Recon: Sangamo Posts Positive Results From Early Hemophilia Gene Therapy Study

• Sangamo Soars as Hemophilia Gene Therapy Results Quiet Bears (Bloomberg) (Fierce) (Endpoints) (Press)
• Drug-device glitches prompt FDA to turn back Evoke Pharma's Gimoti nasal spray (Fierce) (Endpoints)
• Americans Borrowed $88 Billion to Pay for Health Care Last Year, Survey Finds (NYTimes)
• Trump says vote on healthcare can wait until after 2020 election (Reuters) (NYTimes)
• Two Republican attorneys general urge court to uphold Obamacare (Reuters)
• US government boosts 2020 Medicare payments to insurers by 2.53 percent (Reuters)
• Swiss drugmaker Novartis must face doctor kickback suit, US judge rules (Reuters) (STAT)
• Measles count in US this year already more than all of 2018 (NBC)
• Transplant Patients Need Anti-Rejection Drugs. Why Won’t Insurers Pay for Some of Them? (NYTimes)
• Novartis' AveXis buys AstraZeneca site in Colorado as it anticipates gene therapy launch (Fierce)
• Pelosi aide encouraged doubts about 'Medicare for All' (Politico)
• Another day, another $100M-plus biotech megaround as radiopharmaceuticals’ popularity grows (Endpoints)
• Biogen believes failed Alzheimer’s trials may still offer clues to way forward on treatment (STAT)
• Overprescribed: High cost isn’t America’s only drug problem (STAT)

• The IVD industry is undergoing significant change. Join BSI experts at their In-Vitro Diagnostic Regulation Workshop to learn about the most significant changes to the European Regulatory and Compliance Expectations for CE marking. Topics such as an IVDR Overview including Classification and Grouping Devices, interacting with the Notified Body, Technical Documentation Requirements, New Requirements for Performance Evaluation and Using the Remaining Transition Period Effectively will be covered. Register here.

• Congo Ebola outbreak spreading faster than ever: WHO (Reuters)
• What’s next for biosimilars in emerging markets? (McKinsey)
• Merck bags Chinese OK for Keytruda in first-line lung cancer (PMLive) (Pharmafile)
• NICE nod for Lilly’s breast cancer drug Verzenio via CDF (PMLive) (Pharmafile)
• Korea Overhauls Generic Drug Rules To Enhance Pharma’s Responsibility, Competitiveness (Pink Sheet-$)
• Teva's Ajovy injection secures EU approval for the prevention of migraine (Pharmafile)
• AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report (Fierce)
• Pharma asked to consider 5 things as no-deal Brexit looms again (PMLive)
• New report by PAHO and PATH seeks to improve vaccine programs through effective data use (PAHO)

• 5 ways to address the challenges of direct-to-consumer health products (STAT)
• FDA Proposes to Remove Mycoplasma Test Method (Focus)
• Insulin Competition: FDA to Hold Public Meeting (Focus)
• It’s only test tubes and mice, but Rubius Therapeutics hails first new data on red blood cell-derived cancer drugs (STAT)
• The top 20 preclinical biotech deals ranked by cash upfront reveals 3 big players — and some major league stinkers (Endpoints)
• Pharma’s summer of punk: Who’s playing the hits — or taking a hit — on the world innovation tour (Endpoints)
• FDA Finalizes Rule on Biologic Inspections a Year After Pulling the Rule (Focus)
• FDA Targets Homeopathic Medicines With Four Warning Letters (Focus)
• Is Puma off the cancer M&A list? With Nerlyx marketing deal, some investors think so (Fierce)
• What compassionate use means for gene therapies (Nature)
• Does an improved safety profile strengthen Allergan’s case for a wet AMD challenge to Lucentis? (Endpoints)
• Take Your Medicine: This $1.5 Billion Health Startup’s Smart Pills Keep Patients From Forgetting (Forbes)
• Laser-activated eye cancer drug developer Aura Biosciences scores $40M in Medicxi-led round (Endpoints)
• Janssen laying off 4 dozen employees as California plant heads toward closure (Fierce)
• Holobiome and J&J collaborate for second time for microbiome therapeutics (PharmaTimes)
• A CRISPR Approach to Treating Sickle Cell (NIH Director’s Blog)
• Circassia’s COPD drug gets FDA approval (PharmaTimes)
• Despite research boom, few immunotherapy studies targeting pancreatic cancer (BioPharmaDive)
• UK biotech Artios Pharma appoints new medical director (PMLive)
• Pazdur Grills Pd-1/Pd-L1 Companies Over Lack Of Collaboration, Trial Redundancies (BioCentury)
• FDA Takes Steps to Increase Oversight of Medically Important Antimicrobial Drugs (Warren)
• US FDA's 'Great' Generic Approval Engine Can Be Better, New OGD Director Says (Pink Sheet-$)
• As Merck Research Laboratories moves into new facility, 20 staffers get the ax (Fierce)
• Rare Disease Roundtable: How Rare Is Too Rare? (Scrip-$)
• FDA Scraps Biannual Biologics Inspections for Risk-Based Approach (FDANews-$)
• FDA Approves PROIN ER Tablets for Controlling Urinary Incontinence in Dogs (FDA)
• Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket (FDA)
• Pulmonary-Allergy Drugs Advisory Committee (FDA)
• Determination That ONFI (Clobazam) Tablets, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• AACR: Bayer posts early clinical data on follow-up to Loxo's Vitrakvi (Fierce)
• AZ’s Selumetinib granted US Breakthrough Therapy Designation (PharmaTimes)
• EMA Grants Krystal Biotech PRIME Designation for DEB Gene Therapy (GlobalGenes)
• Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia (Press)
• Clovis Oncology Announces Interim Results from Rubraca® (rucaparib) Phase 2 Study in Advanced Pancreatic Cancer and Nonclinical Data in Multiple Solid Tumor Types for Rucaparib and Lucitanib Presented at AACR 2019 (Press)
• Ocular Therapeutix™ Announces Notification of FDA Acceptance of Supplemental New Drug Submission for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery (Press)
• Phase 1b/2 Dose Escalation Trial of Onvansertib in Relapsed/Refractory AML Demonstrates Safety, Tolerability and Relative Durability with Complete Responses at Highest Dose Levels (Press)
• AVEO and Biodesix Announce Positive Results from Phase Ib Ficlatuzumab-Cytarabine Trial in Patients with Relapsed and Refractory AML (Press)
• Ra Pharmaceuticals Announces Acceptance of gMG Phase 2 and Open-Label, Long-Term Extension Data for Emerging Science Dual Presentation at the 2019 AAN Annual Meeting (Press)
• QUE Oncology Launches Phase II Trials in the United States (Press)

• Johnson & Johnson closes Auris Health buyout, sterilization biz sale (MassDevice)
• Apyx Medical Corporation Provides Update on the Premarket Notification 510(k) Submission to the U.S. Food and Drug Administration (FDA) for Use in Dermal Resurfacing Procedures (Press)
• Bio-Rad Announces Innovative Test to Aid in the Diagnosis of Lyme Disease with the FDA Clearance of the BioPlex 2200 Lyme Total Assay (Press)
• Latest insights on FDA expectations from the HFES Health Care Symposium (Emergo)

• FDA Looks To End Athenex's Active Ingredient Suit (Law360-$)
• DeGette Looks to Codify FDA Stance on Exclusivity for Deemed Biologics (Focus)
• Heritage Pharma files lawsuit after drug shipment knocked into a river (Pharmaceutical Manufacturing)
• FTC Calls no-AG Commitment a Pay-For-Delay Agreement (Focus)
• Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019) (Patent Docs)
• Don’t Test Me! FDA Applies “Deemed Triggered” Regulation to 180-Day Generic Drug Exclusivity (FDA Law Blog)
• Another Fraudulent Joinder Win in the Third Circuit (Drug & Device Law)

• FDA Advisory Committee Calendar
• Limited Population Pathway for Antibacterial and Antifungal Drugs; Public Meeting – 12 July 2019

• Defining orphan conditions in the context of the European orphan regulation: challenges and evolution (Nature)
• Novo Nordisk initiates $100m rebuild of facilities for next-gen products (BioPharmaReporter)
• Scottish Govt Explains Approach To No-Deal Brexit Drug Shortages (Pink Sheet-$)
• Takeda takes step towards EU Entyvio extension (PharmaLetter-$)

• Japanese regulators increase medical device registration fees for 2019 (Emergo)
• Takeda spin-out raises $27 million in series B round (PharmaLetter-$)

• Zydus Cadila gets tentative USFDA nod for overactive bladder treatment drug (Economic Times)
• CDSCO makes submission of six-month stability data mandatory for FDC manufacturers (PharmaBiz)
• Strides arm and its partner get USFDA nod for hypokalemia treatment drug (Economic Times)
• Dr Reddy's subsidiary sells, assigns US rights for 3 brands to Encore Dermatology (Economic Times)

• Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants (TGO 54) (TGA)
• Half yearly performance snapshot: July to December 2018 (TGA)

• What Causes Cancer? It’s Complicated (WSJ)
• IVF tied to slight increased risk of rare childhood cancers (Reuters)
• One Day There May Be a Drug to Turbocharge the Brain. Who Should Get It? (NYTimes)