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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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-$)

• FDA Advisory Committee Calendar
• CDER SEND Common Issues and Policy Update – 20 March 2020

• 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)

• Sports doctors may accidentally prescribe banned steroids (Reuters)