Recon: Roche to Buy Spark for $4.8B; GE Sells Biopharma Business to Danaher for $21B

• GE to Sell Its Biotech Business to Danaher for $21 Billion (WSJ) (Endpoints) (BioPharmaDive)
• Roche Bids $4.8 Billion for Spark and Its Gene Therapy (Bloomberg) (STAT) (Reuters) (Financial Times) (Endpoints) (Press)
• Did the FDA ignite the opioid epidemic? (60 Minutes)
• Powerful Senate committee launches bipartisan probe into insulin pricing (STAT) (Reuters) (Senate Finance)
• ‘It’s finally pharma’s turn’: Drug CEOs face Capitol Hill reckoning (Politico) (Financial Times)
• Generics Cos. Say No Grand Conspiracy In Price-Fixing MDL (Law360-$)
• Klobuchar Presses FDA to Address Deceptive Sales Tactics by Opioid Manufacturers (Klobuchar)
• Can Roche’s little tech startup help the FDA change clinical trials? (STAT)
• French pharma company Ipsen set to open Boston incubator this spring (STAT)
• Impact investing: a new way to fund cures for cancer (STAT)
• Here’s how Insys schemed to deceive insurance companies (Boston Globe)
• Novartis gene therapy would be cost effective up to $900,000: U.S. group (Reuters)
• Two drugs for spinal muscular atrophy should be priced how low to be cost effective? (STAT)
• UnitedHealth Loses Case to the Health Venture Begun by Amazon, Berkshire-Hathaway and JPMorgan Chase (NYTimes)
• Doctors plan to test a gene therapy that could prevent Alzheimer’s disease (MIT Technology Review)
• The Greediest Companies In American Healthcare Are Not Who You Think (Forbes)

• Chinese government funding may have been used for ‘CRISPR babies’ project, documents suggest (STAT)
• China’s CRISPR twins: A time line of news (MIT Technology Review)
• Ipsen to buy Clementia Pharmaceuticals in deal worth up to $1.3 billion (Reuters) (Endpoints)
• Novartis aims to pump up cardio business with Ionis deal (Reuters) (Endpoints) (Fierce)
• Drugmakers’ fears of ‘no-deal’ Brexit remain strong, analysts say (MedCity)
• Don’t give me Brexit problems, give me Brexit scenarios (MedicalDevicesLegal)
• Accessing Hong Kong: How China Resources, Charoen Pokphand Aim To Deploy Planned $300m Fund (BioCentury)
• United States charges man accused in leak of Singapore HIV data (Reuters)
• Japan scientists win backing for work on potential Nipah vaccine (Reuters)
• Turkey’s New Fixed Euro Rate Spells More Pressure For Industry (Pink Sheet-$)
• Attackers torch Ebola treatment center in Congo, patients evacuated (Reuters)
• Iran ready to export medicines to Venezuela (Pharmafile)

• By the numbers: Top M&A deals, VC investments and pacts point to a growing hunger for gene therapy deals (Endpoints)
• FDA slammed for ‘reckless decision’ to allow a gout drug to remain available, despite heart risks (STAT)
• FDA Warns of Increased Risk of Death With Gout Medicine Uloric (Focus)
• FDA Defends its Efforts to Ensure Generic Drug Quality (Focus)
• Direct-to-Consumer Ads Are Misleading: Concise Statements of Effectiveness Should Be Required (SSRN)
• The Surprising Truth About The Rising Price Of Generic Medications (Forbes)
• FDA Approves More Generic Drugs, but Competition Still Lags (Pew)
• Bayer to cut 200 jobs at U.S. logistics center as it alters course for pharma (Fierce)
• It’s Time for Pharmaceutical Companies to Have Their Tobacco Moment (NYTimes)
• Takeda and Lundbeck Petition FDA on Trintellix Labeling (FDANews-$)
• Does Pfizer's Xeljanz share its CV safety questions with burgeoning JAK class? (Fierce)
• Pinterest Restricts Vaccine Search Results to Curb Spread of Misinformation (NYTimes)
• Bristol-Myers Squibb Announces Filing of Definitive Proxy Statement in Connection with Proposed Merger with Celgene (Press)
• FDA Staff Hammers Karyopharm Cancer Drug on Safety, Efficacy Concerns (Xconomy) (BioCentury)
• Sharing The Adaptive Ski Experience With The Biotech Community (LifeSciVC)
• AbbVie’s cancer drug Venclexta blocks diabetes in mice by targeting beta cell ‘senescence’  (Fierce)
• I-O startup Geneos raises $10.5M for neoantigen drugs (Fierce)
• Autolus taps Vineti to help deliver personalized cell therapies (Fierce)
• Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period (FDA)
• Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period (FDA)

• AstraZeneca’s clot-fighter Brilinta shows promise in diabetics with heart disease in big study (Endpoints) (Press)
• FDA Grants Priority Review and Accepts sBLA of SOLIRIS® (Eculizumab) as a Treatment for Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) (Press)
• Gamida Cell Announces Immune Reconstitution Data from Completed Phase 1/2 Clinical Study of NiCord® Presented at 2019 TCT Annual Meeting (Press)
• FDA Approves Taiho Oncology's LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (Press)
• Themis Bioscience Receives FDA Fast Track Designation for Chikungunya Vaccine Candidate (Press)
• Exicure Announces Dosing of First Patient in Phase 1b/2 Immuno-oncology Trial (Press)
• Xynomic Pharma Doses First South Korean Patient in Phase 3 Renal Cell Carcinoma Trial and Hires Senior Executive Dr. Sophia Paspal to Head Regulatory Affairs and Quality Assurance (Press)

• CDRH Issues Guidance on Brain-computer Interface Devices (Focus)
• Class 1 Device Recall ChemoLock(TM) Vial Spike (FDA)
• Biotronik wins FDA nod for Orsiro DES (MassDevice) (Press)
• Glooko, Novo Nordisk team up for connected insulin pens (MassDevice)
• SyncThink Scores FDA Breakthrough Device Designation for Concussion Tech (MDDI)
• Axonics wins expanded MRI-safe CE Mark approval for r-SNM system (MassDevice)
• Spirosure Receives FDA Clearance to Sell Its Point-of-Care Asthma Monitor, Fenom Pro™ (Press)

• Governors lay out their health care priorities (Politico)
• Lawmakers Eye Biosimilar-Delay Deals, But None Are Here Yet (Law360-$)
• Kentucky finds PBMs are benefiting from a lucrative profit center (STAT)
• White House doesn't back DeSantis on drug importation from Canada (The Hill)
• Chamber launches ad blitz against Trump drug-pricing proposal (The Hill)
• Amgen, Teva Cut Illegal Deal To Pull Generic, Suit Says (Law360-$)
• Novartis, Express Scripts Beat Kickback Suit Over Discounts (Law360-$)
• Synergy Pharma Faces Pushback Over Ch. 11 Plan Releases (Law360-$)
• Texas Pharma Sales Rep Pleads Guilty To $8M Fraud (Law360-$)
• Drugmaker To Pay $4M To End Claims It Dodged FDA Fees (Law360-$)
• Trump Administration Blocks Funds for Planned Parenthood and Others Over Abortion Referrals (NYTimes)
• Hospital: 5 Patients Given Overdoses May Have Been Treatable (NYTimes)
• Colorado lawmaker moving to eliminate personal belief vaccine exemptions (The Hill)
• Bayer faces second trial over alleged Roundup cancer risk (Reuters)
• Court ruling could help J&J defeat St. Louis talc lawsuits (Reuters)
• Opioids claiming more African-American lives as overdoses spread from Rust Belt to East Coast (NBC)
• Stimwave calls Nevro patent suit ‘baseless, unfounded’ (MassDevice)
• Supreme Court – The Excessive Fines Clause Applies to the States (Drug & Device Law)
• A New Attack in the Opioid Crisis: “First of its Kind” Motion for an Ex Parte Temporary Restraining Order and Complaint Against Two Tennessee Pharmacies and Their Pharmacists, Alleging Unlawful Opioid Dispensing and False Claims Act Violations (FDA Law Blog)

• FDA Advisory Committee Calendar

• Committee for medicinal products for human use (CHMP) Agenda 25-28 February (EMA)
• Medicines marketing authorisation: change of ownership application (MHRA)
• Ireland looking to become gateway to Europe for Indian drug makers post Brexit (PharmaBiz)

• Barcoding Regulation For India’s Domestic Drug Supply (RxTrace)
• Move to fix trade margins on some rare disease, cancer medications rapped; many critical drugs not on list, say patient rights groups (PharmaBiz)
• Health ministry convenes stakeholders’ meeting to formulate new rare disease policy; patients seek creation of CoEs in all states (PharmaBiz)

• Dexcom wins Health Canada nod for G6 CGM (MassDevice)
• Canada ends a probe into J&J for allegedly thwarting biosimilar competition (STAT)

• Update to the advertising complaints and investigation information database improves search features (TGA)
• Consultation: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only) (TGA)