Recon: Medtronic CEO Ishrak to Retire; FDA Approves Kyowa Kirin’s Add-on Parkinson’s Drug

• Medtronic CEO Omar Ishrak to retire in 2020 (Star Tribune) (MassDevice) (Press)
• Decades in the making, Kyowa Hakko Kirin finally wins FDA approval for add-on Parkinson's therapy (Endpoints) (FDA) (Press)
• Chicago company’s online vision test gets pulled by FDA in win for eye doctors (Chicago Tribune)
• J&J verdict hits share prices across opioid industry (Financial Times) (STAT)
• Johnson & Johnson’s Brand Falters Over Its Role in the Opioid Crisis (NYTimes)
• The J&J Opioid Lawsuit Could Let the Real Culprits Off the Hook (Bloomberg)
• Purdue in discussion on $10 billion-$12 billion offer to settle opioid lawsuits (Reuters) (STAT)
• Sacklers Would Give Up Ownership of Purdue Pharma Under Settlement Proposal (NYTimes)
• Vertex sinks on reports of patient deaths tied to cystic fibrosis drug (STAT)
• Celgene Adds Cell Therapies From Immatics With Bristol Sale in Sight (Xconomy) (Endpoints)
• FDA warns testing companies: Don’t tell patients how their DNA influences response to drugs (STAT)
• Pharmacogenetic test cos cheer UnitedHealth coverage, other payers not there yet (BioPharmaDive)

• Dutch health minister threatens to name and shame pharma over prices (STAT)
• Half of all safety warnings issued to drug manufacturers in India and China (Pharmaceutical Journal) (Pharmafile)
• Opioids Threaten to Mess Up Europe, Too (Bloomberg)
• Bristol-Myers, AbbVie's multiple myeloma drug wins second EU nod as part of triple regimen (Endpoints) (PharmaTimes) (Press)
• Singaporean Regulator Invites Companies To Join Electronic Labeling Trial (Pink Sheet-$)
• Kolon TissueGene Faces Delisting In Korea On Invossa Uncertainties (Scrip-$)
• The Woodford effect: Teetering on the edge, his co-investors are feeling the pain (Endpoints)
• AstraZeneca respiratory business gets boost from 3-drug inhaler results (Reuters) (Endpoints)

• FDA's new guidance on heart failure could change the way we treat patients and develop drugs (The Hill)
• Kite partner HiFiBiO closes $67M round for preclinical antibody candidates churned out of single-cell sequencing platform (Endpoints)
• Immatics and Adaptimmune show that T-cell receptor deals aren't dead (Vantage)
• Gene Therapy Developers Issue Principles for Human Genome Editing (Focus)
• U.S. Task Force to Recommend Wider Screening for Hepatitis C (WSJ)
• U.S. prices for multiple sclerosis drugs are on the rise (Reuters)
• CDER Warns Chinese, Indian Manufacturers (Focus)
• Delivering Promising New Medicines Without Sacrificing Safety and Efficacy (FDA)
• It Is Too Early for Pharma Investors to Cheer Opioid Verdict (WSJ)
• Autolus drags on Arix after weak period for CAR-T player (Fierce)
• Meet The Synthetic Biology Company Engineering Your Immune System (Forbes)
• Completed PDUFA VI Deliverables (FDA)
• Sarepta, US FDA Offer Sparring Positions Over Release OF Complete Response Letters (Pink Sheet-$)
• For US Trastuzumab Biosimilars, Development Time Did Not Predict Speed To Market (Pink Sheet-$)
• FDA requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks (FDA)

• Emalex Biosciences Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome (Press)
• Arrowhead Collaborator Janssen Begins REEF-1 Phase 2b Combination Study in Patients with Chronic Hepatitis B Infection (Press)
• PT010 Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease (Press)

• FDA clears ‘cuffless’ blood pressure tracking smartwatch from Biobeat (Fierce)
• Senseonics touts long-term safety data on home-use Eversense (MassDevice)
• Cardinal Health’s Cordis expands recall of some Powerflex Pro catheters (MassDevice)
• Nevro launches clinical trial of diabetic neuropathy treatment (MassDevice)

• HHS Walks Back New Policy On Drug Coupons (Health Affairs)
• HHS OIG to CMS: Avoid Paying Twice for the Same Drugs (Focus)
• Blumenthal slams drug makers for EpiPen shortages (CT Mirror)
• Oklahoma uses century-old property law to win J&J opioid suit — other states could follow (CNBC)
• SC Johnson, ‘A family company,’ threatens to sue Oklahoma AG over use of signature slogan in Johnson & Johnson opioid suit (CNBC)
• Florida’s got a big plan for importing drugs from Canada. But experts warn that there are plenty of potential snags (STAT)
• Mass Tort Plaintiffs Who Failed to Disclose Their Claims in Bankruptcy Court: Standing and Estoppel (Drug & Device Law)
• Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC (Fed. Cir. 2019) (Patent Docs)
• Here We Go Again: FDA Sued for Failure to Meet Yet Another FSMA Deadline (FDA Law Blog)

• FDA Advisory Committee Calendar
• Developing Alpha-1 Antitrypsin Therapeutics; Public Workshop – 16 September 2019

• The EMA Explains How To Obtain Exemptions From Advanced Therapy Import Testing Requirements (Pink Sheet-$)
• Swissmedic eGov services: Delegated user administration and new self-registration via CH-LOGIN from 9 September 2019 (Swissmedic)
• The Royal College of Obstetricians and Gynaecologists (RCOG) call for action over shortages of hormone replacement therapy (HRT) (Pharmafile)
• Roche Wins Two French Early Access Programs In Breast Cancer (Pink Sheet-$)
• PCI Pharma Services takes steps to prepare for Brexit (Fierce)
• Field Safety Notice: 19 to 23 August 2019 (MHRA)
• NICE updates hypertension guideline (PharmaTimes)

• Chinese NMPA publishes UDI system rules for medical device registrants (Emergo)

• China's new drug law may open door for Indian generic medicines: Report (Economic Times)
• Health ministry to waive clinical trials for EU approved medical devices soon (Pharmabiz)
• Indian API maker hosed by FDA over contamination potential (Fierce)

• Mandatory information required in advertising for therapeutic goods (TGA)

• Biosimilar biologic drugs in Canada: Fact Sheet (Health Canada)
• Notice: Regulatory Enrolment Process (REP) Pilot for Clinical Trials (Health Canada)
• Blincyto: Notice of Compliance with Conditions - Qualifying Notice (Health Canada)

• Possible link between C-section and autism, ADHD (Reuters)