress relating to its monoclonal antibody, Xgeva (denosumab). 20 June 2017
Pharmaceutical
The US Food and Drug Administration on Monday approved Baxdela (delafloxacin), a new antibacterial drug to treat acute bacterial skin and skin structure infections (ABSSSI). 20 June 2017
Pharmaceutical
Following the recent presidential election and before the Parliamentary elections in France, Marcel Lechanteur, president of Lilly France and Benelux, a unit of Eli Lilly discussed the main issues for the pharmaceutical sector. 20 June 2017
Biotechnology
The US Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI). 19 June 2017
Biosimilars
Sandoz, Novartis’ biosimilars and generics business, today revealed that the European Commission has approved Rixathon (biosimilar rituximab). 19 June 2017
Biotechnology
The US Food and Drug Administration has filed the New Drug Application (NDA) for the use of Tavalisse (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP). 19 June 2017
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released a new evidence report assessing the comparative effectiveness and value of Tymlos, from US-based Radius Health and Forteo, from Eli Lilly. 19 June 2017
Biosimilars
Biosimilar medicines are transforming treatment by enabling better access to biological medicines in Europe and around the world, as stated during the second day of the joint Medicines for Europe-IGBA conference in Lisbon, Portugal. 19 June 2017
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