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Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

Keeping track of US FDA approvals last week included watching the creative and the familiar.

Approvals Review Pathway

On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations

Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.

Approvals Drug Review

India Pushing Ahead With Rare Disease Policy Plan

India appears to be on course to developing a national rare disease policy, with the adoption of a specific definition for rare diseases and the initiation of a rare disease registry in the country.

Policy Rare Diseases

China FDA Proposes Sweeping Reforms To Incentivize Innovation

The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.

China Intellectual Property

Why Most Regenerative Therapy Applications for US RMAT Designation Fail to Make The Grade

“It didn’t take long for folk to start applying,” a US Food and Drug Administration official says of the 17 applications the agency has received so far for designation under its new regenerative medicine advanced therapy (RMAT) program for fostering the development of such products.

Review Pathway Market Access

Expedited Review Pathways: Three More Breakthroughs, Third RMAT Awarded

US FDA's popular breakthrough therapy designation given to Proteon's vonapanitase for dialysis patients, Synthetic Biologics' ribaxamase to prevent C. difficile infection, and River Vision's teprotumumab for thyroid eye disease; Vericel's cell therapy for heart failure is designated a regenerative medicine advanced therapy.

Review Pathway Regulation

Generic Priority Review Expanded In Senate User Fee Bill

Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.

Review Pathway Generic Drugs

Avastin Redux? Genentech’s Tecentriq Trial Failure Puts Bladder Cancer Claim At Risk

Confirmatory trial misses overall survival primary endpoint, raising question of whether US FDA will seek to revoke accelerated approval of PD-L1 inhibitor’s second-line bladder cancer indication, as it did with Avastin’s breast cancer claim.

Review Pathway Regulation

User Fee Bill Caught In Comey Firing Tidal Wave

Senate committee forced to postpone mark-up of FDA user fee reauthorization legislation; drug pricing fight may be postponed by hearing pledge.

FDA Legislation
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