Regulatory Recon: FDA Approves Allergan Combo Therapy Biden to Launch Database to Advance Cancer Research and More From ASCO 2016 (6 June 2016)

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

In Focus: US

• FDA approves Allergan's combination therapy for hypertension (Reuters) (PR)
• Teva Painkiller Resists Snorting, Injection Abuse, FDA Staff Say (Bloomberg)
• Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA (PR) (Reuters)
• Supreme Court rejects GSK bid to throw out racketeering lawsuits (Reuters)
• ‘Silicon Valley arrogance’? Google misfires as it strives to turn Star Trek fiction into reality (Stat)
• Theranos Says Only 1% of Results Affected; Some Doubt Tests (Bloomberg)
• June 8, 2016 Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (FDA Briefing Documents)
• All of the latest news from the 52nd American Society of Clinical Oncology annual meeting (See ASCO 2016 below)

In Focus: International

• Thousands of Romanians 'unwittingly used as guinea pigs to test drugs' (Telegraph)
• Generic prescription drugs: Are prices excessive? (BBC News) (PharmaTimes)
• £15 billion and counting… Can Britain afford its medicine? (PharmaLetter-$)
• Advanced Therapies: Stakeholders Call for EMA Changes on Regulations, Manufacturing (Focus)

ASCO 2016

• Biden to unveil launch of major, open-access database to advance cancer research (Washington Post)
• Combination Drug Therapies for Cancer Show Promise at Higher Potential Cost (WSJ-$) (Guardian)
• New Cancer Drugs Fire Up Body’s Hunters in Tumor Hide and Seek (Bloomberg) (PR)
• Liquid’ Cancer Test Offers Hope for Alternative to Painful Biopsies (New York Times) (Washington Post)
• Extending Estrogen Suppressor May Aid Breast Cancer Patients, Study Says (New York Times)
• Precision medicine the theme at world's biggest cancer conference (Guardian)
• Winners and Losers from Cancer’s Big Event (Forbes)
• Cancer drug stocks: Winners and losers from ASCO (TheStreet)
• Embargo snafu tarnishes otherwise promising update in TNBC (EP Vantage)
• Ariad Drug Appears To Delay Lung Cancer's Return Longer Than Rival Medicines (Forbes)
• Breast cancer study shows benefit to extended treatment with aromatase inhibitors (Stat)
• Cancer patients keep getting aggressive end-of-life treatment, despite lack of benefit (Stat)
• Cancer drug prices highest in U.S. least affordable in India, China: study (Reuters) (Financial Times-$) (Stat) (Study)
• Cancer cell therapies could be approved next year: Juno, Kite Pharma (Reuters)
• J&J myeloma drug, in combo regimen, delays worsening of the disease (Reuters)
• Roche therapy helps 24 percent of untreated bladder cancer patients: study (Reuters) (PharmaTimes)
• Sanofi and Regeneron report positive skin disease trial (Reuters) (PR)
• BMS Ipilimumab prostate cancer trial fails but where is the data (Biotech Strategy Blog) (Forbes)
• Bristol-Myers’s Drug Combination Boosts Lung Cancer Benefit (Bloomberg)
• AbbVie's New Lung Cancer Drug May Extend Patients' Lives, But Could Disappoint Investors (Forbes) (FierceBiotech) (Bloomberg) (PR)
• Mylan, Biocon's PhIII success for Herceptin knockoff threatens anchor drug for Roche (FierceBiotech) (WSJ-$)
• Ganymed's IMAB362 Extends Survival in Gastric Cancer (PR) (FierceBiotech) (EP Vantage)
• Direct-to-patient outreach comes up big in cancer study enrollment drive (FiercePharma)
• Pfizer Presents Promising Data from Next Generation ALK/ROS1 Inhibitor in Advanced Non-Small Cell Lung Cancer (PR)
• Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma (PR)
• Novartis data show more than 50 percent of eligible Ph+ CML patients maintain Treatment-free Remission (TFR) after stopping Tasigna (PR)
• Kite Pharma Presents Ongoing Complete Responses at 9 Months in Phase 1 of ZUMA-1 in Patients with Chemorefractory Non-Hodgkin Lymphoma (PR)
• Kite Pharma Announces the First Meta-Analysis of Outcomes in Chemorefractory Diffuse Large B-Cell Lymphoma (SCHOLAR-1) (PR)
• Juno Therapeutics’ Investigational CAR T Cell Product Candidate JCAR015 Shows High Response Rates in Adults with B-cell ALL (PR)
• Puma Biotechnology Presents Positive Phase II Data (PR)
• Castle Biosciences Announces Clinical Results of Melanoma Gene Expression Test in 334-Patient Performance Cohort Study (PR)
• Seattle Genetics and Astellas Present ASG-15ME and Enfortumab Vedotin Phase I Clinical Data in Metastatic Urothelial Cancer (PR)
• VB-111 Clinical Data Presented at ASCO Demonstrate Significant Increase in Overall Survival in Platinum-Resistant Ovarian Cancer (PR)

US: Pharmaceuticals and Biotechnology

• Ernst & Young Biotech Report 2016 (Report)
• Biotech execs play musical chairs in hot market (Boston Globe)
• Have drug hunters finally cracked KRas? (C&EN)
• The Valeant Meltdown (Vanity Fair)
• Valeant Looks to Show Steps Toward Normalcy (WSJ-$)
• Price fight for California drug makers as biotech convention rolls in (SF Business Times)
• A ‘family spat’ spills out in public, as scientists debate effort to build a human genome (Stat)
• FDA Must Clarify Off-Label Marketing Rules, House Committee Says (Gray Sheet-$) (Focus)
• Experts Suggest Whistleblower Hotlines For Reporting Data Integrity Problems (Pink Sheet-$)
• Units, Clicks? Novel Diabetes Combos Need A Measurement (Pink Sheet-$)
• Diabetes Combination Studies Leave Market Challenges Unresolved (Pink Sheet-$)
• What's Next For Bristol's Opdivo/Yervoy Combination (Pink Sheet-$)
• Big Biotech is here — and it’s starting to look a lot like Big Pharma (Stat)
• Families Isolated By Rare Genetic Conditions Find New Ways To Reach Out (NPR)
• ProNAi Licenses Cancer Drug Candidate Targeting CDC7 from Carna Biosciences (PR)
• Moderna Therapeutics and Charles River Laboratories Announce Strategic Collaboration to Scale Moderna’s Nonclinical Development Efforts for Novel mRNA Therapeutics (PR)

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

• Vedanta Nabs $50M To Expand Microbiome Into Immune-Boosting Therapies (Xconomy) (Forbes)
• Syros Files For IPO to Push “Gene Control” Drugs Through First Trials (Xconomy)
• Shionogi NDA for Naldemedine accepted for FDA review (PR)

Medical Devices

• Zimmer Biomet reveals FDA warning letter (Mass Device)
• GE Spin-Off Wins FDA Approval For Prostate Cancer PET Tracer (Gray Sheet-$)
• Software startup Valify raises $2m in Series A (Mass Device)
• No PhD, “No Fear”: Alice Zhang, 27, Aims Software At Neuro Diseases (Xconomy)
• FDA Clears Cerêve Device for Treating Insomnia Patients by Helping Them Get to Sleep Faster (PR)

US: Assorted and Government

• Vermont Responds to Drug Price Increases With Transparency Law (FDA Law Blog) (Focus)
• Stakeholders call on FDA to support access to biosimilars without unnecessary label standards (GPhA)
• Advancing Patient Solutions for Lower Costs and Better Care (E&C Committee)

Upcoming Meetings and Events              

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• EC to reward NGOs that identify API manufacturers that pollute (In-Pharmatechnologist)

India

• Government to develop six bulk drugs, device parks (Economic Times)
• Prices of 56 medicines to come down (Economic Times)
• Indian hepatitis C drug patent decision shakes public health community (Lancet)
• Lupin gets US FDA nod for fungal treatment (Economic Times)
• Sun Pharma divests two US sites to Frontida (In-PharmaTechnologist) (Economic Times)
• Aurobindo gets best value from payout to CEO in three years (Economic Times)

Zika

• A Permanent Fund That Could Help Fight Zika Exists, But It's Empty (NPR)
• Opinion Research Study Conducted on Brazilian Life-science/Medical Professionals Regarding the Zika Virus Outbreak and the 2016 Olympics (Poll)
• LabCorp Announces the Availability of the RealStar Zika Virus Test (PR)

General Health and Other Interesting Articles

• Heroin, Painkiller Overdose Antidote Getting Easier to Buy (AP)
• Scientists Find Form of Crispr Gene Editing With New Capabilities (New York Times)
• The U.S. Is Failing in Infant Mortality, Starting at One Month Old (New York Times)
• Understand the Brain? Let’s Try Donkey Kong First. (In the Pipeline)
• U.S. majority favors legal medical pot use, pills for PTSD: poll (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.

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