Recon: Bayer, J&J Settle Xarelto Suits for $775M; Thermo Fisher to Buy Brammer Bio for $1.7B

• Thermo Fisher to Buy Brammer Bio for $1.7 Billion (WSJ) (Endpoints) (BioCentury)
• Tufts taps former US attorney to investigate ties to Sackler family, Purdue Pharma (STAT)
• Bayer, J&J settle US Xarelto litigation for $775 million (Reuters)
• Lilly discloses pricing data on insulin in response to political pressure (STAT) (Endpoints) (CNBC) (WSJ)
• Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up (The Atlantic)
• Werewolf moves into a web of immunotherapy startups (STAT)
• Flood of CBD products put FDA in a bind (Politico)
• Drug Prices on TV? They May Be Coming. (NYTimes)
• FDA rejects Sanofi-Lexicon add-on pill for type 1 diabetes (Reuters) (Press)
• Hackers could take over some implanted defibrillators, FDA says (NBC)
• For Many Boys With Duchenne Muscular Dystrophy, Bright Hope Lies Just Beyond Reach (NYTimes)
• Early test of male birth control pill shows no safety problems (Reuters)
• FDA takes up decades-long debate over breast implant safety (AP)
• How a premature ejaculation drug sparked a $150 million legal battle over trade secrets (CNBC)
• Biogen announces $5 billion buyback days after shelving Alzheimer's trials (CNBC) (Financial Times)

• EU approves AstraZeneca's drug for adjunct use in Type-1 diabetes (Reuters)
• NICE recommend Takeda's lymphoma treatment Adcetris (Pharmafile)
• Otsuka’s Alzheimer’s agitation drug hits the mark (PMLive)
• EU Pharma Wants Staggered Approach For Direct Data Capture In Clinical Trials (Pink Sheet-$)
• U.K. biotech funding climbs 35% in fast start to 2019 (Fierce)
• Bill Gates urges Afghanistan and Pakistan to 'get to zero' in polio fight (Reuters)
• Congo Ebola epidemic exceeds 1,000 cases: health ministry (Reuters)
• WHO delivers medical supplies to scale up pre-hospital trauma care in Gaza (WHO)
• Europe Re-Examines Its Regenerative Medicine Policies (BioCentury)
• EMA on Brexit: Risk for Drug Shortages Decreases (Focus)

• Drug Epidemics, Past and Present (NYTimes)
• Natural History Studies for Rare Diseases: FDA Drafts Guidance (Focus)
• It Will Take More Than a $34,000 Drug to Stop Postpartum Depression (NYTimes)
• Silicon Valley techies are turning to a cheap diabetes drug to help them live longer (CNBC)
• An Alzheimer’s Drug Trial Gave Me Hope, and Then It Ended (NYTimes)
• Are The Risks Of Drugs That Enhance Imaging Tests Overblown? (NPR)
• Biotech IPOs keep coming as Gilead-backed Hookipa Pharma guns for $86M (Fierce)
• What FDA And Industry Are Doing To Improve Manufacturing Of Cell And Gene Therapies (BioCentury)
• How Bayesian Methods Are Gaining Ground In Frequentist-Dominated Clinical Trials (BioCentury)
• Inflazome grabs Fox Foundation funding for Parkinson’s R&D (Fierce)
• Is a severely damaged Biogen looking to shed its ties to a controversial development partner? (Endpoints)
• Roche-backed Arch Oncology gets off $50M round for anti-CD47 cancer work (Fierce)
• Agios blood cancer drug lead jumps ship to Aprea Therapeutics (Fierce)
• Price hikes, a strategic retreat and 1 big new approval has shaken up the rankings of the 20 most expensive drugs on the planet (Endpoints)
• IBM tech explains why some cancer cells die in response to treatment and others don’t (Fierce)
• Bristol-Myers Squibb Board of Directors Sends Letter to Shareholders Highlighting the Compelling Strategic and Financial Rationale of the Celgene Transaction; Company Provides Additional Investor Materials (Press)

• Aimmune’s peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval (Endpoints) (Press)
• Avanir cites ‘encouraging’ progress in PhIII program for Alzheimer’s agitation (Endpoints)
• After ovarian cancer flop, PharmaMar’s lurbinectedin makes the cut in small cell lung cancer (Endpoints)
• Alkahest Presents Positive Results from Phase 2a Open Label Study of AKST4290 in Treatment-Naïve neovascular AMD at Retina World Congress (Press)

• Varex Imaging to pay $85m for Direct Conversion (MassDevice)
• Titan Medical, Teleflex ink collab robotic ligation dev deal (MassDevice)
• Masimo Announces FDA Clearance of the Rad-67™ Pulse CO-Oximeter® with Next Generation SpHb® Spot-check Monitoring & rainbow® DCI®-mini Reusable Sensor (Press)
• BrightWater™ Medical’s ConvertX® Biliary Stent System Receives FDA Clearance (Press)
• Zimmer Biomet Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries (Press)

• Medicare for All Would Abolish Private Insurance. ‘There’s No Precedent in American History.’ (NYTimes)
• Small Changes To Old Drugs Don't Extend Patents, ECJ Says (Law360-$)
• FDA Publishes Notice to Remove Substances from its Bulks List I for Section 503B Outsourcing Facilities … and Let’s Watch What Happens Next (FDA Law Blog)
• Federal Question Jurisdiction Without A Federal Claim? (Drug & Device Law)

• FDA Advisory Committee Calendar

• EU MDR/IVDR Coordination Group Urges Exemption Clarification (Focus)
• Advertising Standards Authority tells therapists to stop marketing 'autism cure' (Pharmafile)

• Clinical trial waiver not enough; rare disease community pitches for increased R&D focus (PharmaBiz)
• Sun Pharma receives 483 for Baska facility, co says responded to USFDA (Economic Times)
• US FDA trains 100 Gujarat FDCA inspectors as part of regulatory harmonization (PharmaBiz)
• NPPA fixes retail prices of 2 formulations under DPCO 2013 (PharmaBiz)
• CDSCO takes action on orthopaedic implant firms for running without valid license (PharmaBiz)