Recon: J&J to Buy Surgical Robotics Firm Auris Health for $3.4B; FDA Panel Backs J&J’s Nasal Spray for Depression

• Johnson & Johnson to buy robotics group Auris Health for $3.4B (Financial Times) (WSJ) (Endpoints) (MassDevice) (Press)
• Johnson & Johnson's nasal spray for depression wins FDA panel backing (Reuters) (STAT) (Endpoints) (NYTimes) (Bloomberg) (Press)
• Former CEO says Insys founder pushed for higher doses of opioid (Boston Globe) (Law360-$)
• Lawmakers ask FDA to explain a controversial decision to approve a powerful painkiller (STAT) (The Hill)
• More larger-cap biopharma companies faced securities fraud lawsuits than ever (STAT)
• Teva CEO: 'Content' with 2/3 access of payers for migraine drug Ajovy (Reuters)
• For Now, Competitive Generic Therapy Exclusivity Is A Mirage (Law360-$)
• Trump Pledged to End HIV But His Policies Veer the Other Way. (NYTimes)
• The Challenges In Bringing An Anti-Aging Pill To Market (Forbes)
• Drug-price debate threatens trade pact's passage (AP)
• Health plans don’t want patients on opioids. So what are they doing for pain? (Politico)
• Tech companies see health data as a huge opportunity, but people don't trust them (CNBC)
• Apple is getting so serious about health, it's started hosting heart-health events at Apple Stores (CNBC)

• Teva Pharmaceutical sees weaker than expected 2019, shares tumble (Reuters)
• King of Generics Pushes Into Biotech Drugs (WSJ)
• 'Outrageous giveaway to Big Pharma': A political 'bomb' over drug prices may threaten NAFTA 2.0 (The Japan Times)
• Clinigen buys US rights to Novartis' cancer drug Proleukin (Reuters) (Pharmafile) (Endpoints)
• Turkey to increase fixed exchange rate for pharma products by 26.4 percent: NTV (Reuters)
• For a Chinese cancer drug developer, Bristol-Celgene deal is poised to have big ripple effects (STAT)
• BIA ‘Reassured’ On Post-Brexit SPC Regime But Data Exclusivity Concerns Remain (Pink Sheet-$)
• China - The Next Promised Land For Korean Biosimilars? (Scrip-$)
• WHO Warns of Falsified Versions of Cancer Drug Iclusig (Focus)
• China To Cut VAT For Rare Disease Drugs (Biocentury)

• Keytruda shows the high price of curing cancer (Financial Times)
• FDA Updates List of Brand Name Companies Blocking Generic Applicants (Focus)
• House Committee Weighs Drug Pricing Proposals (Focus)
• Industry Lauds FDA RWE Framework, Calls for Tweaks (Focus)
• Something Ventured: Finch Therapeutics and three other startups got venture funding a year ago. Did it help them do what they said it would? (STAT)
• Losing “Scalps”? Despite Pharma Fear, A Split on Trump Rx-Price Plans (Xconomy)
• Drugmaker behind ibuprofen recall has history of FDA violations (CBS)
• A cell-killing strategy to slow aging passed its first test this year (MIT Technology Review)
• US FDA Again Looks Outside Generic Drugs Office For New Director (Pink Sheet-$)
• Trump administration’s reference pricing proposal gets thumbs-down from BIO CEO panel (MedCity) (BIO)
• FDA Investigators Will Focus on Simple GMP Lapses when Inspecting Complex Biotech Systems, Former Compliance Official Cosgrove is Advising (IPQ)
• Risk Compensation and Clinical Decision Making — The Case of HIV Preexposure Prophylaxis (NEJM)
• Omadacycline — The Newest Tetracycline (NEJM)
• What’s next in NASH? 6 things to know following the failure of Gilead’s lead drug for fatty liver disease (STAT)
• Sygnature backs Pathios in hunt for GPR65 modulators (Fierce)
• Charles River swoops on early-stage CRO Citoxlab (Fierce)
• Earlier Tamiflu May Cut Death Risk in Some Severe Cases (Medpage)
• The $100M biotech club: Who’s in, and what’s it take to join the top-performing group of biopharmas? (Endpoints)
• Affinivax, Astellas begin clinical quest to beat Pfizer’s Goliath with a new kind of pneumococcal vaccine (Endpoints)
• Vas Narasimhan earned a big pay hike when he moved to the CEO’s suite at Novartis (Endpoints)
• Busy VC 5AM eclipses $125M target for fund to inject capital into existing portfolio, meets goal for sixth biotech fund (Endpoints)
• Determination That LOTRIMIN (Clotrimazole) Topical Solution, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
• Takeda Pharmaceuticals Withdrawal of Approval of a New Drug Application for OMONTYS (peginesatide) Injection (FDA)

• Bavencio combo gets FDA priority review for kidney cancer (PharmaTimes)
• Moderna Announces Positive Interim Phase 1 Data for First Combination Vaccine Against the Respiratory Viruses hMPV and PIV3 (Press)
• Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts (Press)
• Affinivax, Inc. Announces Initiation of Phase 1/2 Clinical Study of ASP3772, Its Novel Pneumococcal MAPS Vaccine, in Collaboration with Astellas (Press)
• Sojournix Announces Positive Top-Line Phase 1 Data Demonstrating Clinical Proof of Mechanism and Once-Daily (QD) Pharmacokinetics for SJX-653 (Press)

• Cybersecurity: Is Medtech Cruisin' for a Bruisin'? (MDDI)
• Leadership In An Age Of Disruption: Q&A With Abbott Chairman And CEO Miles White (Forbes)
• FDA Issues Final Guidance on Least Burdensome Provisions (FDA Law Blog)
• Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola virus; Availability (FDA)
• Intrinsic Therapeutics wins PMA for Barricaid spinal implant despite safety concerns (MassDevice)
• ReWalk Robotics touts first US insurer reimbursement win for exoskeleton devices (MassDevice)
• Clarify Medical wins CMS reimbursement for phototherapy psoriasis treatment (MassDevice)
• 161m medical device units recalled in Q4 2018 (MassDevice)
• West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug (MassDevice)
• Boston Scientific launches AdVance XP male stress urinary incontinence sling (MassDevice)

• PTAB Won't Hear Dr. Reddy's Challenge To Revlimid Patents (Law360-$)
• 3 Takeaways From The Latest Ax Of A Diagnostic Patent (Law360-$)
• Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019) (Patent Docs)
• Parexel nabs high-profile former FDA staffers, beefing up its regulatory offerings (Fierce)
• Parts is Parts: BAAA Preemption Strikes Again (Drug & Device Law)
• Alere Dodges New Trial In Drug-Testing Patent Fight (Law360-$)
• Fed. Circ. Says UK DNA Sequencers Don’t Infringe IP In US (Law360-$)
• Azar: HHS examining insurer policy requiring patients to start over on step therapy (Modern Healthcare)

• FDA Advisory Committee Calendar

• Eisai seeks to widen Fycompa’s EU label to children (PharmaLetter-$)
• Bicycle Therapeutics to tackle AMR with government funding (PMLive)
• New NICE guidelines on antibiotic prescribing for pneumonia (PharmaTimes)
• Notify MHRA about a clinical investigation for a medical device (MHRA)
• Opioid Expert Working Group meets at MHRA (MHRA)
• Additional blood pressure and heart medication recalled from pharmacies (MHRA)
• Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy (MDA/2019/008) (MHRA)
• Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze (MDA/2019/007) (MHRA)

• Asia Regulatory Roundup: India to Treat Implants and Imaging Equipment as Drugs From April 2020 (Focus)

• Indian Pharma market clocks double digit growth of 11.3% in January 2019 to Rs. 11,336 crore (PharmaBiz)
• IPC identifies 22 more AMCs & 13 MDMCs to enhance quality and quantity of ADR and SAE data towards patient safety (PharmaBiz)
• Centre issues first draft regulatory guidelines for developing & evaluating nanopharmaceutical products for therapeutic use (PharmaBiz)

• Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices (TGA)

• Stewart Adams obituary (The Guardian)
• I Had Lynch Syndrome For 30 Hours (Forbes)
• Depression During and After Pregnancy Can Be Prevented, National Panel Says. Here’s How. (NYTimes)