Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Keytruda in Combination with Chemo for Lung Cancer; Pfizer and Sangam

Regulatory Recon: FDA Approves Keytruda in Combination with Chemo for Lung Cancer Pfizer and Sangamo Strike Hemophilia Deal (11 May 2017)

Posted 11 May 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Keytruda in Combination with Chemo for Lung Cancer Pfizer and Sangamo Strike Hemophilia Deal (11 May 2017)

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

In Focus: US

  • Merck boosted by FDA approval for Keytruda use with chemo (Financial Times) (Reuters) (Press)
  • How Big Pharma Might Be Cut Down To Size (Forbes)
  • Pfizer strikes deal with Sangamo, broadening hemophilia pipeline (Reuters) (Fierce) (Endpoints)
  • GSK escapes Advair hit for now as second generic bid fails (Reuters) (PharmaTimes) (Financial Times)
  • FDA warning letter to IONIS-TTRrx trial site hits Ionis stock (Fierce)
  • White House names new members of opioid commission (STAT)
  • Can importing drugs bring down prescription prices for Americans? Yes and no (STAT)
  • Shares soar as 'breakthrough' news in biotech continues to run hot this week (Endpoints)
  • Aetna exiting all ACA insurance marketplaces in 2018 (Washington Post) (Politco)
  • Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia (NEJM)
  • First Imaging Agent For Brain Tumor Surgery Gets US FDA Panel Backing (Pink Sheet-$)
  • User Fee Bill Caught In Comey Firing Tidal Wave (Pink Sheet-$)
  • 5 Top Priorities As Gottlieb Takes Reins At FDA (Law360-$)
  • Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic (SCRIP-$)
  • How the Senate is grappling with health care (Politico)
  • America's 10 most expensive prescription drugs (CNBC)
  • Eli Lilly raised prices on 9 drugs last week (CNBC)
  • NIST issues draft of cybersecurity guidance for wireless infusion pumps (Fierce)
  • Vape Shops Want to Do Good, but Fear FDA Won't Let Them Do Well (NYTimes)

In Focus: International

  • Teva to Sell Assets Such as Women's Health Unit to Cut Debt (Bloomberg)
  • In Europe, U.S., modern AIDS drugs add extra 10 years of life expectancy (Reuters)
  • New Law Could Bring Surge in Clinical Trials to Brazil (Pink Sheet-$)
  • Siam Bioscience Readies Europe Launch Pad For Biosimilars (SCRIP-$)
  • Brexit Impact On Pharmacovigilance Depends On UK MHRA's Access To EU Databases And Systems (Pink Sheet-$)
  • EMA Report on 2016: 27 New Drugs, New Priority Scheme, Trial Transparency (Focus)
  • UK Patients to Get Early Access to AbbVie's HCV Combo (Focus)
  • AbbVie disappointed as NICE issues negative draft appraisal on venetoclax (PharmaLetter-$)
  • Insider Interview: The battle to defeat antimalarial drug resistance (Pharmafile)
  • Astellas scraps NSCLC program after look at phase 3 data (Fierce) (Press)
  • Daiichi cuts 6 meds in last quarter, including Pieris candidate (Fierce)
  • Oxford Genetics licenses CRISPR tech to power synbio push (Fierce)
  • Pharnext surge levels off as investors take in 20 million euro Chinese medicine deal (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Human Antibody Discovery: Of Mice And Phage (Forbes)
  • Cell particles may help spread HIV infection, NIH study suggests (NIH)
  • Abuse-Deterrent Opioids: ICER Value Analysis Could Reinforce Coverage Restrictions (Pink Sheet-$)
  • ANDA Submissions Continue Yo-Yo Pattern, Unlike Approvals (Pink Sheet-$)
  • US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15? (Pink Sheet-$)
  • Argos Says FDA Willing To ADAPT To Longer Follow-Up For Immunotherapy (Pink Sheet-$)
  • What I Told HHS Secretary Tom Price About the 340B Drug Pricing Program (Drug Channels)
  • Vikshara says plant banned by US FDA has stopped making APIs (InPharmaTechnologist)

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

  • Peloton Therapeutics Initiates Patient Dosing in Phase 2 Study of PT2385 for von Hippel-Lindau Disease-Associated Kidney Cancer (Press)
  • Ocular Therapeutix™ Presented Phase 3 Data for DEXTENZA™ at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (Press)
  • Sage highlights 'signal of activity' in Parkinson's data, but questions linger (Fierce)
  • SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Prevention of Clostridium difficile Infection (Press)
  • Xencor's Lead Drug Candidate, XmAb5871, Receives Orphan Drug Designation from FDA for Treatment of IgG4-Related Disease (Press)
  • Aimmune Therapeutics Enrolls First Patient in RAMSES (ARC007), a Phase 3 Clinical Trial of AR101 for the Treatment of Peanut Allergy (Press)
  • Roche to present new data on personalised medicines and cancer immunotherapies at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)

US: Medical Devices

  • Case Study: How Agile Marketing Can Help a Global Device Launch (MDDI)
  • Cardiff Int'l to acquire medical device maker MedicaMetrix (MassDevice)
  • Cook Medical sells vertebroplasty portfolio to IZI Medical (MassDevice)
  • Medtronic wins 1st FDA approval for MRI-safe quad pacers (MassDevice)
  • HRS 2017: Medtronic's Micra leadless pacer performs well in post-approval registry (MassDevice)
  • HRS 2017: Two-year registry data on Boston Scientific's S-ICD (MassDevice)
  • NxStage wins FDA nod for next-gen System One hemodialysis system (MassDevice)

US: Assorted & Government

  • Poll: Doctors Hate Trumpcare Much More Than Obamacare (Forbes)
  • Buffett Says U.S. 'Out Of Whack' On Healthcare More Than On Taxes (Forbes)
  • NIH announces 2017-2018 Medical Research Scholars Program Class (NIH)
  • Another Accutane Verdict Vacated in New Jersey (Drug & Device Law)
  • Astellas Sues Roxane Over Generic Cancer Drug ANDA (Law360-$)
  • To Reduce Regulatory Burdens, Citizen Petition Asks FDA to Permit Interstate Sales of Raw Milk (FDALawBlog)

Upcoming Meetings & Events

Europe

  • Irish ayes: Lilly goes ahead with bioproduction expansion, adding 130 jobs (BioPharmaReporter)
  • EMA Asks for feedback on its communications (EMA)
  • Italian regulators find problems at Kores' API plant in Roha (InPharmaTechnologist)

Asia

  • China Researchers Identify Potential NASH Target (BioCentury)
  • Improving Profitability A Key Mid-Term Focus For Takeda (SCRIP-$)
  • Japan approves Varian Medical's ProBeam proton therapy (MassDevice)
  • The Institute of Medical Science, the University of Tokyo, and Astellas Enter into an Agreement for Expansion of the Scope of Collaborative Research Utilizing Rice-Based Oral Vaccine"MucoRice" Technology (Astellas)

India

  • Focus shifts to expensive pacemakers, lenses, catheters (Economic Times)
  • IDMA cautions govt against weakening pharma industry with its emphasis on generics (PharmaBiz)
  • Govt should remove anomalies in duty structure to boost growth of domestic IVD industry: Khushroo Pastakia (PharmaBiz)
  • US FDA sends Biocon Bangalore plant 483 with 8 observations (Economic Times) (InPharmaTechnologist)

Australia

  • Hazard Alert - Medtronic SynchroMed II implantable infusion pump (TGA)

Other International

  • Chilean pharmacies begin marijuana medicine sales in first for Latam (Reuters)

General Health & Other Interesting Articles

  • He Was on Blood Thinners and Supplements. Could He Still Have Had a Stroke? (NYTimes)
  • Too little focus on lifestyle, preventing symptoms in peripheral artery disease (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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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