Archive for September 2018
CHMP Recommends 13 Drugs at September Meeting
The EMA’s Committee for Medicinal Products for Human Use recommended 13 drugs for human use at its September meeting. Source: Drug Industry Daily
Read MoreCBO Says CREATES Act Would Save Over $3 Billion
The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion. Source: Drug Industry Daily
Read MoreBrazilian Manufacturer Called Out for Slew of Violations
The FDA cited Brazilian OTC drugmaker Pietrobon for multiple violations including testing and equipment problems and poor recordkeeping. Source: Drug Industry Daily
Read MoreDrugmakers Say FDA’s FAR Guidance Contradicts Existing Regulations
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Source: Drug Industry Daily
Read MoreEMA Broadens Valsartan Contamination Investigation
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Source: Drug Industry Daily
Read MoreAllergan Loses Bid to Dismiss Restasis Antitrust Suit
Claims that Allergan repeatedly tried to delay Restasis generics from entering the U.S. market are plausible, a U.S. District Judge ruled on Tuesday, shooting down the pharmaceutical giant’s attempts to have the multi-district litigation dismissed. Source: Drug Industry Daily
Read MoreExpert Committee Recommends Patient-Focused Dissolution Standards
An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Source: Drug Industry Daily
Read MoreSponsors Who Don’t Report Trial Data Could Be Hit With Fines, FDA Says
Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday. Source: Drug Industry Daily
Read MoreClovis Oncology Fined $20 Million for Misleading Efficacy Data
The Securities and Exchange Commission (SEC) Tuesday levied a $20.8 million fine against biopharmaceutical company Clovis Oncology and two company executives for concealing the true efficacy rate of its lung cancer drug Roci (rociletinib). Source: Drug Industry Daily
Read MoreCalifornia Alleges AbbVie Paid Kickbacks to Boost Humira Prescriptions
California’s Department of Insurance filed suit against AbbVie Tuesday alleging the company increased Humira prescriptions through kickbacks and paid nurses to push patients to refill prescriptions. Source: Drug Industry Daily
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