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J.P. Morgan Notebook Day 2: Bristol Humbled By Competition, Sanofi’s Sarilumab Ready For Review, Justifying Spinraza’s Price And More

 
• By Mandy Jackson, Jessica Merrill, Derrick Gingery, Lucie Ellis-Taitt, and Joseph Haas

Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco. Bristol-Myers CEO humbled by PD-1 competition in lung cancer; Sanofi’s sarilumab manufacturing issues resolved; Biogen, Ionis discuss SMA drug’s high cost; Shire happy with Xiidra launch to date; Sarepta says more than 250 patients have started Exondys treatment; J&J’s Gorsky on innovation and pricing; and Amicus reveals US approval strategy for migalastat.

Bristol-Myers Squibb Co. CEO Giovanni Caforio took the stage at the J.P. Morgan Healthcare Conference on Jan. 10 humbled by a clinical trial disappointment and increased competition for the company’s PD-1 inhibitor Opdivo (nivolumab), but he was hopeful about building and maintaining a strong market share across Bristol’s immuno-oncology platform.

The surprising failure of the Checkmate-026 clinical trial testing Opdivo versus chemotherapy in first-line lung cancer opened a huge opportunity for Merck & Co. Inc.’s Keytruda (pembrolizumab) to take...

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More from Approval Standards

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

More from Pathways & Standards

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.