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Keeping Track: New Drugs For Glaucoma, Sickle Cell Submitted; IDegLira, Brineura Reviews Extended; Keytruda Advances In First-Line NSCLC

 
• By Bridget Silverman

The latest drug development news and highlights from our FDA Performance Tracker.

While FDA remains quiet on the approval front, the agency's dance card for 2017 continues to fill. New submissions this week include a new molecular entity eye drug, the first drug intended to head off sickle cell crises in children, and another priority review supplemental indication for Merck & Co. Inc.'s cancer immunotherapy Keytruda (accompanied by another breakthrough therapy designation).

FDA action was delayed by three-month user fee extensions for BioMarin Pharmaceutical Inc.'s breakthrough-designated orphan drug Brinuera and

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More from United States

Drug Distributors Face Aug. 27 Deadline For Electronic Exchange Of Product Tracking Data

 
• By Sue Sutter

Compliance deadline comes three months after manufacturers were required to start sending accurate, electronic product tracking data to distributors. The Healthcare Distribution Alliance said its members are ready and it does not anticipate major supply chain issues.

Pharma’s Move Into Direct-To-Patient Sales Facing Legal, Practical and Political Hurdles

 
• By Cathy Kelly

Only a handful programs by pharmaceutical firms are in operation so far. Some companies may be waiting to see if a broad government-facilitated DTC initiative will materialize.

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion

More from North America

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
• By Sarah Karlin-Smith

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

GLP-1s In Crosshairs As Employers Worry About Health Costs – And Their Own Reliance On Rebates

 
• By Cathy Kelly

Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.