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Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders

CVS ‘Guaranteed Net Cost’ Program Is Alternative To High Price/High Rebate Model

Program likely to generate fewer rebates so it remains to be seen whether payers will embrace the new model in a big way.

Pharmacy Benefit Management Reimbursement

P&G's Personal Health Sector Has Merck Consumer Chief As International Head

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

International Germany

Pfizer Decides Not To Challenge AbbVie's Humira Biosimilar Patents

Pfizer is the seventh company to enter licensing agreement with AbbVie; it has completed development program for its adalimumab candidate.
Biosimilars Commercial

Coppertone, Dr. Scholl’s On The Block As Bayer Narrows Consumer Health Focus

Bayer will sell Coppertone sunscreen and Dr. Scholl’s foot care brands to focus on growing its core consumer health brands. Although the plan represents ‘failure” in turning around sales for both brands, it is a ‘sensible’ move, say analysts.

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