Regulatory Recon: FDA Approves Once-Rejected Schizophrenia Treatment (18 September 2015)

Posted 18 September 2015 | By

Regulatory Recon: FDA Approves Once-Rejected Schizophrenia Treatment (18 September 2015)

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

In Focus: International

  • Biosimilar insulin launched in the UK ( GaBi)
  • Novartis secures Swissmedic approval for Entresto heart failure medicine ( PBR)

US: Pharmaceuticals and Biotechnology

  • Reality Check: Cancer Experts Discuss Hurdles Facing CAR-T Therapy ( Xconomy)
  • Are differences in clinical data between biosimilars and brands a cause for concern? ( Biosimilarz)
  • Biosimilar Development in the US: Top Pharma Considerations ( Informa)
  • Biotech Stock Mailbag: Bristol, Exelixis, Lion Bio, GW Pharma ( TheStreet)
  • Perrigo Looking To Make A Deal ( SCRIP-$)
  • Interchangeability key to US biosimilars market says expert ( BioPharma-Reporter)
  • Report identifies digital trends in life sciences industry ( Pharmafile)

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

  • FDA Grants Qualified Infectious Disease Product Designation to Taksta Cempra's Fusidic Acid Antibiotic ( Press)
  • Lilly diabetes drug slashes deaths in patients with heart risk ( Reuters) ( NBC News) ( NY Times)
  • Advaxis therapy improves survival rates in cervical cancer patients ( Reuters) ( SCRIP-$)
  • Flu Vaccine Protects Well this Year ... So Far ( AP)
  • New analysis shows suicide link for teens on Paxil. ‘Mischief’ in old study claiming drug is safe. ( Washington Post)
  • Radio on 'amazing' diabetes data, biotech's VC boom, and Severin Schwan's hot mic ( FierceBiotech)
  • Hospitalization rates in chemo trials may be misleading ( Reuters)
  • Astellas Granted Label Extension for Qutenza (capsaicin 8% patch) to Include Treatment of Diabetic Patients With Peripheral Neuropathic Pain ( Press)
  • Jubilant Life gets USFDA nod for anti-migraine tablets ( Business Standard)

    US: Medical Devices

  • A Portable Blood Cleanser for Treating Sepsis ( MIT Tech Review)
  • Medtronic Infuse Injury Plaintiff Takes Appeal To Top Court ( Law360-$)
  • 'Artificial Pancreas' Works in Real-World Experiment ( NBC News)
  • FDA OKs Cook’s low-profile Zenith Alpha stent graft ( Mass Device)
  • Off-label, Failure-to-Warn Preemption Cases May Head to Supreme Court ( Gray Sheet-$)

US: Assorted and Government

  • CDC Says Flu Vaccine Should Be More Effective This Season ( NPR)
  • NIH Unveils Precision Medicine 'Working Laboratory' Plan ( SCRIP-$)( Reuters)
  • FDA: Those worries about Addyi and alcohol? We can handle it ( FierceBiotech) ( Vox)
  • Concerns raised over CMS biosimilars reimbursement policy ( GaBi)
  • NIH Launches Undiagnosed Diseases Network (UDN) to Study New and Rare Disorders ( MedGadget)
  • Boustany and Thompson Lead Bipartisan Effort to Combat Deadly Infections ( Press)
  • H.R.3537 - To amend the Controlled Substances Act to clarify how controlled substance analogues are to be regulated, and for other purposes. ( Congress)

Upcoming Meetings and Events              


  • Biosimilars applications under review by EMA – August 2015 ( GaBi)
  • The history of generics in France ( GaBi)
  • France's highest court backs restrictions on BPA plastics chemical ( Reuters)
  • ABPI responds to the National Audit Office Investigation into the Cancer Drugs Fund ( ABPI)


  • New Canadian guideline addresses fracture risk in senior care ( Reuters)


  • Why India Is A Hotbed Of Antibiotic Resistance And Sweden Is Not ( NPR)
  • Indian Regulators Ready Online Clinical Trial Submission System ( Emergo)


  • Novartis hit by China, emerging market slowdown: CEO on CNBC ( Reuters)

Other International

  • Saudi minister says MERS cases are reducing before haj ( Reuters)

General Health and Other Interesting Articles

  • Abortion Bills Advance, Setting Up a Showdown ( NY Times)

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.


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