Regulatory Recon: US District Court Invalidates Four of Teva's Copaxone Patents FTC Investigating Mylan Over EpiPen Practices (31 January 2017)

Posted 31 January 2017 | By Michael Mezher 

Regulatory Recon: US District Court Invalidates Four of Teva's Copaxone Patents FTC Investigating Mylan Over EpiPen Practices (31 January 2017)

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

In Focus: US

  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated (Focus)
  • Trump pushes drugmakers for lower prices, more US production (Reuters) (Bloomberg) (WSJ)
  • Peter Thiel vs. the FDA (Vox)
  • Senate panel to vote on Trump's pick for health secretary (Chicago Tribune)
  • Dems boycott confirmation votes for Trump nominees (The Hill)
  • The year in new drugs (C&EN)
  • Teva Plunges After US Judge Invalidates Four Copaxone Patents (Bloomberg) (PharmaLetter-$) (Fierce) (Press) (Pharmafile) (Reuters)
  • FDA's Plan for Showing Total Biosimilarity Seen Workable (Bloomberg)
  • Do Biopharmas Abuse the Orphan Drug Act? Debate Resurfaces (Bloomberg)
  • Mylan says being investigated over EpiPen practices (CNBC) (WSJ) (Reuters)
  • Drug Makers Accused of Fixing Prices on Insulin (NYTimes) (Drug Delivery)
  • 'Two Out, One In': Trump Signs Executive Order to Repeal Regulations (Focus) (Pink Sheet-$) (Pharmafile) (The Atlantic) (BioCentury)
  • The 21st Century Cures Act: One of Many Reasons Why Trump's Executive Order Is Misguided (Harvard Bill of Health)
  • As Teva wins US approval for GSK Advair copy, main fight yet to come (Reuters)
  • Kaleo Hikes Price Of Opioid Overdose Antidote, Evzio, From $690 To $4500 (Forbes)
  • PhRMA, Lilly and AbbVie Weigh FDA Plan to Study Twitter Drug Ads (Focus)
  • Here's Why Trump Will Struggle To Control 'Murderous' Drug Prices (Forbes)
  • Last Chance To Sign Up For Obamacare, For 2017 And Maybe Forever (NPR)
  • FDA's Next Commissioner: Will Trump Follow Hamburg Or McClellan 'Schedule'? (Pink Sheet-$)
  • FDA Sued Over 180-Day Exclusivity Determination for Generic NAMENDA XR; It's All About the "Causal Connection" (FDA Law Blog)
  • Eli Lilly Profit and Revenue Rise on New Drugs (WSJ) (Press)
  • Pfizer Profit, Forecast Fall Short as Generics to Hurt Sales (Bloomberg) (Press)
  • Rep. Tom Price Got Privileged, Discounted Offer on Biomedical Stock, Company Says (WSJ)
  • Lack of clarity around hiring freeze leaves FDA in lurch (Politico)

In Focus: International

  • African Regulatory Harmonization Project Cuts Drug Approval Times And Saves Scarce Resources (Pink Sheet-$)
  • Can the WHO end its money crunch before it gets worse? (STAT)
  • Ultra-rare, ultra-slow (BioCentury)
  • Sourcing Medical Devices in China: Phase 4 – Customs Requirements (Pacific Bridge Medical)
  • An MDR and IVDR transition plan (MedicalDevicesLegal)
  • China lets the air out of inflated drug prices with new procurement system (BioWorld)
  • Asia Regulatory Roundup: CFDA Offers Guidance on Security of Connected Devices (Focus)
  • First-line malaria treatment fails for the first time in UK (Pharmafile)
  • India's health budget may rise after minister warns of funding crunch (Reuters)
  • How Dong-A revamped its R&D to move into first-in-class products (BioCentury)
  • 2017 Preview: Give And Take Marks Mixed Japan, Korea Outlook (Pink Sheet-$)
  • Takeda to commercialize and develop cabozantinib in Japan (PharmaLetter-$)
  • Update to transparency law takes effect in Spain (PharmaLetter-$)
  • EC further expands use of Novartis' Votubia (PharmaTimes)
  • Novartis says Votubia receives EU approval for new indication (Reuters)
  • In South Africa, Deadly Tuberculosis Strain Is Spread Directly (NYTimes)

US: Pharmaceuticals & Biotechnology

  • Stroke research trials struggle to get enough participants (Reuters)
  • Talent In The Biotech Gig Economy (LifeSciVC)
  • US regulators expand use of Allergan's antibiotic (PharmaTimes)
  • Autoimmune disease vies with cancer to dominate the class of 2017 (EPVantage)
  • Still No Official Word From Biopharma Groups About Trump Travel Ban (Xconomy)
  • RAT Race Begins: FDA Accepting Regenerative Advanced Therapy Designation Requests (Pink Sheet-$)
  • US Regulators Offer Draft Pre-RFD Recommendations for Combination Products (Emergo) (Focus)
  • Pfizer drops phase 2 diabetes drug, two earlier-stage candidates (Fierce)
  • Is the PCSK9 patent fight giving Amgen's Repatha a boost? Script numbers say so (Fierce)
  • The Phase 3 Alzheimer's company few have heard of (MedCityNews)
  • Protecting Foreign Adverse Events (Drug & Device Law)
  • Genentech oncology head jumps ship to Bellicum as CEO (Fierce)
  • Researchers develop immune cells that infiltrate tumors (Drug Delivery)

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

  • FDA grants Breakthrough designation for AMT-060 in hemophilia B (PharmaLetter-$)
  • First-in-class anemia drug passes pivotal clinical test (PharmaLetter-$)
  • GenSight Biologics Receives FDA Orphan Drug Designation for GS030 in Retinitis Pigmentosa (Press)
  • Angion Biomedica Corp.'s Phase 2 "GUARD" Clinical Trial of BB3 in Acute Kidney Injury (AKI) Underway; Complements Ongoing Phase 3 Study in Renal Transplant Recipients with Delayed Graft Function (DGF) (Press)
  • Endo Announces U.S. FDA Approval of Ephedrine Sulfate Injection, USP (Press)
  • Phase 3 hit tees FibroGen, AstraZeneca up for anemia filing (Fierce)
  • OptiNose Announces FDA Acceptance for Filing of the New Drug Application for OPN-375 (Press)

US: Medical Devices

  • Class 1 Recall: Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc - Sheath Separation, Kinking, or Tip Damage (FDA 1, 2)
  • Thick Like Thieves: The Global Specter of Medical Device IP Theft (MDDI)
  • Cancer breath test shows promise in trial (PharmaTimes)

US: Assorted & Government

  • BMS Settles Keytruda Patent Suit Against Merck (Big Molecule Watch)
  • Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2017) (Patent Docs)
  • Sanofi's meningococcal vax rivalry with Novartis ends in $61.5M class-action settlement (Fierce) (Settlement)
  • Science Will Suffer Under Trump's Travel Ban, Researchers Say (NYTimes)
  • Medical students, faculty rally to try to save Obamacare (Reuters)

Upcoming Meetings & Events


  • Costs of unsafe care and costeffectiveness of patient safety programmes (EC)
  • Swissmedic To Prioritize Electronic Adverse Events Reports (Focus)
  • Scancell taps lung cancer nonprofit to accelerate trial recruitment (Fierce)
  • Blood donation criteria for men who have sex with men: blanket exclusion to be lifted (Swissmedic)


  • FibroGen CKD therapy clears Phase III hurdle in China (BioCentury)
  • Astellas buys rights to Auration's ruptured eardrum therapy (Fierce) (Press)
  • Astellas Reports the First Nine Months Financial Results of FY2016 (Press)


  • Union govt to come out with a scheme to support new pharma and medical device parks (PharmaBiz)
  • Govt challenges revocation of FDC drug ban in Supreme Court (Economic Times)
  • Gujarat FDCA registers maximum number of drug samples in the country as part of post-marketing surveillance programme (PharmaBiz)
  • Overlapping of provisions of D&C Act and FSSAI become hurdle for enforcement (PharmaBiz)


  • Prescription medicines: registration of new chemical entities in Australia, 2016 (TGA)
  • Scheduling delegate's final decisions, 31 January 2017 (TGA)
  • Advisory Committee on Medicines (ACM) (TGA)


  • Canadian Lupus drug to enter Phase III with Worldwide Clinical Trials (Outsourcing Pharma)

General Health & Other Interesting Articles

  • Lung Cancer Screening Program Finds A Lot That's Not Cancer (NPR)

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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