Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves First Extended Depth Lenses for People With Cataracts (18 July 2016)

Regulatory Recon: FDA Approves First Extended Depth Lenses for People With Cataracts (18 July 2016)

Posted 18 July 2016 | By Zachary Brennan 

Regulatory Recon: FDA Approves First Extended Depth Lenses for People With Cataracts (18 July 2016)

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

In Focus: US                                      

  • US health officials investigating mysterious case of Zika virus (STAT) (NY Times-$) (Reuters)
  • The Rise in Orphan Drug Designations: Meeting the Growing Demand (FDA Voice)
  • To split or not to split? One Wall Street wag thinks Pfizer may remain intact (STAT)
  • The Next PDUFA: New Performance and Procedural Goals (Focus) (SCRIP-$) (BIO)
  • The White House Is Pushing Precision Medicine, but It Won’t Happen for Years (MIT Tech Review)
  • PatientsLikeMe lures Hall from FDA to expand use of real-world evidence (Fierce)
  • FDA staff concerned on suicide risk of Valeant’s Siliq for psoriasis (PharmaLetter-$) (Scrip-$)
  • E2C(R2) Periodic Benefit Risk Evaluation Report (PBRER) Guidance for Industry (FDA) (Q&A)
  • FDA approves first extended depth of focus lenses for people with cataracts (FDA) (Pharmafile) (Mass Device)
  • Teva, one of the biggest generic makers, joins the the brand-name club (STAT)
  • As Advisers' Role Debated, FDA Chief Says Panels Can't Dictate Decisions (InsideHealthPolicy-$)

In Focus: International

  • Shrinking Pools of Money, Talent May Bind Biotechs After Brexit (Bloomberg News)
  • No minister: UK biotech community loses its dedicated government minister (Endpoints) (PharmaLetter-$)
  • Economic landscapes of human tissues and cells for clinical application in the EU (European Commission)
  • EU regulators to take another look at Merck’s MS pill (PharmaTimes)
  • European Commission Pushes for Closer Convergence With US on Device Regulations (Focus)
  • China approves use of GSK vaccine Cervarix for cervical cancer (Reuters)
  • Countries start to act on noncommunicable diseases but need to speed up efforts to meet global commitments (WHO)
  • Brazilian Regulators Allow More Flexibility for Device Registration Transfers, Extend Tech File Deadline (Emergo)
  • Cost recovery implementation statement 2016-17 (Australia’s TGA)
  • News about electronic pharmacovigilance reports (SwissMedic)

US: Pharmaceuticals and Biotechnology

  • Makers of Humira and Enbrel Using New Drug Patents to Delay Generic Versions (NY Times-$)
  • See you in September, funding fights (Politico’s Prescription Pulse)
  • Do CRISPR enthusiasts have their head in the sand about the safety of gene editing? (STAT)
  • The Pan-Cancer Screen: Still Early for Prime Time (Xconomy)
  • Which big biopharma companies put R&D as their top priority? (Endpoints)
  • FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A and 503B: Outsourcing Facilities (FDA Law Blog) (Focus)
  • GlaxoSmithKline using Apple's ResearchKit for clinical research (ZDNet)
  • ANI Pharma launches first generic nilutamide on FDA approval (PharmaLetter-$)
  • PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination (FDA)
  • The Billion Dollar Lab Scandal (CardioBrief)
  • Healthcare earnings calendar for the week of July 18th (Loncar Blog)

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

  • AstraZeneca's lung cancer drug meets main goal in late-stage trial (Reuters) (FierceBiotech)
  • Playing defense, Roche loses megafranchise gambit as Gazyva flunks head-to-head with Rituxan (Endpoints) (Reuters) (Press)
  • With cash running low, little Evoke loses a crucial PhIII gamble (Endpoints)
  • Brainstorm’s rally fizzles after investors turn sour on questionable ALS data (Endpoints) (Reuters)
  • Five Prime protein beefs rep via GSK license deal; respiratory bid chuffs on (BioWorld)
  • Study Confirms Vaginal Ring Protects Women From HIV (NBC News)

Medical Devices

  • Medtronic wins FDA nod for 2-level cervical fusion with Prestige LP spine implant (Mass Device)
  • Zimmer pays at least $132m for French robot-assisted surgery firm Medtech SA (Mass Device)
  • Intersect ENT jumps on strong Q2 prelims (Mass Device)
  • T2 Biosystems, Bayer ink blood disorder deal (Mass Device)
  • Imaging technology allows 3-D visualization of Alzheimer’s-related plaques (MedCity News)
  • Stryker’s Novel Soft Tissue Anchor Uses Ultrasound for Fixation (MedGadget)

US: Assorted and Government

  • FDA Information Collection Activities; Submission for OMB Review; Comment Request; Bar Code Label Requirement for Human Drug and Biologics (Federal Register)
  • FDA Extends Authority to e-Cigarettes: Implications for Smoking Cessation? (JAMA)

Upcoming Meetings and Events             

Europe                                                                                

  • Samsung Bioepis seeks Europe approval for its Humira copy (Reuters)
  • EMA accepts Merck’s MAA for cladribine tablets in multiple sclerosis (PharmaLetter-$)
  • European Commission Meeting with EuropaBio (European Commission)
  • European Commission Meeting with PPTA (Plasma Protein Therapeutics Association) (European Commission)

India

  • Pharma exports to US, Europe decline by 7% in first quarter, Pharmexcil to hold meeting with exporters (PharmaBiz)
  • Net worth of 30 top Indian pharma cos move up by 20% in 2015-16 (PharmaBiz)

China

  • Titan Medical delays close for $16m placement with Chinese private equity firm (Mass Device)

Zika

  • Zika Data From the Lab, and Right to the Web (NY Times-$)

General Health and Other Interesting Articles

  • Mass Incarceration Is Making Infectious Diseases Worse (Atlantic)
  • Older men and young women drive South African HIV epidemic (Nature News)

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? 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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