Recon: Blackstone, Novartis to Launch Cardiovascular Drug Company; China Drafts New Gene Editing Rules

• Blackstone Life Sciences and Novartis to Launch Cardiovascular Drug Company (WSJ) (Endpoints)
• With positive early results, Sarepta appears to have a second gene therapy with potential (STAT) (Endpoints)
• Mylan quarterly profit, 2019 forecast miss Wall Street estimates -- stock tanks (CNBC) (Financial Times)
• How High Drug Prices Inflate CEOs’ Pay (NYTimes)
• Senate Committee Grills Biopharma Executives on Drug Pricing (Focus) (Reuters) (WSJ) (NYTimes) (CNBC) (Endpoints) (Law360-$)
• Senators say will support Judiciary panel if it looks into drug patents (Reuters)
• FDA experts turn thumbs down on Karyopharm’s troubled pitch for an accelerated OK — but not all of them (Endpoints)
• FDA hands back Adamis’ application for an ED drug, looking for more data (Endpoints)
• Pharma and biotech should embrace ‘Medicare for all,’ not defeat it (STAT)
• Who shined and who sank: How seven executives fared in defending pharma (STAT)
• A small drug maker settles charges for paying others to submit its FDA applications (STAT)
• Novartis, AbbVie dominate the top 10 list of blockbusters prepping for a 2019 marketing launch (Endpoints)
• US House Democrats introduce sweeping 'Medicare for All' bill (Reuters)
• Drowned out by the algorithm: Vaccination advocates struggle to be heard online (NBC)

• China unveils new rules on biotech after gene-editing scandal (STAT)
• Epidemic group invests $34 million in potential vaccine printer tech (Reuters)
• Pharma industry swamped with no-deal Brexit info, says BIA (PMLive)
• UK Offers Pharma Firms Ferry Tickets To Avoid No-Deal Brexit Supply Disruptions (Scrip-$)
• Government identifies 7,000 medicines for no-deal Brexit planning (Pharmaceutical Journal)
• Opinion: The Tory plan for no-deal medical shortages is staggeringly negligent (The Guardian)
• UK scientists pioneer device to deliver drugs into brain (Financial Times)
• India brings 42 non-scheduled cancer drugs under price control (Economic Times)
• Takeda, Microsoft rare disease partnership publishes diagnosis road map (Fierce)
• Notification pathway for Class I devices nearing publication in Brazil (Emergo)
• Regulating medical devices in the event of a no deal scenario (MHRA)

• Parkinson's drug trial offers glimmer of hope for brain cells (Reuters)
• New Cancer Drugs Aim to Offer Alternatives To Chemo (WSJ)
• Wait … what? MannKind posts best-ever quarter of inhaled insulin product sales (STAT)
• Continuous Manufacturing: FDA Drafts Quality Guidance (Focus)
• FDA Plots New Ways to Address Opioid Epidemic in 2019 (Focus)
• Biosimilar Sponsors Say Pharmacokinetic Bridging Studies Should Be The Exception, Not The Norm (Pink Sheet-$)
• CytomX slumps as BMS bails on 3 partnered projects (Fierce)
• Parexel recruits top FDA oncology expert Amy McKee for new R&D initiative (Endpoints)
• Servier terminates CTI cancer pact following clinical failure (Fierce)
• Massive NIH–industry project opens portals to target validation (Nature)
• ViiV Healthcare and Radboud team up for HIV drug targets (PharmaTimes)
• Amicus plans to center its gene therapy R&D in Philadelphia with new lab (Fierce)
• Syncona, Novartis back IL-2 immuno-oncology startup Anaveon (Fierce)
• Big Pharma aces brand valuations for 2019, with Roche once again leading the way (Fierce)
• They’re the next new thing in cancer immunotherapy, but will bispecifics help more patients than CAR-Ts? (STAT)
• Scientists hold out hope for regenerative infusion via brain implant — despite failing its first test in Parkinson’s (Endpoints)
• Schell returns to FDA to lead Surveillance and Compliance for CVM (FDA)

• Bayer completes rolling submission of New Drug Application to FDA for investigational drug darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) (Press)
• Plotting to go toe-to-toe with heavyweight Pfizer, little Eidos plans quick score in PhIII ATTR-CM study (Endpoints)
• US FDA Approves Expanded FARXIGA and XIGDUO XR Labels for Use in Patients with Type 2 Diabetes and Moderate Renal Impairment (Press)
• Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for IV Push (Press)
• Mycovia Pharmaceuticals Initiates Additional Phase 3 Clinical Study Evaluating VT-1161 for the Treatment of Vulvovaginal Candidiasis (Press)

• A simple blood test to predict premature births could save babies’ lives (MIT Technology Review)
• FDA, CMS, CDC Launch Task Force for Emergency Diagnostics (Focus)
• Medtronic wins expanded FDA indication for Resolute DES (MassDevice)
• FDA clears Medtronic Accurian RF nerve ablation device (MassDevice)
• Stryker closes Arrinex buy (MassDevice)
• Endologix misses the mark with Q4, 2018 numbers (MassDevice)
• Robocath wins CE Mark for R-One coronary platform (MassDevice)
• Merit Medical’s Q4, 2018 top The Street (MassDevice)
• LivaNova shares dip despite Q4, 2018 earnings beat (MassDevice)
• ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate (FDA)
• Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator (FDA)

• Many seniors need hearing aids. Why doesn’t Medicare cover them? (STAT)
• Former Novartis exec wins $1.5 million after claiming she was fired for complaining about a study (STAT)
• Bipartisan bill targets prescription drug costs in Wisconsin (New Milford Spectrum)
• Ain’t No Sunscreens When It’s Done (Almost): FDA Issues Proposed Monograph on Sunscreens with Only the Oldies but Goodies Categorized as GRASE (FDA Law Blog)
• D. Mass. Misreads New York Law to Make Patent-Holders Potentially Liable for Pre-Market Testing (Drug & Device Law)
• Bristol-Myers Ends Abilify MDL With Confidential Settlement (Law360-$)
• Lilly Gets PTAB To Review 6 Teva Migraine Biologic Patents (Law360-$)

• FDA Advisory Committee Calendar

• More Work Needed On GDPR And CTR Interplay, Says EU Pharma (Pink Sheet-$)
• GW Pharmaceuticals announce quarterly financial results (PharmaTimes)
• MHRA gives Nuformix’ NXP001 studies the go-ahead (PharmaTimes)
• Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring (MDA/2019/011) (MRHA)

• Hong Kong unveils online tool for IVD device classification (Pacific Bridge Medical)

• India tightens regulation of generic drugs (Pacific Bridge Medical)
• Drug exporters wary of tension between India, Pakistan (Economic Times)
• After separate shelf at pharmacies, govt mulls colour-coding mechanism, symbol on packages to promote generic drugs (PharmaBiz)
• Sun On Course To Launch Safinamide For Parkinson’s In India (Scrip-$)

• Prescription medicines: registration of new chemical entities in Australia, 2018 (TGA)

• World's smallest baby boy goes home from Japan hospital (Reuters)
• Cancer Complications: Confusing Bills, Maddening Errors And Endless Phone Calls (NPR)
• Numerous Mistakes Led to Fatal Blood Transfusion at St. Luke’s in Houston, Report Finds (ProPublica)
• Selma Blair Discusses Multiple Sclerosis, and Many Hear Their Own Story (NYTimes)