Recon: Pfizer Adds $600M to its Venture Group

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

In Focus: US

• Pfizer adds $600M to its venture group (Endpoints) (Press)
• A Biotech Executive Faces End-Stage Cancer As A Patient (Forbes)
• Senate panel schedules vote on controversial drug pricing bill (The Hill) (STAT)
• Alex Azar faces House committee to discuss HHS policies, strategy (Politico)
• Medicare spending on name-brand drugs rose by 77 percent over five years, even as usage fell (NBC)
• US nod for Alimta/Keytruda lung cancer combo (PharmaTimes)
• U.S. Medicare reserves seen lasting three years less than prior forecast (Reuters) (Forbes)
• Picking up the pieces left from an Alzheimer's implosion, Axovant is starting over by diving into gene therapy (STAT)
• Drug prices are falling—but not necessarily in a way that helps patients (CNBC)
• Mylan, Biocon Get CRL For Insulin Glargine Follow-On (BioCentury)
• Ex-FDA Official Jenkins Joins Corbus' Board (BioCentury)
• Millions of Americans could be getting wrong heart meds, study finds (CBS)
• Doctors Scrutinize Overtreatment, As Cancer Death Rates Decline (NPR)
• AbbVie's rheumatoid arthritis drug succeeds in late-stage study (CNBC)
• As CAR-T treatments advance, Washington grapples with ideas for how to pay for them (STAT)

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In Focus: International

• Frontier's HIV Drug Approved In China (BioCentury)
• NICE recommends MSD's Keytruda for advanced PD-L1-positive lung cancer (Pharmafile) (BioCentury)
• NICE rejects Janssen's Zytiga for early, aggressive prostate cancer (PharmaTimes)
• Ukraine Clinic Claims Success In Making Babies With 3 Parents' DNA (NPR)
• Some Brazil 'Zika kids' try school, others fight to survive (ABC)
• A look at Zika and its link to microcephaly (ABC)
• Pharma groups fall foul of China data transfer rules (Financial Times)
• Worldwide drug forecasts rise again, but clouds remain (EP Vantage)

Pharmaceuticals & Biotechnology

• FDA's New Efforts to Advance Biotechnology Innovation (FDA Voice)
• Ovid CEO Jeremy Levin chides pharma for using tax savings for buybacks, not R&D (Fierce)
• Could an old Amgen-developed RA drug make CAR-T treatments safer? (Fierce)
• A Biotech Entrepreneur Aims To Help Us Stay Young While Growing Old (Forbes)
• Appaloosa calls for governance changes at Allergan (Financial Times) (Pharmafile)
• US postal stamp helped fund key breast study (NBC)
• Eli Lilly's President of Oncology to retire (Pharmafile)
• Genentech dives deeper into the microbiome, inking $534M deal with Microbiotica to develop IBD meds (Endpoints) (Press)
• Cash-rich but growth-stymied Gilead promotes dealmaker Dickinson to top strategy post (Fierce)
• Roche's multiple sclerosis drug Ocrevus lowered patients' vaccine responses: study (Fierce)
• Citing 'substantial benefit' for patients, Sanofi hiked Flublok price 12.5% last season (Fierce)
• Prices Keep Rising for Drugs Treating Painful Sex in Women (NYTimes)
• Zai Lab grabs top AstraZeneca cancer executive to prep its first drug rollout (Fierce)
• ARM foundation for cell and gene medicine launched (BioCentury)
• Gilead takes HIV prevention message to TV, pushing PreP awareness with hipster ad (Fierce)
• In May TV spending, Sunovion jumps to 2nd, but AbbVie easily keeps top spot (Fierce)
• Hospira issues nationwide recall for opioid overdose reversal drug (Drug Delivery)
• U.S. drug prices hit by insurer tactic against copay assistance: analysis (Reuters)
• Biomarkers as drug development tools: discovery, validation, qualification and use (Nature)
• Sustainability and affordability of cancer drugs: a novel pricing model (Nature)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

• FDA grants Priority Review to Roche's Hemlibra for people with haemophilia A without factor VIII inhibitors (Press)
• New England Journal of Medicine publishes pivotal cemiplimab trials showing positive results in advanced cutaneous squamous cell carcinoma (Press)
• Dacomitinib Shows More than Seven-Month Improvement in Overall Survival Compared to an Established Therapy in Advanced NSCLC with EGFR-Activating Mutations (Press)
• Partner Therapeutics (PTx) Announces US FDA Approval of Leukine® (sargramostim) for the Treatment of Acute Radiation Syndrome (Press)
• BlackThorn Therapeutics Initiates Phase 1 Study of BTRX-335140, an Investigational Kappa Opioid Receptor (KOR) Antagonist (Press)
• Peloton Therapeutics Initiates Phase 2 Trial of Oral HIF-2α Inhibitor PT2977 for Treatment of von Hippel-Lindau Disease-associated Kidney Cancer (Press)

Medical Devices

• Headspace aims to be first FDA-approved prescription meditation app (CBS)
• Apple opens EHR data to iOS app developers (MassDevice)
• How Autoinjector Technologies Could Change Drug Delivery (MDDI)
• Philips Bets Big on Image-Guided Therapy with Latest Acquisition (MDDI)
• Can Digital Health Companies Avoid the Pitfalls of Bluetooth? (MDDI)
• US Regulators Plan Class II Reclassification of Diagnostic Imaging Devices (Emergo)
• Investors discuss booming, yet crowded, digital health industry at BIO 2018 (mobihealthnews)
• Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value (Press)
• Cybersecurity Vulnerability: Philips' IntelliVue Patient and Avalon Fetal Monitors (ICS-CERT)

US: Assorted & Government

• Trump Withdraws Proposal To Rescind Ebola Funds (BioCentury)
• Terminally ill in California waiting to die, but this court won't let them (NCB)
• Judges Criticize Allergan's Use of Mohawk Tribe's Sovereignty (Bloomberg)
• Statement by FDA's Anna Abram on PAHPA to House E&C Committee (FDA)
• Connecticut Becomes Seventh State to Enact Drug Price Transparency Law (FDA Law Blog)
• Mass Torts and Mass Frauds (Drug & Device Law)

Upcoming Meetings & Events

• FDA Advisory Committee Calendar

Europe

• UK to develop world's first 'hands-free' drug discovery lab (PharmaTimes)

India

• Biocon-Mylan win US nod for another biosimilar drug (Economic Times)
• Glenmark Pharmaceuticals gets USFDA nod for contraceptive drugs (Economic Times)
• MD Rules implementation enters fast track, five govt labs designated to test medical device quality (PharmaBiz)
• Union govt to set up dedicated warehousing hubs for pharma at Ahmedabad, Mumbai and Pune (PharmaBiz)
• India's first medical device park AMTZ gets 'ACCE -HTF Intl Organization Award' for excellence in clinical engineering (PharmaBiz)

Australia

• Electronic Submissions Update – Reminder that the transition period for current Australian regional specification ends 30 June 2018 (TGA)
• Update: Increased application audit requirements for some medical devices applications (TGA)

General Health & Other Interesting Articles

• Prostate cancer survival odds worse for smokers (Reuters)
• Scientists map genetic codes of 3,000 dangerous bacteria (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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