Recon: ICER Says Praluent Still Too Expensive After 60% Price Cut; NICE Backs Perjeta for HER2-Positive Breast Cancer

• High stakes as Trump, Dems open drug price talks (The Hill)
• Praluent price cut still not enough, says ICER (PharmaLetter-$) (ICER)
• Drug Giants Can Save America Billions. But Will They? (Bloomberg)
• The top 10 pipeline blowups, setbacks and snafus for H2 2018 (Endpoints)
• The golden age of dark web drug markets is over (The Verge)
• Trump's Drug Rebate Ban Faces Fraught Legal Path (Law360-$)
• Former FDA Chief Bemoans Belittling of Science Under Trump (Bloomberg)
• FDA To Meet PDUFA Goals Despite Shutdown Bolus (BioCentury)
• US Medicare plans to track CAR-T cancer therapy outcomes (Reuters)
• Merck, Pfizer drug combo extends kidney cancer survival: study (Reuters) (Press)
• Nektar, Bristol combo drug shows signs of tumor reduction in bladder cancer patients (Reuters) (Press)
• CRISPR Gene Editing Makes Stem Cells ‘Invisible’ to Immune System (UCSF)
• CRISPR corrects DMD in mice for a year in Sarepta-supported study (Fierce) (Press)
• Dialysis Is a Way of Life for Many Older Patients. Maybe It Shouldn’t Be. (NYTimes)

• The ‘Netflix’ model for hepatitis C drugs is saving Australia a lot of money (STAT)
• NICE changes its mind on Perjeta (PharmaTimes) (NICE)
• Drug start-ups move out of UK’s ‘golden triangle (Financial Times)
• Japan approves test of iPS cells for treating spinal injuries (Reuters)
• Big opportunities in big data, but EMA and industry just getting started (PMLive)
• UCB signs research deal with King’s College London (PMLive)
• AZ And Ipsen Outline Brexit Contingency Plans (Scrip-$)
• Can We Defeat Neglected Tropical Diseases? (Science Trends)
• Have received inspection closure report from USFDA for Duvvada facility: Dr Reddy's (Economic Times)

• CGT Designations: FDA Explains Process in New Draft Guidance (Focus) (FDA Law Blog)
• J.P. Morgan Roundtable: The Regulatory Role In Accelerating Complex Therapies (Pink Sheet-$)
• One Exposure to Anesthesia in Children Does Not Cause Learning Disabilities, New Research Shows (NYTimes)
• The Case Against Cough Medicine (NYTimes)
• FDA Kicks Off List of 503A Bulk Drug Substances List (Focus)
• Newly prequalified Active Pharmaceutical Ingredient (API) - Levofloxacin  (WHO)
• Egalet's 70% price increase shows the buy-and-hike strategy is alive and well (Fierce)
• Andera Looks Early For Cancer Immunotherapy (Biocentury)
• Embedding Digital In Lilly’s Portfolio (Biocentury)
• Nodthera: Inhibiting The Inflammasome For NASH (Biocentury)
• ADCs’ Inflection Point: How Fit-For-Purpose ADCs Could Open The Modality’s Floodgates (Biocentury)
• The multiple myeloma drug market (Nature)
• WilmerHale-Led Stealth Biotherapeutics Debuts With $78M IPO (Law360-$) (Xconomy)
• Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts (Pink Sheet-$)
• US and EU patent offices invalidate Immunex' patents claiming antibodies to the IL-4 receptor (PharmaLetter-$)

• Vivacelle Bio, Inc. Receives FDA Clearance to Enroll Patients into its Phase IIa Clinical Trial of VBI-1 for Severe Blood Loss and/or Raising Blood Pressure in Hypovolemic Subjects (Press)
• Further Data Analysis of Bionomics’ Phase 2 Post Traumatic Stress Disorder Trial Shows the Potential for Significant Patient Benefit When Drug Exposure Is Adequate (Press)

• FDA approves device to treat heart defect in tiniest of babies (CBS)
• CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations (Focus)
• Medtronic Statement Regarding Revised IN.PACT Post Market Study Data (Press)
• Medtronic Announces Preliminary PRODIGY Results: a Global Study to Identify Patients at High Risk for Opioid-Induced Respiratory Compromise (Press)
• FDA gives massive Medtronic recall Class I designation (MassDevice) (FDA)
• IEEE publishes safety standards draft for medtech interoperability (MassDevice)
• These medtech companies raised the most VC in 2018 (MassDevice)
• Innovasive rebrands as Amplify Surgical (MassDevice)
• NeoTract’s UroLift system gains expanded insurance coverage (MassDevice)
• Could Your IoT Device Put Patients at Risk? (MDDI)

• Some Issues Continue to Raise Questions (Alliance for a Stronger FDA)
• Judge Skeptical Of JHL's Defense In Genentech Case (Biocentury)
• First Amendment Musings About Compelled Speech (Drug & Device Law)
• Epic CEO Judy Faulkner: We would never sell to Apple (CNBC)
• FTC Wants More Info On Boston Scientific's £3.3B BTG Buy (Law360-$)
• AbbVie, Eli Lilly Beat Insurer's RICO Suit in Testosterone MDL (Law360-$)
• Insulin Giants Beat RICO Claims Brought By Patients (Law360-$)
• A First Look At New HHS Prescription Drug Safe Harbors (Law360-$)
• Restasis Patent Redo Bid 'Inappropriate,' Fed. Circ. Told (Law360-$)

• FDA Advisory Committee Calendar

• Clinical trials on medicinal products submitted to the ANSM as part of the FastTrack procedure (ANSM)
• Chemicals companies shift to EU regulation in no-deal survival plan (The Guardian)
• Widening the availability of naloxone (MHRA)
• Good clinical practice for clinical trials (MHRA)
• Fibrates: first-line treatment not recommended (MHRA)
• Medical Device Alerts issued in January 2019 (MHRA)
• Letters and drug alerts sent to healthcare professionals in January 2019 (MHRA)
• SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) (MHRA)
• Carbimazole: risk of acute pancreatitis (MHRA)
• Carbimazole: increased risk of congenital malformations; strengthened advice on contraception (MHRA)
• Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19) (MHRA)

• Zydus Cadila and Macleods Pharma suspend Kashmiri employees, issue show-cause notices (Economic Times)
• Gujarat FDCA strengthens drug regulatory system in state under Centre -State sponsored scheme (PharmaBiz)

• What is the patient impact of my medicine shortage and do I have to report it to the TGA? (TGA)
• Australian company pays fine for illegal medicine exports (TGA)

• The Alluring Mirage Of Digital Health (Forbes)
• This Protocol May Reduce MRSA Infections After Discharge From The Hospital (Forbes)
• Scientist warns against discoveries made with AI (Financial Times)
• Smokers Less Likely To Survive Dangerous Form Of Skin Cancer Than Non-Smokers (Forbes)