Regulatory Focus™ > News Articles > Regulatory Recon: Baxter, Lilly Beat Sales Estimates; Gilead Lowers Guidance Amid Lower HCV Sales (2

Regulatory Recon: Baxter, Lilly Beat Sales Estimates Gilead Lowers Guidance Amid Lower HCV Sales (26 July 2016)

Posted 26 July 2016 | By Michael Mezher 

Regulatory Recon: Baxter, Lilly Beat Sales Estimates Gilead Lowers Guidance Amid Lower HCV Sales (26 July 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

  • Celgene drug fails to extend survival in lymphoma study (Reuters) (The Street)
  • US health officials update Zika transmission and testing guidance (Reuters) (Medpage) (CDC)
  • Newron to resubmit troubled Parkinson's drug to FDA; abuse risks cleared (Fierce) (Press)
  • Roche getting under the skin of biosimilar competition (In-PharmaTechnologist)
  • Pharma trade group says price gougers are outliers, but then accepts two more (STAT)
  • APNewsBreak: Pfizer: Arkansas Execution Would 'Misuse' Drug (ABC)
  • Baxter Beats Earnings Estimates, Raises Full-Year Guidance (Bloomberg)
  • UDI Form and Content: FDA Offers Draft Guidance (Focus)
  • DNC may go easy on Pharma (Politico)
  • WATCH: See how a superbug is created (STAT)
  • CMS Proposal for Part B Drug Payment: A Poorly Conceived Experiment (ASCO Post)
  • Patients With Severe Schizophrenia Aren't Getting The Help They Need (Health Affairs Blog)
  • Lilly sales beat estimates on demand for new drugs (Reuters) (Bloomberg)
  • The Third Time's the Charm for RAVICTI and Orphan Drug Designation: Another "Greater Safety" Clinical Superiority Precedent (FDA Law Blog)
  • FDA Continues Steady Reduction of Generic Drug Application Backlog (Focus)
  • Big Data and Imaging Analysis Yields High-Res Brain Map (NIH)
  • An ex-con is taking his debt-ridden, cash-burning biotech public. Why are people investing? (STAT)
  • Gilead Readying for Earnings Report , Lowers 2016 Guidance Amid Slowing HCV Sales (The Street) (BioCentury)
  • Despite a deck stacked in its favour, Tobira fails in NASH (EP Vantage)(Fierce) (Press)
  • Pharma companies gain access to de-identified data on adherence for specific drugs (MedCityNews)
  • FDA Sends Untitled Letter to Danish Drugmaker Over GMP Issues (Focus)
  • The ethical battle for the future of pharma (Pharmafile)
  • Children Exposed To Hepatitis C May Be Missing Out On Treatment (NPR)

In Focus: International

  • Olympics unlikely to worsen global spread of Zika (Reuters)
  • CFDA Minister Bi Jingquan meets WHO Director-General Dr Margaret Chan (CFDA)
  • PTC Therapeutics Duchenne Drug Stuck on Conditional Approval Status in Europe (The Street)
  • Boehringer stops Gilotrif trials (PharmaTimes) (PMLive)
  • Germany plans to extend price brake for drugs under statutory insurance (Reuters)
  • India rejects 955 pharma patent applications in last three years (Economic Times)
  • Sandoz repeats tests and Teva pulls malaria pill as EMA calls for suspension of Semler trialled drugs (Economic Times)
  • Vietnamese pharma to reach $6.6 bn by 2020 (BioSpectrum)
  • WHO and Ministry of Health expand cholera response to minimize future risk (WHO)
  • NICE approves Servier's Lonsurf as third-line cancer therapy (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Flu vaccine may help keep diabetics out of the hospital (Reuters)
  • Is 'Generic Viagra' Legitimate? (NYTimes)
  • The effects of direct-to-consumer advertising on medication use among Medicaid children with asthma (Health Marketing Quarterly)
  • Opioid contracts, meant to curb addiction, can harm patients (STAT)
  • Saving Money on Cardiac Care (Bloomberg)
  • Takeda launches new DTC campaign for renamed depression med Trintellix (Fierce)
  • Ex-Amgen team nabs $14M from Merck, Gates Foundation for cheap biologics (Fierce)

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

  • J&J, Genmab bag breakthrough status for Darzalex, shortening route to second-line use (Fierce) (Press)
  • AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C (Press)
  • Spark Therapeutics, Pfizer Present Updated Data From Ongoing SPK-9001 Trial (Press)
  • Alzheimer's biotech Alzheon to move once-failed drug into new PhIII (Fierce) (Press)
  • Bristol-Myers Squibb Announces New Research Collaboration with Janssen in Immuno-Oncology Focused on Lung Cancer (Press)
  • Astellas and FibroGen Announce First Patient Treated in Phase 3 Studies and Positive Phase 2 Results of Roxadustat in Patients with Chronic Kidney Disease in Japan (Press)
  • Alnylam Announces New Positive Interim Phase 1 Study Results for Fitusiran, a Once-Monthly, Subcutaneous, Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia and Rare Bleeding Disorders (Press)

US: Medical Devices

  • Benefiting From FDA's Medical Device Risk-Benefit Guidance (Law360-$)
  • Zimmer Biomet initiates select recall of Persona Trabecular metal tibial plate sets (MassDevice)
  • Patient and Provider Notification (PPN): What to expect if your facility is ordered to perform a PPN (FDA)
  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044 (FDA)
  • Instrumentation Laboratory Receives US FDA Clearance For New HemosIL HIT-Ab(PF4-H) Assay (Press)
  • Syneron Medical wins FDA 510(k) for short-wavelength PicoWay laser (MassDevice)
  • Bigfoot Biomedical launches artificial pancreas trial (MassDevice)

US: Assorted & Government

  • Sanders convention speech cites Clinton health care concessions (STAT)
  • Problems After Using Hair Conditioner Prompt An FDA Warning (NPR Shots)
  • New Animal Drugs; Change of Sponsor (FDA)
  • Can Reference Sponsor Forfeit Right To Sue Under BPCIA? (Law360-$)
  • What Kaine's record reveals on health care (Politico Pulse)
  • Massachusetts class-action lawsuit filed over Alere's blood test (Boston Business Journal)
  • Democrats Address Opioid Epidemic At DNC (Forbes)
  • New Jersey Accutane Plaintiff Verdict Vacated – Appellate Division Strongly Criticizes Evidentiary Rulings (Drug and Device Law)
  • FDA: Draft Guidance - Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees (Policy and Medicine)

Upcoming Meetings & Events


  • BMS names Fouad Namouni as new oncology development head (Pharmafile) (Press)
  • Pharma expert: new 'value added medicines' offer cheaper, customized treatment (EurActiv)
  • IBS-D treatment Truberzi receives positive opinion from CHMP (Pharmafile)
  • Eisai receives positive CHMP opinion on new indication for anticancer agent (BioSpectrum)
  • Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products (EMA)


  • China struggles with vaccine shortage after safety crackdown (Financial Times)
  • CANbridge's CAN-008 Approved for Phase I/II Trial in Newly-Diagnosed Glioblastoma Multiforme in Taiwan (Press)
  • China's Zixin Pharmaceutical buys majority stake in U.S. genome firm Nabsys (Fierce)
  • Medtronic launches VariLock plate system in China (MassDevice)


  • Government may regulate e-Pharmacies soon (Economic Times)
  • Many prohibited drugs available in markets: Ananth Kumar (Economic Times)
  • Claris Life gets USFDA nod for generic anesthetic injection (Economic Times)
  • Reliance Life gains global rights for copies of Infliximab (Economic Times)


  • Colombia declares end to Zika epidemic inside country (Reuters)
  • Spain registers first case in Europe of baby born with Zika-related defect (Reuters)
  • Up to 1.65 million women of childbearing age at risk for Zika (Reuters)

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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