Regulatory Focus™ > News Articles > 2019 > 4 > Recon: AskBio Raises $235M for Gene Therapy Trials

Recon: AskBio Raises $235M for Gene Therapy Trials

Posted 11 April 2019 | By Michael Mezher 

Recon: AskBio Raises $235M for Gene Therapy Trials

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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 $80m for new hormone-free contraceptive (Financial Times)
  • House members introduce companion medical device tax repeal bill (MassDevice) (AdvaMed)
  • AIDS activists skewer CDC for conflicting stance on collecting HIV drug royalties (STAT)
In Focus: International
  • Chinese scientists have put human brain genes in monkeys—and yes, they may be smarter (MIT Technology Review)
  • WHO Member States Must Grasp Opportunity to Improve Medicines Price Transparency (HAI)
  • JPMA Not Envisioning Asia-Version EMA at This Point: Chief (PharmaJapan)
  • Russian Drug Maker Gains World's First Approval for Biosimilar Eculizumab (Center for Biosimilars)
  • ESMO drives EU-level action to tackle shortages of essential medicines (EPR)
  • Bayer considers legal options after French court rules for farmer (Reuters)
  • Indian execs 'named' in US pharma case (Economic Times)
  • International Red Cross says stepping up aid to Venezuela (Reuters)
  • Australia’s TGA considering, but not yet implementing, textured breast implant ban (MassDevice)
  • New Zealand's Medsafe to participate in TGA working group on textured breast implants (Medsafe)
  • IPEC-Americas Publishes DMF FAQs in the Excipient Master File Guide (IPEC)
  • Why IMI PARADIGM? – The industry perspective (Efpia)
Pharmaceuticals & Biotechnology
  • Missing from the PBM hearings: value-based drug reimbursement (STAT)
  • Electronic health records are still waiting to be transformed (STAT)
  • Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation (Focus)
  • Wave delays key data readout for Huntington's therapy (BioPharmaDive)
  • Biosimilar Interchangeability Policies Need Closer Alignment (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • EFPIA Laments 'Unfortunate' Exclusions From ICH Guide On Nonclinical Pediatric Safety (Pink Sheet-$)
  • EU Regulatory Roundup: Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans (Focus)
  • GenePOC Receives CE Mark for Drug-Resistant Bacteria Test (GenomeWeb)
  • MHRA: policy for handling conflicts of interest (MHRA)
Asia
  • South Korea court strikes down abortion law in landmark ruling (Reuters)
  • What Can Korea Learn From The Invossa Trial And Error Case? (Pink Sheet-$)
India
  • Kool-ex cold chain bets on changing pharma distribution guidelines (Economic Times)
Australia
  • 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)
General Health & Other Interesting Articles
  • Safety Commission May Ask For A Recall Of Fisher-Price Baby Cot Tied To Infant Deaths (NPR)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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