Recon: Massachusetts AG Says Sackler Family Pushed Opioid Sales

• Sacklers Directed Efforts to Mislead Public About OxyContin, New Documents Indicate (NYTimes) (Reuters) (WSJ) (NBC)
• FDA nervous about PDUFA (Politico) (CNN)
• Senators Ask FDA to Update Rules on Certain Pot Products (NYTimes)
• ABC documentary on Theranos features ex-CEO deposition tapes (Reuters)
• Can Trump claim credit for $26 billion in savings on prescription drugs? (Washington Post)
• FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls (STAT)
• Novartis CEO Who Wanted To Bring Tech Into Pharma Now Explains Why It's So Hard (Forbes)
• Rep. DeGette, newly atop an oversight subcommittee, promises to grill drug industry CEOs and investigate insulin makers (STAT)
• House Dems fire first salvo in drug pricing fight (The Hill)
• Pallone Announces Energy & Commerce Committee Roster (House E&C)
• Dem chairman Cummings meets with Trump health chief to discuss drug prices (The Hill) (Baltimore Sun)
• For Children With Cancer, Hope for New Treatments (WSJ)
• Allergan and a Mohawk tribe ask the Supreme Court to review their controversial patent deal (STAT)
• Azar Defends Plan to Lower Part B Drug Costs (Medpage)
• Patients Turn To GoFundMe When Money And Hope Run Out (KHN 1, 2)

• European nations weigh impact of Brexit on drug supplies (Reuters)
• Industry pleads for compromise after Brexit defeat (PMLive) (EPR)
• EU Extends Pilot Of New Drug Safety Reporting System (Pink Sheet-$)
• Pharmaceutical companies spent $34m on patient advocacy groups, research finds (The Guardian)
• UK’s NICE Under Fire For New HTA Fees (Pink Sheet-$)
• EMA To Bring Anticancer Drugs Guide Up To Speed With Biomarker Development (Pink Sheet-$)
• Random Checks Now Routine: China To Inspect Your Factories Near And Far (Pink Sheet-$)
• How A No-Deal Brexit Would Affect Life Sciences Cos. (Law360-$)
• More donor livers could be used for transplantation thanks to exciting new development, NICE says (NICE)

• Venture Volatility: 2018’s Banner Year Closed Cautiously (LifeSciVC)
• Biopharma startup financing had strong showing in 2018, report shows (MedCityNews)
• Merck And The Future of Immuno-Oncology: A Chat With Roger Perlmutter (Xconomy)
• FDA is “Discouraged” by Dearth of HCT/P Manufacturers that have Reached Out to Agency During Enforcement Discretion Period (FDA Law Blog)
• Acadia looks to 'blow up the paradigm' with Parkinson's psychosis drug Nuplazid (Fierce)
• Copay coupons help (a little) with CV drug adherence but not outcomes: study (Fierce)
• Sen. Schumer curiously links Shingrix shortage to shutdown, but Glaxo says there's no connection (Fierce)
• Demystifying industry–academia collaboration (Nature)
• Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management (Pink Sheet-$)
• Lower Prescription Drug Prices – for Everyone (US News & World Report)
• After 37 years of trying, this biotech nears a first drug approval in breast cancer (STAT)
• Experimental patch could offer once-a-month contraceptive option (CBS)
• AmerisourceBergen will eliminate 15 percent of workers at a troubled compounding unit (STAT)
• Anti-aging startup Juvenescence bags $46M for pipeline push (Fierce)
• Life Biosciences raises $50M as longevity race heats up (Fierce)
• Five Prime cuts 41 jobs, narrows focus to clinical-stage drugs (Fierce)
• An economic model of the cost-utility of pre-emptive genetic testing to support pharmacotherapy in patients with major depression in primary care (Nature)

• Acurx Receives FDA Fast Track Designation for ACX-362E for the Treatment of C. difficile infection (Press)
• United Neuroscience Announces Positive Top-Line Results from Phase 2a Clinical Study of UB-311 Vaccine in Patients with Alzheimer's Disease (Press)
• Neurotech Pharmaceuticals, Inc. and Lowy Medical Research Institute Announce Publication of NT-501 Phase 2 Results (Press)
• Aradigm Announces Detailed Third Party Evaluation Results for Apulmiq (FDA)/Linhaliq (EMA) (Press)
• NeoImmuneTech Receives Authorization to Proceed from the FDA for IND Application to Evaluate Hyleukin-7 in Combination with a PD-L1 Inhibitor in Advanced High-Risk Skin Cancers (Press)

• MIM Software Inc. Receives FDA 510(k) Clearance for Molecular Radiotherapy Dosimetry (Press)
• Abbott to acquire mitral valve device maker Cephea Valve Tech (MassDevice)
• FDA Approves Abbott's Device for Treating Premies with an Opening in Their Hearts (MDDI)
• IschemaView wins expanded FDA nod for Rapid neuroimager (MassDevice)
• Additive Ortho wins FDA nod for 3D-printed customized foot & ankle implants (MassDevice)
• Ortho dev Ossio wins FDA nod for bio-integrative bone pins (MassDevice)

• Certification of Complete Document Production: Completely Unnecessary (Drug & Device Law)

• FDA Advisory Committee Calendar

• The Falsified Medicines Directive: steps to compliance (EPR)

• Novo Nordisk Pharmatech A/S signs distribution agreement with DKSH for eleven markets in Asia Pacific (Pharmafile)
• How to seek launch excellence in China (PharmaLetter-$)
• Luye Pharma out-licenses promotion rights for Xuezhikang in mainland China (PharmaLetter-$)

• Notice for Consultation – Proposed new regulatory activity types for transactions filed to the Marketed Health Products Directorate (MHPD) (Health Canada)

• TGA vs Industry time for GMP clearance applications (TGA)
• Ongoing stability testing for listed and complementary medicines (TGA)
• Product Quality Reviews (PQRs) for listed and complementary medicines (TGA)
• Process validation for listed and complementary medicines (TGA)