Regulatory Recon: FDA Clears Computerized Test for Post-Concussion Cognitive Function Bioclinica Bought by Private Equity Firm in $1.4B Deal (23 August 2016)

Posted 23 August 2016 | By Michael Mezher 

Regulatory Recon: FDA Clears Computerized Test for Post-Concussion Cognitive Function Bioclinica Bought by Private Equity Firm in $1.4B Deal (23 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Experimental cancer therapy holds great promise — but at great cost (STAT)
  • Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan's EpiPen (Focus) (Reuters)
  • PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations (Focus)
  • USPTO Launches Cancer Moonshot Challenge (USPTO)
  • Celltrion ships biosimilar medicine to US (Korea Times)
  • FDA Complains That Drugmakers Abuse Petition Process To Try To Hold Up Drug Approvals (KHN) (Focus)
  • Got a Thyroid Tumor? Most Should Be Left Alone.(NYTimes)
  • Harnessing 21st Century Science for 21st Century Cures (Energy & Commerce)
  • Bioclinica acquired by private equity firm (Outsourcing-Pharma) (Reuters) (WSJ)              
  • Industry, Patient Groups Respond to FDA Guidance on Sharing Patient-Specific Device Data (Focus)
  • Apple Purchases Medical Startup Gliimpse (WSJ)
  • Why Eli Lilly Execs Say Alzheimer's Drug Development Is Far From Dead (Forbes)
  • Gilead, Galapagos start PhIII of RA drug, 8 mo after AbbVie began rival program (Fierce) (Press)
  • Cost pressures turning pharma towards automation tech, says Zenith (In-PharmaTechnologist)
  • Regeneron Wins Up to $8.9M from BARDA toward MERS Therapies (GEN) (Fierce) (Press)
  • The Flaws in Pfizer's Plan to Acquire Medivation (NYTimes)
  • With $14 Billion Purchase, Pfizer Signals Cancer Drug Prices Will Remain High (Forbes) (Reuters)
  • The $150 million winner and losers in Pfizer's $14 billion takeout of Medivation (BiotechSF)
  • Pfizer's Medivation buy seen prescribing more biotech M&A (Reuters)

In Focus: International

  • South African Medical Device Regulatory System Set for Implementation (Emergo)
  • ANVISA Adds LNE G-Med to List of MDSAP Auditors (Emergo)
  • Gilead using Data Exclusivity in Ukraine to monopolise Hep-C drug Sofosbuvir (Don't Trade our Lives Away)
  • Daiichi case: Ex-Ranbaxy promoters say Singapore tribunal award can't be enforced in India (Economic Times)
  • CDSCO Issues Notice Saying it Only Recognizes Applicants, Not Consultants in Submissions (CDSCO)
  • Court defers decision on Roche's plea against Zydus' cancer drug (Economic Times)
  • Indian Medical devices industry to submit comments on draft Device Rules by Aug 31 (PharmaBiz)
  • China FDA Grants Expedited Review to MammaTyper Breast Cancer Dx (GenomeWeb)
  • WHO Africa regional office proposal to address fake medical products (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Sage Products Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination - Second Expansion (FDA)
  • Guidance: Bioequivalence Recommendations for Fidaxomicin (FDA)
  • Setting Up A US Biotech Subsidiary: Cambridge, Old England To Cambridge, New England (LifeSciVC)
  • White Paper: A Milestone Moment (or a Dead Jellyfish) for the Global Transparency Movement (Porzio)
  • Social class may influence multiple myeloma survival (Reuters)
  • Stem cell therapy heals injured mouse brain (NIH)
  • Actavis pulls Patheon-made diabetes pills after out-of-spec tests (In-PharmaTechnologist)
  • Preventive Care, Specialists Key To Controlling Kidney Failure Treatment Costs (KHN)
  • The Underused HPV Vaccine (NYTimes)
  • Jimmy Carter: I Thought I Had 'Two or Three Weeks to Live' After Cancer Diagnosis (NBC)
  • After a fracture, patients often continue meds that boost fracture risk (Reuters)

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

  • Tokai Pharmaceuticals continuing to evaluate unblinded data from its recently discontinued armor3 clinical trial (Reuters)
  • Bristol-Myers Squibb and Pfizer to Present New Eliquis (apixaban) Analyses at ESC Congress 2016 (Press)
  • Hansa Medical: Top line results from the Swedish ongoing Phase II study with IdeS in sensitized patients presented (Press)
  • Perrigo Announces Tentative FDA Approval For Generic Version Of Suprep® Oral Solution And Confirms Patent Challenge For Generic Version Of Mirvaso® Gel (Press)

US: Medical Devices

  • Endologix Ovation Alto Abdominal Stent Graft Implanted In First Patients (medGadget)
  • Bay Area Startup Creates Device To Predict Asthma Attacks In Kids ((ABC)

US: Assorted & Government                                                                                  

  • FDA Prevails in PRADAXA Patent Term Extension Regulatory Review Period Challenge (FDA Law Blog)
  • FDA Proposes Amending Regulations to Expand Scope of Clinical Investigator Disqualification for New Animal Drugs (FDA)
  • A Lesson in What Losing Credibility Can Cost (Drug  and Device Law)
  • Globus wins patent infringement suit lodged by Flexuspine (MassDevice)
  • Biotech Asks Full Circ. To Resolve Patent Review Conflict (Law360-$)

Upcoming Meetings & Events


  • Clinical trial lay summaries: a clearer picture emerges (PharmaPhorum)
  • EC approves Truvada for PrEP (BioCentury)
  • EMA reviewing Puma's neratinib (BioCentury)
  • Merrion Pharmaceuticals announces liquidation plan (Sunday Business Post)
  • DS Biopharma spins out Afimmune (PharmaTimes)
  • Early access to medicines scheme (EAMS) scientific opinion: venetoclax for the treatment of chronic lymphocytic leukaemia (CLL) (MHRA)


  • Astellas Announces Personnel Changes  (Press)
  • North China Pharmaceutical unit gets nod for clinic trial (Reuters)


  • Hyderabad HC's stay order on land acquisition to delay Telangana govt's pharma city project (PharmaBiz)


  • Flocare Infinity enteral feeding pumps (TGA)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)

General Health & Other Interesting Articles

  • Women with dense breasts may need annual mammograms (Reuters)
  • Sex bias evident in surgical research (Reuters)
  • NIH researchers discover otulipenia, a new inflammatory disease (NIH)

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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