Regulatory Recon: GSK, Alphabet Team Up for $715 Bioelectronics Venture Pfizer Acquires Bamboo Therapeutics (1 August 2016)

Posted 01 August 2016 | By Michael Mezher 

Regulatory Recon: GSK, Alphabet Team Up for $715 Bioelectronics Venture Pfizer Acquires Bamboo Therapeutics (1 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

  • Watch Theranos' Elizabeth Holmes Present Data on Theranos Technology Live (Periscope)
  • Immunotherapy Offers Hope to a Cancer Patient, but No Certainty (NYTimes 1, 2, 3)
  • Biogen pays Ionis $75 million to develop muscle drug after trial success (Reuters) (The Street) (Press)
  • FDA Prevails in Otsuka Challenge to Scope of ABILIFY 3-Year Exclusivity, Leaving Intact ARISTADA 505(b)(2) NDA Approval (FDA Law Blog)
  • To co-develop or not; FDA's latest CDx draft (Reuters)
  • Pfizer acquires Bamboo Therapeutics to beef up gene therapy arsenal (Reuters) (Endpoints)
  • Tokai Pharmaceuticals takes ax to 60% of workforce after PhIII blowout (Fierce) (GEN)
  • The Odd Juxtaposition In Biotech Venture Capital: Delivering Returns Amidst Sliding Market Share (LifeSciVC)
  • Celgene Accused of Using Charities in 'Scheme to Gain Billions' (Bloomberg)
  • Ethically speaking: What's the right thing to do? (Reuters Bioworld)
  • Theranos' Holmes on the rise, fall and maybe rise again of a medical tech darling (CNN) (KQED) (Washington Post)
  • First Wi-Fi-Enabled Smart Contact Lens Prototype (MIT Technology Review)
  • How Valeant Cashed In Twice on Higher Drug Prices (NYTimes)
  • Is The Golden Era Of Pharmaceutical Profits Over? (Forbes)
  • Seres' microbiome therapy misses Phase II endpoint (BioCentury) (MIT Technology Review)
  • Donald Trump And Drug Companies (Forbes)

In Focus: International

  • GSK teams up with Alphabet for $715m bioelectronics venture (Financial Times 1, 2) (Reuters)
  • EMA to Cut One Drug Division, Strengthen Collaborations With National Competent Authorities (Focus)
  • AstraZeneca: Retaining current regulatory procedures crucial, post-Brexit (InPharmaTechnologiist)
  • An ugly summer for science: Turmoil rocks Canadian research community (STAT)
  • UK Drugmakers Martindale, Morningside Said to Consider Sale (Bloomberg)
  • European Commission to Overhaul Concept of 'Similar' Medicines Within Context of Orphan Legislation (Focus)
  • European Commission approves Zepatier for chronic hepatitis C infection (Pharmafile)
  • Rare blood cancer therapy Oncaspar gets NICE green light (PMLive)
  • MSF and Pfizer battle over patent application for life-saving pneumonia vaccine (Economic Times)
  • NICE denies cystic fibrosis patients access to Orkambi (PharmaTimes)
  • South African pharmaceutical workers launch pay strike (PharmaAfrica)
  • Court charges Sun Pharma with unfair labour practices (Economic Times)
  • The impact of Brexit on the pharmaceutical industry: some preliminary considerations (Pharmafile)
  • EMA Offers First Guidance Devoted Entirely to PBPK Modelling (Focus)

US: Pharmaceuticals & Biotechnology

  • Anavex Stock Price Crash: A Fault By Trial Design? (SCRIP-$)
  • Let's Be Realistic About Mechanochemistry (Forbes)
  • MIT Team Develops Portable Drug Production System (GEN)
  •  Peter Thiel Is Very, Very Interested in Young People's Blood (Inc.
  • Requests for Nominations: Individuals and Consumer Organizations for Advisory Committees (FDA)
  • Pfizer to repurpose warehouse space in $150m Michigan investment (InPharmaTechnologist)
  • Keryx withdraws 2016 forecast on renal drug supply disruption (Reuters)
  • CTTI Recommendations for Streamlining Protocol Elements for Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) Trials (Clinical Trials Transformation Initiative)
  • Guidance: Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use (FDA)
  • inVentiv cancels IPO as it announces major investment from Advent (Fierce)
  • Cancer Patients Shouldn't Fear Fentanyl, A Truly Useful Drug For Severe Pain (Forbes)
  • Pfizer-backed GSK spinout advances schizophrenia drug following PhI success (Fierce)
  • Thermo Fisher: 'Biopharma's drive for efficiency plays into our sweet spot' (BioPharmaReporter)
  • Merck Results Underscore Need To Go Big Or Go Home In Diabetes Market (Forbes)
  • FDA Must Do More … But How Much More for Less? (Alliance for a Stronger FDA)
  • Biotech investors still feeling the pain (Financial Times)
  • Is the Reduction in Fines in the Pharmaceutical Industry a Good Sign? (Pharmaceutical Compliance Monitor)
  • Open-source drug discovery project advances drug development (OutsourcingPharma)

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

  • CEL-SCI Reports Monthly Patient Enrollment in July for Its Phase 3 Head and Neck Cancer Trial (Press)
  • MEI Pharma's Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Chemotherapy (Press)
  • Takeda and Seattle Genetics Announce Positive Data from Phase 3 ALCANZA Clinical Trial of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma (Press)
  • Heron Therapeutics Reports Positive Top-Line Results from Phase 2 Studies of HTX-011 for Management of Post-Operative Pain (Press)
  • Autifony Therapeutics successfully completes Phase I study of AUT00206, a first-in-class Kv3 modulator for schizophrenia (Press)
  • TRACT Therapeutics, Inc. Presents Follow-Up Phase I Clinical Data in Kidney Transplant Recipients at the American Transplant Congress 2016 (Press)
  • Eisai Presents Results Of Additional Analysis Of Phase III Study Of Anticancer Agent Halaven® At 14th JSMO Annual Meeting Plenary Session (Press)
  • Neon Therapeutics Announces FDA Acceptance of Investigational New Drug Application for Cancer Vaccine NEO-PV-01 (Press)
  • Sunovion Submits New Drug Application for SUN-101/eFlow to the FDA for the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) (Press)
  • Shire Announces FDA Approval of adynovate with BAXJECT III Reconstitution System (Press)
  • Intersect ENT Announces FDA Submission of NOVA Bioabsorbable Steroid Releasing Implant for Patients With Chronic Sinus Disease (Press)
  • Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older (Press)

US: Medical Devices

  • CareFusion recalls select AVEA ventilators over electrical issues (MassDevice)
  • Latest advance of UDI initiative to keep Big Data geeks busy (MedCityNews)
  • FitBits Be Free: General Wellness Products Are Not (Generally) Medical Devices (Harvard Bill of Health)
  • SPR Therapeutics wins FDA nod for peripheral nerve stim pain relief device (MassDevice)
  • New Immunoassay for the Specific Detection of Hydrocodone Receives FDA 510 (k) Clearance (Press)
  • Micro Interventional Devices wins FDA nod for Permaseal (MassDevice)
  • Alcon wins FDA nod for CyPass Micro-Stent (MassDevice)
  • HDA publishes new bar coding guide (Securing Industry)
  • Thermo Fisher Scientific Receives FDA Clearance for EliA Anti-Thyroglobulin and Anti-Thyroid Peroxidase Tests for Autoimmune Thyroid Disease (Press)
  • Essential Medical Inc. Announces FDA Approval to Begin a U.S. Clinical Trial for the X-Seal 6F Vascular Closure Device (Press)

US: Assorted & Government

  • Firm Stops Communications After Merck's Cease and Desist (New Jersey Law Journal)
  • Lilly joins drugmakers probed by DOJ about PBMs (Fierce)
  • There's Nothing Green About Jill Stein's Vaccine Stance (Forbes)
  • When the American Medical Association Cheered Hillary (Forbes)
  • A Ransomware Epidemic And An Overdue National Health IT Safety Center (Health Affairs Blog)

Upcoming Meetings & Events


  • "Crazy" European Orphan Drug Pricing System Has To End (Pink Sheet-$)
  • Revised EudraVigilance stakeholder change management Plan (EMA)
  • Cancer Drugs Fund relaunched (BioCentury)
  • Sartorius doubles production capacity in UK with new facility (Pharmafile)
  • Development of medicines to treat tuberculosis: Comments invited until 31 January 2017 (EMA)
  • Sanofi should be thinking longer duration in GLP-1s (EP Vantage)
  • For the first time, GSK's respiratory newcomers offset Advair's decline (Fierce)
  • Sanofi/Regeneron eye 2017 EU approval for Humira-beater sarilumab (Fierce) (Pharmafile)
  • 170,000 people alive 25 years after cancer diagnosis (OnMedica)


  • Japan's Astellas shows nearly 50% gain in Q1 even as sales drag on price revisions (Fierce)
  • Takeda restructuring R&D in U.S., Japan (BioCentury)
  • 945-million-yen lawsuit filed over cervical cancer vaccines (Asahi)
  • "Belt and Road Initiative" State Drug Regulatory and Development Cooperation Forum held in Beijing (CFDA)


  • HCV drug price wars seen as Gilead confirms Indian firms to make Epclusa (Fierce)
  • NPPA's latest price cap: More cancer, HIV drugs to become cheaper (Economic times)
  • Cipla appoints Kedar Upadhye as Global CFO (Economic Times)


  • Concordia CEO Faces Off With Short Seller in Libel Suit (WSJ-$)


  • Trendy Miami neighborhood is first in U.S. with local Zika spread (Reuters)
  • More locally transmitted Zika in U.S. expected: official (Reuters)
  • UK urges pregnant women to reconsider travel to Zika-hit Florida (Reuters)
  • One Zika Vaccine Should Protect Against Any Virus (Forbes)
  • Siemens Healthcare Diagnostics Inc. Receives Emergency Use Authorization from FDA for its VERSANT® Zika RNA 1.0 Assay (kPCR) Kit (Press)
  • Zika Cases in Puerto Rico Are Skyrocketing (NYTimes)

General Health & Other Interesting Articles

  • Ovarian cancer risk nearly doubles in women who douche (Reuters)
  • Changes In Eskimo Diet Linked To Increase In Heart Disease (CardioBrief)

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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