Recon: AskBio Raises $235M for Gene Therapy Trials

• AskBio’s $235 million financing provides clues to the direction of gene therapy investment (STAT) (Xconomy)
• Grassley, Wyden Ask HHS Watchdog to Investigate Middlemen ‘Spread Pricing’ (Senate Finance)
• Gilead Sciences to lay off one-fifth of sales force as financial pressures build (STAT) (Endpoints)
• Blame Game Continues at House E&C Hearing on Insulin Prices (Focus) (KHN)
• Intercept Tries to Outrun Pharma in Race for the Next Blockbuster (Bloomberg) (BioPharmaDive)
• Medicare Spending on 22 Drugs Jumped 500% From 2013 Through 2017 (Bloomberg)
• Medicare Could Jumpstart Our Failing Biosimilars Markets (Forbes)
• Jude Samulski’s gene therapy company just raised $235M for clinical development (Endpoints)
• Regeneron, Alnylam spell out a research alliance that could run beyond a decade, with billions built in for success (Endpoints)
• Gilead shores up hope for NASH cocktail with a glimpse at positive proof-of-concept data (Endpoints)
• Bristol-Myers details its failure on Checkmate 451, highlighting a bleak future for their checkpoint combo (Endpoints)
• Pharma lobbyists flooded Maryland to block a drug-pricing bill. Opponents pushed back — and won (STAT)
• Evofem Biosciences raises $80m for new hormone-free contraceptive (Financial Times)
• House members introduce companion medical device tax repeal bill (MassDevice) (AdvaMed)
• AIDS activists skewer CDC for conflicting stance on collecting HIV drug royalties (STAT)

• Chinese scientists have put human brain genes in monkeys—and yes, they may be smarter (MIT Technology Review)
• WHO Member States Must Grasp Opportunity to Improve Medicines Price Transparency (HAI)
• JPMA Not Envisioning Asia-Version EMA at This Point: Chief (PharmaJapan)
• Russian Drug Maker Gains World's First Approval for Biosimilar Eculizumab (Center for Biosimilars)
• ESMO drives EU-level action to tackle shortages of essential medicines (EPR)
• Bayer considers legal options after French court rules for farmer (Reuters)
• Indian execs 'named' in US pharma case (Economic Times)
• International Red Cross says stepping up aid to Venezuela (Reuters)
• Australia’s TGA considering, but not yet implementing, textured breast implant ban (MassDevice)
• New Zealand's Medsafe to participate in TGA working group on textured breast implants (Medsafe)
• IPEC-Americas Publishes DMF FAQs in the Excipient Master File Guide (IPEC)
• Why IMI PARADIGM? – The industry perspective (Efpia)

• Missing from the PBM hearings: value-based drug reimbursement (STAT)
• Electronic health records are still waiting to be transformed (STAT)
• Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation (Focus)
• Wave delays key data readout for Huntington's therapy (BioPharmaDive)
• Biosimilar Interchangeability Policies Need Closer Alignment (Pink Sheet-$)
• How FDA Says Its KASA Plan Will Streamline Quality Reviews (Pink Sheet-$)
• Cambrex opening new high-potency API facility in U.S. (Fierce)
• Nobel laureate behind Bristol's I-O superstar Opdivo demands a bigger cut (Fierce)
• As microbiome companies develop new therapies, it’s academics who are doing the heavy lifting (STAT)
• Dramatic Rise in STIs With PrEP Among Gay, Bisexual Men (Medpage)
• Treating cancer patients who smoke may cost extra $3.4 billion each year (Reuters)
• Alzheimer's-focused M3 Biotechnology rebrands as Athira Pharma (Fierce)
• Childhood HPV vaccination 'profoundly' cuts cervical disease in young women (Reuters)
• Sheer Heart Attack: What Happens When Your Partner Gets Acquired in The Middle of Negotiations (LifeSciVC)
• FDA Warning Letter to Inova Raises Questions About Agency Overreach Into Practice of Medicine (GenomeWeb)
• Scynexis finds itself in the spotlight with a weapon that may fight a superbug that’s scaring the world to death (Endpoints)
• Two Syncona-backed players join forces to take on retinal gene therapies (Endpoints)

• Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks (Press)
• Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019 (Press)
• Concert Pharmaceuticals to Present CTP-543 Phase 2 Interim Data in Alopecia Areata at 2019 World Congress for Hair Research Annual Meeting (Press)
• AriBio Co., Ltd. Announces First Patient Dosing in Phase 2 Study of AR1001 for Alzheimer's Disease (Press)
• Takara Bio submits Drug Master File to US FDA for RetroNectin® GMP grade (liquid format) (Press)

• Concussion Assessments: FDA Warns Against Using Unapproved Devices (Focus) (FDA)
• Elucent Medical wins FDA nod for EnVisio breast surgery navigation device (MassDevice) (Press)
• Helius Medical shares tank on FDA denial (MassDevice)
• Bedfont wins FDA nod for ToxCO carbon monoxide monitor (MassDevice)
• CIVCO Radiotherapy and POLL Medical Announce FDA 510(k) Clearance to Market GrayDuck Tongue-Displacing and Immobilization Oral Stents (Press)

• Opioid crisis cost US government nearly $38 billion in lost taxes (Pharmafile)
• As Sanders Officially Revives Medicare-For-All, Plan B For Democrats Gains Traction (KHN)
• 14 things you didn’t know were in Bernie’s Medicare for All plan (Politico)
• Indivior Knew Suboxone Film Did Not Have Greater Child Safety Than Tablet, Grand Jury Claims (Pink Sheet             -$)
• Acorda Asks Justices To Abolish 'Blocking Patent' Doctrine (Law360-$)
• Plan Sponsors Should Beware Hidden Costs From PBMs (Law360-$)
• FTC’s Impax Decision Shows Hard Line On Reverse Payments (Law360-$)
• Sandoz Says Antitrust Row Can’t Hinge On Drug Patent Case (Law360-$)
• Another California Action in which Private Plaintiffs Are Seemingly Enforcing the FDCA (Drug & Device Law)
• Is the Government All Fired Up About Charging Individuals? (FDA Law Blog)
• FTC Makes $25M Deals With 'Viagra For Your Brain' Sellers (Law360-$) (FTC)
• Where Calls for Overturning Bruesewitz v. Wyeth Go Wrong (Harvard Bill of Health)
• Rite Aid To Sell CBD Products Amid CEO Search And Pharmacy Pressure (Forbes)

• FDA Advisory Committee Calendar
• Project Facilitate: Enhancing the Single Patient IND Process for Oncology Health Care Providers – 16 May 2019
• Regulatory Education for Industry (REdI) Annual Conference – 29-30 May 2019

• EFPIA Laments 'Unfortunate' Exclusions From ICH Guide On Nonclinical Pediatric Safety (Pink Sheet-$)
• EU Regulatory Roundup: Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans (Focus)
• GenePOC Receives CE Mark for Drug-Resistant Bacteria Test (GenomeWeb)
• MHRA: policy for handling conflicts of interest (MHRA)

• South Korea court strikes down abortion law in landmark ruling (Reuters)
• What Can Korea Learn From The Invossa Trial And Error Case? (Pink Sheet-$)

• Kool-ex cold chain bets on changing pharma distribution guidelines (Economic Times)

• Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, June 2019 (TGA)
• Mallinckrodt's INOmax™ (Nitric Oxide) Gas, for Inhalation, Approved in Australia for Pulmonary Hypertension in Adults in Conjunction with Cardiovascular Surgery (Press)

• Safety Commission May Ask For A Recall Of Fisher-Price Baby Cot Tied To Infant Deaths (NPR)