Posted 12 February 2019 | By Michael Mezher 

Recon: Mylan Launches Generic Advair at One-Third Price of Original
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Mylan launches Advair generic at one-third price (Reuters)
  • FDA Panel to Assess Risks of Women’s Surgical Mesh (WSJ)
  • Vaccine storage too often fails to meet standards (KHN)
  • Gilead’s Liver-Drug Setback Clouds $35 Billion Dream (Bloomberg) (STAT) (Endpoints) (Reuters) (Press)
  • A big PBM wants drug makers to agree to rebate demands that would preserve its bottom line (STAT) (Fierce)
  • AbbVie must fork over Humira documents after judge slams a ‘nonsense’ argument (STAT)
  • Catalyst Pharma sees net price of drug, once free, topping $300,000 (Reuters)
  • Almost half of US heart disease patients struggle with medical bills (Reuters)
  • BMS can breathe easier now: Celgene’s Revlimid has escaped a big patent challenge (Fierce)
  • Indivior loses US district court battle, copycat launches imminent (Reuters)
  • Our Year In Review: Annual Talk On Macro, Biotech, and Atlas (LifeSciVC)

In Focus: International

  • Industry concerned about ‘rushed’ Brexit withdrawal legislation (PMLive)
  • One of India’s biggest drug makers has a ‘deeply troubling’ pattern of manufacturing problems (STAT)
  • Hillhouse Capital endorses China-based HaiHe Biopharma’s cancer pipeline in $146M round (Endpoints)
  • Boehringer Ingelheim and IBM link up for blockchain-powered clinical trials in Canada (Fierce)
  • What It Will Take For Trump To End AIDS ‘Beyond’ America (NPR)
  • China’s EpimAb Advances Bispecific Antibody To Rival Janssen Candidate (SCRIP-$)
  • EU Looks to Craft Harmonized Definition of a Drug Shortage (Focus)
  • Poland, Slovenia Added to GMP Agreement Between US and EU (Focus)
  • UK’s NICE Rejects US Industry Attack On Its HTA Methods (Pink Sheet-$)
  • Lung cancer treatment combo given initial NHS ‘no’ in England (CRUK) (NICE)
  • Blood cancer drug Kymriah approved by NHS is denied to Scots (The Times) (PharmaTimes)
  • IPA appeals to USTR to remove India from Priority Watch List as country made rapid progress on number of fronts (PharmaBiz) (IPA)
  • Global Regulators Promote Convergence With New Biowaiver Evaluation Template (Pink Sheet-$)
  • Spain’s Competition Watchdog Targets Radiology Drug Makers (Law360-$)
  • Tanzanian Tycoon Reginald Mengi To Establish Stem Cell Research Center (Forbes)

Pharmaceuticals & Biotechnology

  • The high rollers: The top 20 blockbuster biopharma deals of the past decade (Endpoints)
  • Combination Products: US FDA Aims For Limited Two-Application Solutions (Pink Sheet-$)
  • Bladder cancer readout sees Nektar shares hit (Fierce)
  • Dr. Reddy’s Bachupally plant experiences a version of FDA déjà vu (Fierce)
  • HHS Floats Digital Health PreCert Approach as CDRH Limits Pilot Participation (Focus)
  • CERSI Collaborations With FDA: Priority Research (Focus)
  • Dr Reddy’s launches erectile dysfunction treatment drug in US (Economic Times)
  • REMS Abuse Website: Has It Changed The Behavior Of Innovators? (Pink Sheet-$)
  • The J.P. Morgan Healthcare Conference has grown. How can we make it work for everyone? (STAT)
  • Generic Advair’s Labeling Variation Stems From Permissible Design Differences, US FDA Says (Pink Sheet-$)
  • Sanofi name current CMO Dr Ameet Nathwani as new Chief Digital Officer (Pharmafile)
  • Pfizer Questions Drug ‘Total Content’ in Biosimilar Guidance (FDANews-$)
  • Defending the middlemen: JC Scott on testifying before Congress, challenging Trump, and revamping PBMs’ image (STAT)
  • NIH researchers home in on genes linked to age-related macular degeneration (NIH)
  • As digital medicine explodes in the zeitgeist of healthcare, Sanofi follows peers in appointing chief digital officer (Endpoints)
  • Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer (Pink Sheet-$)
  • After a short stint at Intercept, Rachel McMinn makes the leap from biotech analyst to biotech CEO (Endpoints)
  • Once interim, now full-time, Siffert becomes new Abeona chief (Fierce)
  • Q&A: OIR Director Timothy Stenzel Discusses Precision Medicine Efforts During His First Year at FDA (GenomeWeb)
  • GV names ex-Agios CEO David Schenkein as general partner (Fierce)
  • Parexel Appoints Former FDA Senior Executives to Global Regulatory Consulting Services (Press)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; XADAGO (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ZEJULA (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; EUCRISA (FDA)
  • Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications (FDA)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • Merck, Pfizer combo treatment boosts kidney cancer survival (Reuters) (Endpoints)
  • Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (Press)
  • Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for Primary Biliary Cholangitis (Press)
  • Pfizer, Astellas chase new Xtandi nod with big survival numbers in prostate cancer (Fierce) (Press)
  • GenSight Biologics Announces Publication of Positive Safety Data from Phase I/II Trial of GS010 in the JAMA Ophthalmology (Press)
  • FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma (Press)
  • Neurotech Pharmaceuticals, Inc. Granted Fast Track Designation from the U.S. FDA for the Treatment of Macular Telangiectasia type 2 (Press)
  • Clementia Granted Rare Pediatric Disease Designation by FDA for Palovarotene for Fibrodysplasia Ossificans Progressiva (Press)

Medical Devices

  • Carl Zeiss Meditec revenue up nearly 10% in Q1 (MassDevice)
  • Qualcomm Sells Medical Device Connectivity Business to PE Firm (Xconomy)
  • Brain tumor ‘monorail’ lands FDA breakthrough device nod (MassDevice)
  • Edwards Lifesciences to acquire Casmed for $100m (MassDevice)
  • ConMed closes $365m Buffalo Filter buy (MassDevice)
  • Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System (Press)

US: Assorted & Government

  • Genetic Testing Company Agrees to Pay $1.99 Million to Resolve Allegations of False Claims to Medicare for Medically Unnecessary Tests (DoJ)
  • FTC Returns Almost $3.5 Million to Consumers Who Bought Deceptively Marketed “Weight-Loss” Supplements from Direct Alternatives and Original Organics, LLC (FTC)
  • The ‘Big Pharma’ candidate? As he runs for president, Cory Booker looks to shake his reputation for drug industry coziness (STAT)
  • Sen. Amy Klobuchar’s 2020 policy agenda: Lower drug costs, prepare for ‘digital disruption,’ expand savings accounts (Washington Post)
  • Utah GOP partially rolls back voter-approved Medicaid expansion (Politico)
  • GenomeDx Biosciences to Pay $2M to Settle Allegations of Improper Medicare Billing (GenomeWeb)
  • Roche To Settle Enzo Biotech IP Fight For $21M (Law360-$)
  • $785M In Debt, Diagnostics Provider Files For Bankruptcy (Law360-$)
  • Fed. Circ. Backs J&J Trial Win In Contact Lens Patent Suit (Law360-$)
  • What About Sikkelee and Conklin? (Drug & Device Law)
  • FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message (FDA Law Blog)

Upcoming Meetings & Events


  • NHS Announces Workforce Plan For Genomics, AI And Digital Medicine (Forbes)
  • MHRA Clarifies Medical Devices Policies for Users (Focus)



  • Traditional knowledge, cheaper drugs on India’s agenda for WTO (Economic Times)


  • Australia Proposes to Reclassify Spinal Implants in Line With EU MDR (Focus)

General Health & Other Interesting Articles

  • A.I. Shows Promise as a Physician Assistant (NYTimes)
  • The ‘Strange Science’ Behind The Big Business Of Exercise Recovery (NPR)
  • One in six U.S. kids have mental health disorders (Reuters)
  • ‘Church Of Safe Injection’ Offers Needles, Naloxone To Prevent Opioid Overdoses (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.
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A story’s inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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