Regulatory Recon: Kite CAR-T Drug Gets a Pass on Advisory Committee Review; FDA Again Rejects Valeant Glaucoma Drug Over Manufacturing Issues at Florida Site (8 August 2017)

Posted 08 August 2017 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Prepping for a rapid-fire launch, Kite Pharma gets a pass from FDA on axi-cel panel review (Endpoints)
  • Vertex Pharmaceuticals And The Price Of Inspiration (Forbes)
  • Valeant's Top Drug Is Growing Again, Offsetting Wider Slump (Bloomberg) (CNBC)
  • Valeant's site for sore eyes: US FDA again issues CRL (InPharmaTechnologist) (Press)
  • Allergan's Brent Saunders Is Charging Into Medical Aesthetics. Should Others Follow? (Forbes)
  • How To Try An Experimental Drug When You Don't Qualify For A Clinical Trial (Forbes)
  • Experimenting With Drugs While Terminally Ill (NPR)
  • Drug makers deserve to be publicly shamed for thwarting competition from generics (STAT)
  • Why innovative products aren't enough for a successful pharma launch (McKinsey)
  • How to save our miracle drugs (Washington Post)
  • ANDA Submissions Top 1,000 with Two Months to Go in FY 2017 (FDANews-$) (Pink Sheet-$)
  • In 10 years of M&A, which were stars—and which were duds? (Fierce)
  • Shire shifts vaccine facility from Baxalta deal to MSD (Pharmafile)
  • Abuse-Deterrent Opioids: Final Evidence Report (ICER)
  • Follow the Dollar Math: How Much Do Pharmacies, Wholesalers, and PBMs Make From a Prescription? (Drug Channels)
  • New Novartis rival Kisqali hasn't slowed down Pfizer's Ibrance—at least not yet (Fierce)
  • FDA's generic competition push hits Valeant's Isuprel, a price-hike poster child (Fierce)

Sponsored Content: FDA Recommendations for Cybersecurity in Life Sciences

In Focus: International

  • Roche sells off its struggling IL-13 drug lebrikizumab in $1.4B Dermira deal (Endpoints)
  • Drugmakers' hopes for gene therapy rise despite tiny sales in Europe (Reuters)
  • Israel Urges Teva to Bring Jobs Back Home, Hinting at Aid Plans (Bloomberg) (The Street)
  • Biosimilars: Adoption Of Global Reference Comparator Would Eliminate Bridging Studies (Pink Sheet-$)
  • EMA To Clarify Member State-Specific Requirements For New EudraVigilance System (Pink Sheet-$)
  • Professor Sir Michael Rawlins re-appointed MHRA Chair (MHRA)
  • European Commission approves Dompé's orphan drug (PMLive)
  • NICE recommends plaque psoriasis contender for NHS use (Pharmafile)
  • Merck scores expanded NICE recommendation in head, neck and oral cancer (Pharmafile)
  • SMC recommends three new medicines (PharmaTimes)
  • Sanofi believes it's still not too late to become a top player in cancer drug market (Endpoints)
  • Rapid Malaria Tests Work, but With Unexpected Drawbacks (NYTimes)
  • Mylan gets approval to launch HIV drug in India, says it will be priced "lower" than others (Economic Times)

Pharmaceuticals & Biotechnology

  • An Insider's Guide to Bridging the Biotech Gender Gap (Xconomy)
  • Esperion shares bounce up on an effective triplet approach to slashing LDL (Endpoints)
  • Prepping for PhIII cancer study, Sellas reverse merges its way to a public listing (Endpoints)
  • Pew to Launch Information-Sharing Platform to Spur Antibiotic Discovery (Pew) (BioCentury)
  • Deaths from drug overdoses soared in the first nine months of 2016 (Washington Post)
  • Money for Marrow, Finally (WSJ)
  • Flexibility and innovation in FDA's novel regulatory approval strategies for hematologic drugs (Blood Journal)
  • US FDA finds faults at Biocon plant slammed by French regulators in July (InPharmaTechnologist)
  • Cellular 'garbage disposal' units fingered in Alzheimer's development (Fierce)
  • Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC (IPQ)
  • La Jolla Pharmaceutical Company Announces Launch of Expanded Access Program for LJPC-501 (Press)
  • At uniQure, changes at the top signal preparation for US expansion (PharmaLetter-$)
  • Pfizer bringing 40 high-paying jobs to Sanford (Fayetteville Observer)
  • Dermatology faces big changes, but pharma can help ease transition: expert (Fierce)
  • Mitsubishi Tanabe Announces US Launch of Radicava (Press)
  • Interview – Santhera readies muscular dystrophy push (EP Vantage)
  • Vantage View – Statistical Wars: A New Low (EP Vantage)
  • NIH Researchers Identify Genes Essential For Immunotherapy (BioCentury) (NIH)
  • Investor Urges Acorda To Sell (BioCentury) (Fierce)
  • Interview: Real World Evidence's Commercial Facet (SCRIP-$)
  • Hansa Medical Nears Market With IdeS For Sensitized Transplant Patients (SCRIP-$)
  • FibroGen shares rocket up on positive PhII data in idiopathic pulmonary fibrosis (Endpoints) (Fierce)
  • FDA Warns Philippines-Based Company for Distributing Unapproved Drugs (FDA)
  • FDA Warns Canadian Firm Cellex-C  Over GMP Issues (FDA)
  • Alligator boosts collaboration with Stanford University in immuno-oncology (PharmaLetter-$)
  • Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018 (DEA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Mitobridge's Novel Treatment Approach for Duchenne Muscular Dystrophy Advances into Clinical Development (Press)
  • Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma (Press)

Medical Devices

  • Med Device Deals Dominate Other Healthcare Subsectors (MDDI)
  • J&J Vision to acquire TearScience (MassDevice)
  • Siemens to update PET scanner systems in light of cybersecurity vulnerability (MassDevice)
  • Why Meditech values cybersecurity (Q&A) (MedCity)
  • First patient treated with Biostage's esophageal implant (MassDevice)
  • FDA approves 4-year intrauterine device (Drug Delivery)
  • J&J's DePuy Synthes inks co-marketing deal with Medical Enterprises Distribution (MassDevice)
  • CDRH Schedules Inaugural Meeting of Patient Engagement Advisory Committee (FDA Law Blog)
  • In2Bones USA Announces FDA Clearance on Two Key Implant Systems (Press)
  • Optovue First in US to Receive FDA Clearance for Corneal Epithelial Thickness Mapping (Press)
  • Mauna Kea wins FDA nod for CelioFlex Cellvizio miniprobes (MassDevice)
  • MiMedx files IND for Achilles tendonitis trial (MassDevice)

US: Assorted & Government

  • Endo To Pay $775M To End 'Virtually All Known' Mesh Suits (Law360-$)
  • A doctor's murder over an opioid prescription leaves an Indiana city with no easy answers (STAT 1, 2)
  • Joe Biden just brought the debate over medical records into the limelight (CNBC)
  • Facing Trump Subsidy Cuts, Health Insurance Officials Seek a Backup Plan (NYTimes)
  • Anthem to pare back Obamacare offerings in Nevada and Georgia (Reuters)
  • Fla. Doctor Gets 6 Years For Using Foreign, Unlicensed Drugs (Law360-$)
  • Coherus Targets Amgen's Enbrel Patent In IPR (Law360-$)
  • FDA Ignoring Abuse-Deterrent Opioid Concerns, Suit Says (Law360-$)
  • Medicare Competitive Bidding Program Realized Price Savings For Durable Medical Equipment Purchases (Health Affairs)
  • Enzo Biochem Inc. v. Applera Corp. (Fed. Cir. 2017) (Patent Docs)
  • Personal Jurisdiction Moves Front and Center in the Pinnacle Hip Implant MDL (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • EU Regulators Demand Reformulation Of Methylprednisolone Injections (Pink Sheet-$)
  • Lonza buys Micro-Macinazione to bolster micronization biz (InPharmaTechnologist)

Asia

  • Current law and practices related to medical use claim in South Korea (PharmaLetter)
  • Takeda reveals collaboration aimed at bolstering oncology pipeline (Pharmafile)

India

  • CDSCO to launch another phase of inspections of drug mfg facilities for GMP compliance (PharmaBiz)
  • Experts concerned over govt's move to grant marketing approval for drugs without clinical trials (PharmaBiz)
  • Safety studies of BVS stents yet to complete following CDSCO medical device alert (PharmaBiz)
  • Pharma, medical devices should be under one ministry: Mandaviya (Economic Times)
  • Government forms panel to make drugs more affordable (Economic Times)
  • India's pharmaceutical market set to hit $100bn by 2025 (EPR)

General Health & Other Interesting Articles

  • Tiny biotech firm offers Big Tobacco model to curb its nicotine habit (Reuters)
  • Midlife cardiovascular risk factors may increase chances of dementia (NIH)
  • South Texas Fights Tuberculosis One Blood Test At A Time (KHN)
  • Researchers Track an Unlikely Culprit in Weight Gain (NYTimes)

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 news@raps.org.

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

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