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

In Focus: US

• Celgene in discussions to buy Juno Therapeutics (Financial Times) (CNBC)
• FDA and Pentagon Forge Breakthrough Designation Agreement (Focus) (Reuters) (FDA)
• FDA expects IV fluid shortage to improve in coming weeks, months (Reuters) (FDA)
• Is Juno worth a $10B-$12B buyout price? Analysts see megabucks deal in the making on reported Celgene talks (Endpoints)
• Transparency: FDA to Release Portions of Redacted Clinical Study Reports (Focus)
• An open letter to Dr. Scott Gottlieb on FDA transparency (STAT)
• Medical device tax: Shutdown-averting stopgap would delay tax, Senate bill would kill it outright (MassDevice)
• It's time to levy penalties for failing to report clinical trial results (STAT)
• HHS readying new rule to expand 'conscience' protections (Politico)
• Amazon is hiring a health privacy expert for 'new initiative' (CNBC)
• The biotech scorecard for the first quarter: 11 make-or-break industry events to watch (STAT)
• Colorado lawmaker pushes pricing transparency bill for diabetes drugs (STAT)
• Wal-Mart launches program to safely dispose of unused opioids (Reuters)
• Boehringer's Gilotrif widens its reach in crowded EGFR lung cancer field (Fierce)

In Focus: International

• Novartis's Kymriah wins speedy reviews in US, Europe (Reuters) (Endpoints) (Press)
• J&J attracts Chinese interest for diabetes business in potential $3B to $4B deal: Sources (CNCB)
• PhRMA is angered by Colombia's move to cut prices for hepatitis C drugs (STAT)
• Brexit: MHRA Promises 'No Sudden Changes' to UK Regulations (Focus)
• Merck KGaA taps UK cancer research organizations to feed pipeline (Endpoints) (PharmaTimes)
• China biotech unicorn Innovent in talks on $200M IPO and new funding — report (Endpoints) (Fierce)
• Pfizer asked to submit CDF proposal for Xalkori (PharmaTimes)
• NICE approves CDF funding for Janssen's Darzalex (PharmaTimes)
• WHO recommends yellow fever shot to Sao Paulo visitors (Reuters)
• Siemens Healthineers to cut costs by $290m ahead of IPO (MassDevice)
• Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live  (Focus)
• Hologic Receives WHO Prequalification for HIV Assay, Initiates $1B Senior Notes Offering (GenomeWeb)
• Korea Stepping Up I-O R&D To Catch Up With Global Players, Trends (SCRIP-$)
• French To Import Czech Version Of Sandoz' Penicillin For Syphilis Amid Global Shortage (Pink Sheet-$)
• World leading cancer dataset shows improvements in diagnosis (GOV.UK)

Pharmaceuticals & Biotechnology

• Dr Reddy's recalls over 1,000 vials of cancer drug from US (Economic Times)
• 6 big medical advancements to expect in 2018 (CNCB)
• FDA Warns Imprimis for False and Misleading Website and Twitter Promotions (Focus)
• Is the pharmaceutical industry good at innovation? (EPR)
• The Accidental Poison That Founded the Modern FDA (The Atlantic)
• GAO to FDA: Publish Plans to Issue or Revise Guidance on Complex Generic Drugs (Focus)
• Burgess and Green Highlight GAO Recommendations for Nonbiological Complex Drugs (House E&C)
• Reaping What We Sow: Seeds Planted Long Ago Prepare to Bear Fruit In 2018 (LifeSciVC)
• AbbVie's silent IBD awareness ad sparks angry backlash, but also draws support (Fierce)
• Employers Are Extracting More of Their Rebate Dollars from PBMs (Drug Channels)
• How to sidestep pricing pain? Lean on cancer, not diabetes or inhalers (Fierce)
• Drug Pricing and Quality Are Top Issues for 2018 (PharmTech)
• Allergan Deal Clears 2031 Launch Of Sun's Linzess Generic (Law360-$)
• After a bruising year, Aeterna Zentaris inks a $24M upfront US pact for growth hormone asset (Endpoints)
• In conversation with: Sarepta CEO Doug Ingram (Fierce)
• Sanofi taps TriNetX to up efficiency: 'We're at a stage of true transformation' (Outsourcing Pharma)
• Novo Nordisk teams with 'Black-ish' star Anthony Anderson for small-screen diabetes diagnosis (Fierce)
• FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS (National Law Review)
• Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter (FDA)
• Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

• First Patient Dosed in a Phase 2 Trial with Transgene's TG4010 + Nivolumab + Chemotherapy for the First-Line Treatment of Lung Cancer (NSCLC) (Press)
• Ipsen and Exelixis announce phase 3 trial results of cabozantinib demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma (Press)
• Pharming Announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST for Prophylaxis of Hereditary Angioedema Attacks (Press)
• OBI Pharma Announces FDA Clearance Of IND Application For A Phase 1 Study Of A Monoclonal Antibody Cancer Immunotherapy (OBI-888). (Press)

Medical Devices

• FDA Proposes Rule for Appealing CDRH Decisions (Focus)
• Medtronic Receives FDA Clearance for Riptide(TM) Aspiration System (Press)
• Diabetes data company urges FDA to make pre-cert program scalable (MassDevice)
• Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication (FDA)
• J&J's Biosense Webster launches WaveCrest study (MassDevice)
• Medicine Is Moving From Implantables To 'Chipables' (Forbes)
• Is This Struggling EVAR Player on Its Last Leg? (MDDI)
• Abbott, Nevro tout spinal cord stimulation tech (MassDevice)
• The Biomarker Disruptor: Would you rather get a biopsy or a blood test to check for prostate cancer? (MDDI)
•  Centric Medical Announces FDA 510(k) Clearance of the Cannulated Screw Internal Fixation System for Foot and Ankle Indications (Press)

US: Assorted & Government

• Trump is fit for duty, but should hit the gym: White House doctor (Reuters)
• Opioid Crisis Blamed For Sharp Increase In Accidental Deaths In US (NPR)
• US healthcare uninsured rises most in near decade: Gallup (Reuters)
• US faces oversupply of antibiotic-free chicken: Sanderson Farms (Reuters)
• Nevada Posts FAQ and Reporting Requirements on Transparency Law (Policy & Medicine)
• Medicaid: CMS Should Take Additional Steps to Improve Assessments of Individuals' Needs for Home- and Community-Based Services (GAO)
• PhRMA Statement on Comments to CMS Regarding Proposed Part D Rule and RFI Exploring Pass-Through Rebates to Seniors at Point of Sale (PhRMA)
• New Jersey Finalizes New Limits on Pharmaceutical Manufacturer Gifts and Payments to Prescribers (FDA Law Blog)
• No Way For Non-Resident Plaintiffs To "MacGyver" Their Way Into Illinois Court Due To Forum Non Conveniens (Drug & Device Law)

Upcoming Meetings & Events

• FDA Advisory Committee Calendar

Europe

• Statement And Background On The CRISPR Patent Process (Broad Institute)
• French police search Lactalis sites after baby milk scare (Reuters)
• Parents and carers advised to inspect Buccolam oral syringes before use (MHRA)
• Russia grants Hermes GMP certification at German and Austrian plants (InPharma)

Asia

• Telix sets up subsidiary to make and trial radio-labelled meds in Japan (InPharma)

India

• Piramal Enterprises explores re-entry into Indian formulations business (Economic Times)
• JB Chemicals & Pharma's Gujarat facilities get European nod (Economic Times)

Australia

• Reformatting Product Information: Frequently asked questions (TGA)
• TGA actions after review into urogynaecological surgical mesh implants (TGA)

General Health

• Patient Voices: Lung Cancer (NYTimes)
• Unraveling the Biocircuitry of Obesity (NIH)
• NIH Striving to Avoid False Hope in Chronic Fatigue (Medpage)

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.

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