Regulatory Focus™ > News Articles > Regulatory Recon: New FDA Guidance on Assay Development and Validation; Battle Over Drug Pricing Hit

Regulatory Recon: New FDA Guidance on Assay Development and Validation Battle Over Drug Pricing Hits Germany (25 April 2016)

Posted 25 April 2016 | By Zachary Brennan 

Regulatory Recon: New FDA Guidance on Assay Development and Validation Battle Over Drug Pricing Hits Germany (25 April 2016)

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

In Focus: US

  • Theranos’s fate rests with a founder who answers only to herself (NY Times)
  • Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (FDA Draft Guidance)
  • More drugmakers are taking hefty price hikes on more drugs (STAT)
  • Week ahead: Drug pricing back in focus (The Hill)
  • Group Calls for Value-Based Care, Transparency in Drug Industry (Morning Consult) (Washington Post)
  • Novartis could refuel M&A machine with $14 billion Roche stake sale (Reuters)
  • A healthy agreement (Washington Post)
  • Preview to Sarepta's Eteplirsen FDA Advisory Panel Meeting (Washington Post) (TheStreet) (Reuters)
  • AbbVie Receives FDA Approval of sNDA for Viekira Pak without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis (PR)
  • Califf Pushes For Modern National Evidence Generation System (InsideHealthPolicy-$)
  • OMB Begins Reviewing Final Rule To Overhaul Lab Fee Schedule (InsideHealthPolicy-$)
  • Novartis CEO: The racehorse drug launch is over in the U.S. (FiercePharma)

In Focus: International

  • Germany Is New Battlefield for Drugmakers Facing Price Scrutiny (Bloomberg) (WSJ-$)
  • Big Pharma Gets Solace From Europe (WSJ-$)
  • China bars vaccine sales by drug wholesalers after scandal (Reuters)
  • China Eases Path for Foreign Drugmakers’ Hepatitis C Treatments (WSJ-$)
  • European Parliament calls on the Commission to boost production and export of generic and biosimilar meds (PharmaLetter-$)
  • Health Canada Guidance Document - Labelling of In Vitro Diagnostic Devices (Health Canada)
  • Why transgenic insects are still not ready for prime time (Nature News)
  • Experimental Ebola vaccines need testing (Financial Times-$)
  • Novo Nordisk to Spend More Than €100M to Expand in France (Contract Pharma)
  • Brexit bad for biosimilar developers, says new industry group (In-PharmaTechnologist)
  • TB superbugs spur need for new vaccine (Financial Times-$)
  • Asia 1Q Preview: Japan Policy Worries, Indian Mixed Bag (SCRIP-$)
  • On World Malaria Day, a push to eliminate malaria (WHO)

US: Pharmaceuticals and Biotechnology

  • AstraZeneca launches project to sequence 2 million genomes (Nature News)
  • AACR interview – Juno’s search for bells and whistles (EP Vantage)
  • The Dangers of ‘Polypharmacy,’ the Ever-Mounting Pile of Pills (NY Times)
  • Valeant Names Perrigo's Joseph Papa as CEO to Lead Turnaround (Bloomberg)
  • AbbVie Partners With Argenx In Cancer Deal Spree (SCRIP-$)
  • BriaCell gains investment by US biotech fund, lists Nasdaq hopes (FierceBiotech)
  • Cells Weekly – April 24, 2016 (Stem Cell Assays)
  • GSK plant to supply US after Zebulon line operational (In-PharmaTechnologist)
  • Video Interview: Xbrane CEO On Biosimilar Lucentis (SCRIP-$)
  • ViiV Healthcare expands dolutegravir deal with MPP (PharmaLetter-$)
  • Aytu Buys U.S. Rights to Natesto from Acerus (GEN)

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

  • Researchers push for personalized tumour vaccines (Nature News)
  • Fountain of Youth? Drug Trial Has Seniors Scrambling to Prove They’re Worthy (WSJ-$)
  • Gene Tx Offers Hope in Degenerative Brain Disorder (MedPage Today)
  • Bristol-Myers Squibb’s Opdivo (nivolumab) Receives Breakthrough Therapy Designation from FDA for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (PR)
  • Problematic images found in 4% of biomedical papers (Nature News)
  • Ablynx gets eight million Euro milestone in Boehringer collaboration (PharmaLetter-$)
  • Systematic Analysis of Adverse Event Reports for Sex Differences in Adverse Drug Events (Study)
  • Off-label innovation: characterization through a case study of rhBMP-2 for spinal fusion (Study)
  • Practices of US health insurance companies concerning MS therapies interfere with shared decision-making and harm patients (Study)
  • Pfizer, GSK’s anti-smoking drugs not linked to increase in serious neuropsychiatric adverse events – Study (Pharmafile) (AP)
  • Research opens new treatment strategies for specific form of psoriasis (PR)

US: Medical Devices

  • J&J Pinnacle plaintiffs fight for full $360 mln punitive-damage award (Reuters)
  • FDA Approves Investigational Device Exemption for RTOG Trial of Novocure’s Optune together with Bevacizumab for Patients with Bevacizumab-Refractory Recurrent Glioblastoma (PR)
  • Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Extension of Comment Period (Federal Register)
  • Google Glass startup Augmedix raises $14m in strategic investment round (Mass Device)
  • MITA releases FAQs about transition from CR to DR (MITA)

US: Assorted and Government

  • BARDA talks medical countermeasure manufacturing (Outsourcing-Pharma)
  • NewLink Genetics Awarded $21.6 Million Contract Option by BARDA for Ebola Vaccine Development (PR)

Upcoming Meetings and Events


  • European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV (PR)
  • First DNA vaccine in the EU recommended for use in salmon (EMA)
  • Audio conference of the HSC on vaccine shortages and AMR (European Commission)


  • Semler gets WHO notice of concern over violation of ideal laboratory and clinical practices (Economic Times)
  • Office of CDSCO to function from Baddi to facilitate companies (MHFW)


Zika funding battle steals states’ public health emergency money (Washington Post) 

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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