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Mary Jo Laffler

Mary Jo Laffler oversees US commercial content for Informa’s pharmaceutical news publications, working with a group of talented reporters and editors covering business, commercial and clinical news. She brings 16 years of experience reporting on the pharmaceutical industry for the Pink Sheet and affiliated publications, serving previously as Bureau Chief for Clinical Development and Business News, managing editor of the Pink Sheet and as one of the first managing editors for the Pink Sheet DAILY. While wearing many hats has given Mary Jo a wide-ranging knowledge of the commercial and regulatory challenges facing the pharmaceutical industry, her specialty is in analyzing drug development news and R&D strategy.
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Latest From Mary Jo Laffler

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards

Biomarker Is King In Latest US FDA Cancer Drug Approval

Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US regulatory agency has granted an indication that does not specify the location of the tumor – a change that precision-medicine researchers have been eager to make.

Approvals Innovation

Biomarker-Led Claim Is Small Step For Merck's Keytruda, Giant Leap For Cancer Indications

Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US FDA has granted an indication that does not specify the location of the tumor – a change precision medicine researchers have been eager to make.

Approvals Personalized Medicine

Few Clouds On High-Priced, Ultra-Orphan Drug Horizon

With BioMarin's Brineura hitting the market with a $702,000 annual price tag, recent experience for other high-priced rare disease drugs supports the theory that payers will accept high costs for ultra-rare pediatric disease therapies.

Launches Pricing Debate

FDA Commissioner-Nominee Gottlieb Pressed More On Drug Development Than Industry Ties

Scott Gottlieb's industry connections were expected to be a major focus of his US Senate confirmation hearing. However, our analysis of the questions asked show drug development was the top priority.

FDA Companies

Amgen Says Repatha Outcomes Trial Backs Up Its Pricing Math

Amgen walks through its price-setting model for PCSK9 inihibitor Repatha and says new outcomes data just presented at ACC provides more evidence that "prices that exist in the market are indeed value-based."

Health Technology Assessment Reimbursement
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