Recon: FDA Places Hold on LogicBio Study; Pfizer Exits Glycomimetics Sickle Cell Disease Pact

• US biotechs fear the coronavirus outbreak will delay their China-based research (STAT) (Reuters)
• FDA slaps a hold on LogicBio and its gene editing plans — shares tumble (Endpoints) (Fierce)
• Merck walks away from KalVista, who turns their sights on HAE (Endpoints)
• Pfizer uncouples from GlycoMimetics and its failed sickle cell disease drug (Endpoints)
• Exelixis bounces back with new prostate cancer data (PMLive) (STAT) (Endpoints) (Press)
• Novartis lung cancer drug gets priority US review (Reuters) (Endpoints)
• Elizabeth Holmes’ attorneys ask judge to throw out Theranos fraud case (CNBC) (Business Insider) (Law360-$)
• Priscilla Chan charts an ambitious, unglamorous course to fight disease. (Her husband is involved, too.) (STAT)
• In Trump’s Budget, Big Health Care Cuts but Few Details (NYTimes 1, 2) (Alliance for a Stronger FDA) (Politico) (Focus)
• Pharma Pay-For-Delay Deals Called ‘Cost of Doing Business’ (Bloomberg Law)
• Pharma Megadeals Pass First Checkup (WSJ)

• Coronavirus death toll surges past 1,000 as fears grow for Chinese economy (Reuters)
• Disease caused by the novel coronavirus officially has a name: Covid-19 (STAT)
• Africa’s silent killer: fake drugs (Financial Times)
• Bayer, Nuvisan Create New Research Unit In Berlin (Reuters) (BioPharmaDive) (Press)
• Sanofi and Regeneron's Libtayo approved on NHS Scotland for cutaneous squamous cell carcinoma (Pharmafile)
• Mubadala to significantly increase investment in life sciences, medical technology (Reuters)
• Japan's halt of regular HPV vaccine to cause thousands of cancer deaths: study (Reuters)
• ITC Trial Wraps Up on Botox Trade Secret Case (Big Molecule Watch)

• Botox strength bolsters Allergan ahead of AbbVie takeover (PMLive)
• Private Equity-Backed PCI Pharma Services Weighs a Sale (WSJ)
• FDA eases hold as Marker Therapeutics T-cell manufacturing issues addressed (Fierce)
• Current System of Overseeing Drug Trials in Developing Countries by the FDA Is Dangerous (Annals of Pharmacology)
• Super-precise CRISPR tool enhanced by enzyme engineering (Nature)
• Faster Approval Does Not Mean Faster Reimbursement (Pink Sheet-$)
• China Unlikely To Be Included In US FDA's Project Orbis In The Near Term (Pink Sheet-$)
• HHS Partners With Pharma On New Disaster Response Biotech Facility (Pink Sheet-$)
• A Daily Aspirin for Pregnancy? (NYTimes)
• Will That Antidepressant Work For You? The Answer May Lie In Your Brain Waves (NPR)
• Moderna eyes $500M secondary offering on upbeat coronavirus vaccine update — almost ready for the clinic (Endpoints)
• Agios' Lewis Cantley returns with a new company and, he claims, a major oncological discovery (Endpoints)
• Upstart cancer biotech recruits a top Pfizer oncology researcher as CSO — could an IPO be far behind? (Endpoints)
• AZ, Daiichi's new cancer drug Enhertu gets off to the races with quick U.S. launch (Fierce)
• The Value of Priority Review Vouchers – GAO’s Two Cents (FDA Law Blog)
• Healthcare Distribution Alliance Names Chip Davis President and Chief Executive Officer (HDA)

• Merck-allied Seattle Genetics’ positive update on its 2nd ADC may point to an accelerated dash to the FDA finish line (Endpoints) (Press)
• Moderna Announces Progress in Prophylactic Vaccines Modality with CMV Vaccine Phase 2 Study Data Now Expected in Third Quarter 2020 and Expands Investment in This Core Modality with Three New Development Candidates (Press)
• Moderna Announces First Patient Enrolled in Phase 1/2 Study of mRNA-3704 for Methylmalonic Acidemia (Press)
• Sirnaomics' siRNA Therapeutic Candidate, STP705, Granted Orphan Drug Designation By US FDA for Treatment of Hepatocellular Carcinoma (Press)
• NANOBIOTIX Announces Fast Track Designation Granted By U.S. FDA For Investigation of First-in-class NBTXR3 In Head and Neck Cancer (Press)
• Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma (Press)
• Crescita Announces Positive Topline Results from Two Pivotal Phase 3 Clinical Studies for its Lead Pipeline Product in Patients with Plaque Psoriasis (Press)
• T3D Therapeutics Begins Enrollment in the PIONEER Phase 2 Clinical Trial of T3D-959 in Patients with Mild to Moderate Alzheimer's Disease (Press)
• Da Volterra Announces Positive Top-line Results from a Phase 2 Clinical Trial Evaluating DAV132 in 260 Patients (Press)
• Elicio Therapeutics and Natera To Collaborate in Phase I/II Pancreatic Cancer Study of ELI-002 (Press)

• Intuitive buys IT startup for surgical video sharing, archiving, analysis (MedtechDive)
• Renewed calls for Impella RCT as JAMA details bleeding, death rate findings (MedtechDive)
• BioIntelliSense wins FDA nod for BioSticker continuous vital sign monitor (MassDevice)
• Medicrea wins FDA clearance for patient-matched spinal interbody cages (MassDevice)
• Wearable heart rate sensor accuracy didn't vary across skin tones in small Duke study (MedtechDive)
• FDA clears Rist Neurovascular radial artery catheter (MassDevice) (Press)

• Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer (FDA)
• Trump administration proposes removing FDA's authority over tobacco regulation (The Hill)
• Could New Hampshire boost single-payer focus? (Politico)
• Exploring Duty in the Third Restatement of Torts (Drug & Device Law)
• Fed Circ. Says Drug Ingredient Doesn't Decide Product Origin (Law360-$)
• Melinta Gets Nod For Ch. 11 Auction Starting At $140M (Law360-$)
• Acer Therapeutics Tries To Shake Suit Over FDA Rejection (Law360-$)

• FDA Advisory Committee Calendar
• 12th Annual FDA Sentinel Public Workshop – 20-21 April 2020
• Public Workshop - Detecting Circulating Tumor DNA for Cancer Screening – 9 March 2020
• AdvaMed and Biocom to Strategically Partner for The Digital MedTech Conference 2020 – 19-20 May 2020
• Patient-Focused Drug Development for Vitiligo; Public Meeting – 30 March 2020

• UKRI launches ‘Nucleic Acid Therapy Accelerator’ (PharmaTimes)

• Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard (Emergo)

• Govt taking steps to reduce country's dependence on imports of antibiotic raw materials (Economic Times)
• J B Chemicals gets EIR from USFDA for unit in Gujarat (Economic Times)
• Dr. Reddy's API plant still struggling to satisfy FDA (Fierce)
• Indian Pharma Market growth slips to 7.6% in January 2020 (Pharmabiz)

• Researcher considerations for medical devices (TGA)

• Expert sees coronavirus over by April in China, WHO still alarmed (Reuters)
• Mike Pompeo and Alex Azar: Our coronavirus response is protecting Americans (USA Today)
• Overview of U.S. Domestic Response to the 2019 Novel Coronavirus (2019-nCoV) (CRS)
• China launches coronavirus app to detect whether users have come in ‘close contact’ with the sick (CNBC)
• Countries rush to build diagnostic capacity as coronavirus spreads (Reuters)
• Novacyt biotech company says winning race for high-speed virus test (Reuters)
• US allows government staff to leave Hong Kong over coronavirus worries (Reuters)
• World Bank not considering new China loans to fight coronavirus, president says (Reuters)
• Coronavirus case confirmed in California, takes US total to 13 (Reuters) (CDC)
• Thailand reports new case of coronavirus, total now 33 (Reuters)
• Vietnam's coronavirus cases climb to 15, baby infected (Reuters)

• Many in US worry about affording healthcare in retirement (Reuters)