Regulatory Focus™ > News Articles > Regulatory Recon: Former FDA Commissioner Califf Offers Advice to Gottlieb; DoJ Raids Perrigo in Pri

Regulatory Recon: Former FDA Commissioner Califf Offers Advice to Gottlieb DoJ Raids Perrigo in Price Fixing Probe (3 May 2017)

Posted 03 May 2017 | By Michael Mezher 

Regulatory Recon: Former FDA Commissioner Califf Offers Advice to Gottlieb DoJ Raids Perrigo in Price Fixing Probe (3 May 2017)

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

In Focus: US

  • Here's the advice the last FDA commissioner has for his successor (CNBC)
  • Perrigo Offices Searched by U.S. Agents in Drug Price Probe (Bloomberg) (USA Today) (The Street)
  • A Year After Approval, Gene-Therapy Cure Gets Its First Customer (MIT Technology Review)
  • Gottlieb Q&A: Off-Label Communications And Right-To-Try (Pink Sheet-$)
  • 'Right To Try' And PDUFA VI: Patient Advocates, Industry Fight Senate Add-On (Pink Sheet-$)
  • Clock is Ticking on GOP Bill: 5 Ways Health Care Tug-Of-War May Play Out (KHN)
  • House Republicans shy of votes to pass healthcare reform: lawmaker (Reuters)
  • GOP Scrambles as a Crucial Voice Shuns the Latest Health Bill (NYTimes)
  • Carmat buoyed by approval to resume artificial heart trial (Reuters)
  • HELP Preparing Skinny User Fee Bill (BioCentury)
  • FDA Issues Waiver to Allow Advisory Committee Member to Participate on Panel, Despite Financial Conflicts (FDA)
  • A Child's Suffering Drives A Mother To Seek Untested Treatments (NPR)
  • Doctors Prescribe More Generics When Drug Reps Are Kept At Bay (NPR) (Reuters)
  • Philips CEO: The future of medicine is prevention (CNBC)
  • Valeant Pharmaceuticals Open to Name Change, CEO Papa Says (The Street)
  • Is Pfizer really weighing a BMS buy? Clues from Q1's earnings call say it just may be (Fierce)
  • New FDA Warning Letter, Form 483 for Two Indian Companies (Focus)
  • House Committee Considers Four Device Bills to Add to User Fee Reauthorization (Focus) (The Hill)
  • Eli Lilly's insulin pricing scrutiny intensifies with newly disclosed state AG probes (Fierce)
  • Merck's Cancer Sales Soar In White-Hot Market (Forbes)
  • Gardasil posts big Q1 beat to push Merck vaccines to 21% growth (Fierce)
  • Gilead slips after quarterly results miss estimates (Financial Times) (The Street)
  • Look out, Glaxo: Advair is Express Scripts' next big cost-savings target (Fierce)
  • B is for biotech: Alphabet, and its search for life science glory (Fierce)

In Focus: International

  • MDR and IVDR to be published this Friday (Medical Devices Legal)
  • EMA to Pharma Companies: Prepare for UK to EU Shift (Focus)
  • BioIndustry Association calls for governmental support ahead of UK general election (Pharmafile)
  • Brexit regulatory uncertainty 'threatens UK med tech' (Reuters) (Pharmafile)
  • Real-world data: High on the life science agenda (Pharmafile)
  • NICE nod for Amgen's rare leukaemia drug (PharmaTimes)
  • Brazil Yellow Fever Outbreak Spawns Alert: Stop Killing the Monkeys (NYTimes)
  • Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (Focus)
  • Shire creates 150 jobs with Dublin HQ relocation (Pharmafile)
  • Towards control of the global HIV epidemic: Addressing the middle-90 challenge in the UNAIDS 90–90–90 target (PLOS)
  • Returns From Sanofi Consumer Expansion Could Point To More (Pink Sheet-$)
  • Biosimilars: the future of Pharma? An interview with Boehringer Ingelheim (EPR)
  • Sunesis slumps after pulling plug on leukemia drug vosaroxin in Europe (Fierce)
  • Suspense Continues Over Formal EMA Hosting Criteria, October Decision On New Home Likely (Pink Sheet-$)
  • Bayer recruits former Sanofi exec to lead US oncology business (PharmaLetter-$)
  • PLOS Blogs Opinion Series Discusses Who Should Fill Role Of Next WHO Director General (KFF)

US: Pharmaceuticals & Biotechnology

  • Roche on excipient inconsistencies: 'Don't blame suppliers, work with them' (BioPharmaReporter)
  • Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn (Pink Sheet-$)
  • Menichella, fresh from helping Bamboo to Pfizer buyout, given dealmaking remit at helm of CureVac's US outpost (Fierce)
  • Conservative Group Targets Drug Firms' Positions on ACA (Medpage)
  • Seniors face steep costs for many generic skin creams (Reuters)
  • Oncologists are skeptical of genomics now but see a promising future (Fierce)
  • Merck Confident About Keytruda/Chemo Combo May Date With FDA (SCRIP-$)
  • Lyndra Secures Funding From The National Institute Of Allergy And Infectious Diseases For The Development Of Ultra-Long Acting Oral HIV Therapies (BioSpace)
  • NIH discovery in mice could lead to new class of medications to fight mid-life obesity (NIH)
  • BioMarin's Brineura Approval Shows FDA's Open Door For Orphan Drugs (Pink Sheet-$)
  • Gene therapy no longer science fiction: IRB launches biosafety committee service (OutsourcingPharma)
  • AMRI gets 5-year NIH API manufacturing and process dev contract (InPharmaTechnologist)
  • FDA OKs BioDelivery Sciences' Bunavail opioid dependence film (Drug Delivery)
  • CA Stem Cell Agency Chief Randy Mills to Leave After Three Years (Xconomy)
  • Pharma, stop trying to sell drugs like they're cars or shoes, agency vet urges (Fierce)
  • Caribou Biosciences Announces Grant of a Key CRISPR-Cas9 Patent in the U.S. (Press)

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

  • Pfizer Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for XELJANZ (tofacitinib citrate) for the Treatment of Adult Patients with Active Psoriatic Arthritis (Press)
  • Secretive Moderna reveals first-in-human data from mRNA vaccine tech (Fierce) (Press)
  • Genkyotex Announces FDA Approval of IND for Phase 2 Trial of GKT831 in Patients with Primary Biliary Cholangitis (Press)
  • Rigontec Starts First-In-Human, Phase I/II Trial of RIG-I Agonist RGT100 and Appoints Eugen Leo as Chief Medical Officer (Press)
  • Soligenix Receives FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients (Press)

US: Medical Devices

  • The Necessary Overhead of Quality Processes in Medical Device Product Development (MDDI)
  • Meet the computer-automated drill that cuts surgery time down to minutes (MassDevice)
  • Designing Heart-Assist Devices with Multiphysics Simulation (IEEE)
  • Class 1 Device Recall Newport Medical" HT70 and HT70 Plus Ventilators (FDA)
  • LivaNova buys out Caisson Interventional for $72m (MassDevice)
  • FDA Approves Roche's PD-L1 Test for Bladder Cancer (GenomeWeb) (Press)
  • Private equity shops form medical device portfolio management company (MassDevice)
  • TherOx Completes Enrollment in Study of Next-Generation Therapy System Designed to Improve AMI Outcomes (Press)
  • Glaukos Completes Patient Enrollment in Phase II Clinical Trial for iDose Travoprost Intraocular Implant in Glaucoma Patients (Press)
  • Baxter Achieves Regulatory Milestone for New Peritoneal Dialysis Technology (Press)
  • Acutus Medical Receives FDA Clearance for AcQGuide Steerable Sheath (Press)
  • Luminex Corporation Receives FDA Clearance for ARIES Bordetella Assay (Press)
  • Interscope Announces FDA Clearance of the EndoRotor, the First Flexible Shaver Technology for Interventional Gastroenterology (Press)

US: Assorted & Government

  • The New Federal Budget Protects Medical Marijuana (Forbes)
  • Molina, Key Provider Under Obamacare, Ousts C.E.O., a Trump Critic (NYTimes)
  • Patients Who Rely on Obamacare Protections Are Worried (NYTimes)
  • Patent Infringement Litigation For Antiemetic Agent Aloxi® In The United States (Astellas)
  • President Trump's Budget Should Boost Rather Than Cut Funding For The NIH (Forbes)
  • Southern District of Illinois Excludes Plaintiff's Experts in OTC NSAID Kidney Injury Case (FDA Law Blog)
  • Cerveny – "Clear Evidence" Preemption Wins on What Matters Most (Drug & Device Law)
  • Duke University v. Biomarin Pharmaceutical Inc. (Fed. Cir. 2017) (Patent Docs)
  • FDA Postpones and Reconsiders Menu Labeling Regulation; Comments Due July 3, 2017 (FDA Law Blog)
  • Theranos Settles $96M Investor Damage, Share Swap Suits (Law360-$)
  • Hogan Lovells Hires Pharma Partner From DEA (Law360-$)

Upcoming Meetings & Events

Europe

  • Annals of Oncology Cancer Drugs Fund study "sensationalist and misleading" (ABPI)
  • Ferring Looks For Early Microbiome Wins, But Willing To Do Heavy Lifting (SCRIP-$)
  • Boehringer backs €20M Series A in checkpoint inhibitor startup (Fierce)
  • Sartorius launches next-gen bioreactor range and pushes volume up to 2,000L (BioPharmaReporter)

Asia

  • China's MAH pilot forecast to provide further opportunities for international pharma (PharmaLetter-$)
  • WuXi NextCODE lands $75M Series B led by Temasek and Jack Ma-backed Yunfeng (Fierce)

India

  • DCGI starts evaluation of safety data related to BVS cardiac stents following their restricted use (PharmaBiz)
  • DoP asks NPPA to refix prices of "Methotrexate 2.5mg, 7.5mg & 10mg tabs" by considering only 8 formulations with SKU-wise MAT of more than 1% market share (PharmaBiz)
  • SeQuent's arm Alivira gets USFDA nod for Visakhapatnam API facility (Economic Times)

Australia

  • Consultation: TGA - enhancing sanctions and penalties in the Therapeutic Goods Act 1989 (TGA)

Other International

  • New Zealand OKs CE Mark trial for Medeon Biodesign's XPro large-bore vascular closure device (MassDevice)
  • First-trimester artemisinin derivatives and quinine treatments and the risk of adverse pregnancy outcomes in Africa and Asia: A meta-analysis of observational studies (PLOS)
  • A universal testing and treatment intervention to improve HIV control: One-year results from intervention communities in Zambia in the HPTN 071 (PopART) cluster-randomised trial (PLOS)

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe