Regulatory Focus™ > News Articles > Regulatory Recon: Biopharma and Legislative Questions for 2018 (2 January 2018)

Regulatory Recon: Biopharma and Legislative Questions for 2018 (2 January 2018)

Posted 02 January 2018 | By Zachary Brennan 

Regulatory Recon: Biopharma and Legislative Questions for 2018 (2 January 2018)

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

In Focus: US

  • After Hurricane Maria, IV bags are still in short supply (Newsweek)
  • FDA chief: I'm surprised it took big tech this long to get into health care (CNBC)
  • Trump FDA Chief Scott Gottlieb Isn't Pharma's BFF After All (Bloomberg)
  • Toward Better-Quality Compounded Drugs — An Update from the FDA (NEJM)
  • In 2018, we will CRISPR humans (Gizmodo)
  • Mallinckrodt pays $1.2bn for Sucampo (Bloomberg)
  • Prices of Generic Drugs Associated with Numbers of Manufacturers (NEJM Letter)
  • New US drug approvals hit 21-year high in 2017 (Reuters) (Focus) (Forbes)
  • FDA approves Mylan's copy of Allergan's vaginal cream (Reuters)
  • Precision Medical Treatments Have A Quality Control Problem (NPR)
  • Trump v. Drug Makers? And 6 More Burning Biopharma Questions for 2018 (Xconomy)
  • 3 legislative battles to watch in 2018 (Stat)
  • Pharma, under attack for drug prices, started an industry war (Washington Post-$)
  • Cancer Drug Price Rises 1,400% With No Generic to Challenge It (WSJ-$)
  • Targeted Importation: A Drug Pricing Mechanism For 'Predatory Actors' And An A-Pauling HHS Confirmation Dilemma (Pink Sheet-$)

In Focus: International

  • Why Brexit Keeps Drugmakers Up At Night (Bloomberg)
  • Apotex Faces Uncertainty After Founder’s Mysterious Death (Wall Street Journal-$)
  • India sets up panel to assist launch and pricing of new drugs (C&EN)
  • China FDA issues guidelines for cell therapy testing (BioCentury-$)
  • Japan eyes individualized cancer therapy in fiscal 2018 (Asahi Shimbun)
  • Mylan and Biocon biosimilar approval expands to Brazil (Pharmafile)
  • Merck’s Keytruda (pembrolizumab) Approved in Japan for Use in the Treatment of Patients with Urothelial Carcinoma (Press)
  • Shanghai's SARI Pays $359M for Italian Cancer Biopharma NMS (Press)
  • ‘Nobody Thought It Would Come to This’: Drug Maker Teva Faces a Crisis (NY Times-$)
  • Non-cancer Drugs Shine in Israel’s List of New Meds in Subsidized 'Health Basket' (Haaertz)
  • Implementation of the PIC/S guide to GMP PE009-13 (TGA)
  • Comparable overseas regulators (CORs) for prescription medicines (TGA)
  • Early access to medicines scheme (EAMS): scientific opinions (MHRA)
  • Abbott India, Gujarat FDCA collaborate to train new drug inspectors on auditing medical device facility (Pharmabiz)

Pharmaceuticals & Biotechnology

  • A Market Cynic's Biotech Year In Review (Forbes)
  • Biotech’s Breakthrough Year (Wall Street Journal-$)
  • Pharma news over the Christmas period (EP Vantage)
  • In an end-of-year IPO blitz, 4 biotechs pitch new offerings totaling $370M (Endpoints)
  • Valeant, Pershing Square settle insider trading cases for $290M (Fierce)
  • Using an old Merck drug, Menlo hopes to scratch an itch with $98M IPO (Fierce)
  • Why are investors pulling money out of biotech? (Stat-$)
  • Shifting forecasts reveal the winners and losers of 2017 (Evaluate)
  • 7 Notable Biotechs With Data Expected By Year's End (Benzinga)
  • Celgene Takes a $411M Hit From Discontinuation of Crohn's Disease Trials (BioSpace)
  • Bay Area's Depomed Reveals 328 Job Cuts in WARN Notice (BioSpace)
  • Sandoz Prospects for Copy of Allergan Glaucoma Drug Brighten (Bloomberg)
  • AstraZeneca Unloads Four NDAs to ANI Pharmaceuticals in $46.5M Deal (Press)
  • Swallowing a Spy — The Potential Uses of Digital Adherence Monitoring (NEJM)
  • Glial Ties to Persistent Pain (The Scientist)
  • Shire to Build New Plasma Mfg. Facility in GA (Contract Pharma)
  • Eloxx Pharmaceuticals Hires New CEO (Contract Pharma)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Preliminary study hints that genetically modified T cells might fight HIV (Stat)
  • First in vivo gene-editing drugs enter the clinic (Nature Reviews-$)
  • Epilepsy drugs work for most patients, but there’s room for improvement (Reuters)
  • Improving Public Health Requires Inclusion of Underrepresented Populations in Research (JAMA)
  • Bioengineers mimic natural development to create complex living tissues (Fierce)
  • Syros Announces Clinical Supply Agreement with Janssen (Press)
  • FDA Accepts Supplemental Biologics License Application and Grants Priority Review for Adcetris (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma (Press)
  • Protalix BioTherapeutics Reports Positive Interim Data from Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis (Press) (Fierce)
  • Selecta Biosciences Announces FDA Acceptance of IND for LMB-100 and SVP-Rapamycin Combination Therapy (Press)
  • DNAnexus Announces $58 Million Investment to Accelerate Expansion (Press)
  • Achaogen Announces Positive Top-Line Results from First Clinical Trial of Orally-Administered Antibacterial Candidate C-Scape (Press)
  • Achaogen Announces FDA Acceptance of NDA with Priority Review for Plazomicin for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections (Press)
  • Atara Biotherapeutics Announces FDA Clearance to Initiate Two Phase 3 Clinical Studies to Evaluate Tabelecleucel in Patients with Rituximab-Refractory Epstein-Barr Virus Associated Post-Transplant Lymphoproliferative Disorder (EBV+PTLD) (Press)
  • Ignyta Reports FDA Clearance of IND for RXDX-106, a Novel Immunomodulatory Agent and TYRO3, AXL, MER (TAM) Inhibitor (Press)
  • Edge's EG-1962 Phase 3 NEWTON 2 Study Continues as Planned Following Completion of Futility Analysis (Press)
  • BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Hepatocellular Carcinoma (Press)
  • Inovio Enters License and Collaboration Agreement with ApolloBio To Develop and Commercialize VGX-3100 in Greater China (Press)
  • Clover Receives CTA Approval For Enbrel Biosimilar (Contract Pharma)

Medical Devices

  • 5 medtech stories you might’ve missed last week (Mass Device)
  • Medtech news over the Christmas period (EP Vantage)
  • Priority review designations medical devices (including IVDs) (TGA)
  • FDA approves diabetic foot ulcer shock wave device (Pharmaphorum)
  • BD closes $24B Bard buy-out (Mass Device)
  • Masimo Announces CE Marking and Release of Oxygen Reserve Index rainbow Lite Sensors (Press)

US: Assorted & Government

  • Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders: Draft Guidance for Industry (FDA)
  • FDA “Finalizes” Rule on Health Care Antiseptic Drug Products Ahead of Time (FDA Law Blog)
  • FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response (FDA)

Upcoming Meetings & Events

General Health & Other Interesting Articles

  • Neuroscientist Ben Barres, who identified crucial roles of glial cells, dies at 63 (Stanford)
  • America's opioid epidemic began more than a century ago – with the civil war (Guardian)

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? Send him an email at news@raps.org A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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