Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Roche Skin Cancer Combo, Orders Audit of Dr Reddy's (11 November 2015

Regulatory Recon: FDA Approves Roche Skin Cancer Combo, Orders Audit of Dr Reddy's (11 November 2015)

Posted 11 November 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Roche Skin Cancer Combo, Orders Audit of Dr Reddy's (11 November 2015)

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

  • FDA approves Roche's Cotellic for combination skin cancer therapy (Reuters) (WSJ) (FDA) (Press)
  • Groups with ties to pharma want to block CDC opioid prescribing guidelines (Pharmalot)
  • PhRMA Responds to NYTimes Op-Ed (NYTimes, Op-Ed)
  • Alzheimer's: A disease on track to bankrupt Medicare (CNBC)
  • Senate Confirmation Hearing on Califf Nomination Set For Nov. 17 (FDANews-$)

In Focus: International

  • Generic Nexium Pill Blocked in US Over Purple Color (WSJ-$) (Economic Times)
  • Reforms To China's Drug Approval Process Are More Important Than Ever (Forbes)
  • Dr Reddy’s says US FDA seeks audits across its network (LiveMint)
  • India eases testing norms for new drugs (Economic Times) (Focus)
  •  Drug industry bemoans Britain's lack of science skills (Reuters)
  • The WHO financing dialogue: global health leadership needs to be paid for (BMJ)

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US: Pharmaceuticals and Biotechnology

  • Drugmaker Valeant to feel sting of closing controversial pharmacy (Reuters)
  • 3 Pressing Challenges For Personalized Medicine (Law360-$)
  • Express Scripts Cutting Off Pharmacy That Sold Drugs From Horizon Pharma (WSJ-$) (NYTimes)
  • R&D Renaissance? FDA Commissioner Nominee Asks Stakeholders For Ideas (RPM Report-$)
  • An inconvenient truth (Bioworld Perspectives)
  • Pharmacists’ skills underused in battle to halt inappropriate antibiotic prescribing, survey suggests (Pharmaceutical Journal)
  • Merck's IMPROVE-IT: FDA Panel Review Has Implications Beyond Zetia, Vytorin (Pink Sheet-$)
  • Commonly Prescribed Drug May Increase Mortality Risk in Hospitalized Patients (MPR)
  • Is Eliquis Safer Than Xarelto And Pradaxa If It Causes Fewer Dangerous Major Bleeding Events (Drug Injury Watch)
  • Replacing Animals: An Emerging Multi-Billion Dollar Industry (SCRIP-$)
  • Tresiba Gains Early Approval in US Basal Insulin Market (Life Sciences Connect)
  • The Common Rule NPRM: Biospecimens (Harvard Bill of Health)

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

  • AHA: Remote Monitoring Flops for Cutting HF Admissions (MedpageToday)
  • Destiny Pharma Announces Qualified Infectious Disease Product Designation Granted by US FDA for Novel Antibacterial Product (Press)
  • City of Hope Clinical Trial Will Test Cancer Vaccine with Anti-Tumor Drug (Press)
  • PEGASUS-TIMI 54 Sub-Analysis Outlines Long-Term Tolerability Data for BRILINTA (Press)
  • Allergan Announces Submission of Prior Approval Supplement for RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05% Multi-Dose Preservative-Free Bottle (Press)
  • Sophiris's prostate drug meets main goal in late-stage study (Reuters) (Press) (SCRIP-$)
  • Afferent Pharmaceuticals Announces Phase 2 Clinical Trial with AF-219 in Cough in Idiopathic Pulmonary Fibrosis (IPF) Patients (Press)
  • Santhera plans for US and EU approval filing of Raxone for DMD (PharmaLetter-$)
  • Boehringer Ingelheim Announces Completed Enrollment of Phase III Clinical Trial for Biosimilar Candidate to Adalimumab (Press)
  • Amgen announces positive Phase 3 results of ABP 501 compared with adalimumab (BiosimilarNews)
  • Coherus and Baxalta announce positive Phase 3 results of etanercept biosimilar (BiosimilarNews)
  • Genkyotex’s GKT137831 Granted Orphan Drug Designation in the US and EU for the Treatment of Systemic Sclerosis (Press)
  • 74% of patients reached LDL cholesterol goals with Praluent treatment (PharmaLetter-$)
  • FORUM Pharmaceuticals Inc. Announces Removal of Partial Clinical Hold on Phase 3 Encenicline Program for Cognitive Impairment in Schizophrenia (Press)
  • Aimmune Therapeutics Reports Positive Findings for ARC002 Follow-On Phase 2 Study of AR101 for Treatment of Peanut Allergy (Press)

US: Medical Devices

  • Safeway, Theranos Split After $350 Million Deal Fizzles (WSJ-$)
  • Guest Column: Don't Let These 2 Quality Nightmares Keep You Up At Night (Gray Sheet-$)
  • SYMBIS Brain Biopsy Robot FDA Cleared for Procedures Inside MRI (medGadget)
  • A treasure trove of new cancer biomarkers (MNT)
  • Smartphone compatible listening device may rival gold standard stethoscope (MNT)
  • Xeltis completes 2nd feasibility trial of cardiac valve system (MassDevice)
  • Medtronic’s Covidien, J&J’s Ethicon bury most of the hatchet in surgical shears spat (MassDevice)
  • GE Healthcare, Shine advance tech to create imaging radioisotope without weapons-grade uranium (FierceMedicalDevices)
  • IBM brings Watson to Boston Children's Hospital for rare pediatric disease diagnosis (FierceMedicalDevices)
  • Intersect ENT touts economic data from from Propel study (MassDevice)
  • ReVision Optics files for PMA for presbyopia inlay (MassDevice)
  • Thermowand Enters Final Testing Phase (Press)

US: Assorted and Government

  • Fixing Drug Pricing? Congress Enacts Generic Inflation Rebate And Turns Up Heat On FDA (RPM Report)
  • Why Republicans will stumble on drug pricing policy (Health Business Blog)
  • Supreme Court Declines To Hear Benicar Patent Suit (SCRIP-$)
  • Allergan Asks Supreme Court to Overturn Injunction on Mandatory Drug Production (FDANews-$) (Focus)
  • Endo Has No Privilege To Withold SEC Drafts In Drug MDL (Law360-$)
  • Federal Circuit Hands Mixed Ruling to Momenta on 271(g) and 271(e)(1) Issues (OrangeBookBlog)
  • FDA Communications Key To Court Dismissal Of Diabetes Product Liability Suits (Pink Sheet-$)
  • Texas Proposes Repeal of Price Reporting Requirement (FDA Law Blog)
  • Jury still out on omega-3s for depression (Reuters)
  • Yes, Plaintiffs, There is Clear Evidence (Drug and Device Law)
  • FDA issues first product marketing orders through premarket tobacco application pathway (FDA) (Reuters)
  • GPhA lauds Christie for signing N.J. biosimilar bill (DSN)
  • In Apparent Shift, FDA Engages on “Natural” (FDA Law Blog)

Upcoming Meetings and Events              


  • Update: British prosecutor drops case against Japan’s Olympus (MassDevice)
  • O'Neill: Pharma Is Intrigued, Irritated But Respects The UK AMR Review (SCRIP-$)


  • NPPA revises prices of 6 formulation packs under DPCO, 2013 (PharmaBiz)


  • China, South Korea Tariffs on Medical Devices Could Prevent Access to Life Saving Technologies (WSJ-)
  • WuXi PharmaTech and Lilly collaborate on novel therapeutic in China (PharmaLetter-$)


  • Health Canada Approval for MolecuLight i:X Marks Significant Clinical Advancement in Wound Care Diagnosis (medGadget)


  • Consultation: Proposed amendments to the Poisons Standard - ACMS meeting, March 2016 (TGA)
  • Australian government and GBMA agree policy priorities for PBS and industry viability (PharmaLetter-$)

Other International

General Health and Other Interesting Articles

  • New SARS-Like Virus Can Jump Directly From Bats to Humans (ICT)
  • Asymptomatic People Transmit Dengue Virus to Mosquitoes (ICT)

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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