Recon: Generic Industry Warns Brexit Threatens Low Prices; Judge Halts Treatments at US Stem Cell Clinic

• Health care costs package gets mark up (Politico)
• How Judges Added to the Grim Toll of Opioids (Reuters)
• Big Pharma Has to Bet Big on M&A. Investors Don’t. (Bloomberg) (Axios)
• AbbVie hopes Botox-maker Allergan can iron out its wrinkles (Financial Times) (Endpoints)
• AbbVie deal may conclude a tumultuous 4 years for Botox-maker Allergan (CNBC)
• How Brent Saunders’ Allergan experiment failed (STAT)
• Judge Halts Treatments at Florida Stem Cell Clinic (NYTimes) (DoJ) (FDA)
• Unproven stem cell therapies often peddled by doctors without training (Reuters)
• Takeda plans to vacate all 1,000 staff from US HQ by the year's end (Pharmafile)
• Fate of opioid litigation hinges on government 'police power' (Reuters)
• Senate Finance leaders in talks on deal to limit drug price increases (The Hill)
• Million-dollar drugs pose new challenge for Congress (The Hill)
• Risk for Dementia May Increase With Long-Term Use of Certain Medicines (NYTimes)

• Generic drugs industry warns of Brexit threat to low prices (Financial Times)
• Opioid use booming as tramadol crisis emerges in Africa - UN drug report (Reuters)
• DNDi receives 1 billion yen from Takeda to improve access to treatment for neglected patients (DNDi)
• Oxford Biomedica, Santen enter retinal disease R&D alliance (PharmaTimes)
• NICE publishes draft guidance on adult leg ulcers (PharmaTimes)
• Rare disease player rakes in a meaty $81M in Spain's biggest ever private biotech fundraise (Endpoints) (Fierce)
• The top 15 mega-deals in biopharma: AbbVie and Bristol-Myers acquisitions stir fresh debate over what's too big to buy (Endpoints)
• Switzerland aims to legalise medical marijuana (Reuters)
• What is the most dangerous drug? (The Economist)

• Who's the next Big Pharma takeout target? Biogen, uniQure, AZ top the list: report (Fierce)
• Samsung Bioepis CEO urges patience as US biosimilar market lags (BioPharmaDive)
• Pfizer leases Puerto Rico plant to medical marijuana producer (Fierce)
• Two biotech unicorns swell proposed IPOs, eyeing a $600M-plus windfall (Endpoints)
• They turn to Facebook and YouTube to find a cure for cancer — and get sucked into a world of bogus medicine (Washington Post)
• UPDATED: Chris Varma unveils MPM's latest startup — eyeing 'undruggable' cancer targets and powered by machine learning, $67M (Endpoints)
• Vesalius gets to work on €120M Fund III — expect more on women's health, oncology (Endpoints)
• After raising $158M, this upstart's founders have star backers and plans to break new ground in gene therapy (Endpoints)
• ‘An Arm And A Leg’: Why Are Drug Prices So Random? Meet Mr. PBM (KHN)
• Elderly in U.S. emergency depts often can't afford medicines (Reuters)
• Theolytics: Survival of the fittest oncolytic virus (BioCentury)
• Gilead to add lipid kinase inhibitors to pipeline via Carna deal (BioCentury)
• Pediatric Cancer: US FDA Will Take ‘Rational’ Approach To Requiring Combination Studies (Pink Sheet-$)
• Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says (Pink Sheet-$)
• No one should die from a blood transfusion. So why did it happen at MD Anderson, the nation's top cancer hospital? (NBC)
• New BIO White Paper: Incorporating Real-World Evidence Within the Label of an FDA-Approved Drug (BIO)
• Remarks by Dr. Sharpless at the opening of “Our Story,” FDA’s New History Exhibit (FDA)
• NIH launches large TB prevention trial for people exposed to multidrug-resistant TB (NIH)
• Study funded by NIH supports optimal threshold for diagnosing COPD (NIH)
• FDA Warns Chinese, Indian Drugmakers and US-Based Kratom Sellers (Focus)

• ImmusanT cans phase 2 celiac trial after interim efficacy review (Fierce) (Endpoints)
• Cosentyx successful in plaque psoriasis trial (PharmaTimes)
• U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure (Press)
• Acceleron Completes Target Enrollment in the PULSAR Phase 2 Trial of Sotatercept in Pulmonary Arterial Hypertension (Press)
• X4 Pharmaceuticals Initiates Pivotal Phase 3 Clinical Trial of Mavorixafor for the Treatment of WHIM Syndrome (Press)
• Blue Earth Diagnostics Announces Results from Investigational Clinical Study of Safety and Effectiveness of 18F-Fluciclovine PET Imaging in Adult Glioma (Press)
• Lilly's AWARD-11 trial studying higher investigational doses of Trulicity® (dulaglutide) demonstrated superiority in A1C reduction in people with type 2 diabetes (Press)
• InDex Pharmaceuticals Enrolls Last Patient in Phase IIb Study CONDUCT With Cobitolimod (Press)
• Bioasis Announces FDA Response to Pre-IND Submission (Press)

• CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices (Focus)
• Boston Scientific opens Irish facility (MassDevice)
• Report: Smith & Nephew mulls shift to U.S. listing (MassDevice)
• Wall Street shrugs as Boston Scientific sets growth goals (MassDevice)
• Medtronic covers upsized $4B tender with €5B notes offering (MassDevice)
• ICS Advisory (ICSMA-19-164-01) BD Alaris Gateway Workstation (US-CERT)
• ICS Alert (ICS-ALERT-19-162-01) DICOM Standard in Medical Devices (US-CERT)

• Supreme Court decision keeps ‘Auer deference,’ which strengthens power of government regulators (CNBC) (Reuters)
• House E&C Committee Seeks Answers From FDA on Opioids (Focus)
• Big Pharma's Biggest New Cases Of 2019: Midyear Report (Law360-$)
• Pharma, Tech Cos. Back Proposal To Expand Patent Eligibility (Law360-$)
• Jury Orders Express Scripts To Pay $82M In Sale Fraud Suit (Law360-$)
• Perhaps Another Supreme Court Preemption Case? (Drug & Device Law)
• SCOTUS Makes it Easier for Government to Withhold Commercial or Financial Information (FDA Law Blog)

• FDA Advisory Committee Calendar

• EMA Offers Q&A on Using OOS Batches of Authorized ATMPs (Focus)
• Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Addendum 1 (EMA)
• EC Aide-Memoire Aims to Help Drugmakers Comply With GMP Inspections Related to Falsified Medicines Delegated Regulation (Focus)
• European Commission forecasts potential supply disruptions due to MDR, IVDR (Emergo)
• Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024) (MHRA)
• EAMS Opinion: polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant (MHRA)

• South Korean trade group KMDICA teams with Emergo by UL for medical device RA/QA support (Emergo)
• Asia Regulatory Roundup: TGA Creates Guidance on Device Standards for Quality Management Systems (Focus)
• China’s Inward Tilt Could Cripple It (WSJ)

• GSK to fund doctoral programs at Regional Centre for Biotechnology (Economic Times)

• Mandatory reporting requirements for hospitals (Health Canada)

• Brazil ANVISA modifies custom-made medical device regulations (MassDevice)