Regulatory Focus™ > News Articles > 11 > Recon: FDA Expands Use of BMS’ Empliciti; AbbVie Sues NHS Over HCV Procurement

Recon: FDA Expands Use of BMS’ Empliciti; AbbVie Sues NHS Over HCV Procurement

Posted 07 November 2018 | By Michael Mezher 

Recon: FDA Expands Use of BMS’ Empliciti; AbbVie Sues NHS Over HCV Procurement

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Democrats' new health care math (Politico) (Forbes) (Law360-$) (STAT) (NYTimes)
  • With a new Congress, a window opens to finally bring down drug prices (STAT)
  • Pelosi sees possible 'common ground' with Trump on drug prices (The Hill)
  • Bound to the hip with Trump, ex-Celgene chief Bob Hugin gets whipped in New Jersey Senate race (Endpoints)
  • Indicted for biotech insider trading, Rep. Chris Collins keeps his seat (STAT)
  • FDA approves new use for BMS’ Empliciti (PharmaTimes) (PharmaLetter) (Press)
  • What if the Placebo Effect Isn’t a Trick? (NYTimes)
  • Eli Lilly Raises 2018 Guidance after Strong 3Q (WSJ)
  • Momenta Becomes the Latest to Settle With AbbVie Over Humira (Center for Biosimilars) (Press)
  • AmerisourceBergen suffers another setback with its ‘real doozy’ of a compounding business (STAT)
  • AMA delegates to consider a proposal for personal importation of drugs from Canada (STAT)
  • Landmark RNAi drug gets off to a slow start in sales, but Alynylam calls for patience (STAT)
  • Despite stepped-up scrutiny of patient assistance programs, pharma appears unprepared (STAT)
  • Bristol-Myers lays off the last 63 staffers at ZymoGenetics, shutters Seattle operations (Endpoints)
  • A star drug in Mallinckrodt’s $1.2B Sucampo buyout flops in pivotal trial (Endpoints)
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In Focus: International
  • Just $2 per person a year could halt deadly superbugs, OECD says (Reuters)
  • EU Accelerated Assessment Tracker: Second Half Trumps First By Far (Pink Sheet-$)
  • Endocrine disruptors: A strategy for the future that protects EU citizens and the environment (EC)
  • Call on Harris to focus on supply of medicines after Brexit (The Irish Times)
  • Greek minister: Effective health and pharma policy needs stronger EU Commission role (EurActiv)
  • GSK among businesses wooed as Brexit reckoning nears (PMLive)
  • AbbVie sues NHS England over hep C procurement (PMLive)
  • Better Together: New Deal Adds Weight To China Biosimilar/Biobetter Swap (SCRIP-$)
  • Ukrainian Draft Law Would Weaken IP Rights (Pink Sheet-$)
  • EMA grants accelerated review for quizartinib (PharmaLetter-$)
  • Uganda Vaccinates Front-line health-workers against Ebola (WHO)
  • WHO guidelines: Management of physical health conditions in adults with severe mental disorders (WHO)
Pharmaceuticals & Biotechnology
  • Foamix's treatment for common skin condition meets late-stage trial goals (Reuters) (Endpoints)
  • That generic Advair you've been expecting for months? It'll come, but let's talk other products, Mylan says (Fierce)
  • Eylea crosses quarterly US blockbuster line for Regeneron as Dupixent nears new FDA expansion (Forbes)
  • Consumers may not like health data sharing, but pharma sure does (Fierce)
  • FDA’s Response to HHS’ Revised Common Rule: Four Things to Know (National Law Review)
  • Which media reaches cancer patients? Depends on their diagnosis: report (Fierce)
  • Why Pharma Risk Is Inherently Unpredictable And Why It Matters (Forbes)
  • Eli Lilly's new launches step up in time to fill the growing Cialis gap (Fierce)
  • Risk-Sharing Arrangements May Boost Fortunes Of Certain Prescription Drugs (Forbes)
  • FDA Approves Elanco Cattle Drug, the First for Reducing Gas Emissions (Xconomy) (FDA)
  • Moment of truth looms for Nektar, Bristol-Myers with a major update to NKTR-214 combo — and the latest snapshot is not promising (Endpoints)
  • Families often share potentially dangerous antibiotics: study (Reuters)
  • The changing biosimilar landscape: Lesser-known firms, blockbuster molecules (BioPharmaReporter)
  • How Technology Fails Us In The Battle Against Opioid Addiction (Forbes)
  • The resurrection of LUM001: Mike Grey gets his drug back from Shire — along with $120M to gamble on PhIII trials (Endpoints)
  • Centrexion eyes $70M-$80M in IPO with big plans for PhIII non-opioid painkiller (Endpoints)
  • Dana-Farber team identifies new ‘gene traffic control’ targets in two rare, aggressive cancers (Endpoints)
  • Achaogen cuts costs again and puts up ‘for sale’ sign (Fierce)
  • Jnana President Joanne Kotz to take on CEO role (Fierce)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping (Federal Register)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (Federal Register)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Bone Therapeutics halts phase 3 for futility, sinking stock (Fierce)
  • SpringWorks Therapeutics Receives FDA Fast Track Designation for Nirogacestat for the Treatment of Adult Patients with Desmoid Tumors (Press)
  • Aridis Pharmaceuticals Announces Publication of Positive AR-301 Phase 1/2a Data in "Intensive Care Medicine" and "The Lancet Respiratory Medicine" (Press)
  • Shionogi to Present Clinical Data on Mulpleta® (lusutrombopag) at the Liver Meeting® 2018 of the American Association for the Study of Liver Diseases (AASLD) (Press)
  • Early Phase 1 Data from Merck’s Oncology Pipeline for Investigational Anti-LAG-3 Therapy (MK-4280) and Anti-TIGIT Therapy (MK-7684) to Be Presented at SITC’s 33rd Annual Meeting (Press)
  • Rocket Pharmaceuticals Announces FDA Clearance of IND Application for RP-L102 Gene Therapy for Fanconi Anemia (Press)
  • Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (Press)
  • Lupin receives FDA green light for generic Hectorol (DSN)
  • Elite, Glenmark launch generic methadone tablets (DSN)
Medical Devices
  • FDA clears Siemens Healthineers mobile 3D imaging arm (MedTechDive)
  • Senseonics wins another FDA approval for its implantable CGM (Drug Delivery)
  • Meet The Woman Behind 23andMe's Plan To Keep Your Data Safe (Forbes)
  • K2M shareholders approve Stryker merger (MassDevice)
  • Boston Scientific’s Eluvia drug-eluting stent succeeds in long lesions (Drug Delivery)
  • Dexcom raises outlook after Q3 results top Wall Street estimates (Drug Delivery)
  • FDA grants de novo clearance to AI Biomed, FluoOptics parathyroid tissue detection devices (MassDevice)
  • Medtronic touts five-year data for In.Pact Admiral drug-coated balloon (Drug Delivery) (Press)
  • Cybersecurity Vulnerability: Roche Point of Care Handheld Medical Devices (DHS)
  • Spinal Elements® Announces FDA Clearance of Ti-Bond® Titanium Coating as a Macro-, Micro-, and Nano-Surface (Press)
US: Assorted & Government
  • What Lawsuit to Gut Obamacare? Oh, That One (NYTimes)
  • Endocyte's $2.1B Sale To Novartis 'Unfair' To Investors: Suit (Law360-$)
  • Trump Administration Takes a Turn at Medicare Part B Payment Reform (FDA Law Blog)
  • D. Colorado Applies Learned Intermediary Rule to Medical Devices (Drug & Device Law)
  • CVS tops earnings, revenue estimates, says it expects Aetna acquisition to close before Thanksgiving (CNBC)
  • Buffett-owned DaVita jumps 10% after voters reject cap on dialysis revenue (CNBC)
  • Missouri Votes To Legalize Medical Marijuana (Forbes)
  • Utah Voters Approve Medical Marijuana (Forbes)
  • Idaho Medicaid Expansion Sails To Victory (Forbes) (The Hill)
  • Utah voters approve ObamaCare's Medicaid expansion for low-income adults (The Hill)
  • Nebraska Voters Approve Medicaid Expansion In Snub To Gov. Ricketts (Forbes) (The Hill)
Upcoming Meetings & Events Australia
  • AEMS guidance for health professionals (TGA)
  • AEMS guidance for sponsors (TGA)
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.
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