Recon: Insys, Mallinckrodt Settle Opioid Cases; Takeda Drops Late-Stage Amyloidosis Study

• Third Rock raises $770 million in new funding round (STAT) (Endpoints) (Fierce)
• Liberals fight their own party over drug prices (Politico) (The Hill)
• Insys to pay $225 million, plead guilty in US over opioid kickbacks (Reuters) (NYTimes) (STAT) (Endpoints) (Law360-$) (DoJ)
• Mallinckrodt to settle U.S. drug marketing probe, fight kickback case (Reuters) (STAT) (DoJ)
• Top Senate Republican outlines a path forward for bipartisan drug pricing bill (STAT)
• Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision (Endpoints) (Press)
• Motif Bio: Plunges as lead drug trips on FDA hurdle (Reuters) (Endpoints)
• Trump administration moves to end U.S. research using fetal tissue from abortions (Reuters)
• Pfizer scoops Calico exec Jeff Settleman to head big oncology R&D ops in La Jolla (Endpoints) (Fierce) (Press)
• The Uber of prescription drugs: Web startups raise concerns about access to Rx medicine (USA Today) (The Atlantic)
• Growing Hack of Health-Care Data Gets Scrutiny From Congress (Bloomberg)
• US records 1,000th case of measles, officials blame misinformation for outbreak (Reuters)

• Will Europe's clampdown on faulty medical devices hurt patients? (Reuters)
• WHO sees progress in Ebola response, but others see a grimmer reality (STAT)
• One in four Ebola cases undetected in Congo: WHO (Reuters)
• Strengthening engagement between EMA and general practitioners (EMA)
• Fresenius says tighter EU rules could trigger antibiotic shortage (Reuters)
• AstraZeneca's blood cancer drug meets main goal in late-stage trial (Reuters)
• Takeda scraps late-stage amyloidosis study (Reuters) (Endpoints) (PMLive) (Press)
• China’s Hansoh raises $1bn in Hong Kong IPO (Financial Times)
• Woodford/UK biotech: calamitous catalyst (Financial Times)
• What Is A Drug Shortage? First EU Definition Due This Month (Pink Sheet-$)
• Big pharma is denying children like my son vital drugs. So I've set up a buyers club (The Guardian)
• Ebola, HIV, Spanish Flu, SARS — the 20th Century’s Deadliest Hits (NYTimes)
• A million people a day get sexual infections, WHO warns (Reuters)
• Israel's Pitango launches $150 million health technology fund (Reuters)

• One of the world’s best drug hunters went after Alzheimer’s. Here’s how he lost (STAT)
• GDUFA III May Rely Less On PDUFA As A Role Model (Pink Sheet-$)
• Protalix, Chiesi fire up accelerated approval pitch for Fabry disease treatment (Endpoints)
• Controlling CRISPR–Cas9 activity (Nature)
• Inhibiting insulin degradation (Nature)
• Opening up a pathway for disease modification in osteoarthritis (Nature)
• Towards a vaccine for equine encephalitis viruses (Nature)
• Phage therapy for Mycobacterium abscessus (Nature)
• Bristol-Myers Squibb to Announce Results for Second Quarter 2019 on July 25, 2019 (Press)
• Biotechs dive deeper into targeted cancer research, despite costs (BioPharmaDive)
• New BIO chair hopes for greater policy focus on rare diseases (MedCity)
• From BIO meeting, Merck CEO backs capitalism, rebuts industry's critics (BioPharmaDive)
• 3 takeaways from cancer's biggest conference (BioPharmaDive)
• AstraZeneca stocks up on Calquence ammunition for big BTK rivalry with J&J, AbbVie (Endpoints)
• Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products (Focus)
• New York OTC Drugmaker Scolded for Missing Lab Studies, GMP Training (FDANews-$)
• Vivek Ramaswamy recruits Eli Lilly R&D vet Salzmann as new CEO; Axovant drops collaboration (Endpoints)

• First-of-its-kind data shows Novartis' iscalimab extends survival of transplanted kidneys (Pharmafile)
• Vivacelle Bio Announces Submission of an IND Application with U.S. FDA for VBI-S, an Injectable Fluid for the Treatment of Patients with Severe Septic Shock (Press)
• vTv Therapeutics Announces Positive Topline Results from Part 1 of the Phase 2 Simplici-T1 Trial in Patients with Type 1 Diabetes (Press)
• Goldfinch Bio Initiates Phase 1 Clinical Trial of GFB-887 for Kidney Disease (Press)

• Solutions and services in medical devices: White space or white elephants? (McKinsey)
• Emergo Regulatory Recap: Global Trends June 2019 (Emergo)
• NESTcc Taps Apple Watch as First Wearable Project (Focus)
• DT Medtech wins PMA nod for Hintermann H3 total ankle system (MassDevice)
• CyMedica launches another trial of muscle-strengthening device (MassDevice)
• BrainBox wins FDA breakthrough nod for TBI test, launches pivotal trial (MassDevice) (Press)

• PTAB Struggles To Parse Arguments In Acne Drug Patent Suit (Law360-$)
• Bayer’s weedkiller woes offer a scientific cautionary tale (Financial Times)
• Opko Health says over 400,000 customers likely affected by data breach (Reuters)
• By the numbers: A look at the Part B International Pricing Index Model (PhRMA)
• Kalobios Successor Sued Over Drug Development Deal (Law360-$)
• Two more big states take aim at PBM pricing practices, which one lawmaker calls ‘the wild west’ (STAT)
• Pennsylvania Peculiarities No Bar to Removal Before Service (Drug & Device Law)

• FDA Advisory Committee Calendar
• Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes – 11-12 July 2019
• Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations – 17 July 2019

• EU Regulatory Roundup: MHRA Advises Against Use of Paclitaxel Devices Amid Mortality Fears (Focus)

• Alembic Pharma gets USFDA nod for Parkinson's disease treatment drugs (Economic Times)
• USFDA issues 9 observations to Natco Pharma's Kothur facility (Economic Times)

• Final decision(s) for matter(s) referred to the March 2019 Joint ACMS-ACCS meeting (TGA)
• Interim decisions and invitation for further comment on substances referred to the March 2019 ACMS/ACCS meetings (TGA)