Regulatory Focus™ > News Articles > 2019 > 4 > Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study

Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study

Posted 19 April 2019 | By Michael Mezher 

Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Federal judge scolds Purdue, Endo and Mallinckrodt for stall tactics in opioids case (Fierce) (Law360-$)
  • 'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst (Fierce)
  • Judge rejects challenge of New York City's mandatory measles vaccination order (Reuters)
  • Washington State Senate Passes Bill Removing Exemption For Measles Vaccine (NPR)
  • Nationwide Recall of Popular Blood Pressure, Heart Drugs Expanded Over Cancer Concerns (NBC) (FDA)
  • Consumer watchdog petitions FDA for black box warning on Amgen's Prolia (Fierce)
  • Lower dose of Pfizer-Lilly painkiller misses main goals in late stage study (Reuters) (STAT) (Endpoints) (Press)
  • FDA Sends Warning Letters on Dietary Supplements (WSJ)
  • BI and Lilly's diabetes drug Jardiance reverses heart failure in animal models (Fierce)
  • US launches four-state study to find ways to reduce opioid overdose deaths (Reuters) (NIH)
  • Medicare payment rules hinder the fight against superbugs (STAT)
  • Breaking Down 3 New Senate Bills Targeting Drug Prices (Law360-$)
  • A Hippocratic Oath for Big Data (The Hill)
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In Focus: International
  • Mereo’s shareholders back OncoMed takeover (PMLive)
  • Lonza reports pharma strength as rest of business falters (BioPharmaDive)
  • Australia and Canada Jointly Approve Breast Cancer Drug (Focus)
  • Nearly 70 million people to be vaccinated during Vaccination Week of the Americas (PAHO)
  • Chilean minister pushes back against pharma move to pressure its pricing policies (STAT)
  • El Al Airline Warns of Measles After Flight Attendant Falls Into Coma (NYTimes)
  • Roche throws in the towel on Tecentriq bladder, myeloma trials (Fierce)
Pharmaceuticals & Biotechnology
  • A Promising Anti-HIV Drug Poses A Dilemma (NPR) (Study)
  • Many young cancer patients regret initial treatment decisions (Reuters)
  • Two-wave U.S. flu season is now the longest in a decade (STAT)
  • Bispecific Antibodies: FDA Drafts Guidance for Developers (Focus)
  • DTC Drug Advertising: Study Finds Mixed Impact on Patients, Prescribers (Focus)
  • Onpattro, Tegsedi Cardiac Imaging And Serum Biomarker Data Failed To Impress US FDA (Pink Sheet-$)
  • BI and Lilly's diabetes drug Jardiance reverses heart failure in animal models (Fierce)
  • Chutes & Ladders—Gilman buckles in as Arrakis raises $75M, while Wotton takes over at Obsidian (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Innovus Pharma Announces FDA Approval of New ANDA for Supply of FlutiCare (Press)
Medical Devices
  • 10 Deals That Shook up the Diagnostics Industry (MDDI)
  • AngioDynamics to Divest its Fluid Management Portfolio (MDDI)
  • CDRH Drafts Guidance on Quantitative Imaging (Focus)
  • CDRH Draft Guidance Tackles Nitinol Devices (Focus)
US: Assorted & Government
  • Genetic Testing Is On FTC's Radar (Law360-$)
  • Talk Of Medicare For All Unnerving Investors (Forbes)
  • Maine seeks to clarify limits on gifts and payments that pharma can give doctors (STAT)
  • Wall Street, K Street step up criticism of 'Medicare for All' (Politico)
  • Novartis Pharmaceuticals Corp. v. Par Pharmaceutical Inc. (D. Del. 2019) (Patent Docs)
  • Doc Linked To Insys Denies New Charges In Patient's Death (Law360-$)
  • Warning Causation Sinks Another Generic “Failure To Update” Claim (Drug & Device Law)
  • If UnitedHealth Doesn’t Get Magellan, It Fits Anthem’s Services Strategy (Forbes)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors (Focus)
Asia
  • Indian generics contenders; Chi-Med's HK listing; Qilu Pharma explosion (Fierce)
  • Asia Executives On The Move: New Daiichi CEO, WuXi CMO (Scrip-$)
General Health & Other Interesting Articles
  • Is Dentistry Safe and Effective? (Marginal Revolution)
  • This Genetic Mutation Makes People Feel Full — All the Time (NYTimes)
  • Can Botox and Cosmetic Surgery Chill Our Relationships With Others? (NYTimes)
  • Why Do Doctors Overtreat? For Many, It's What They're Trained To Do (NPR)
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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