Regulatory Focus™ > News Articles > Regulatory Recon: Array Withdraws Binimetinib Application Ahead of Advisory Committee; Amgen Submits

Regulatory Recon: Array Withdraws Binimetinib Application Ahead of Advisory Committee Amgen Submits Herceptin Biosimilar for EU Approval (21 March 2017)

Posted 21 March 2017 | By Michael Mezher 

Regulatory Recon: Array Withdraws Binimetinib Application Ahead of Advisory Committee Amgen Submits Herceptin Biosimilar for EU Approval (21 March 2017)

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

In Focus: US

  • US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants (Pink Sheet-$)
  • Study shows Novartis' Cosentyx may modify course of psoriasis (PharmaTimes)
  • Array BioPharma in disarray over withdrawal of NDA (Pharmafile) (BioCentury)
  • When No Treatment Exists, Parents Turn to Gene Therapy to Save Their Kids (MIT Technology Review)
  • Popular Prostate Cancer Therapy Is Short, Intense and Unproven (NYTimes)
  • An End to Heart Disease? Not Quite (NYTimes) (Forbes)
  • Here's one drug safety rule the FDA should enact — quickly (STAT)
  • Inescapable Gravity Of Biotech's Key Clusters: The Great Consolidation Of Talent, Capital, & Returns (Forbes)
  • A Better Balance Between Accelerated Access And High-Priced New Drugs: A New Conditional Approval Option (Health Affairs Blog)
  • PhRMA Statement on NAFTA Tribunal Decision in the Eli Lilly Case (PhRMA)
  • Humacyte Receives First of FDA's Regenerative Medicine Designations (Focus)
  • FDA Approved Nearly All Expanded Access Requests in FY2016 (Focus)
  • FDA Offers 2016 Report on Medical Countermeasure Activities (Focus)
  • Astellas pens pact to discover drugs in X-Chem's library (Fierce)
  • ACA repeal: Is this the week we get a vote that matters? (Politico)
  • House Republicans revise healthcare bill in effort to secure votes (SNL)
  • GOP Bill's Unheralded Changes In Rules Could Undermine Health Of Neediest (KHN) (NPR)
  • Trump to speak to House Republicans Tuesday on healthcare: aides (Reuters)
  • Health Spending Projections By CMS Could Influence AHCA Votes (Forbes)

Sponsored Content: IDMP is Delayed Again

In Focus: International

  • Australia's TGA seeks feedback on support needs for SMEs (PharmaLetter-$)
  • Drugmakers Weigh on Indian Stocks Amid US Regulatory Concerns (Bloomberg)
  • Commission Defends GMP Guide For ATMPs As PIC/S Cautions Against Divergence (Pink Sheet-$) (InPharmaTechnologist)
  • India Releases National Health Policy Report for 2017 (CDSCO)
  • Amgen Has Filed For EU Approval For Herceptin (Trastuzumab) Biosimilar (Big Molecule Watch)
  • Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (Focus)
  • J&J chief Gorsky, in China for official summit, straddles Trump's globalism divide (Fierce) (CNBC)
  • Asia-Pacific NSCLC market to more than double to $6.2bn by 2023 (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Studies shed light on opioid exposures among U.S. children and young adults (Reuters)
  • What's on the biopharma's auction block? EY tracks a growing appetite for pipeline divestment deals (Endpoints)
  • Care guidelines for cancer survivors often unclear (Reuters)
  • How Will Changes At FDA Impact Clinical Trials? (Clinical Leader)
  • Which PBM Best Managed Drug Spending in 2016: CVS Health, Express Scripts, MedImpact, or Prime? (Drug Channels)
  • Regulating Black-Box Medicine (SSRN)
  • Murphy in Morning Consult: "The fentanyl crisis needs our immediate attention…" (House Energy & Commerce)
  • BE Recommendation Revision Again Demonstrates OGD Recognition of Q1 and Q2 Value (Lachman Consultants)
  • The ACC skinny: Amgen's PCSK9 outcry, AZ's SGLT2 death cuts, Xarelto's aspirin beat (Fierce)
  • Which Pharma Firm Increases US Prices The Most? (Pink Sheet-$)
  • Regulatory Pathways Emerge For Gene-Edited Products (Law360-$)
  • In Current Political Climate, Can Precision Medicine Initiative Enroll Underrepresented Groups? (GenomeWeb)

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

  • Struggling Heat gets a warm response to a snapshot on cancer vax data (Endpoints)
  • Madison Vaccines Incorporated Expands Clinical Trial of MVI-118 for Prostate Cancer to University of Washington (Press)
  • Mylan Receives Tentative Approval for "TLE400" Under PEPFAR (Press)
  • A nasal spray for bulimia? Opiant enters Phase 2 trials (MedCityNews)
  • Tarrex Biopharma Announces FDA Acceptance of IND Application for TX803 to Commence Phase I Clinical Trials in Colorectal Cancer Patients (Press)

US: Medical Devices

  • Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most (Emergo)
  • Medtech Startup Showdown 2017: Round 1 (MDDI)
  • The Ups and Downs of the Latest Absorb Data (MDDI)
  • InVivo Therapeutics Announces Submission to the FDA of Its Nonclinical Studies Module for the Neuro-Spinal Scaffold (Press)

US: Assorted & Government

  • The Unfolding Medicaid Story: Congress, Governors, And The Trump Administration (Health Affairs Blog)
  • In Deep-Red Western NC, Revered Congressman Leads Charge Against GOP Bill (KHN)
  • House Republicans Turn to Upstate New York to Lure Votes for Health Bill (NYTimes)
  • On Health Law, G.O.P. Faces a Formidable Policy Foe: House Republicans (NYTimes)
  • All Things "Considered": Plaintiffs' Experts Ordered To Produce Patient Records (Drug & Device Law)
  • DeLauro and Lowey Statement on Delaying Budget Hearings for the NIH and Department of Education (DeLauro)
  • PTAB Life Sciences Report -- Part IV (Patent Docs)
  • Trump's HHS Moving Fast To Grant Industry Wishes (Law360-$)
  • Justices Reject Bid To Revive $340M Becton Antitrust Verdict (Law360-$)

Upcoming Meetings & Events


  • Meda recalls EpiPen batch in Denmark after reports of defects (InPharmaTechnologist)
  • Envigo adding non-animal tech ahead of new regulations (OutsourcingPharma)
  • Opthea gets positive feedback from European regulatory groups for wet-AMD injection (MassDevice)


  • Divi's Lab gets US FDA import alert for Visakhapatnam unit: Amit Rajan, Celogen Life Science (Economic Times)
  • India's NPPA slashes more drug prices (PharmaLetter-$)
  • Lupin veteran quits to start his own venture (Economic Times)
  • Daiichi Sankyo accuses Singh brothers of perjury (Economic Times)
  • India aims to become "a global innovation hub" for biotechs by 2020 (Pharmafile)
  • Health ministry sanctions Rs.15 cr for setting country's first dedicated medical device testing lab in Gujarat (PharmaBiz)
  • Jubilant Life Sciences looks to buy specialty pharma business in US (Economic Times)
  • Indian pharma cos ready to move into South East Asian market by setting up mfg facilities (PharmaBiz)
  • Norms for issue of licenses for FDCs declared rational by Prof Kokate panel & approved by DCGI (PharmaBiz)
  • Glenmark gets USFDA nod for skin ointment (Economic Times)

Other International

  • Yellow fever vaccine advised for travel to Brazil's Rio, Sao Paulo states (Reuters)
  • Biogaran acquires production foothold in Nigeria with Swipha acquisition (Pharmafile)
  • Sex drugs worth $1.6 million seized in South Africa (Reuters)

General Health & Other Interesting Articles

  • Hospitals have lower death rates during surprise inspections (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.

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