Regulatory Recon: Whistleblowers Say DEA Went Easy on McKesson Ultragenyx Sells PRV to Novartis for $130M (18 December 2017)

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

In Focus: US

The Winners and Losers in the Tax Bill (NYTimes)
Whistleblowers: DEA attorneys went easy on McKesson, the country's largest drug distributor(60 Minutes) (Washington Post) (STAT)
Ultragenyx Sells Priority Review Voucher to Novartis for $130 million (Press) (Endpoints)
In Opioid Battle, Cherokee Want Their Day in Tribal Court (NYTimes)
CRISPR in 2018: Coming to a Human Near You (MIT Technology Review)
Tiny stem cell companies close in on major heart disease goals (Reuters)
CDC gets list of forbidden words: Fetus, transgender, diversity (Washington Post) (NYTimes) (NPR) (PBS)
Allergan, Richter's bipolar depression drug succeeds in key trial (Reuters) (Endpoints)
On a new deal spree, Regeneron buys into ISA in pursuit of a checkpoint combo (Endpoints)
Roche, Shire court fight escalates over hemophilia drug (Reuters)
This old drug was free. Now it's $109,500 a year. (Washington Post)
The New Price of Hope: Families Face Hurdles to Access SMA Drug Spinraza (Boston Globe)
In Election Year, Drug Industry Spent Big To Temper Talk About High Drug Prices (NPR)
NIH tweaks plan to award more grants to younger researchers (Science)
Teva plans 'risky' price rise on US medicines (Financial Times)
Teva rolls out exclusive generic of Gilead's Viread at the end of an awful week (Fierce)
What's Coming in 2018: FDA's Regulatory Agenda (Focus)
FDA Offers Two New Draft Guidances on Developing Targeted Therapies (Focus)
FDA to Begin Issuing Deficiency Review Letters to Generic Drugmakers (Focus) (FDA)

In Focus: International

Commission closes infringement procedure against Roche without penalty (European Commission)
Boehringer antes up on a €627.5M deal for rights to Autifony's schizophrenia drugs (Endpoints) (Fierce)
Drug Company Under Fire After Revealing Dengue Vaccine May Harm Some (NYTimes)
Ebola victims sue Sierra Leone government over mismanaged funds (Reuters)
Pharma's reach for post-Brexit harmony on medicines (Financial Times)
Small-cap focus: UK biotechs target Alzheimer's (Financial Times)
Another key Teva executive departs, leaving a generics experience void (Fierce)
EU Regulatory Review – What Pharma Should Remember From 2017 (SCRIP-$)
EU Initiative Flags Up Challenging Products For Regulators (Pink Sheet-$)
EMA: Amsterdam HQ Won't Be Ready in Time for Move (Focus)
Police Say Deaths of Apotex Founder and Wife Being Investigated as Homicides (WSJ) (Forbes) (The Guardian) (NYTimes)
MHRA awarded over £980,000 for collaboration with Gates Foundation & WHO (MHRA)
Gov't to Draw Up Plan to Strengthen Drug Discovery, Boosting Budgets to Improve R&D Environment (PharmaJapan)
Novartis loses top oncology executive Strigini to retirement (Fierce) (Pharmafile)

Pharmaceuticals & Biotechnology

Consortium Outlines Clearer Path To Value-Based Drug Pricing (BioCentury) (Duke Margolis Center for Health Policy)
AbbVie vet John Leonard moves up to the helm at CRISPR/Cas9 pioneer Intellia, focused on looming human studies (Endpoints)
A New PARP Drug For Breast Cancer? I'm Thrilled! (Forbes)
Rare disease medicines access faces a perfect storm (Pharmafile)
Cancer Research UK agrees largest drug discovery collab to date (Pharmafile)
Electronic Submission of Postmarket Safety Reports (FDA)
Oncologists, Beware: Expensive Liquid Biopsy Tests Produce Conflicting Results (Forbes)
FDA Releases Draft Guidelines to Clarify Regulatory Framework Supporting Precision Medicine (GenomeWeb)
Aptinyx bags $70M to fund multidrug CNS trial strategy (Fierce) (Endpoints)
Challenges in Minimizing Post-Surgical Opioid Use (Medpage)
Few California pharmacists prescribing birth control (Reuters)
CRISPR biotech Intellia promotes R&D head to CEO post (Fierce)
Stevenage Bioscience Catalyst Names Forsyth CEO (BioCentury)
Parabens and Phthalates: What Patients May Want to Know (Medpage)
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

US priority review for AZ' Tagrisso (PharmaTimes) (Press)
FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program (Press)
Novocure Receives FDA IDE Approval for its PANOVA 3 Phase 3 Pivotal Clinical Trial in Advanced Pancreatic Cancer (Press)
NanOlogy Announces First Patient Enrolled in a Pancreatic Cancer Phase 2 Clinical Trial of NanoPac Adding to Trials in Prostate and Ovarian Cancers (Press)
Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Yervoy (ipilimumab) for the Treatment of Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma (Press)
IntelGenx gets green light to launch Ph2 Alzheimer's study in Canada (Drug Delivery)
SciFluor Announces Positive Top-Line Results of Phase 1/2 Study of SF0166 Eye Drops to Treat Wet Age-Related Macular Degeneration (Press)
Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer (Press)
RXi Pharmaceuticals Announces Positive Results from Phase 2 Trial with RXI-109 for Dermal Scarring (Press)

Medical Devices

2017 Medtech Company of the Year: Readers' Choice (MDDI)
The Year Abbott Showed Us What It's Made Of (MDDI)
Vascular Dynamics taps ex-Ellipse Tech CEO Roschak as chief exec (MassDevice)h
CompactCath wins CE Mark for compact intermittent urinary cath (MassDevice)
A Bionic Hand Fit for the Last Jedi (MDDI)
Why It Is Crucial that CMOs, Suppliers, and Biologic Manufacturers Work Closely Together (MDDI)
XableCath Receives FDA Clearance for Broadly Effective Catheter Aimed at Peripheral Arterial Disease Market (Press)
Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device (FDA)
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator (FDA)
Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (FDA)

US: Assorted & Government

Litigation Is Not The Solution To The Opioid Epidemic (Law360-$)
PTAB Invalidates Hologic Patent, Rejects Claim Fixes (Law360-$)
Mitsubishi Says Generics Co.'s ANDA Infringes Diabetes Med (Law360-$)
Bayer, Belmora Spar Over TM, Antitrust Bids In Flanax Feud (Law360-$)
Judge blocks Trump administration rules on contraceptive coverage (Reuters)
US employers say CVS-Aetna deal would affect health-benefits decisions: survey (Reuters)
Ni-Q, LLC v. Prolacta Bioscience, Inc. (D. Or. 2017) (Patent Docs)
Hamburger chain Wendy's to reduce antibiotic use in beef supply (Reuters)
Another State Drug Pricing Law… Another Legal Challenge; Trade Group Sues California in Latest Lawsuit against Drug Pricing Transparency Bill (FDA Law Blog)
Quasi Guest Post – 50 State Survey On General Jurisdiction Through Consent By Registration To Do Business: Putting Bauman And Baseball Back Together (Drug & Device Law)

Upcoming Meetings & Events

FDA Advisory Committee Calendar
New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products – 9 January 2018

Europe

MHRA gender pay gap report (MHRA)
Semaglutide's CHMP Backing Stipulates Post-Approval Safety Studies (SCRIP-$)
Modified-release paracetamol-containing products to be suspended from EU market (EMA)
Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics (EMA)
ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers (EMA)
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials (EMA)

India

CDSCO, Maha FDA to conduct joint inspections of Schedule M units across state to verify GMP compliance (PharmaBiz)
Drug makers can now expect more regular checkups from USFDA (Economic Times)
SC for relook into 349 FDC medicines by drug advisory board (Economic Times) (PharmaBiz)
Aurobindo, Dr Reddy's Laboratories frontrunners to buy out bankrupt Orchid Pharma (Economic Times)
India and Morocco sign MoU for enhanced cooperation in healthcare (Economic Times)

Canada

Notice: Consultation on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product (Health Canada)
Canada Vigilance adverse reaction online database (Health Canada)

Australia

Draft list of permitted indications - closed for comment (TGA)

Other International

ICH Meeting in Geneva, Switzerland, 11–16 November 2017 (Swissmedic)

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 [email protected].

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

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