Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Puma's Breast Cancer Drug Nerlynx; US Court Upholds Takeda Patent on

Regulatory Recon: FDA Approves Puma's Breast Cancer Drug Nerlynx US Court Upholds Takeda Patent on Velcade (18 July 2017)

Posted 18 July 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Puma's Breast Cancer Drug Nerlynx US Court Upholds Takeda Patent on Velcade (18 July 2017)

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

In Focus: US

  • The Myth of Drug Expiration Dates (ProPublica)
  • Gottlieb Lays Out Plans to Bolster FDA's Staff (Focus)
  • Health Care Overhaul Collapses as Two Republican Senators Defect (NYTimes) (Politico) (Reuters)
  • Old Truth Trips Up GOP on Health Law: A Benefit Is Hard to Retract (NYTimes)
  • King cancer: The top 10 therapeutic areas in biopharma R&D (Endpoints)
  • US court upholds Takeda patent on cancer drug Velcade (Reuters) (CNBC) (Fierce)
  • Puma wins big FDA OK for neratinib after running the gamut with investors (Endpoints) (Reuters) (FDA) (Press)
  • Clarus Raises $910m For Latest Drug Fund (Boston Globe)
  • Paratek goes 3-for-3 in PhIII, but antibiotic stumbles on side effect profile (Endpoints) (Fierce)
  • Nektar Therapeutics reports progress in making an opioid pain pill that drug users don't much like (STAT) (Endpoints)
  • The art of the deal? Why a money-back guarantee for drugs is a bad idea (STAT)
  • Big Pharma Share Buybacks Not Impacting R&D Budgets (Forbes)
  • Valeant Takes Haircut on 2013 Obagi Deal as Debt Pile Looms, Divestitures Continue (The Street) (Fierce)
  • Escaping Big Pharma's Pricing With Patent-Free Drugs (NYTimes)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

In Focus: International

  • Global health price tag could be $371 billion a year by 2030, WHO says (Reuters) (WHO)
  • 1 in 10 infants worldwide did not receive any vaccinations in 2016 (WHO)
  • European regulators say Teva, Cephalon violated antitrust laws (STAT) (Reuters) (Financial Times) (PharmaTimes) (EC)
  • 'Burden of cancer' increasing as UK trails behind Europe in cancer care (ABPI)
  • Novartis confirms 2017 outlook as profit dips (Financial Times) (The Street)
  • TGA to Take Over Medical Device Advertising Complaint Oversight in 2018 (Emergo)
  • GSK completes further high-profile staff acquisition (Pharmafile)
  • Dengue kills 21 in Indian tourist hotspot, crisis looms (Reuters)
  • German Merck to lay off 200 as part of 5-year reorganisation plan (Pharmafile)
  • Ireland At Impasse As 'Crunch Meeting' Fails To Unblock New Drug Logjam (Pink Sheet-$)
  • Single Gateway For EMA-HTA Advice May Answer All Stakeholders' Needs (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • BioMarin may have lost the battle in DMD rivalry, but it won a $35M argument with Sarepta (Endpoints)
  • Merck's new Keytruda flat dose could add $1B each year to U.S. healthcare spending (Fierce)
  • Emergent Broadens Bioterror Offering In $125m Sanofi Smallpox Vaccine Buy (SCRIP-$)
  • Zarxio Coverage On Par With Innovators Even Without Interchangeable Designation (Pink Sheet-$)
  • Talking cents in pharma? PhRMA finally launches campaign to discuss drug costs (Fierce)
  • NIH scientists find rare disease clues in cell's recycling system (NIH)
  • Takeda shrinks its Deerfield workforce, as it adds in Boston (Chicago Business)
  • Cyber attacks top digital risk for life science companies (EPR)
  • Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences Part XI: Agriculture and the Microbiome (Patent Docs)
  • Biotech Movers: Impax Shares Jump on FDA Approval for Generic Version of Concerta (The Street)
  • Arena Pharma Skyrockets on Heart Disease Data, Stock Could Still Double -Firm Says (The Street)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • U.S. FDA Designates Mallinckrodt's StrataGraft® as Regenerative Medicine Advanced Therapy (Press)
  • Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel® Topical Gel, 1.62% Packets (Press)
  • Samumed Successfully Completed Phase I Study for Potential Treatment of Idiopathic Pulmonary Fibrosis (Press)
  • CymaBay takes a peek at liver disease candidate data (Fierce)

Medical Devices

  • AR and VR Are Poised to Revolutionize Medtech—Are You Ready? (MDDI)
  • Emergo survey: Medical device R&D spending expected to rise through 2018 (Emergo)
  • Q2 med device VC funding, deals down from Q1 (MassDevice)
  • Johnson & Johnson's medical device sales set the Q2 pace (MassDevice)
  • Novartis unit Alcon posts modest Q2 gain (MassDevice)
  • CSA Medical wins expanded FDA nod for TruFreeze system (MassDevice)
  • Abbott launches tender offer for Alere in $5.3B merger (Drug Delivery)
  • Whitehouse Labs expands drug delivery device testing capabilities (Drug Delivery)
  • Baxter Appoints Cathy R. Smith to its Board (Press)

US: Assorted & Government

  • Drug Discount Program: Update on Agency Efforts to Improve 340B Program Oversight (GAO)
  • Bio Defense: Additional Information That Congress May Find Useful as It Considers DOD's Advanced Development and Manufacturing Capability (GAO)
  • Post-BMS Personal Jurisdiction is Pretty Straightforward (Drug & Device Law)
  • Ninth Circuit Revives False Claims Act Case Applying Escobar Materiality Standard (FDA Law Blog)
  • Hogan Lovells Hires Top FDA Lawyer (Bloomberg)
  • Accountant for Martin Shkreli's drug company describes reviewing firm's 'chaotic' books (CNBC)
  • Missouri judge slashes 86 plaintiffs from Essure suit against Bayer (MassDevice)

Upcoming Meetings & Events


  • Health ministry soon to release pharmacovigilance guidelines for better risk management (PharmaBiz)
  • Karnataka drug dept seizes 11 not-of-standard-quality drugs in its inspection drive (PharmaBiz)

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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