Regulatory Recon: BMS Sees Mixed Results for Opdivo, Yervoy Combo in Kidney Cancer South Carolina Sues Purdue Over Opioid Marketing (16 August 2017)

Posted 16 August 2017 | By Michael Mezher 

Regulatory Recon: BMS Sees Mixed Results for Opdivo, Yervoy Combo in Kidney Cancer South Carolina Sues Purdue Over Opioid Marketing (16 August 2017)

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

In Focus: US

  • Who gets all that biopharma lobbying money? (STAT)
  • Trump tweets up a storm on drug prices but delivers little change (Politico)
  • As Trump lashes out at Frazier again, J&J's Alex Gorsky says he's not abandoning president's council (Endpoints)
  • Trump doesn't 'know the facts' when he says Merck is shipping jobs overseas (CNBC)
  • FDA chief says drug makers are gaming the system to slow generic competition; vows action (USA Today)
  • South Carolina sues OxyContin maker Purdue over opioid marketing (Reuters)
  • Mixed results for BMS' Opdivo, Yervoy combo in kidney cancer (Pharma Times) (Endpoints) (Xconomy) (Press)
  • Inside Jawbone's High-Risk Plan to Become a Medical Device Maker (Bloomberg)
  • FDA's Standards for Device Approvals Under Scrutiny (Medpage)
  • Goldman has a new favorite biotech because of potential Alzheimer's 'blockbuster' (CNBC) (The Street)
  • Questions About The FDA's New Framework For Digital Health (Health Affairs Blog)
  • Drug companies are growing less generous in helping patients pay for meds (LA Times)
  • Pharma's social status: LinkedIn and FB up, Twitter down, Instagram finally appears (Fierce)
  • Trump Threat to Obamacare Would Send Premiums and Deficits Higher (NYTimes) (Reuters)

Sponsored Content: RWS Acquires LUZ

In Focus: International                         

  • Eli Lilly's odyssey to use a fake rule and fake news to protect bad patents (STAT)
  • Johnson & Johnson in breach of UK rules over Nicorette marketing (MM&M)
  • The big revamp at GlaxoSmithKline R&D includes a new collaboration on AI (Endpoints)
  • EMA Updates EudraVigilance Q&As With Over 100 Questions From Sponsors (FDA News-$)
  • Novo Nordisk reshuffles Executive Management team with two major additions (Pharmafile)
  • China's Zai Lab files for $115M Nasdaq IPO to take Tesaro, Bristol-Myers cancer drugs through late-phase trials (Fierce) (Endpoints)
  • Celgene-partnered Antengene preps new China deals as $21M round lands (Endpoints) (Fierce)
  • Latest China Cybersecurity Proposal Could Impose Heightened Scrutiny On Biopharma (Pink Sheet-$)
  • Victorious declarations that the 'scales have tipped' against HIV/AIDS don't hold true for children (STAT)
  • Teva Must Clear Three Big Hurdles to Reclaim Its Perch (The Street)
  • GSK opens new aluminium salts facility in Scotland (PharmaTimes)
  • India introduces price controls for knee implants (Reuters)
  • Biocon pulls application for EU approval of two drugs (Economic Times)
  • Director-General leads WHO delegation to the Belt and Road Forum for Health Cooperation (WHO)

Pharmaceuticals & Biotechnology

  • Tesaro's Zejula rolls to No. 1 PARP position with big Q2 (Fierce)
  • Diplomat Sees Declining DIR Fee Impact—and Perhaps Readies a PBM Strategy (Drug Channels)
  • FDA Warning Letters: First Half Of 2017 Trends (AssurX)
  • Chronic Low Back and Neck Pain: Draft Evidence Report (ICER)
  • Payers line up to back Mitsubishi Tanabe's pricey new ALS therapy Radicava (Fierce)
  • Amgen rolls new Prolia osteoporosis ads, just weeks after next-gen Evenity hits a snag (Fierce)
  • Employment rate sluggish at large biotechs (PharmaLetter-$)
  • Opioid Emergency May Raise Scrutiny Of Purdue's Buprenorphine Pediatric Application (Pink Sheet-$)
  • Bioproduction bottlenecks increasing due to staff shortages, says report (BioPharmaReporter)
  • Takeda R&D reboot continues with Stanford drug discovery deal (Fierce)
  • Here's Why Healthcare and the Free Market Don't Mix (Medpage)
  • Fast-tracking drug development one robot at a time (MedCityNews)
  • FDA Asks Drugmakers to Report PDUFA-Eligible Products, Orange Book Changes (FDA News-$)
  • Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials (PLOS)
  • Programming Announced for 2017 BIO Investor Forum (BIO)
  • Applied StemCell Awarded $1.3 Mil USD From NIH for TARGATT Gene Editing (Press)
  • Amneal Pharmaceuticals Issues Voluntary Nationwide Recall of Lorazepam Oral Concentrate, USP 2mg/mL, Due to Misprinted Dosing Droppers Supplied with the Product (FDA)
  • Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Accepts Portola's Resubmitted BLA For Factor XA Antidote (BioCentury) (Press)
  • FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma (Press)
  • Perrigo Announces FDA Final Approval for its AB Rated Generic Version of Mycolog® II Cream (Press)
  • FDA Accepts Medivir´s IND Application for MIV-711, Enabling Clinical Development in the US (Press)
  • Exelixis Submits U.S. Supplemental New Drug Application for CABOMETYX® (cabozantinib) for the Treatment of Previously Untreated Advanced Kidney Cancer (Press)

Medical Devices

  • Can a simple household coil one day prevent prosthetic infections — and save billions of dollars? (STAT)
  • Cook Medical Inc. Recalls Zenith Alpha Thoracic Endovascular Graft for the treatment of Blunt Traumatic Aortic Injury (BTAI) Due to the Potential Formation of Thrombus Inside the Device After Implantation (FDA)
  • New imaging technique could predict whether primary breast cancer will spread to the lung (MRC)
  • Allergan gel-based stents are treating glaucoma (Medical Design & Outsourcing)
  • Medical Device Cybersecurity Top Challenge to IoT Ecosystem (Health IT Security)
  • Alphabet acquires Senosis, a stealthy health app from serial entrepreneur Shwetak Patel (MobiHealthNews)
  • Glytec lands another 510(k) clearance for diabetes management software (Drug Delivery) (Press)
  • Siemens inks tech supply, R&D deal with Houston Methodist Hospital (MassDevice)
  • Stryker's Spine Division Receives FDA Clearance for Serrato Pedicle Screw (Press)
  • Tandem Diabetes launches clinical trial for its automatic insulin delivery suspension (MobiHealthNews)
  • DHS Issues Cybersecurity Advisory for BMC Medical and 3B Medical Luna CPAP Machine (ICS-CERT)

US: Assorted & Government

  • Federal Circuit Confirms Innovators Must Sue Blind When Biosimilar Makers Withhold Information (Biologics Blog)
  • FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision (FDA Law Blog)
  • Centene to sell Obamacare plans in Nevada next year (Reuters) (NYTimes)
  • Perrigo Sues IRS For $163M From Drug Sales, Patent Rows (Law360-$)
  • White House Advisor Philipson Brings Industry-Aligned Views On Drug Value (Pink Sheet-$)
  • Coherus Files PTAB Petition Against Amgen's Enbrel (FDA News-$)
  • Generic Lobby Can't Block Drug Price-Gouging Law, Md. Says (Law360-$)
  • DC Circ. Clears DEA To Block Supplier From Selling Opioids (Law360-$)
  • 'Dark money' and drugs: Ohio pricing activists cry foul over secret donors (Fierce)
  • Appeals court splits Stryker-DePuy poaching beef (MassDevice)
  • New Favorable Risperdal Decisions (Drug & Device Law)
  • More Bad Legal News for Athena Diagnostics: Don't Mess with Mayo (Genomics Law Report)
  • Teen Drug Overdose Deaths Doubled From 1999 to 2015 (Forbes)
  • New CEO Named At UnitedHealth Group As Wichmann Succeeds Hemsley (Forbes)
  • Ambry Genetics Investors Seek To Block $1B Sale To Konica (Law360-$)

Upcoming Meetings & Events


  • EMA bids to clarify API starting material info pharmas should provide (InPharmaTechnologist)
  • Clearing 2017: Pharma and Life Sciences (ABPI)
  • Career profile: Bioinformatician (ABPI)
  • UK Health officials urge young people to get meningitis jab (PharmaTimes)
  • UCB collaborates with UK's Medical Research Council (PMLive)


  • Zero Compliance With Indian GMP/GLP Self-Inspection Rule Prompts New DCGI Notice (Pink Sheet-$)
  • Pharmexcil urges African lawmakers to recognise Indian Pharmacopoeia (PharmaBiz)
  • Zydus Cadila gets USFDA nod for blood pressure drug (Economic Times)
  • USFDA issues EIR for Granules India's Gagillapur plant (Economic Times)
  • Lupin, Natco Pharma get FDA approval for Fosrenol chewable generic (DSN)


  • Canadian drugmaker Prometic closes China JV deal (BioPharmaDive)
  • GMP Problems Stop Canadian Firms' Topical OTC, Homeopathic Imports (Pink Sheet-$)

General Health & Other Interesting Articles

  • 'Body Brokers' Get Kickbacks To Lure People With Addictions To Bad Rehab (NPR)
  • Increased risk of heart attack, stroke soon after cancer diagnosis (Press)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles