Recon: HHS Goes After Rebates Paid to Pharmacy Benefit Managers

• Trump Officials Move to Lower Drug Prices by Passing On Rebates to Patients (NYTimes) (Politico) (STAT 1, 2) (Endpoints) (Reuters) (AP) (The Hill) (Bloomberg) (CNBC) (FDA Law Blog) (HHS)
• Trump administration unveils drug strategy document after lengthy delay (STAT)
• Prescription drug wholesalers reaped windfall from alleged price-fixing (Washington Post)
• Romney warns drug execs: 'change is coming' (The Hill)
• Alphabet's Verily has been working on health-tracking shoes to measure movement, weight and falls (CNBC)
• Massachusetts releases its full lawsuit against Purdue, the maker of OxyContin (STAT) (NBC)
• Sackler Scion’s Email Reveals Push for High-Dose OxyContin, New Lawsuit Disclosures Claim (NYTimes)
• Teva's generic EpiPen launch stalls months after approval (Reuters)
• EpiPens weren’t working. It took 3 years and the FDA stepping in before serious change — with potentially deadly outcomes (Business Insider)
• Novo bets on swift FDA review for oral diabetes drug semaglutide (Endpoints) (PMLive)
• Shortage of Anxiety Drug Leaves Patients Scrambling (NYTimes)
• Merck profit tops estimates on strong cancer drug sales (Financial Times)
• Edwards Lifesciences beats on revenue but forecast lags estimates (Reuters)
• Rogues and Regulation of Germline Editing (NEJM)
• New US Experiments Aim To Create Gene-Edited Human Embryos (NPR)

• Top WHO official sees progress in grueling fight against Ebola outbreak (STAT)
• Cancer patients in poor countries needlessly denied pain relief: WHO (Reuters)
• Canada budget to include limited coverage for prescription drugs – sources (Reuters)
• A matter of life and death? UK stockpiles drugs as no-deal Brexit feared (Reuters)
• Novartis changes NICE's mind on Kymriah, giving CAR-T rival Gilead some company (Fierce) (Endpoints) (PharmaTimes) (NICE)
• UK Parliament To Debate Compulsory Licensing Of Vertex's Orkambi (Endpoints)
• Novartis spend on digital and data ‘in the 100s of millions’ (PharmaTimes)
• Teva's migraine drug gets EU panel nod (Reuters)
• 400 Pfizer employees in Ireland set to strike over pensions (Pharmafile)
• Less than half of UK pharmacies will be ready for FMD (Pharmaceutical Journal)
• Facing rejection, CTI pulls European filing for pacritinib (Fierce)
• Samsung BioLogics sees sales rise but profit fall as it continues expansion (Fierce)

• The modern tragedy of fake cancer cures (STAT)
• PhRMA Muscles In With Post-Brexit Trade Deal Wish List (Pink Sheet-$)
• New Formulations Can Delay Generic Drug Entry, Study Finds (Focus)
• CRISPR-Cas9 commercialization may be slowed by delivery and manufacturing challenges (STAT)
• Playing hardball, Bristol-Myers bought out a battered Celgene with last-minute terms sweetened in its own favor (Endpoints)
• Gains in Rare Cancers Makes ASCO's Top Advance of the Year (Medpage)
• How Do Opioids Affect Patients With Cardiac Disease? (Medpage)
• US FDA Considers Mapping Generic Drug Complaints To Spot Safety Trends (Pink Sheet-$)
• Even with new competition, Botox can hold its own in growing migraine field: Allergan executives (Fierce)
• Partial Oral Therapy for Osteomyelitis and Endocarditis — Is It Time? (NEJM)

• Crunch time for ImmunoGen as phase 3 readout looms for lead ADC (Fierce)
• Sangamo Therapeutics To Host Conference Call To Review Interim Results From Phase 1/2 CHAMPIONS And EMPOWERS Studies For MPS II And MPS I (Press)
• Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations (Press)
• CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer (Press)

• Class 1 Device Recall Swan Ganz Thermodilution Catheter (FDA)
• GS1 Guidance to Support Point-of-Care Scanning of UDI Data for Implantable Devices (Focus)
• FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices (Focus)
• Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings (MassDevice)
• Senseonics wins MRI-safe FDA nod for Eversense CGM (MassDevice)
• Real-World Data on Medtronic's Lung Cancer Device Is Promising (MDDI)
• Zimmer Biomet shares rise on Q4, 2018 earnings beat (MassDevice)

• Rep. Ocasio-Cortez and Where Drugs Come From (In the Pipeline)
• Taking Aim at Contraceptive Coverage — The Trump Administration’s Attacks on Reproductive Rights (NEJM)
• This Cannot Stand, Man! The BLOCKING Act of 2019 Would Unnecessarily Reform 180-Day Generic Drug Exclusivity (FDA Law Blog)
• Remand Denied in Two Shingles Vaccine Cases out of the District Of New Jersey (Drug & Device Law)
• Will US Government Pursue Fewer False Claims Act Cases In 2019? (Pink Sheet-$)
• DOJ Ends Saline Price-Fixing Probe Against Baxter (Law360-$)
• Feds Urge Guilty Verdict For Ex-Pharma CEO In $100M Fraud (Law360-$)
• Judge awards plaintiffs’ attorneys $366 million in Boston Sci pelvic mesh cases (MassDevice)

• FDA Advisory Committee Calendar

• EU Begins Transition to Electronic Product Information for Medicines (Focus)
  EU Regulatory Roundup: UK to Prioritize Medicines Over Food if No-Deal Brexit Occurs (Focus)
• Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer (Emergo)

• China’s NMPA Cites Overseas Device, IVD Companies (Focus)

• Guidelines on the evidence required to support indications for listed complementary medicines (TGA)

• The DIY designer baby project funded with Bitcoin (MIT Technology Review)