Recon: FDA Approves Kala's Post-Surgery Eye Pain Drug Inveltys and Shire's HAE Drug Takhzyro

• FDA approves Kala Pharma's eye pain drug (Reuters) (Press)
• FDA approves Shire drug for rare swelling disorder (Reuters) (Endpoints)
• Are long lists of side effects backfiring? FDA wants to know whether drug ads ‘overwarn’ consumers (STAT)
• Senate passes $90 billion HHS spending bill (Modern Healthcare) (CNBC) (Endpoints) (Senate HELP)
• No Clear Winner In $4.3B Akorn Deal Row: Vice Chancellor (Law360-$)
• AstraZeneca's Bevespi takes discouraging hit in head-to-head test against GSK (Fierce)
• GBT picks up Roche’s dropped heart drug for its sickle cell disease pipeline in $127M deal (Fierce)
• Prescription Drugs Account for 1-in-4 Dollars Spent by a Commercial Health Plan (Health Affairs)
• Gilead paid $510M for drug and just sold it for $3 million (CNBC)
• 23andMe will no longer let app developers read your DNA data (CNBC)
• Sangamo researcher charged with insider trading (Endpoints)
• Immunotherapy Drugs Slow Skin Cancer That Has Spread to the Brain (NYTimes)
• Russian Trolls Used Vaccine Debate to Sow Discord, Study Finds (NYTimes) (NBC)
• Bayer's Monsanto faces 8,000 lawsuits on glyphosate (Reuters)

• Congolese doctor infected with Ebola in high insecurity zone: WHO (Reuters)
• Latin America Regulatory Round-Up: A Red Tape Reduction In Brazil, Mexico (Pink Sheet-$)
• Sobi secures NHS reimbursement for Ravicti (PharmaTimes)
• China prosecuting managers of Juxin Biotech after plant explosion kills 10 (Fierce)
• Expanded Medical Device Regulations in Egypt Set for September 2018 (Emergo)
• Council of Europe Protocol on Genetic Testing Could Serve as Blueprint for New Laws (GenomeWeb)
• Rakuten’s CEO raises $150M to fund his biotech outfit Aspyrian's cancer photoimmunotherapies (Fierce)
• Regulatory Science Society Says “No” to Off-Label Info Supply by Drug Reps Conditionally OK’ed in Draft MHLW GLs (PharmaJapan)
• WHO Prequalifies Sun Pharma's Tenofovir Disoproxil Fumerate API (WHO)
• China Approves Lynparza In Ovarian Cancer (BioCentury)
• New indication for Bayer’s Xarelto (PharmaLetter-$) (PipelineReview)
• Brazil’s New Data Protection Law Introduces Heavy Fines (Pink Sheet-$)
• French Agency On How To Avoid Valsartan Shortages (Pink Sheet-$)

• VC-Backed Bay Area Biotech Files Plans For $80M IPO (Law360-$)
• FDA's New Generic EpiPen Approval Exemplifies Progress on Drug Price Reform (Forbes)
• Novartis Pharma CEO On Star Products, Pricing And Rebates (Pink Sheet-$)
• Homeopathic medicines specialist King Bio enacts nationwide recall (Pharmafile)
• More US adolescents up to date on HPV vaccination (CDC)
• PatientsLikeMe, FDA explore how patient-generated data could help event reporting (mobihealthnews)
• A new avenue for diet pill makers? UC San Diego researchers uncover root of leptin resistance (Endpoints)
• Expanding the medicinal chemistry synthetic toolbox (Nature)
• After early budget woes, flu-shot expert Seqirus swings to its first-ever profit (Fierce) (BioPharmaDive)
• 69 percent of patients abandon medicines when cost sharing is more than $250 (PhRMA) (IQVIA)

• FDA approves DIACOMIT (Stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam (Press)
• Peptilogics Completes Successful Pre-IND Meeting With the Food and Drug Administration (FDA) for PLG0206 in Prosthetic Joint Infections (PJI) (Press)

• Verily researchers, former FDA commissioner call for device sensors, data analytics adoption in psychiatry (mobihealthnews)
• Cybersecurity Vulnerability Identified for BD Alaric Plus (DHS ICS-CERT)
• Medical Alley charts path for Minnesota’s medtech cluster (MassDevice)
• FDA grants digital therapeutic for Alzheimer's symptoms Breakthrough Device designation (mobihealthnews)
• FDA wants Pavmed to re-submit for CarpX carpal tunnel device (MassDevice)
• Gore touts regulatory wins for new balloon catheter (MassDevice)
• Olympus and FlexDex take aim at big, expensive robots (Medical Design & Outsourcing)

• What's next for the Kentucky Medicaid waiver? (Politico)
• Judge affirms multibillion-dollar talc verdict against J&J; case set for appeals (Fierce)
• Firms stop kid-friendly packaged e-cigarette liquids sales after FDA push (Reuters)
• Lawyers For Texas Counties In Opioid Cases May Not Have Valid Contracts (Forbes)
• Eli Lilly To Face Remaining Claims In Father's Birth Defect Suit (Law360-$)
• DePuy Hit With $8.2M Verdict In Implant Patent Fight (Law360-$)
• Calif. High Court Will Hear Niaspan Pay-For-Delay Appeal (Law360-$)
• Investors Need New Leader For Biotech IPO Suit, Judge Says (Law360-$)
• Paxil Verdict Overturned on Appeal – Preemption Evidence Couldn’t Be Clearer (Drug & Device Law)
• DexCom Shines in Busy M&A Season with TypeZero Buy (MDDI)

• FDA Advisory Committee Calendar

• Antibiotics should not be issued as first line of treatment for a cough, says NICE and PHE (NICE)
• Vertex appoints new commercial lead amid NHS, Orkambi price war (PMLive)
• Middle-East resident diagnosed with MERS in Britain (Reuters)

• US FDA officials visit Gujarat FDCA for capacity building towards global regulatory harmonization (PharmaBiz)
• Niti Aayog proposal to cap medical device trade margins to hurt consumers, put Indian brands ‘at a strategic disadvantage’ (PharmaBiz)
• Pharma industry associations seek hike in ceiling prices of NLEM drugs as API prices rise significantly (PharmaBiz)

• CVS, Walgreens Stress Face-To-Face Care Amazon Doesn't Yet Have (Forbes)
• Heart rehab pays off in fewer hospitalizations and deaths (Reuters)
• Sacha Baron Cohen tried to prank Francis Collins. He got a science lesson instead (STAT)
• What is Guillain-Barré syndrome? NFL player’s diagnosis shines light on rare disorder (CBS)