Regulatory Focus™ > News Articles > Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refu

Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017)

Posted 08 December 2017 | By Michael Mezher 

Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017)

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

In Focus: US

  • Pfizer breast cancer drug superior to chemotherapy in late stage study (Reuters) (Endpoints) (Press)
  • AHA Calls Regulatory Burden on Hospitals 'Unsustainable' (AHA)
  • Activists press Alexion for stepped-up guidance, boardroom edits: report (Fierce) (Endpoints)
  • M&A slows to a trickle in 2017, but Big Pharma could be on deck for mega deals (Endpoints)
  • Gilead Bets on Cell Therapy Again with $567M Cell Design Labs Deal (Xconomy) (Endpoints)
  • Genetic Programmers Are the Next Startup Millionaires (MIT Technology Review)
  • More than 2,000 drugs now in cancer immunotherapy race (Reuters) (Annals of Oncology)
  • Drug development in the era of precision medicine (Nature)
  • Drug development for neurodevelopmental disorders: lessons learned from fragile X syndrome (Nature)
  • Drug makers continue to owe FDA numerous clinical trials (STAT)
  • FDA proposal on health software provides no clarity on artificial intelligence (STAT)
  • As foreign powers approve Ebola vaccines, US drug makers lag in development pipeline (STAT)
  • Amid harassment reports from STAT, Orbimed's Sam Isaly suddenly departs (Fierce)
  • Denali pulls off 2017's biggest biotech IPO, pocketing $250M for Parkinson's, Alzheimer's trials (Fierce) (Xconomy) (Endpoints)
  • Intuitive Surgical pays $274m, closes $2B share buyback deal (MassDevice)
  • With GOP threatening to break promise, where will Susan Collins go? (Politico)
  • Ohio tech fund awards $10 million to develop new ideas to curb opioid crisis (STAT)
  • US Department of Justice investigating fetal tissue transfers (Reuters) (Daily Beast)
  • Antibiotics sales for use in US farm animals dropped in 2016: FDA (Reuters) (FDA)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

  • Roche is investigated by Romania for anticompetitive practices (STAT)
  • NICE nods for AbbVie in hep C and Novartis in lung cancer (PharmaTimes)
  • Philippines to seek refund of $59 million from Sanofi amid vaccine risk (Reuters)
  • Roche study finds cancer 'Velcro' that halts T-cell attack (Reuters)
  • Venezuela's chronic shortages give rise to 'medical flea markets' (Reuters)
  • Erytech rocked by phase 2b failure in AML (Fierce)
  • Brexit breakthrough welcomed by UK life sciences (Pharmaphorum) (ABPI)
  • Will 'Transformative' UK Life Sciences Sector Deal Help Offset the Brexit Effect? (Pink Sheet-$)
  • RWE and Clinical Trials To Take Center Stage In UK Sector Deal Prospects (SCRIP-$)
  • UK and China agree £70 million of business in health sectors (MHRA)
  • GW Raises $276m In Follow-On (BioCentury)
  • Uganda ends Marburg virus disease outbreak (WHO)
  • India's USV Joins Line-Up For Biosimilar Neulasta In Europe (SCRIP-$)
  • EMA Points Out Shortfalls To Avoid When Seeking Novel Methodology Qualification (Pink Sheet-$)
  • Australia approves Mavenclad for relapsing-remitting multiple sclerosis (PharmaLetter)
  • Glenmark Pharma begins clinical trial of anti-myeloma drug (Economic Times)
  • ICH Experts Aim To Set Elemental Impurity Exposure Limits For Topical Drug Products (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • The biotech industry needs to pay more attention to women's health (STAT)
  • Researchers use data mining to expedite effective prescriptions for depression patients (Fierce)
  • Covington Lures Back FDA Drug Quality Leader (Law360-$)
  • Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says (Pink Sheet-$)
  • IO Biomarkers: Where Do We Stand In 2017? (SCRIP-$)
  • Medicines access group takes aim at Sovaldi patents (PharmaLetter-$)
  • Revance Raises $150m In Follow-On (BioCentury)
  • Spotlight – CAR-T: the next generation (EP Vantage)
  • Childhood cancer survivors have more blood pressure problems (Reuters)
  • A Clinical Trial By Any Other Name … (The Health Care Blog)
  • Fondation Ipsen announces Dr James Levine as new President (Pharmafile)
  • Animal Drugs at FDA Phase 3 Implementation (FDA)
  • Researchers Advance Techniques To Change Gene Regulation And Treat Disease In Mice (Forbes)
  • Study Explains How Malaria Tricks the Immune System (ICT)
  • Common Fungus Helps Dengue Virus Thrive in Mosquitoes (ICT)
  • Life Sciences Recruitment Site Clora Raises $3.3 Million To Accelerate New Therapies (Forbes)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Sangamo Announces European Medicines Agency Recommendation Of Orphan Medicinal Product Designation For Investigational Genome Editing Treatments For MPS I And MPS II (Press)
  • Sanofi Explores Combination Treatments For Multiple Myeloma In New Late-Stage Trials (Press)
  • Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (FDA)
  • Long-Term Efficacy Data from the Phase III GeparSepto Study in High Risk Early Breast Cancer Patients Treated with ABRAXANE® Vs. Solvent-Based Paclitaxel to Be Reported (Press)
  • ERYTECH Reports Top-line Results of Phase 2b Study of Eryaspase for the Treatment of AML (Press)
  • Sandoz announces new Phase I data showing proposed biosimilar pegfilgrastim matches reference medicine (Press)
  • Nordic Nanovector: Invitation to Conference Call for Updated Results From the LYMRIT 37-01 Phase 1/2 Trial, to be Presented at ASH (Press)
  • ARMO BioSciences Presents Efficacy Data from its Phase 1b Trial in Patients with Metastatic Renal Cell Carcinoma at ESMO Immuno-Oncology Congress 2017 (Press)
  • Impax Receives Tentative FDA Approval of Generic Coreg CR® (Carvedilol Phosphate) Extended-Release Capsules (Press)

Medical Devices

  • Report: Deal volumes still down, values up in medtech M&A (MassDevice)
  • How a New Device Could Ease the Pain of Biologics (MDDI)
  • A better mammogram? Large study putting 3D scans to the test (CBS)
  • VitalConnect gets FDA nod to extend VitalPatch life from four days to five (MobiHealthNews)
  • Another round of layoffs ahead for Invacare (MassDevice)

US: Assorted & Government

  • Note to Experts: Do Not Cruelly Disparage Your Client's Decedent, Curse Out Your Judge, and Flout the Court's Orders, or You May Face Steep Personal Sanctions (Drug & Device Law)
  • Puma Exec's Brother Traded On Cancer Drug Info, SEC Says (Law360-$)
  • Feds Blast Ex-Pharmacist's Acquittal Bid In Meningitis Row (Law360-$)
  • Amgen Urges Full Fed. Circ. Hearing On Repatha Patents (Law360-$)
  • The Opioid Abuse Deterrence Act and DOJ Initiatives: Just What the Doctor Ordered? (FDA Law Blog)
  • 4th Circ. Frees Pfizer From Antitrust Suit Over Celebrex Patent (Law360-$)
  • Eli Lilly and Company v. Perrigo Co. (Fed. Cir. 2017) (Patent Docs)

Upcoming Meetings & Events

Europe

  • StemBioSys Continues Expanding Distribution, Adding Western Europe (Xconomy)
  • EudraVigilance Web Application (EVWEB) v.1.1 Release Notes  (EMA)
  • EFPIA response to EXPH draft opinion on payment for high-cost novel meds (PharmaLetter)

Asia

  • Hisun-Pfizer Split: What Went Wrong And What Next? (SCRIP-$)
  • FiercePharmaAsia—JLABS' Shanghai site, Sanofi's Dengvaxia crisis, Astellas' $450M DMD buy (Fierce)

India

  • Govt asks 250 AMCs to report India specific ADRs on priority basis through intensive ADR monitoring (PharmaBiz)
  • India's commitment to 'Ending the AIDS' epidemic (PharmaLetter-$)
  • Zydus gets USFDA nod for schizophrenia treatment drug (Economic Times)
  • Maha FDA circulates NPPA order for strict compliance of stent prices by hospitals (PharmaBiz)

Australia

  • TGA presentations: Evaluation Panel Roadshow, November 2017 (TGA)
  • Presentation: Evaluation Panel Roadshow - Overview of Toxicology Evaluations (TGA)
  • Presentation: Evaluation Panel Roadshow - Overview of Chemistry Evaluations (TGA)

General Health & Other Interesting Articles

  • Nothing Protects Black Women From Dying in Pregnancy and Childbirth (ProPublica)

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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