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Merck Oncology Strategy: With First-Line Lung Data, A New Day Dawns For Keytruda

 
• By Jessica Merrill

Merck claims to have the broadest clinical development program for an anti-PD-1/L1 drug, with more than 270 trials under way testing Keytruda in 30 tumor types and 100 combinations.

For Merck & Co. Inc., succeeding in immuno-oncology centers on the PD-1 inhibitor Keytruda (pembrolizumab). The company is moving aggressively to expand Keytruda into as many indications as possible, and during a briefing at the American Society of Clinical Oncology (ASCO) meeting in June, management claimed the drug is being tested in the broadest clinical development program for an anti-PD-1/L1 in the industry.

Keytruda is being tested in more than 270 trials in 30 types of tumors, including in100 combination studies, the company...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.