EMA Sees 28 Percent Increase in Orphan Drug Applications in 2016
The European Medicines Agency saw a 28 percent increase in the number of applications for orphan product designations in 2016 compared to the previous year. Source: Drug Industry Daily
Regeneron Joins String of Pharma Companies Subpoenaed Over Pricing Programs
Regeneron Pharmaceuticals received a subpoena last month as part of a Department of Justice investigation into the nonprofit organizations that play a key role in reducing the sticker price of…
Court Revives Antitrust Suit Against Takeda
An appeals court has revived a class action suit charging that Takeda stifled generic competition. Source: Drug Industry Daily
DOJ Seeks to Intervene in Multistate Antitrust Suit Against 6 Generics Makers
The Justice Department filed a motion to intervene in a multistate antitrust lawsuit accusing six generics makers of colluding to raise the prices of the antibiotic doxycycline hyclate and the…
Grassley Planning to Investigate Orphan Designation’s Impact on High Drug Prices
Sen. Chuck Grassley (R-Iowa) is planning to examine the FDA’s orphan drug programs to find out if companies are using the designation to justify higher prices for common drugs. Source:…
Price Set to Begin Work Repealing ACA, Cutting Costs
Tom Price was confirmed by the Senate as the next Secretary of HHS in a late-night Thursday vote and swiftly sworn in Friday morning by Vice President Mike Pence. Source:…
Risk Rankings Can Help Manage Suppliers, Expert Says
Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and identify those that might need to be dropped. Source: The GMP Letter
Becton Dickinson Caribe Gets Form 483 for Process Validation
Becton Dickinson Caribe received a Form 483 for its corrective and preventive action, device acceptance, and process validation procedures. Source: The GMP Letter
Best Medical Canada Lands Form 483 for Complaint Procedures
Best Medical Canada landed a Form 483 for not establishing adequate complaint procedures or ensuring that its devices conformed to specifications. Source: The GMP Letter
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