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Best Of BIO: Policy & Regulatory Updates From BIO 2017

Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.

ImmunoOncology Market Access

Liability Win For Industry As US Supreme Court Curtails Forum-Shopping

State courts cannot exercise specific jurisdiction over personal injury claims brought by out-of-state residents, high court says in favorable decision for Plavix marketer Bristol-Myers Squibb. Ruling likely to result in smaller mass tort lawsuits, but more of them across the country.

Legal Issues Distribution

REMS Class-Action Lawsuit Against Celgene Is First By Patients

Patients For Affordable Drugs Founder David Mitchell alleges Celgene's unlawful delay tactics like REMS obstruction kept generic versions of Thalomid and Revlimid off the market, forcing plaintiffs to pay higher costs.

Drug Safety Generic Drugs

UK Competition Body Backs Up Claim That Pfizer & Flynn Abused Dominant Position With ‘Excessive’ Prices

The UK CMA has explained why it believes Pfizer and Flynn Pharma abused a dominant market position by charging “excessive and unfair” prices for a generic epilepsy drug, while the two companies have laid out their the grounds for appealing against the decision.

Pricing Strategies United Kingdom

PTAB Tosses Two More Humira Patents; Will Supreme Court Eliminate IPR Proceeding?

Patent Trial and Appeal Board rules for Coherus in its challenge of Humira patents and takes up review of Cialis patent. US high court to consider constitutionality of inter partes review proceeding.

Intellectual Property Legal Issues

US Supreme Court Permits Earlier Biosimilar Launches; Penalty For Declining Patent Dance Uncertain

Court says biosimilar sponsors may provide 180-day notice of marketing prior to FDA approval; Federal Circuit to decide if innovators can seek an injunction under state law if sponsors do not provide application and manufacturing information; Justice Breyer offers FDA invitation to weigh in.

Biosimilars Legal Issues
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