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RSS FeedPosted by Michael Wonder on 17 Jun 2020
A mad scramble to stock millions of malaria pills, likely for nothing
16 June 2020 - Before the F.D.A. withdrew its waiver to stockpile the drugs as coronavirus treatments, the Trump administration had ...
Posted by Michael Wonder on 17 Jun 2020
An ‘America first’ pharma supply chain sounds good. But it won’t work.
17 June 2020 - With a stroke of the president’s Executive Order pen, the Trump administration awarded a $354 million, ...
Posted by Michael Wonder on 17 Jun 2020
Most coronavirus tests cost about $100. Why did one cost $2,315?
16 June 2020 - U.S. health care prices are unregulated, opaque and unpredictable. When Congress required insurers to cover COVID-19 testing, ...
Posted by Michael Wonder on 17 Jun 2020
Regulators discuss accelerated approvals, Project Orbis at DIA
16 June 2020 - Regulators from the US FDA, European Medicines Agency and Health Canada gave their perspectives on different ...
Posted by Michael Wonder on 17 Jun 2020
Novartis Cosentyx receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis
17 June 2020 - FDA approval for Cosentyx is based on the Phase III PREVENT trial, demonstrating efficacy in active ...
Posted by Michael Wonder on 16 Jun 2020
FDA approves first treatment for adult onset Still’s disease, a severe and rare disease
16 June 2020 - The U.S. Food and Drug Administration today approved Ilaris (canakinumab) injection for the treatment of active Still’s ...
Posted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted by Michael Wonder on 16 Jun 2020
FDA approves gemtuzumab ozogamicin for CD33-positive AML in paediatric patients
16 June 2020 - Today the FDA extended the indication of gemtuzumab ozogamicin (Mylotarg, Wyeth Pharmaceuticals) for newly-diagnosed CD33-positive acute ...
Posted by Michael Wonder on 16 Jun 2020
Supreme Court will not hear generic drug price fixing discovery dispute
16 June 2020 - The U.S. Supreme Court on Monday declined to hear generic drug makers’ challenge to a court ...
Posted by Michael Wonder on 16 Jun 2020
FDA approves Lyumjev (insulin lispro-aabc injection), Lilly's new rapid-acting insulin
15 June 2020 - The U.S. FDA has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and ...
Posted by Michael Wonder on 16 Jun 2020
Acadia Pharmaceuticals submits supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
15 June 2020 - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 ...
Posted by Michael Wonder on 15 Jun 2020
FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD
15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function ...
Posted by Michael Wonder on 15 Jun 2020
Jazz Pharmaceuticals announces U.S. FDA accelerated approval of Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer
15 June 2020 - Zepzelca is approved under accelerated approval based on overall response rate and duration of response demonstrated in ...
Posted by Michael Wonder on 15 Jun 2020
COVID-19 update: FDA revokes emergency use authorisation for chloroquine and hydroxychloroquine
15 June 2020 - Today, the U.S. FDA revoked the emergency use authorisation that allowed for chloroquine phosphate and hydroxychloroquine sulphate ...
Posted by Michael Wonder on 15 Jun 2020
Biogen’s FDA application for Alzheimer’s drug drags on
15 June 2020 - Biogen’s filing of aducanumab, an investigational Alzheimer’s drug, for U.S. approval is drifting from its initial ...