Recon: Scientists Report First In Vivo CRISPR Use; Congress Poised to Pass $8B Coronavirus Package

ReconRecon | 04 March 2020 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Congress Reaches $8 Billion Deal to Combat Coronavirus (WSJ) (Politico)
  • Doctors try 1st CRISPR editing in the body for blindness (AP) (NPR) (MIT Technology Report) (Endpoints)
  • US sues Mallinckrodt, accuses drugmaker of defrauding Medicaid (Reuters) (STAT) (Law360-$)
  • New estimate says developing a drug costs $1.3 billion, which is a lot, but less than companies often say (STAT) (Endpoints) (JAMA)
  • Drug prices rose three times faster than inflation over the past decade, despite discounts (STAT) (Fierce) (JAMA)
  • Regeneron CEO hopes to have coronavirus treatment ready for human testing possibly by this summer (CNBC)
  • Vir And Alnylam Expand Collaboration To Advance RNAi Therapeutics For Treatment Of Coronavirus Infection, Including Covid-19 (Reuters)
  • AbbVie says Allergan takeover delayed by FTC verdict (PMLive) (Endpoints)
  • BMS partners with Voluntis to co-develop oncology digital therapeutics (PMLive) (Press)
  • Roche gets US breakthrough tag for liver cancer diagnosis approach (Reuters) (Press)
In Focus: International
  • Last Congo Ebola patient discharged with end of outbreak in sight (Reuters)
  • Japan's Takeda Pharma says it is developing coronavirus drug (Reuters) (Endpoints) (Press)
  • China approves use of Roche arthritis drug for coronavirus patients (Reuters)
  • Four pharma companies found guilty of anti-competitive behavior (PharmaTimes)
  • As costs continue to soar ever higher, AstraZeneca sees new HQ sticker price gyrate to $1.28B (Endpoints) (Fierce)
  • Industry ‘Disappointed’ By UK Plans For Free Trade Deal With US (Pink Sheet-$)
  • UK Parliament advances regulatory bill and publishes factsheets (Emergo)
Coronavirus Outbreak
  • WHO says coronavirus death rate is 3.4% globally, higher than previously thought (CNBC)
  • WHO warns of global shortage of medical equipment to fight coronavirus (Reuters)
  • China encourages export of medical suits to meet overseas demand amid virus outbreak (Reuters)
  • IMF announces $50 billion program for coronavirus relief (CNBC)
  • Facebook is giving free ads to the WHO and taking down ‘conspiracy theories’ about coronavirus (CNBC)
  • Researchers identify two coronavirus types as China cases dwindle (Reuters)
  • Inside China’s All-Out War on the Coronavirus (NYTimes)
  • Coronavirus median incubation period 5-7 days, maximum 14: Chinese Medical Association (Reuters)
  • Waive Fees for Coronavirus Tests and Treatment, Health Experts Urge (NYTimes)
  • U.S. Will Drop Limits on Virus Testing, Pence Says (NYTimes) (Reuters)
  • Coronavirus claims three more lives in Seattle-area as outbreak goes cross-country (Reuters)
  • N.H. coronavirus patient breaks isolation, potentially exposing others (NBC)
  • First coronavirus case at EU council before ministers' emergency meetings (Reuters)
  • Iran has 92 coronavirus deaths, 2,922 infections: health ministry (Reuters)
  • Japan coronavirus cases hit 1,000 mark as Tokyo insists Olympics on track (Reuters)
  • Coronavirus cases in Britain rise to 85 in biggest daily jump (Reuters)
  • Italy to shut all schools, universities over coronavirus: government source (Reuters)
  • Italy may set up new quarantine zone as coronavirus death toll jumps (Reuters)
  • Germany reports 44 new confirmed coronavirus cases in Germany (Reuters)
  • France reports fourth coronavirus death, Macron says crisis could last months (Reuters)
  • Spain reports first coronavirus death in Valencia (Reuters)
  • India's coronavirus cases rise to 28, including 16 Italians (Reuters)
  • South Korean president declares war on coronavirus as sect leader tests negative (Reuters)
  • Chile records first confirmed case of coronavirus: health ministry (Reuters)
  • Argentine health minister confirms country's first case of coronavirus (Reuters)
Pharmaceuticals & Biotechnology
  • Two in five US diabetics struggle with medical bills (Reuters)
  • AMAG CMO hits the exit just as biotech searches for new CEO to right a ship rocked by Makena controversy (Endpoints)
  • TG Therapeutics cops to another blood cancer drug trial delay, as excuses wear thin (STAT)
  • Amunix grabs $73M from Frazier, Omega to fuel shift to T cell engagers (Endpoints)
  • New CDER Lab Will Help Push Advanced Manufacturing Adoption (Pink Sheet-$)
  • Can reformulation of an AstraZeneca castoff rival Takeda's new heartburn drug? Here's a $26M bet on yes (Endpoints)
  • Pfizer adds Coca-Cola, GE vets to board to help navigate post-Upjohn growth (Fierce)
  • EYLEA (Aflibercept) Biosimilar Development Updates (Big Molecule Watch)
  • 'Filthy' equipment of suppository maker repaired with plastic wrap, FDA warning letter says (Fierce)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; FASENRA (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension: INGREZZA (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Moderna Completes Enrollment of Cytomegalovirus (CMV) Vaccine (mRNA-1647) Phase 2 Study (Press)
  • ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation for Trofinetide for the Treatment of Rett Syndrome (Press)
Medical Devices
  • AdvaMed, Medtronic among top 20 pharma and health product lobbyists over 2 decades: study (MedtechDive)
  • Remarks by FDA Commissioner Stephen Hahn to the American Clinical Laboratory Association (FDA)
  • Call for NESTcc Governing Committee Members (due 19 March 2020) (NESTcc)
  • Olympus-backed Medi-Tate gets FDA nod for prostate device (MedtechDive)
  • Life Spine wins additional clearance for Lateral ProLift expandable system (MassDevice)
  • DxTerity Gets CE Mark for At-Home Blood Sample Collection Device (GenomeWeb)
  • Warning Letter: Jiangsu JDC Medical Devices Co., Ltd. (FDA)
  • Mauna Kea Technologies Receives FDA Clearance And CE Marking For Its Next-Generation Cellvizio® Platform (Press)
US: Assorted & Government
  • CRISPR Housekeeping (Patent Docs)
  • Maine Voters Keep Tightened Vaccine Requirements (WSJ)
  • Confronting The Coronavirus: Perspectives On The Response To A Pandemic Threat (House Homeland Security Committee)
  • McSally Introduces Legislation to Lower the Cost of Prescription Drugs (McSally)
  • S.D. Fla. Holds that Breast Implant Failure to Warn Claims are Preempted (Drug & Device Law)
  • Enzo Tells Justices Fed. Circ. Set ‘Lax’ New Enablement Test (Law360-$)
Upcoming Meetings & Events Europe
  • One Hundred Clinical Trial Applications Authorised under the Combined Ways of Working (CWoW) pilot (MHRA)
  • Patients asked to return Emerade 150 micrograms adrenaline pens (MHRA)
  • Emiel van Galen elected as chair of the Committee for Herbal Medicinal Products (EMA)
  • Philippines FDA Tackles Confusion Over Pharmacovigilance Requirements (Pink Sheet-$)
  • Incentives scheme on cards to give impetus to API manufacturing (Economic Times)
  • Submissions received and TGA response: Review of the regulation of certain self-testing IVDs in Australia (TGA)
General Health & Other Interesting Articles
  • Sports doctors may accidentally prescribe banned steroids (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
Need to contact the editor of Regulatory Reconnaissance? Email us at
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy