Recon: EMA’s CHMP Recommends 7 Drugs for EU Approval

• A drug that was once inexpensive gets a new price tag: $375,000 (STAT) (In the Pipeline)
• Cure ‘futures’ offer a way to pay for million-dollar medicines (STAT)
• HHS on best behavior as Democratic House looms (Politico)
• This is the FDA’s year to shine, but can biopharma keep up as regulators continue to rev up chart-topping numbers? (Endpoints)
• Can the pharmaceutical industry really police itself? An episode involving Astellas begs the question (STAT)
• Two years and $78M later, Amgen washes its hands of Advaxis’ I/O drug (Endpoints)
• Under pressure, drugmakers dilute price hikes, but nothing is set in stone just yet (Endpoints)
• NIH report scrutinizes role of China in theft of US scientific research (STAT)
• What’s a polygenic risk score and how good is it at predicting disease? (STAT)
• Purdue’s secret OxyContin papers should be released, appeals court rules (STAT)
• Senate Democrats introduce bill to allow government to block drug price rises (Reuters)
• Axovant buys more gene therapies, setting it up for a busy 2019 (Fierce) (Endpoints)
• AZ still sees route to approval for Imfinzi in MYSTIC trial (PMLive) (Endpoints)
• Despair, Love and Loss: A Journey Inside West Virginia’s Opioid Crisis (NYTimes)

• WHO establishing expert panel to develop global standards for governance and oversight of human gene editing (WHO)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018 (EMA)
• EMA Management Board: highlights of December 2018 meeting (EMA)
• Astellas gains three cancer drugs with $405m Potenza buy (Pharmaphorum) (Scrip-$) (Press)
• Behind the Brexit Chaos: A Faulty U.K. Negotiating Strategy (WSJ)
• Big Pharma Grants License to Kill Drug Programs as Costs Surge (Bloomberg)
• NICE appraisal fees to be introduced despite opposition (PMLive)
• Beware 'Unrealistic' Claims Around Tech Saving Money For The NHS (Forbes)
• ‘Young miracle’: Baby recovers from Ebola in Congo outbreak (STAT)
• South Africa's Aspen strikes distribution deal with U.S. drugmaker Mylan (Reuters)
• UK Inquiry Into ‘Unfair’ Orkambi Pricing Risks Pricing Confidentiality (Pink Sheet-$)
• Merck looks past Sanofi's dengue woes in development deal with Brazilian vaccine institute (Fierce)

• Why The M&A Boom Many Expected In 2018 Didn’t Happen (Scrip-$)
• Dragonfly signs Celgene as partner for NK cell platform (PMLive)
• Orchard to build gene therapy manufacturing plant in California (BioPharmaDive)
• Neurocrine's 3rd Ingrezza flop in Tourette dashes hopes for sales expansion (Fierce)
• Can Bristol-Myers' latest Opdivo results preserve its small-cell lung cancer nod? (Fierce)
• Shield expecting US decision on Feraccru in July (PharmaTimes)
• FDA Works to Keep Injectable Opioids Available to Treat Animals’ Surgical and Trauma Pain During Ongoing Supply Shortage (FDA)
• Flu vaccinations rise sharply in both children and adults (STAT)
• Bellicum reports first data on ‘controllable’ CAR-T (Fierce)
• Cost Concerns May Hinder Naloxone Co-Prescribing Ideas (Pink Sheet-$)

• Pfizer Initiates Phase 3 Program for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older (Press)
• Sosei doses first patient with experimental neurodegenerative drug (PharmaTimes)
• Sensorion’s vertigo drug hits tolerability endpoint in phase 2 (Fierce)
• Janssen Submits Supplemental New Drug Application (sNDA) to FDA for XARELTO® (rivaroxaban) to Prevent Venous Thromboembolism (VTE) in Acute Medically Ill Patients (Press)
• Sunovion and PsychoGenics Announce Positive Results from Pivotal Phase 2 Study of Novel Investigational Agent SEP-363856 for the Treatment of Schizophrenia (Press)
• Sensorion’s vertigo drug hits tolerability endpoint in phase 2 (Fierce)
• Virtus Announces FDA Approval of its AB Rated Generic Levorphanol Tartrate 2mg Tablets CII (Press)

• Verily, Sanofi-backed diabetes management program to offer Orpyx's foot ulcer sensors (mobihealthnews)
• Comments on FDA’s Proposed Rule Governing the De Novo Classification Process (FDA Law Blog)
• Edwards to add 370 employees in Costa Rica (MassDevice)
• FDA: GE R860 ventilator safety guard recall is Class I (MassDevice)
• Check-Cap wins conditional IDE approval for C-Scan pilot study (MassDevice)

• N.I.H. to Scrutinize Private Donations to Scientific Research Projects (NYTimes)
• 5 Of 6 NECC Defendants Guilty In Latest Trial (Law360-$)
• BIO Comments on Objectives for U.S. Japan Trade Agreement (BIO)
• How Life Sciences Cos. Can Prepare For Legal And PR Crises (Law360-$)
• Hatch Introduces Bill To Restrict Generics' PTAB Challenges (Law360-$)
• Hologic touts win in trade secret case (MassDevice)
• Insys Slams BCBS Privilege Claim In $19M Fentanyl Suit (Law360-$)
• Health Costs Bear Down On Families Who Don't Qualify For ACA Subsidies (NPR)
• Calif. Medical Board Begins Tracking Docs' FDA Warning Letters (Medpage)
• U.S. appeals court narrows order on Trump birth control rules (Reuters)

• FDA Advisory Committee Calendar

• China's digital healthcare challenges and opportunities (mobihealthnews)

• Review of the Narcotic Drugs Act 1967 (TGA)
• TGA action against Peptide Clinics Pty Ltd for alleged advertising breaches (TGA)

• Notice - Release of ICH Q3C(R7): Impurities: Guideline for Residual Solvents (Health Canada)

• A Virus Can Eavesdrop On Bacterial Communication (NPR)
• UK scientists find link between Alzheimer’s and surgery (Financial Times)