Recon: Sobi Buys US Rights to AstraZeneca’s Infant Lung Infection Drug Synagis for $1.5B

• Sobi buys rights to AstraZeneca infant drug for $1.5 billion upfront (Reuters) (Endpoints)
• Roche's Tecentriq wins fast FDA review in tough-to-treat breast cancer (Reuters) (Press)
• Some pharmacies fail to offer easy access to naloxone, or to stock it, despite anti-opioid initiatives (STAT)
• New ads push lawmakers to keep the drug pricing promises they made on the campaign trail (STAT)
• Express Scripts offers new formulary for lower list-price drugs (Reuters) (STAT)
• Walmart, Home Depot adopt health insurer tactic in drug copay battle (Reuters)
• As Roivant’s unicorn valuation swells to $7B, Ramaswamy scoops up $200M to back a new burst of startups (Endpoints) (Fierce)
• Fleece vs Future: How Small Companies Can Help Build Biotech Talent (LifeSciVC)
• Gottlieb Announces FDA Panel On Opioid Dosage, Addiction (BioCentury)
• A $3 Billion Startup's Shares Gain On Hopes For A Cancer Blood Test (Forbes)
• Cancer surpasses heart disease as leading cause of death in many US counties (CNN)
• GE CEO Culp's quick comments about health spinoff could mean an 'outright sale' (CNBC)
• As Amarin stock drops, CEO says investors should 'understand our data better' (CNBC)
• Novartis' $4 Million Gene Therapy -- Real Price or a Negotiation Ploy? (Forbes)

• Big Share Of EU Decentralized Procedures Still Seeking Post-Brexit Home (Pink Sheet-$)
• Moment Of Truth For Pacritinib And Other EU Approval Hopefuls (Pink Sheet-$)
• EMA Outlines Regulatory Expectations On Use Of Patient Registries (Pink Sheet-$)
• CStone braves the HKEX with late-stage plans brewing for newly beefed up I/O pipeline (Endpoints)
• Biomérieux Grows China Footprint With Majority Stake In Hybiome (BioCentury)
• Takeda/Japan activism: importunate imports (Financial Times)
• Bayer reports flat earnings, plans to challenge weedkiller ruling (Financial Times)
• Revised Korean Innovative Drug Pricing System Draws Strong Pharma Objections (Pink Sheet-$)
• Samsung Biologics shares fall by 20% after Korean investigation (Pharmafile)
• England sees “steep rise” in measles cases (PharmaTimes)
• Brexit to blame as firm plans to leave UK for Ireland (PMLive)

• New FDA approved synthetic opioid serves a good purpose (The Hill)
• Five things we learned from Moderna’s pre-IPO information dump (STAT)
• Concert’s initial alopecia data fall short against Pfizer, prompting investor blow back (Endpoints) (BioCentury)
• First data with NantKwest’s cancer vaccine ‘unclear’ (Fierce)
• Novartis' Entresto tops enalapril in stabilised heart failure patients (Pharmafile)
• Gilead appoint Pfizer and AbbVie veteran as VP of governmental affairs (Pharmafile)
• The Meta-Physics Of Meta-Analysis: US FDA’s Curious Framing Of New Safety Guidance (Pink Sheet-$)
• Deerfield sets up $80M to pursue protein degradation R&D at new Dana-Farber center (Fierce)
• On the heels of an Eli Lilly deal, NextCure’s hot hand in I/O attracts a $93M trans-Pacific venture round (Endpoints) (Fierce)
• Kymera raises $65M from global syndicate as it aims for the clinic with protein degradation tech (Endpoints) (Xconomy)
• Merck, Amgen back a $30M play for Ribometrix — one of the upstarts making its mark in drugging RNA (Endpoints) (Fierce)
• Merck suits up for another Opdivo showdown with Keytruda liver cancer approval (Fierce)
• Fewer state Medicaid programs restrict access to hep C meds, but some hurdles still exist (STAT)
• New cancer target? GSK highlights oncology ambitions with its move into the clinic with RIP1 drug for pancreatic cancer (Endpoints) (Fierce)
• Oxford BioDynamics signs deal to develop ASD biomarkers (PharmaTimes)
• Evox bags grant from Duchenne UK to engineer exosomes (PharmaTimes)
• Repurposing Viagra: the ‘little blue pill’ for all ills? (Pharmaceutical Journal)
• Specialty Generics: Barriers To Uptake (Forbes)
• NCTR Research Highlights (FDA)

• Quantum Genomics’ brain-targeting blood pressure drug meets phase 2b endpoints (Fierce)
• NeuroRx Receives FDA Breakthrough Therapy Designation for NRX-101, First Oral Drug Targeting Suicidal Bipolar Depression (Press)
• PolyPid Announces FDA Clearance of Investigational New Drug Application (IND) to Commence Pivotal Phase 3 Clinical Trial of D-PLEX[100] for the Prevention of Sternal Wound Infection Post-Cardiac Surgery (Press)
• Viking Therapeutics Presents Results from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol (Press)
• Phase 2 Results on Efficacy of PMZ-2010 (Centhaquin) in Patients with Hypovolemic Shock Presented at AHA Scientific Sessions 2018 (Press)

• Medtronic wins CE Mark for Valiant Navion thoracic stent graft (MassDevice) (Press)
• A 29-Year-Old CEO Who's Shaking Up Diagnostics & Other Stories From The 2019 Healthcare 30 Under 30 (Forbes)
• Philips launches below-the-knee PAD trial for drug-coated balloon (Drug Delivery)
• FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence (Press)
• Lumendi Receives FDA 510(k) Clearance for Innovative DiLumen™ EIP Device Modification to Improve Tissue Retraction During Therapeutic Endoscopy (Press)

• FDA Parries on Teva 180-Day Exclusivity Suit (FDA News-$) (Pink Sheet-$)
• Coming today: More flexibility on IMD exclusion (Politico)
• IDE Preemption Affirmed in Kentucky (Drug & Device Law)
• More Kryptonite for Kratom (FDA Law Blog)

• FDA Advisory Committee Calendar

• Good laboratory practice (GLP) for safety tests on chemicals (MHRA)
• European Commission’s Latest Updates to Borderline & Classification Manual (Emergo)

• Aurobindo Pharma to acquire under development product, related assets from Advent for $12.5m (Economic Times)
• Cipla's subsidiary to acquire US-based Avenue Therapeutics for $ 215 million (Economic Times)
• Lupin gets USFDA nod for Asthma drug (Economic Times)
• Suven Life gets product patents from Australia, Hong Kong (Economic Times)