Regulatory Recon: AstraZeneca Immunotherapy Fails in Lung Cancer Study FDA Panel Votes Against Intelli's Long Acting Opioid (27 July 2017)

Posted 27 July 2017 | By Michael Mezher 

Regulatory Recon: AstraZeneca Immunotherapy Fails in Lung Cancer Study FDA Panel Votes Against Intelli's Long Acting Opioid (27 July 2017)

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

In Focus: US

  • AstraZeneca inks $8.4B pact with Merck as crucial MYSTIC study fails and shares plunge (Endpoints) (STAT) (Reuters) (PharmaTimes) (The Guardian) (NYTimes)
  • FDA panel votes against approving Intellipharma's opioid painkiller (Reuters) (Pink Sheet-$)
  • Eagle Pharma shares tank after FDA stiff-arms its application for heat stroke remedy (Endpoints) (Reuters)
  • First Human Embryos Edited in US (MIT Technology Review) (Reuters)
  • Don't limit the powers of the FDA (Boston Globe)
  • As drug prices drop, generics makers fight back with deals (Reuters)
  • Key partner cuts ties with brash biotech startup Moderna, raising big questions about its pipeline (STAT)
  • The Price of Crossing the Border for Medications (NEJM)
  • Practical Improvements for Medical Device Evaluation (JAMA)
  • Gilead boosts outlook higher after healthier-than-expected results (Financial Times) (Press)
  • Many pharma transparency policies are vague, ambiguous, and contradictory (STAT)
  • Senator expands opioid probe to more drug makers and wholesalers (STAT)
  • Bristol-Myers slides with Wall St eyeing key cancer drug (Financial Times) (Reuters) (Press)
  • Case of Zika Virus, Likely Spread by Mosquito, Is Reported in Texas (NYTimes)
  • Senate Health Care Vote: Here's Where They Left Off and What's Next (NYTimes)
  • FDA Will Soon Begin Alerting Generics Firms To Facility Compliance Status (Pink Sheet-$)
  • Fitting New Scientific Advances Into an Old Regulatory Paradigm (Part 2): Gene Therapy and Orphan Drug "Sameness" (FDA Law Blog)
  • Amgen shares fall after Q2 earnings reveal 'bare' pipeline (Drug Delivery)
  • We Need To Raise The Bar To Improve Cancer Treatments. What's The Best Way To Do It? (Health Affairs Blog)

In Focus: International

  • Tesaro partners with Takeda in Asia, bagging a $340M deal for Zejula (Endpoints)
  • Roche Lifts Full-Year Outlook After Solid Q2 Earnings Beat (The Street) (Press)
  • GSK's First-of-a-Kind Gene Therapy Cure Has Struggled to Find a Market (MIT Technology Review) (Reuters)
  • Bayer shares drop after profit warning (Financial Times) (Press)
  • ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data (Focus)
  • Study contradicts widely held belief on length of antibiotics use (Pharmafile) (CNBC) (The BMJ)
  • Romania to pass vaccination law to deal with immunization gaps (Reuters)
  • UK's NICE Updates Policy For Preventing Bias In Advisors (Pink Sheet-$)
  • WHO Prequalifies first Generic Version of Sovaldi (WHO)
  • China Cybersecurity Law Catches Pharma Firms Unawares (Pink Sheet-$)
  • ABPI defends SSRIs from documentary's murder accusations (PharmaLetter-$) (ABPI)
  • EU OKs first-line use of AZ' Faslodex (PharmaTimes)
  • EU nod for Chiesi's COPD therapy (PharmaTimes)
  • Final NHS nod for Allergan's Ozurdex, AbbVie's Humira in uveitis (PharmaTimes)
  • Human Tissue May Be Chinese Drone Ehang's Most Popular Transport Item (Forbes)

Pharmaceuticals & Biotechnology

  • Alexion joins the R&D reorganization gala, pruning a slate of projects and revving up new deals (Endpoints)
  • With $39B in cash and biosim threats looming, could Amgen use a deal? Executives say not yet (Fierce)
  • ICER Proposes Changes To Its Assessments Of Orphan Drugs (BioCentury)
  • Patient Reps – Bringing the Voice of Patients to FDA (FDA Voice)
  • Giant-Cell Arteritis — More Ecstasy, Less Agony (NEJM)
  • FDA issued 39 Product Recalls, Import Alerts, and Consent Decrees in June 2017 (FDAZilla)
  • Discovery documentary First in Human gives an up-close look at how advances in medicine are made at the NIH Clinical Center (NIH)
  • For Kids With Cancer, Focusing on Quality of Life (NYTimes)
  • Diabetes Crisis Continues To Rage, But Biopharma's Response Is Tepid (Forbes)
  • FDA Approves Eisai's FYCOMPA® (perampanel) for Use as Monotherapy for the Treatment of Partial-Onset Seizures (Press)
  • Fear keeps many eczema patients from using steroid creams (Reuters)
  • Better at-home drug management needed to counter rising errors (Reuters)
  • Glaxo runs into double trouble in HIV (EP Vantage)
  • Sienna Bio bags $65M in the latest successful biotech IPO (Endpoints)
  • Risks of Steroid Use for Glaucoma (MedpageToday)
  • J&J Prepares For US Sirukumab Launch After Regaining Rights From GSK (SCRIP-$)
  • NIH looks to diversify precision medicine data with new community partners (Fierce)
  • Astellas shutters Agensys and shrugs off a $387M-plus investment, moving away from ADC tech (Endpoints) (Press)
  • Discount dancers: Pfizer's infliximab matching Merck's new biosimilar rival (BioPharmaReporter)
  • How PARP inhibitors might prove useful in more than just BRCA cancers (Fierce)
  • Novartis preps production platform for alternative to Lucentis (BioPharmaReporter)
  • Baxter Completes Acquisition of Claris Injectables, Expanding Generic Injectable Medicines Portfolio (Press)
  • Maryland Drugmaker Warned on Sterility (FDANews-$)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Quark RNAi drug hits endpoints in phase 2 kidney trial (Fierce)
  • European Commission Grants Orphan Drug Designation to Allena Pharmaceuticals' Investigational Therapy for the Treatment of Primary Hyperoxaluria (Press)
  • Opportunities to build upon enhanced competition for medicines in the marketplace (PhRMA)
  • Eiger Announces FDA Fast Track Designation Granted for Pegylated Interferon Lambda in Hepatitis Delta Virus Infection (Press)
  • Trovagene Announces FDA Approval of IND for Phase 1b/2 Trial of PCM-075 in Patients with Acute Myeloid Leukemia (Press)
  • Positive Phase III Results of Genentech's Actemra (Tocilizumab) for the Treatment of Giant Cell Arteritis Published in New England Journal of Medicine (Press)
  • BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial (Press)
  • AMO Pharma Receives FDA Orphan Drug Designation for AMO-02 for Treatment of Congenital Myotonic Dystrophy (Press)
  • Aradigm Submits New Drug Application (NDA) to FDA for U.S. Marketing Approval of Linhaliq in Non-Cystic Fibrosis Bronchiectasis (Press)
  • Acella Pharmaceuticals, LLC, announces approval of generic to Vituz® Oral Solution (Press)

Medical Devices

  • Immersive Technologies Are Promising Tools for Human Centric Design (MDDI)
  • EnteroMedics inks deal with Verily-GSK JV Galvani Bioelectronics (MassDevice)
  • Agfa HealthCare Receives FDA 510(k) Clearance for Advanced Clinical Applications on XERO Universal Viewer (Press)
  • Spectranetics wins FDA nod for Stellarex DCB (MassDevice)
  • Invuity shares fall on Q2 earnings miss, lowered outlook (MassDevice)
  • Edwards Lifesciences shares rise on Q2 earnings beat (MassDevice)
  • Boston Scientific swings to Q2 black (MassDevice)
  • Smith & Nephew tops Q2 estimates (MassDevice)
  • Integra LifeSciences slides on Q2 results (MassDevice)
  • Zimmer Biomet slides on Q2 earnings miss (MassDevice)
  • FDA Issues De Novo Decisions for Multiple Devices (FDA 1, 2, 3, 4, 5, 6)

US: Assorted & Government

  • Republican Gamble on Fast-Track Rules for Health Care Hits Wall (NYTimes)
  • Lisa Murkowski, a Swing Vote on Health Care, Isn't Swayed (NYTimes)
  • Health Plans Rip 'Skinny Repeal' As Disaster For Insurance Markets (Forbes)
  • Hospitals Face Growing Cybersecurity Threats (NPR)
  • Judge rejects dismissal request by Martin Shkreli's lawyers as 'pharma bro' braces for long closing arguments Thursday (CNBC)
  • What US Budget Cuts To Global Health Could Mean For Future Funding (Health Affairs Blog)
  • McKesson shareholders vote against executive pay structure (Reuters)
  • As Cost Of U.S. Health Care Skyrockets, So Does Pay Of Health Care CEOs (NPR)
  • Eleven Generic Companies Must Face Class-Action Pricing Lawsuit (FDANews-$)
  • Plaintiff's Expert's Opinions Trimmed Post-Remand in Mesh Litigation (Drug & Device Law)

Upcoming Meetings & Events


  • Lonza sets CHF7.5bn 2022 sales target citing pharma drivers (InPharmaTechnologist)
  • Sartorius takes €10m hit on media sales due to Lonza's regulatory woes (BioPharmaReporter)
  • People with chronic kidney disease should be offered statins, says NICE (PharmaLetter-$)


  • BeiGene to use Medidata's ePRO solution for oncology studies (Fierce)
  • South Korea to downgrade bird flu alert from highest level (Reuters)
  • Myanmar tracks spread of H1N1 as outbreak claims sixth victim (Reuters)


  • Dr. Reddy's Q1 FY18 Financial Results (Press)
  • Dr Reddy's and CHD Bioscience sign up for licensing of a wound care drug (Economic Times)



  • SME Assist workshop: Meeting your obligations – medicine (TGA)

Other International

  • Study finds half of cardiovascular drugs in Africa fail on quality (Securing Industry)

General Health & Other Interesting Articles

  • Study questions newer treatments to help premature babies breathe (Reuters)
  • Scientists find sunscreen potential in Antarctic plants (Reuters)
  • Silver Birch Genetics Explained (Patent Docs)

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