La vaccination contre les papillomavirus étendue aux garçons

USA – FDA Warns of Dosing Errors With Compounded Injectables

The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may...
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment

USA – Clinical Trials: FDA Releases Two Draft Guidances

The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer...
Ibrance given NICE green light in breast cancer

USA – US green light for Pfizer’s lung cancer drug

The drug has been cleared under the brand name Vizimpro as a first-line treatment of patients with locally advanced or metastatic non-small cell lung...
US approves AZ’ hairy cell leukaemia drug

USA – US approves AZ’ hairy cell leukaemia drug

The decision allows physicians to prescribe the drug for patients with relapsed or refractory HCL who have received at least two prior systemic therapies,...
FDA awards another non-opioid pain drug breakthrough status

USA – FDA awards another non-opioid pain drug breakthrough status

The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD). Concentric specialises in...
AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status

USA – AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status

The therapy is being developed for use in patients who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers. The...
FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

USA – FDA approves new dosage strength of buprenorphine and naloxone sublingual film as...

The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid...
FDA on Pace for Record Generic Approvals in 2018

USA – FDA on Pace for Record Generic Approvals in 2018

With two months of data outstanding, the US Food and Drug Administration (FDA) is on pace to approve a record number of abbreviated new...
Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

USA – Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on...

Companies took issue with specific elements of the draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure. Roche/Genentech explained,...
Lawmakers Reiterate Call to Integrate UDIs With Insurance Claim Forms

USA – Drug Prices in Ads: Senate Passes Amendment

The Senate spending bill passed Thursday and with it an amendment from Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) to require prescription drug...

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