CDER Reports on Drug Safety Priorities During Second Pandemic Year
In its latest annual report on Drug Safety Priorities released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) noted that much of its focus in 2021 remained on…
Roche’s Vision Loss Therapy to Compete With Regeneron’s Blockbuster
The FDA has approved Roche’s Vabysmo (faricimab-svoa) for treating the two most common forms of vision loss, paving the way for the drug to go head-to-head with Regeneron Pharmaceuticals’ blockbuster,…
Madrigal Unveils Positive Topline Data for Investigational NASH Therapy
Madrigal Pharmaceutical’s investigational drug resmetirom reduced liver fat by up to 48 percent over one year, raising hopes of a first-in-class approval for nonalcoholic steatohepatitis (NASH), company executives said yesterday.…
Chinese Officials Arrest AstraZeneca Employees Accused of Insurance Fraud, Executives Summoned
Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds.…
FDA Outlines Premarket Pathways for Combination Products
The FDA explains how combination products are assigned for review within the agency in a newly released final guidance. Source: Drug Industry Daily
Deadlines Approach for CARES Act Information Reports
Deadlines are approaching for drugmakers to file their CARES Act Amount Information report, detailing the amount of listed drugs and biological products they’ve produced and sold over the year. Source:…
EU Launches Long-Awaited Clinical Trials Regulation and Portal
A new consolidated, online clinical trials database that becomes active today in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with…
CHMP Recommends Seven New Drugs, Including Two Biosimilars
The European Medicines Agency’s (EMA) human medicines committee endorsed seven drugs for new indications during its monthly meeting last week, including Pfizer’s highly effective COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir).…
Regeneron and Sanofi Withdraw sBLA for Checkpoint Inhibitor Libtayo for Cervical Cancer
Regeneron Pharmaceuticals and Sanofi are pulling their supplemental Biologics License Application (sBLA) for the indication of cervical cancer for their human monoclonal antibody, Libtayo (cemiplimab-rwlc). Source: Drug Industry Daily
ITC to Investigate Two AbbVie Competitors for Potential Use of Humira Trade Secrets
The U.S. International Trade Commission (ITC) will investigate whether Alvotech and its partner Teva Pharmaceuticals misappropriated trade secrets in producing a biosimilar candidate for AbbVie’s autoimmune mega-blockbuster Humira (adalimumab). Source:…
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