Executive Summary: Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.

Justice Sotoymayor suggests 'the deck is stacked' against private citizen who is dragged by government into AIA's post-grant review proceedings. Court denies petition seeking to revive Maryland's anti-price gouging law.

First-ever implementation of often-discussed reimbursement approach for high-cost drugs would involve group of commercial payers to address “portability” issue and may start with Novartis’ Zolgensma.

A new bill going through the German legislative process could oblige manufacturers of orphan drugs and certain other products to submit real-world data from registries that would impact pricing.

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Study using US FDA’s Information Exchange and Data Transformation (INFORMED) program will focus on shift from weight-based to flat dosing for Opdivo and Keytruda.

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.

Jury finds one comment in an investor call was false or misleading, limits damages award to $4.50 per share, or $64,000 for the lead plaintiff, a fraction of what was sought. Case suggests that sometimes taking a stock drop case to trial may limit liability.

FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and is unchanged from a proposed rule. The agency allows six bulk drug substances to be compounded by traditional pharmacies and rejects four that it had considered for inclusion, overruling the objections of pharmacy groups that argued for retaining them on the compounding list.

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Pfizer consumer health sales up 4% to $3.6bn in 2018 as it prepares to move business into JV with GSK anticipated to close in the second half of 2019. Following 2% growth in 2017, a flat year in 2016 and a dip in 2015, Pfizer's view is confirmed of consumer health as a reliable revenue stream but not a strong growth driver.

Former Biotene owner Laclede ordered by US federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.