Years after a scathing Indian parliamentary report flagged concerns around regulatory lapses for drug approvals, an expert panel has endorsed the continued marketing of ambrisentan and everolimus in the country. But dronedarone, also featured in the report, is no longer sold by Sanofi in India.

The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.

Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.

A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.

FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.

Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.

In case that could impact challenges of biopharma patents, Supreme Court questioned the consequences of not allowing courts to review PTAB institution decisions when petition may be time barred.

The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.

Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.

Sanofi spends 70% of vaccine production on quality control, Sanofi Pasteur exec VP David Loew tells the Pink Sheet; company is working on next generation flu vaccines that may provide greater efficacy.

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.

Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.

US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.