Regional Coverage
Asia Pacific
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Latest From Asia Pacific
Pakistan Explains Updated Risk-Based Criteria For GCP Inspections
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good clinical practice inspections.
Australia To Give Consumers More Formal Role In HTA Processes
The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and lifesaving medicines might never be assessed for funding due to “a lack of commercial incentive for pharmaceutical companies.”
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
Risks For Pharma Industry Remain As BIO Shifts Course On BIOSECURE Act
Trade group’s break from WuXi Apptec allows BIO to reset its lobbying approach under its new CEO but doesn’t negate the business and supply chain disruptions that biopharma would feel from the proposed legislation.
China Biotech Hopes Innovation Wins The Day As Legislative Attacks In US Congress Increase
The latest development shows that BIOSECURE Act is gaining momentum in the US Congress and off Capitol Hill. In the meanwhile, the Chinese biotech sector embraces uncertainty but hopes that common interests in health innovation will prevail in the end.
Japan Drug Price Revision: Cuts, Increases Aim To Balance National Healthcare Costs
Japan will raise reimbursement prices for selected essential and clinically valuable drugs in April, while cutting back prices for a higher than usual number of other products through the broad application of market expansion repricing rules. The overall regular revision will see prices cut by 4.7% on average.
Europe
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Latest From Europe
All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds.
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
New EU Filings
Seladelpar, CymaBay Therapeutics's investigational treatment for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone
Proposals to overhaul the general pharmaceutical legislation will ensure that the EU “continues to have one of the most generous systems of incentives in the world,” the European Commission says.
EU Reaches Last-Minute Agreement On Health Data Space After Tough Negotiations
European co-legislators have reached a compromise on the text of the European Health Data Space that will see the controversial opt-out mechanism included in the framework
Vertex Resolves To Reverse English Funding Rejection For CRISPR Sickle Cell Gene Therapy
The health technology assessment institute, NICE, is not yet ready to recommend Casgevy for sickle cell disease and says it wants more data. Meanwhile, an access agreement relating to the treatment’s use for transfusion-dependent β-thalassemia is making progress in England, as are reimbursement talks for SCD in other European countries.
United States
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Latest From United States
US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments
FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.
The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
AstraZeneca Joins The $35 Inhaler Club; Medicare Patients Waiting On Congress For Membership
AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For inhalers, political pressure on out-of-pocket costs has produced copay caps in the commercial market first, not Medicare.
CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals
US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center saw an overall increase of more than 30.
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
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