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Roche/Spark Acquisition: First Gene Therapy Deal Clears FTC With No Divestiture

 
• By Brenda Sandburg

FTC found Roche would not have incentive to delay or discontinue development of Spark's gene therapy for hemophilia A. Outcome shows deals can survive closer FTC scrutiny.

WASHINGTON, DC - SEPTEMBER 28, 2013: Federal Trade Commission Building in Washington, DC.
FTC finds no antiturst issues in Roche's proposed acquisition of Spark Therapeutics

While the US Federal Trade Commission appears to be giving greater scrutiny to biopharma mergers, its clearance of Roche's acquisition of Spark Therapeutics Inc. shows that it remains focused on whether a transaction will harm competition. The outcome provides assurance that deals will go through if parties can demonstrate they can accommodate overlaps between existing and pipeline products.

The FTC announced on 16 December that it had closed its investigation of the Roche-Spark proposed deal following an "exhaustive, 10-month investigation" by its staff. The commission said a key...

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

More from Advanced Technologies

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.