Recon: NICE Backs Merck’s Prevymis for CMV; China’s Hansoh Pharma Eyes $1B IPO

• Merck’s R&D boss sees more promise in his big drug and a $1 billion deal (STAT)
• Biologic medications for arthritis and psoriasis have flooded the market — and been linked to 34,000 deaths (Journal Sentinel)
• California may make anti-HIV drug available without prescription for 30 days (SF Chronicle)
• Groupon Cofounder’s Cancer Startup Is Now Worth $3.1 Billion (Forbes) (MedCity)
• Shareholders' transparency proposals for Big Pharma executive pay flop (Axios)
• FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation (FDA)
• Pharma company settles claims of kickbacks to dermatologists (AP) (Fierce) (Law360-$) (DoJ)
• Amarin shares soar after FDA grants priority review for its prescription strength fish oil pill for heart patients (CNBC) (BioPharmaDive) (Press)
• Thrive, with $100 million, strides into the crowded race to develop a blood test to detect cancer (STAT) (Fierce) (Endpoints)
• FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday (CNBC)
• The HELP Committee’s Fix For 180-Day Generic Marketing Exclusivity: Does It Solve The Problem? (Health Affairs)

• Chinese pharma company Hansoh aims for $1bn IPO (Financial Times) (Reuters)
• Pfizer focuses on regional China after price cuts hit sales (Financial Times)
• Cancer cell therapy trials are booming as China rivals US on new projects (Endpoints)
• NICE backs Merck & Co's Prevymis for CMV (PharmaLetter-$) (Fierce)
• Canada told drugmakers it would limit scope of some new price rules (Reuters)
• An Experimental Ebola Cure May Also Protect Against Nipah Virus (NYTimes) (NIH)
• Congo's Ebola epidemic inflicts heavy toll on children (Reuters)
• Finding a winner in VX-445, Vertex hustles CF combo to regulators on both sides of Atlantic (Endpoints) (Xconomy) (Press)
• Biopharma in China: Insights into a market at a crossroads (McKinsey)
• EMA’s CHMP Offers Negative Opinion for Sickle Cell Drug Approved by US FDA (Focus)
• The global pipeline of cell therapies for cancer (Nature)
• EU Regulators Plan To Harmonize Risk Management Plans For Same Active Substances (Pink Sheet-$)

• When shots start younger, more teens get meningococcal vaccine (Reuters)
• Benefit-Risk Math: US FDA Still Favors Simple Calculations (Pink Sheet-$)]
• AIDS Activists Take On The High Price Of HIV Prevention Pill (NPR)
• Start-ups focus on early-stage cancer diagnosis (Financial Times)
• Let’s talk AI: Top R&D execs tackle where we are and where we’re headed with this crucial new technology (Endpoints)
• Oncology Approvals At US FDA Could Pick Up Over Summer (Pink Sheet-$)
• FDA Officials Call for Patient-Friendly Terminology in Oncology (Focus)
• After generating ASCO fervor, Iovance unveils plans to build $75M cell therapy manufacturing plant (Endpoitns)
• Sequoia helps fuel Whole Biome’s planned launch for ‘medical probiotics’ in $35M Series B (Endpoints)
• When Expanded Access Also Means Off-Label Use, US FDA May Need New Policy (Pink Sheet-$)
• Mallinckrodt tweaks its spin-out plans (BioPharmaDive)
• US FDA's Benefit-Risk Assessment Could Include More Emphasis on Patient Involvement (Pink Sheet-$)
• How FDA Is Refreshing Its Recall Readiness Guidance (Law360-$)
• Sanofi hires ex-Genentech SVP Berger to head development (Fierce) (Endpoints)
• Audentes loses 2 executives, hires Sangamo CMO to fill vacancy (Fierce)
• Compound growth at MilliporeSigma (McKinsey)
• Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• Janssen presents strong Phase 3 showing for Darzalex in multiple myeloma subgroup (Pharmafile) (Press)
• Troubled Biogen shows off its me-better approach to MS on PhIII update — but is it really just a patent play? (Endpoints)
• Positive late stage rheumatoid arthritis trial results for Abbvie (PharmaTimes)
• Investigational Novartis therapy smashes primary and secondary endpoints in uncontrolled asthma (Pharmafile) (Endpoints)
• Arcus Biosciences to Present Preliminary Data from the Ongoing Phase 1 Dose-Escalation Trials of AB928 in Combination with Chemotherapy or AB122 at the 2019 ASCO Annual Meeting (Press)
• Zymeworks' Lead Asset, ZW25, Granted Fast Track Designation from the FDA (Press)
• Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma (Press)
• Galt Pharmaceuticals Receives FDA Priority Review for Non-Controlled Pain Management Drug, Orphengesic Forte, an Opioid-Free Alternative for Patients (Press)

• NESTcc Advances Data Quality and Study Design Frameworks (Focus)
• Resolution Liquid Biopsy Assay Receives Breakthrough Device Designation from FDA (Press)
• Nemaura Medical wins CE Mark for SugarBeat CGM (MassDevice)
• Shape Memory Medical’s embolization plug wins FDA clearance (MassDevice)
• Philips touts Stellarex drug-coated balloon data (MassDevice)
• Bayer taps a second partner to develop Vitrakvi's companion diagnostic (BioCentury)

• Durbin alarmed that new FDA chief may 'disappoint' on e-cigs (Politico) (The Hill)
• Hatch-Waxman Presuit Considerations For Generics: Part 1 (Law360-$)
• Hemp Producers, Rev Your Engines (FDA Law Blog)
• No Duty to Report to FDA in North Carolina, No “Parallel” Claim (Drug & Device Law)
• University Of California Gets 5th CRISPR Patent (Law360-$)
• Allergan Looks To Have Shire's Eye Drug Suit Tossed Again (Law360-$)
• Why tech companies keep hitting the same wall when they try to get into health care (CNBC)
• Complete Genomics Files Lawsuit Against Illumina (MDDI)

• FDA Advisory Committee Calendar
• Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations; Public Workshop – 17 July 2019

• EU Device Industry Groups Call to Accelerate MDR Implementation (Focus)
• EC Drops New Batch of MDR Eudamed Guidelines (Focus)
• EMA gives trastuzumab biosimilar Marketing Authorisation Application (PharmaTimes)
• EMA Offers Free Early Dialogue For Anti-Bacterials, Anti-Fungals (Pink Sheet-$)
• Emmaus and Mitsubishi Tanabe Refuse To Take EU Approval Blows Quietly (Pink Sheet-$)
• Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 – risk of patient awareness due to inadequate anaesthesia (MHRA)
• Italian Medicines Agency Nails Drugmaker for Major Deficiencies (FDANews-$)

• Maharashtra FDA concludes training of officers to implement new Medical Device Rules 2017 (PharmaBiz)

• TGA presentations: CMA Therapeutic Goods New Advertising Code and Complaints System Seminar, Sydney, 1 May 2019 (TGA)