Regulatory Recon: FDA Approves Teva's Asthma Drug Cinqair and Lilly's Psoriasis Drug Taltz (23 March 2016)

Posted 23 March 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Teva's Asthma Drug Cinqair and Lilly's Psoriasis Drug Taltz (23 March 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA Requires New Labels for Opioids (Focus) (WSJ) (Reuters) (Pink Sheet-$) (FDA 1, 2)
  • US FDA approves Eli Lilly drug for psoriasis (Reuters) (WSJ) (Press) (FDA)
  • FDA approves Cinqair to treat severe asthma (FDA)
  • AstraZeneca heart drug fails in key stroke trial (Reuters) (EPR)
  • LVADs Prolong Life But Sow Confusion (CardioBrief)
  • Bioprospecting For Novel Antibiotic Drugs With The Leafcutter Ant (Forbes)
  • Down Amongst the Ugly Variables (In The Pipeline)
  • Supreme Court Case on Contraceptives Mandate May Offer Little Closure (NYTimes) (Reuters)
  • FDA Updates Breakthrough Therapy Program: Meet the Preliminary Breakthrough Therapy Designation Request (FDA Law Blog)
  • Merck Gets Win Over Gilead in Hepatitis C Drug Patent Dispute (WSJ) (Reuters)

In Focus: International

  • Thirty-seven arrested in China vaccine scandal (Pharmafile) (Reuters)
  • EU High Court Upholds Orphan Exclusivity Ruling (Focus)
  • CDSCO Publishes Expert Committee Report on Fixed Dose Combinations (CDSCO)
  • UK cost agency says 'no' to pricey Vertex cystic fibrosis drug (Reuters) (SCRIP-$) (BioCentury)
  • Birth Defects Tied to Zika in Panama (NYTimes)
  • India defends right to issue drug 'compulsory licenses' (Reuters)
  • IQWiG unimpressed with Cosentyx in two new indications (PMLive)
  • IMDRF Tackles Confusion Over Clinical Evidence Expectations for Device Software (Clinica-$)
  • England cuts back plans for Truvada in HIV prevention (PharmaPhorum)

US: Pharmaceuticals & Biotechnology

  • FDA Warning Hits Triad Over Sterility Concerns (FDANews-$)
  • BMS Secures The Keys To Padlock (LifeSciVC)
  • Sanofi, Regeneron unveil positive Praluent cholesterol study (Reuters)
  • FDA Approved 3D Printed Drug Available In The US (Forbes) (Press)
  • US FDA Advisory Committees to Review Opioid Prodrug by KemPharm – MAY 5, 2016 (AADPAC-DSRM) (Tarius)
  • Meringue? No, you're not wrong: TxCell outlines unusual Ovasave delivery method (BioPharma-Reporter)
  • Dear Biopharma: Give Us Better Therapies for Pain (Xconomy)
  • FDA reviewing Anacor's dermatitis candidate (BioCentury)
  • Study finds no link between SSRI drugs and heart risk (OnMedica)
  • Sartorius introduces assays for testing biosimilarity of three leading biologics (BioSpectrum)
  • Patient-centricity and rebuilding trust – lessons for pharma (PharmaLetter-$)
  • Amicus begins expanded access program (BioCentury)
  • Drug Used for Organ Rejection Prophylaxis Effective in Autoimmune Hepatitis (MPR)

US: Pharmaceuticals & Biotechnology: Clinical Study Results, Filings & Designations

  • Evenamide (NW-3509): Evidence of Anti-Psychotic Efficacy as an Add-On to Antipsychotics in Ongoing Phase 2 Study May Suggest an Alternative Approach to the Treatment of Schizophrenia (Press)
  • Crohn's disease: new Phase 3 data announced for STELARA (MNT)
  • Ironwood Pharmaceuticals Initiates Phase IIb Clinical Trial of IW-3718 in Refractory Gastroesophageal Reflux Disease (Press)
  • New Senate Bill Would Change the Way FDA Regulates Devices (Focus) (Gray Sheet-$)
  • The $3 billion wasted drop in the well (MedCityNews)
  • World-first prostate cancer trial will harness new technology to dramatically reduce treatment time for men (MNT)
  • Boehringer Ingelheim launches RE-COVERY DVT/PE™: global observational study on management of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) with Pradaxa (dabigatran etexilate) (Press)
  • Placon Therapeutics Announces Company Launch and FDA Acceptance of IND for Novel Platinum Candidate BTP-114 (Press)

US: Medical Devices

  • FDA Challenges Direct-To-Consumer Genetic Tests (Law360-$)
  • GE Seeks to Sell Power, Medical Equipment to Cuban Government (WSJ-$)
  • FDA likely to approve expanded indication of Abiomed's Impella heart pump: SEC filing (Fierce)
  • The Importance of Conducting Risk Assessments to Prepare for a Cybersecurity Breach (Pharmaceutical Compliance Monitor)
  • The IUD revolution (Vox)
  • FDA Probes Third-Party Service and Repair of Medical Devices (ICT)
  • Guidance Outlines Testing Parameters For MRI-Compatible Devices (Gray Sheet-$)
  • In Vitro Diagnostics – The Basics (imarc)
  • Wearables Startup Takes Slow, Deliberate Path Toward FDA (MDDI)
  • Great Basin Receives FDA 510(k) Clearance for Shiga Toxin Direct Test (Press)
  • ACell, Inc. Receives FDA Clearance for Concurrent Use of its Wound Management Devices (Press)

US: Assorted & Government

  • Abbott Faces $219M FCA Trial Over Off-Label Stent Marketing (Law360-$)
  • Zubik v. Burwell, Part 5: These Exceptions are Unexceptional (Harvard Bill of Health)
  • Zubik v. Burwell, Part 6: The Accommodation is the Least-Restrictive Option (Harvard Bill of Health)
  • Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims (Drug and Device Law)
  • An Empty Obama-Clinton-Sanders Plan on Drug Costs (WSJ-$)
  • Mylan Ruling Cements Del., NJ As Top ANDA Venues (Law360-$)
  • Sequenom Files Petition for Cert. After Invalidation of Cff Patent (National Law Review)
  • GMP Documentation, Identity Testing Continue To Trip Supplement Firms (Tan Sheet-$)
  • US, Mexico Interpret NAFTA In Lilly's Canadian Patent Fight (Law360-$)
  • Shkreli Judge Stays SEC Case, Offers Quick Criminal Trial (Law360-$)
  • Ackman Tries to Calm Investors on Valeant (WSJ-$)
  • HHS Marks Sixth Anniversary Of Affordable Care Act (Health Affairs Blog)

Upcoming Meetings & Events


  • European Medicines Agency closed 24-28 March 2016 (EMA)
  • MHRA Halts Kickback Scheme for Independent Pharmacies (Focus)
  • EFPIA Working Group On Health Technology Assessment (EFPIA)
  • France finds suspected mad cow case (Reuters)
  • EU Negotiators Make Headway Toward New Device 'Scrutiny' Mechanism (Gray Sheet-$)
  • Tesco and Waitrose supplier Marksans banned from shipping non-critical meds to UK (In-PharmaTechnologist)
  • UK vaccines body under scrutiny over Men B jab restrictions (PharmaPhorum)
  • Industry taskforce launched to secure the future of manufacturing advanced therapy medicines in the UK (ABPI)
  • Patenting and Patent enforcement in Europe - a unified approached? (PharmaLetter-$)
  • Cytori Granted SME Status by European Medicines Agency (Press)


  • Asia Regulatory Roundup: CFDA Investigates $88M in Improperly Refrigerated Vaccines (Focus)
  • China lays out priorities for the pharma industry till 2020 (PharmaLetter-$)
  • One Startup's Journey To Improve Healthcare Access In China (Forbes)
  • Korea stock? Celltrion stores Remicade biosimilar but minimises risks (BioPharma-Reporter)
  • Eisai withdraws application for neurodegenerative-disease drug in Japan (Pharmafile)


  • Karnataka govt allocates Rs. 135 cr to healthcare in its Budget 2016-17 (PharmaBiz)
  • Sun Pharma, AstraZeneca tie up to sell latest anti-diabetes drug Dapagliflozin (Economic Times)
  • NPPA backs ban on 'irrational' drugs, revises price fixation guidelines (Economic Times)
  • Pharma practices code rollout deferred again (Economic Times)
  • Svizera: Premature WHO suspension notice at Indian plant 'hugely damaging' (In-PharmaTechnologist) (SCRIP-$)
  • 4 of 6 drugs ineffective in 70% of deadly TB cases, Mumbai doctors say (Economic Times)


  • CDC adds Dominica to interim travel guidance related to Zika virus (CDC)
  • WHO begs for $4 million to prepare for millions of Zika cases (Reuters)
  • House Speaker Ryan says U.S. has 'plenty of money' for Zika (Reuters)
  • Zika: More than 2,500 babies born with microcephaly in Brazil, WHO predicts (Washington Post)
  • U.S. CDC urges doctors to prevent Zika spread during labor, delivery (Reuters)
  • WHO Director-General briefs the media on the Zika situation (WHO)
  • Lessons From Rubella Suggest Zika's Impact Could Linger (NPR)

Other International

  • Fifth person dies in Guinea Ebola flare-up (Reuters)
  • We can eradicate Hepatitis C in the emerging world - here's how (PharmaPhorum)

General Health & Other Interesting Articles

  • The Secrets to a Happy Life, From a Harvard Study (NYTimes)
  • Knowledge of genetic risk doesn't prompt behavior changes (Reuters)
  • Heart rehab goes better with added stress management (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles