Recon: Pfizer Reports Promising Early Data for DMD Gene Therapy

• Pfizer gene therapy for rare muscle disease shows promise in small, early study (Reuters) (Endpoints) (STAT) (Press)
• Drug pricing bill in HELP package reveals divide (Politico)
• Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies (Focus)
• FDA Approves Pfizer’s Avastin Biosimilar, Launch Date Unknown (Focus) (Reuters) (Press)
• Pfizer Appoints Gottlieb to Board of Directors (Focus) (CNBC) (Financial Times) (STAT) (Press)
• Health Care Gets Heated On Night 2 Of The Democratic Presidential Debate (KHN) (Politico) (NYTimes) (STAT)
• FDA approves Janssen’s Darzalex for transplant-ineligible multiple myeloma (Pharmafile) (Press)
• Lollipop made with powerful opioid fentanyl was illegally marketed, ex-pharma rep says (CBS)
• Health Complications Cited After 50 of MiMedx’s Graft Treatments (Bloomberg)
• Adaptive Biotechnologies takes flight in IPO debut (Financial Times)
• Vaccine No Match Against Flu Bug That Popped Up Near End (AP)
• CDC panel recommends hepatitis A vaccination through age 18 and for HIV patients (CNN)
• US Government Seeks Part of Oklahoma's $270M Opioid Deal (AP)
• Pelosi Aims For Feds To Negotiate Drug Prices, Even For Private Insurers (KHN)
• House Committee Questions FDA on Foreign Drug Manufacturing Inspections (Focus) (Bloomberg)

• Unfazed by failure, PTC Therapeutics to appeal negative EMA decision on its disaster prone Duchenne drug (Endpoints) (Press)
• CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer (Press)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019 (EMA)
• MHRA licenses two jet-lag treatments (PharmaTimes)
• UK ‘running out of time’ to eliminate no-deal Brexit disruption (PharmaTimes)
• Doctors Without Borders accuses Gilead Sciences of breaking a pledge for an HIV-related drug (STAT)
• Sun Pharma arm enters pact with China Medical System (Economic Times)
• Pharma reputation lags behind real value, study suggests (PMLive)
• US 'gag rule' linked to 40% jump in abortions in parts of Africa (Reuters) (NPR)

• FDA set for 'exceptionally light month' of generic drug approvals in June (BioPharmaDive)
• Sleek and sometimes secretive, Draper is carving out a role in drug development (STAT)
• FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics (Focus)
• FDA Drafts Guidance on Heart Failure Treatment Endpoints (Focus)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• Prospecting for new antibiotics (Nature)
• Germany Joins EU-US GMP Mutual Recognition Pact (Focus)
• Eyeing a drug launch in early ’20, Esperion lines up a new, $200M funding deal (Endpoints)
• Puretech-backed Karuna makes Nasdaq debut with $89M IPO (Endpoints)
• Evan Loh climbs the ladder to become CEO at Paratek Pharmaceuticals; Codiak's Doug Williams takes chairman's role at AC Immune (Endpoints)
• Sierra doubles down on ex-Gilead drug, deprioritizes other assets (Fierce)
• Carrick hires ex-Tesaro CFO, shifts focus toward U.S.  (Fierce)
• Adaptive Trial Designs Need Elaborate Firewalls To Prevent Data "Leakage," US FDA Says (Pink Sheet-$)
• An Ex-Commissioner’s Bleak Take On The State Of Biopharma Innovation (Pink Sheet-$)
• CDC Press Release: Most Americans Have Never Had an HIV Test, New Data Show (CDC)
• HPV Vaccines Are Reducing Infections, Warts — and Probably Cancer (NYTimes)
• Over-the-counter painkillers often suffice after minor surgery (Reuters)

• Aimmune Submits Marketing Authorization Application to European Medicines Agency for AR101 for Peanut Allergy (Press)
• vTv Therapeutics Initiates Phase 2 Clinical Trial Evaluating Azeliragon in Patients with Mild Alzheimer's Disease and Type 2 Diabetes (Press)

• FDA Warns of Cyber Risk With Medtronic Insulin Pumps (Focus)
• Study: Boston Sci’s Watchman cheaper than drugs long-term (MassDevice)
• Mole-Mapping App Miiskin Uses AI To Help Adults Detect Warning Signs Of Melanoma (Forbes)
• Boston Scientific adds 600 employees in Costa Rica (MassDevice)
• Boston Scientific gets in on $75m round for Saluda Medical (MassDevice)

• The Upcoming U.S. Health Care Cost Debate — The Public’s Views (NEJM)
• Bernie Sanders on Drug Costs (NYTimes)
• Patent Thicketing Provision Cut From Bill Passed By US Senate Judiciary Committee (Pink Sheet-$)
• Senate Panel OKs Bill Targeting Tribes' Drug Patent Buys (Law360-$)
• Ancestry.com Shared Private Health Info Of Thousands: Suit (Law360-$)
• Encompass Health to pay $48 million to resolve False Claims Act allegations: DOJ (Reuters) (DoJ)
• House Democrats launch investigation into Trump administration's Medicaid changes (The Hill)
• SEC Targets 4 Attys Over Alleged Roles In PixarBio Fraud (Law360-$)
• FDA Issues Final Guidance on Declaration of Added Sugars for Single Ingredient Products and Certain Cranberry Products (FDA Law Blog)
• This Is Why Communications With Consultants Are (Or Are Not) Privileged And Protected (Drug & Device Law)

• FDA Advisory Committee Calendar
• Endpoints for Drug Development in Heart Failure; Public Workshop – 26 July 2019

• French Court Paves Way to End Life Support for Man in Vegetative State (NYTimes)

• Japanese Regulator Approves Foundation Medicine CDx Assay for Roche's Rozlytrek (GenomeWeb)

• Industry urges govt to introduce investment based tax incentives to boost API manufacturing in India (PharmaBiz)

• Application for approval to use a restricted representation in advertising (TGA)
• Guidance for submitting an application for approval to use a restricted representation (TGA)

• Notice: Revisions to the Administrative Guidance Document (Health Canada)