Regulatory Focus™ > News Articles > Regulatory Recon: Allergan CEO Vows to Limit Drug Price Increases; Danaher to Buy Cepheid for $4B (6

Regulatory Recon: Allergan CEO Vows to Limit Drug Price Increases Danaher to Buy Cepheid for $4B (6 September 2016)

Posted 06 September 2016 | By Michael Mezher 

Regulatory Recon: Allergan CEO Vows to Limit Drug Price Increases Danaher to Buy Cepheid for $4B (6 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter

In Focus: US

  • Allergan CEO Vows to Limit Drug Price Increases (Forbes) (Allergan)
  • Is Biogen's Rough Ride Over? (The Street)
  • Danaher to buy Cepheid for about $4 billion, including debt (Reuters)
  • The secretive system for vetting cancer drug use needs an urgent overhaul (STAT)
  • Left on the garbage heap of the 114th Congress? (Bioworld) (Science)
  • On the Wondrous U.S. Market For Prescription Drugs (HealthcareBlog)
  • FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths (Focus)
  • Drug Industry Group Starts Ad Campaign to Push Back on Pricing (Bloomberg)
  • Allergan Acquires Gene Therapy Company RetroSense Therapeutics Adding First-In-Class Technology to Company's Innovative Eye Care Pipeline (Press)
  • Antibacterial Wash Companies Have One Year To Remove 19 Banned Ingredients, FDA Final Rule Says (Focus)
  • Apple's move to tighten digital health criteria could have bigger impact than FDA (MedCityNews)
  • Novartis on CAR T division: 'Reintegrated but still committed' (BioPharma-Reporter)
  • AZ's first respiratory biologic meets primary endpoints in Phase III trials (Pharmafile) (Reuters) (Press)
  • Sanofi, Zealand retake lead in diabetes race after FDA delays decision on Novo drug (Fierce)
  • FDA approves Concentric Medical's Trevo clot retrievers (MassDevice) (FDA) (Medpage)
  • The Lesson of EpiPens: Why Drug Prices Spike, Again and Again (NYTimes)
  • US lawmakers question Mylan's Medicaid EpiPen rebates (Reuters)
  • How Vaccines May Become Like Pants: Tailor Made For You (Forbes)

In Focus: International

  • Too costly for Indonesia to thoroughly test for Zika: health official (Reuters)
  • Aurobindo plans to launch 19 drugs in US in next 3 quarters (Economic Times)
  • ESC: MORE-CARE Fails to Prolong HF Survival (Medpage)
  • UK MHRA Adapts Inspections Program To Account For Increase In Pharmacovigilance Outsourcing (Pink Sheet-$)
  • Recall of GlucaGen HypoKits used by diabetics in an emergency (MHRA)
  • Manufacturer of Accu-Chek Insight insulin pumps issues updated handling instructions following user feedback (MHRA)
  • India: Code for pharma firms to have more teeth (Economic Times)
  • Lars Fruergaard Jorgensen a model for 'Novo Nordisk Way' (Financial Times)
  • Real world data back efficacy of GSK's Bexsero (PharmaTimes) (Pharmafile)
  • Eisai Cannot Understand German IQWiG's Recommendation to Reject Halaven (Pink Sheet-$) (Pharmafile) (EPR)
  • Added benefit of Empliciti combo in multiple myeloma not proven, says IQWiG (PharmaLetter-$)
  • NICE rejects Roche's melanoma combo (PharmaTimes) (PharmaLetter-$)
  • Australia: More than 2,000 medicine brands to drop in price (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • FDA Makes 'Significant Changes' To Drug Registration Rules (Pink Sheet-$)
  • The Real Science of Abortion Drugs (NYTimes)
  • FDA cancels Dynavax advisory meeting (BioCentury) (Fierce)
  • US FDA slams Elite Pharma for adverse reaction monitoring failures (In-PharmaTechnologist)
  • ViiV Poised To Take HIV PrEP Injectable In Late-Stage Trials (SCRIP-$)
  • Is EpiPen a Brand-Name or a Generic Drug? Mylan Casts It Both Ways (NYTimes)
  • ADHD Nation: The Disorder. The Drugs. The Inside Story by Alan Schwarz – review (The Guardian)
  • FDA Urges Firms To Control Metal Impurities From Equipment And Containers (Pink Sheet-$)

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

  • New data on Chiesi COPD fixed ICS/LABA/LAMA combination treatment (PharmaLetter-$)
  • Santalis Pharmaceuticals Initiates a Phase 2 Study of Mild, Moderate and Severe Atopic Dermatitis - Enrolls First Patient Into Its Australian Clinical Trial Site (Press)
  • Arrowhead Pharmaceuticals Initiates Phase 2 Study of ARC-AAT (Press)

US: Medical Devices

  • Judge fast-tracks Alere suit against Abbott, urges mediation (MassDevice)
  • New Guidance Gives Device Makers More Leeway With 510(k)s for X-Rays (Focus)
  • US FDA Explains its Approach to "Real-World" Evidence and Data for Medical Devices (Emergo)
  • Cheaper genetic tests point way to a gentler cancer treatment (Financial Times)

US: Assorted and Government

Upcoming Meetings & Events

Europe

  • First generic copy of Copaxone launched in Europe by Alvogen (PharmaLetter-$)
  • The European Core Health Indicators (ECHI) (EC)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August - 2 September 2016 (EMA)
  • Negotiations regarding Monsanto acquisition advance (Bayer)
  • Joint statement: Business groups express their continued support for TTIP negotiations (EFPIA)
  • Russia Probes Suspected Collusion That Keeps Prices High In Drug Tenders (SCRIP-$)
  • Europe expands use of diabetes drug Xultophy (PharmaTImes)
  • European Commission Approves Bristol-Myers Squibb's ORENCIA® (abatacept) for the Treatment of Highly Active and Progressive Disease in Adult Patients with Rheumatoid Arthritis Not Previously Treated with Methotrexate (Press)

Asia

  • FDA Warning Letter Could Hamper Zhejiang Medicine's US Foray (SCRIP-$)
  • Asia 100: Operating Profit Returns To Asian Pharma Sector (SCRIP-$)
  • Sun Pharma strikes distribution alliance with Mitsubishi Tanabe in Japan (Economic Times)

India

  • Dr Reddy's Rituximab Build-Up And Going Beyond The Pill (SCRIP-$)

Australia

  • Medical Devices Safety Update, Volume 4, Number 5, September 2016 (TGA)

Zika

  • Philippines confirms first case of Zika virus this year: ministry (Reuters)
  • Malaysian infected by Zika died from heart disease complications: ministry (Reuters)
  • Singapore says confirms 26 more local transmission Zika cases (Reuters)
  • Singapore says will no longer isolate Zika patients (Reuters)
  • No Zika Cases Reported During Rio Olympics, W.H.O. Says (NYTimes)

General Health & Other Interesting Articles

  • Memory Loss Associated With Alzheimer's May Be Preventable And Reversible (Forbes)
  • Should we keep doing face transplants? (Reuters)
  • Research links eczema and hay fever to early antibiotic use (Reuters)

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.

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