Top News & Features

FDA Priority Review For Some Generics Urged To Address 'Market Failure' / Senate Aging Committee hearing addresses generic drug priority reviews at FDA, compounding and publicizing a “watch list” of off-patent drugs with no competition as ways of deterring dramatic price increases for such products. / “The Pink Sheet” DAILY December 9 2015 6:55 PM / Read more

Alexion Gets Second Priority Review Voucher With Approval Of Rare Enzyme Disorder Drug / Kanuma, the first approved treatment for lysosomal acid lipase deficiency, will launch in January at an average annual treatment cost of $310,000. / “The Pink Sheet” DAILY December 8 2015 9:50 PM / Read more

Merck's Keytruda Data Brighten Picture For PD-1 Inhibitors In Myeloma / Data from the American Society of Hematology meeting suggest role for checkpoint inhibitors in hematology could extend past what looks like a sure thing in Hodgkin lymphoma, but it’s early days yet. / “The Pink Sheet” DAILY December 7 2015 6:20 PM / Read more

FDA Dietary Supplement Division Soon May Need Office Accommodations / Without an objection from Congress, FDA’s Division of Dietary Supplement Programs becomes a CFSAN office on Dec. 21. Objections or questions from one or more members are possible, but HHS likely would not make the notification without high confidence Congress would not object. / “The Tan Sheet” December 7 2015 12:07 AM / Read more

J&J Hears Consent Decree Echoes In Litigation From ‘Silent’ Motrin Recall / J&J intends to appeal to Oregon’s Supreme Court the state appellate court’s decision that the absence of proof of harm to consumers from sales of Motrin 200mg that failed to meet dissolution standards does not preclude unfair trade litigation filed by the state attorney general. / “The Tan Sheet” December 1 2015 12:00 AM / Read more

California DTSC's Alternative Analyses Guide Falls Short Of Industry Needs / The Department of Toxic Substances Control's guidance for conducting the stage-1 alternatives analyses under California's Safer Consumer Products program lacks detail on the agency's "most basic internal process for evaluating data and other product information" to inform compliance decisions, industry coalitions say. The groups cite numerous areas in need of clarification in November comments to the agency. / “The Rose Sheet” December 4 2015 2:35 PM / Read more

Homeland Security Stepping Up Proactive Device Cybersecurity Efforts / A division of the Department of Homeland Security is funding and developing proactive tools to protect medical devices from future cybersecurity threats. / “The Gray Sheet” December 1 2015 3:35 PM / Read more

Nevro Spine-Stim Patents Escape Re-Review By PTO / The Patent Trial and Appeals Board won’t review a Nevro spinal cord stimulator patent after a challenge from Boston Scientific claimed the patent was invalid because it was too similar to prior knowledge in the field. The unusual decision not to even launch a so-called inter partes review in this case should be comforting to device patent holders, an attorney says. / “The Gray Sheet” December 3 2015 4:00 PM / Read more

FDA Emphasizes Timesavers In New eCopy Guidance / CDRH has again updated its eCopy guidance to highlight tools that the device center believes will speed up the premarket submissions and review process. The new document clarifies how the center wants sponsors to submit PDF files, spotlights a submission validation tool and includes other tips to reduce unnecessary eCopy holds that can delay submissions, a center official tells "The Gray Sheet." / “The Gray Sheet” December 4 2015 12:35 PM / Read more

FDA Priority Review For Some Generics Urged To Address 'Market Failure' / Senate Aging Committee hearing addresses generic drug priority reviews at FDA, compounding and publicizing a “watch list” of off-patent drugs with no competition as ways of deterring dramatic price increases for such products. / “The Pink Sheet” DAILY December 9 2015 6:55 PM / Read more

Alexion Gets Second Priority Review Voucher With Approval Of Rare Enzyme Disorder Drug / Kanuma, the first approved treatment for lysosomal acid lipase deficiency, will launch in January at an average annual treatment cost of $310,000. / “The Pink Sheet” DAILY December 8 2015 9:50 PM / Read more

Merck's Keytruda Data Brighten Picture For PD-1 Inhibitors In Myeloma / Data from the American Society of Hematology meeting suggest role for checkpoint inhibitors in hematology could extend past what looks like a sure thing in Hodgkin lymphoma, but it’s early days yet. / “The Pink Sheet” DAILY December 7 2015 6:20 PM / Read more

AstraZeneca Immuno-Oncology Hopes Buoyed By Tremelimumab / Quick path to lung cancer approval may not happen for durvalumab, but AstraZeneca could make its immuno-oncology debut with first CTLA-4/PD-L1 combination. Outlook in nephrology is also looking good, firm says at pipeline review. / “The Pink Sheet” December 7 2015 12:01 AM / Read more

All-Star CEOs Discuss Pricing, But Come Up Short On Solutions / "Unless we make changes in the system people won’t be able to afford" drugs coming out of our pipelines, Merck’s Frazier says; Pfizer’s Read contends competition is best way to curtail prices. / “The Pink Sheet” December 7 2015 12:01 AM / Read more

Lilly's Portrazza: Box Warning + Modest Efficacy Could Still = Sales Success / EGFR inhibitor necitumumab may find place in first-line squamous type non-small cell lung cancer market due to limited treatment options – at least for now. / “The Pink Sheet” December 7 2015 12:00 AM / Read more

Purdue’s Head Of R&D Has Broad Remit To Bring In New Assets / Newly appointed senior VP-R&D Alan Dunton is charged with curing the firm's dependency on pain products. / “The Pink Sheet” DAILY December 2 2015 3:10 PM / Read more

FDA Dietary Supplement Division Soon May Need Office Accommodations / Without an objection from Congress, FDA’s Division of Dietary Supplement Programs becomes a CFSAN office on Dec. 21. Objections or questions from one or more members are possible, but HHS likely would not make the notification without high confidence Congress would not object. / “The Tan Sheet” December 7 2015 12:07 AM / Read more

J&J Hears Consent Decree Echoes In Litigation From ‘Silent’ Motrin Recall / J&J intends to appeal to Oregon’s Supreme Court the state appellate court’s decision that the absence of proof of harm to consumers from sales of Motrin 200mg that failed to meet dissolution standards does not preclude unfair trade litigation filed by the state attorney general. / “The Tan Sheet” December 1 2015 12:00 AM / Read more

California DTSC's Alternative Analyses Guide Falls Short Of Industry Needs / The Department of Toxic Substances Control's guidance for conducting the stage-1 alternatives analyses under California's Safer Consumer Products program lacks detail on the agency's "most basic internal process for evaluating data and other product information" to inform compliance decisions, industry coalitions say. The groups cite numerous areas in need of clarification in November comments to the agency. / “The Rose Sheet” December 4 2015 2:35 PM / Read more

J&J Petitions Supreme Court On Pre-emption, ‘Clear Evidence’ In OTC Litigation / Johnson & Johnson files a writ of certiorari asking the Supreme Court to review a $140m judgment against the firm in Massachusetts. Questions over “clear evidence” needed for FDA decision to pre-empt state courts are at heart of issue and need the court’s consideration. / “The Tan Sheet” November 30 2015 12:07 AM / Read more

Setting RCT ‘Health’ Endpoints Suggested To Measure Supplement Efficacy / Dietary supplement industry researchers should move away from the medicine model in trials, the scientific director for KGK Synergize says. Researchers should consider new endpoints more appropriate for supplements than for drug ingredients. / “The Tan Sheet” November 30 2015 12:00 AM / Read more

Cosmetic Preservation Issue Taken Up By ICCR Regulators / At the ninth iteration of the International Cooperation on Cosmetics Regulation, regulators from the US, EU, Canada, Japan and Brazil accepted an FAQ document on the role of cosmetic preservatives and agreed to assist in driving eyes to the resource once it publishes. The Personal Care Products Council's Executive VP of Global Affairs Francine Lamoriello characterized the development as a meeting highlight. / “The Rose Sheet” November 25 2015 3:10 PM / Read more

Industry Roundup: Nexium 24HR Tablet, Glanbia Deal, FDA Warnings / FDA approves Nexium 24HR tablet; Glanbia grabs thinkThin; Nature’s Mojo spooks FDA; warning shadow on Seeds Of Light; Mobius crowd-funds for launch; doctors mum on probiotics for IBS; and more news in brief. / “The Tan Sheet” November 30 2015 12:05 AM / Read more

Homeland Security Stepping Up Proactive Device Cybersecurity Efforts / A division of the Department of Homeland Security is funding and developing proactive tools to protect medical devices from future cybersecurity threats. / “The Gray Sheet” December 1 2015 3:35 PM / Read more

Nevro Spine-Stim Patents Escape Re-Review By PTO / The Patent Trial and Appeals Board won’t review a Nevro spinal cord stimulator patent after a challenge from Boston Scientific claimed the patent was invalid because it was too similar to prior knowledge in the field. The unusual decision not to even launch a so-called inter partes review in this case should be comforting to device patent holders, an attorney says. / “The Gray Sheet” December 3 2015 4:00 PM / Read more

FDA Emphasizes Timesavers In New eCopy Guidance / CDRH has again updated its eCopy guidance to highlight tools that the device center believes will speed up the premarket submissions and review process. The new document clarifies how the center wants sponsors to submit PDF files, spotlights a submission validation tool and includes other tips to reduce unnecessary eCopy holds that can delay submissions, a center official tells "The Gray Sheet." / “The Gray Sheet” December 4 2015 12:35 PM / Read more

FDA MDUFA III Performance, By The Numbers / Here's a snapshot of FDA's current premarket device review activity in seven interactive graphics. / “The Gray Sheet” November 19 2015 2:50 PM / Read more

New World Of Regulation Awaits IVD Companies In Europe From Coming Reforms / EU power players are currently negotiating vast changes to how in vitro diagnostics are regulated in Europe. The resulting system will involve a lot more external oversight than today for most IVDs. / “The Gray Sheet” November 24 2015 11:00 AM / Read more

PODCAST: Masimo CEO Bets Smart Glasses Are The Future Of Patient Monitoring / When Masimo chairman and CEO Joe Kiani saw Atheer's smart glasses and virtual reality platform, he thought the possibilities for patient monitoring were endless. Now the two companies have joined forces and are moving quickly to turn virtual reality into a clinical reality with a prototype interactive display and novel patient monitoring system that they say has the power to transform health care and the market for patient monitoring, which is estimated at more than $2 billion in the US alone according to an upcoming report from Medtech Insight. / Medtech Insight November 19 2015 3:00 AM / Read more

INTERVIEW: Bioabsorbable Stents? No, Drug-Filled Stents Is Way Forward, Says Medtronic Cardiac Intervention CMO / The world’s largest medtech pureplay, Medtronic, believes drug-filled stents (DFSs) will be a major advance in coronary stent technology, which is why it is bypassing bioabsorable technologies like Abbott’s Absorb BVS stent and planning its next steps toward bringing DFSs to market. / Medtech Insight November 17 2015 3:00 AM / Read more