Regulatory Recon: FDA Staff Question New Lung Cancer Drug (8 April 2016)

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

In Focus: US

• Off-patent drugs at brand-name prices: a puzzle for policymakers (Journal of Law and Biosciences)
• Briefing Information for the April 12, 2016 Meeting of the Oncologic Drugs Advisory Committee (ODAC) (FierceBiotech) (Reuters) (FirstWord Pharma)
• FDA Panel Backs Approval of Liver-Disease Drug (WSJ-$) (FierceBiotech) (SCRIP-$)
• Request FDA to issue an immediate Class I recall of all BSC products made with counterfeit, Chinese resin (Petition)
• Sen. McCaskill letter to FDA’s Califf on dietary supplements (Letter) (Tan Sheet-$)
• ICER Draft Report on Drugs for Multiple Myeloma Posted for Public Comment (ICER)
• Elizabeth Holmes’s Theranos under fire (FT Magazine)
• The Scientific Swap Meet Behind the Gene-Editing Boom (MIT Tech Review)
• Valeant: Why Moneyball Failed in the Pharmaceutical Industry (New Yorker)
• FTC Wins Order Barring Japan Drug Co. From Generics Deals (Law360-$)
• FDA Forms Cross-Center Combo Products Council To Resolve Reg Issues (InsideHealthPolicy-$)
• New and Generic Drug Approvals by US FDA in April (FDA)

In Focus: International

• EU approval for Revolade for children with rare blood disorder (PharmaTimes)
• BMS' Opdivo gets two new indications in Europe (PMLive)
• BMS' Opdivo Heading Towards Indian Debut? (SCRIP-$)
• Time Of The Essence As 8th EU Regulatory Trilogue Makes Slow Progress (Clinica-$)
• Japan's Astellas eyed to buy Kaketsuken's vaccine business (FiercePharmaAsia) (Nikkei Asian Review) (Pharma Japan)
• Saudi Arabia's Pharma Market Is 'Open For Business' (SCRIP-$)
• Minutes of the PRAC meeting on 08-11 February 2016 (EMA)
• 8th Annual PQT Medicines Quality Assessment Training (WHO)
• Form 483 Raises GMP Concerns About Sweden’s Apotek (FDANews-$)
  
  

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US: Pharmaceuticals and Biotechnology

• Cashing In on Opioid War: Alkermes and Its $1,300-a-Month Shot (Bloomberg)
• Drugs with no patents and no competition – list of new ‘price-gouging’ targets (PharmaCompass)
• Juno Therapeutics and WuXi AppTec announce new company to develop novel cell-based cancer immunotherapies in China (Manufacturing Chemist) (BioCentury) (Fierce) (PR)
• Effective Collaboration Leads to Better cGMP Outcomes in Pharmaceutical Manufacturing (PharmaPro)
• US aseptic packaging demand to reach US$6.4bn in 2020 (Manufacturing Chemist)
• Valeant gets extra month to file annual report (Reuters)
• Researchers watch biomolecules fold (C&EN)
• After ZS Pharma buyout, Relypsa slated to be next on the hit list (FierceBiotech)
• Obscure medical technician catches eye of Biden (Stat)

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

• AstraZeneca, Eli Lilly move closely watched BACE Alzheimer's trial into PhIII (WSJ-$) (FierceBiotech) (PharmaFile) (Pharmaphorum) (EP Vantage) (Press Release)
• Pioglitazone after Ischemic Stroke or Transient Ischemic Attack (NEJM)
• HIV overcomes CRISPR gene-editing attack (Nature News)
• J&J Must Face Cherokee Risperdal Suit In State Court (Law360-$)
• Ask Well: Do Pain Relievers Heal Tendinitis, or Just Ease Pain? (NY Times)
• FDA Sends Warning Letters to CIs for Deviating from Protocols (FDANews-$)

US: Medical Devices

• Abbott Prevails In $219M Whistleblower FCA Trial (Law360-$) (MassDevice) (Modern Healthcare)
• Northwestern Memorial Hospital and Star CV Surgeon Found Not Guilty in Myxo Ring Case (TCTMD)
• Fed. Circ. Sets New IP Trial Over J&J Expert’s False Claims (Law360-$)
• Focal Therapeutics Launches BioZorb LP, Expanding Utility of 3D Implant for Breast Cancer Patients (PR)
• EmboMedics raises $4.3m for embolization microbeads (MassDevice)

US: Assorted and Government

• FDA Extends Comment Period for Draft Environmental Assessment for Genetically Engineered Mosquito (FDA)
• Tale of 2 Agencies: CDC Avoids Gun Violence Research But NIH Funds It (JAMA)
• MedPAC Passes Part D Proposals That Could Save $10 Billion (InsideHealthPolicy-$)
• CMS Delays New Medicaid Rebate Rules For 5i Drugs, But Rest Of Rule In Effect (InsideHealthPolicy-$)
• Mississippi Right to Try bill advances (Bill)

Upcoming Meetings and Events              

• RAPS' FDA Advisory Committee Meeting Tracker
• FDA Small Business Regulatory Education for Industry (REdI) Conference May 2016 (FDA)
• Public Workshop – Liquid Biopsies in Oncology Drug and Device Development, an FDA-AACR public workshop, July 19, 2016 (FDA)
• European Pharmacopoeia Reference Standards Training Session (EDQM)

Europe

• How one lab challenged a grant rejection and won €5 million (Nature News)
• England's pledge to recruit more GPs failing (PharmaTimes)
• Government pushes on with junior doctor contract imposition (PharmaTimes)
• France to ban some glyphosate weedkillers due to health concerns (Reuters)
• MedDay Raises €34m For US Trial As EU Filing Of MS Drug Nears (SCRIP-$) (FierceBiotech)

China

• Academia Sinica chief apologizes over controversial stock sales (FiercePharmaAsia) (Focus Taiwan)

Zika

• WHO: Zika causes microcephaly and Guillain-Barre syndrome (CNN)

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 [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.