Recon: FDA Approves Biohaven Migraine Drug; WHO Says Global Risk of Coronavirus is ‘Very High’

• Biohaven drug wins US FDA approval for use in relieving migraine headaches (Reuters) (Endpoints)
• US mulls using sweeping powers to ramp up production of coronavirus protective gear (Reuters)
• Mixed messages, test delays hamper US coronavirus response (Reuters) (Politico)
• US workers without protective gear assisted coronavirus evacuees, HHS whistleblower says (Washington Post)
• Why FDA Can’t Disclose the First Coronavirus-related Drug Shortage (Focus) (CNBC)
• FDA says no medical device shortages due to virus outbreak (Reuters)
• California monitoring 8,400 people for possible coronavirus (Reuters)
• Gilead Sciences Makes Takeover Approach to Forty Seven (Bloomberg) (Endpoints)
• Biogen, Sangamo partner to develop genome-editing therapies for Alzheimer’s and Parkinson’s disease (STAT) (Endpoints) (BioPharmaDive)

• WHO raises global risk of coronavirus from 'high' to 'very high' (Reuters)
• Coronavirus spreads in three continents; $5 trillion wiped off markets (Reuters)
• Mylan warns of possible drug shortages, financial hit due to coronavirus (Reuters)
• Boehringer links up with Trutino for cancer R&D (PMLive) (Fierce) (Press)
• GSK seeks EU approval for Trelegy in adult asthma patients (PMLive)
• Biotech group Novacyt announces deals for coronavirus test product (Reuters)

• Who were biopharma's Q4 growth stars? Vertex, thanks to a new launch, plus Alexion, Regeneron and GSK (Fierce)
• UK-US GCP Collaboration Going Strong But Mutual Recognition Not Feasible (Pink Sheet-$)
• US FDA Divided On Expanded Access Requests For Off-Label Use Of Approved Drugs (Pink Sheet-$)
• Rare Disease Advocates Lobby US Congress For FDA Center of Excellence (Pink Sheet-$)
• The Challenges Of Combating Rare Diseases - And Five Innovations Making A Real Difference (Forbes)
• Turned away from five clinical trials, a cancer patient waits for one that will take him (STAT)
• After the field left her behind, a scientist-turned-investor gets her first R&D job; Nouscom finds new leadership for its cancer vaccines (Endpoints)
• Sage confirms suspension of 2 depression trials after PhIII flop; Esperion follows up maiden approval with combo OK (Endpoints) (Press)
• Turning focus to clinical work, Verastem axes 31 jobs, scales back cancer drug promotion after disappointing sales (Endpoints)
• Ex-Sanofi chief Olivier Brandicourt, current Blackstone advisor, jumps on Alnylam board (Endpoints)
• Jim Wilson's gene therapy startup Passage Bio bucks market sentiments, raising upsized $216M IPO (Endpoints)
• American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity (FDA)

• Harbour BioMed Announces FDA Approval of IND for Its Next Generation anti-CTLA-4 Antibody, HBM4003, to Treat Cancer (Press)
• Zoetis Receives FDA Approval for Simparica Trio™, A New Combination Parasite Preventative for Dogs (Press)
• Innocoll Holdings Limited Resubmits New Drug Application to FDA for XARACOLL® for the Management of Postsurgical Pain after Open Inguinal Hernia Surgery (Press)
• Antibe Therapeutics Announces Enrollment of Last Patient in Phase 2B Dose-ranging, Efficacy Study of Lead Drug, ATB-346 (Press)

• AI has arrived in medical imaging. Now the FDA needs to monitor its impact on patients (STAT)
• FDA Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized (FDA)
• FDA posts trio of medical device warning letters (MedtechDive)
• California's new cybersecurity law sidesteps most medical devices, lawyers say (MedtechDive)
• Baxter wins FDA nod for Peri-Strips Dry staple-line reinforcements (MassDevice)
• Singapore HSA revises guidance and technical reference documents (MassDevice)
• Ibex wins CE Mark for AI-powered cancer detection software (MassDevice)
• Alphatec to purchase EOS Imaging (MassDevice)
• Glaukos down despite Street-beating Q4 (MassDevice)

• When the Billionaire Family Behind the Opioid Crisis Needed PR Help, They Turned to Mike Bloomberg (ProPublica)
• Azar has a ‘tin ear’ when it comes to pricing a potential coronavirus treatment (STAT)
• US Supervised Injection Site Put on Hold Amid Opposition (AP)
• Have Methadone, Will Travel: DEA Proposal Facilitates Mobile Narcotic Treatment Programs (FDA Law Blog)
• The Sun Shines on Heightened Pleading Standards in Arizona (Drug & Device Law)
• Court Certifies RICO, State Antitrust Classes In EpiPen MDL (Law360-$)
• PTAB Says Prior Art In Pain Treatment Case Is Authentic (Law360-$)

• FDA Advisory Committee Calendar
• Developing Antifungal Drugs for the Treatment of Coccidiodomycosis (Valley Fever) Infection – 8 May 2020

• ‘No Unified Patent Court For Us’ Says UK Government (Pink Sheet-$)
• European Parliament considering virtual meetings, plenary due to virus (Reuters)

• Coronavirus outbreak: Drug pricing regulator asks companies to give information on price, inventory (Economic Times)

• Medicine shortages: Report on the first 12 months of the mandatory reporting scheme (TGA)

• Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19) (WHO)
• US spy agencies monitor coronavirus spread, concerns about India: sources (Reuters)
• White House Names AIDS Expert Debbie Birx To Help Lead Coronavirus Response (NPR)
• CDC aggressively evaluating whether coronavirus survives on surfaces: agency chief (Reuters)
• CDC chief says all suspected coronavirus cases should be tested (Reuters)
• New coronavirus cases in mainland China fall to lowest since January (Reuters)
• South Korea reports 315 new coronavirus cases, takes total to 2,337 – KCDC (Reuters)
• Iran coronavirus death toll rises to 34: health ministry (Reuters)
• Mexico says may have first coronavirus case from man who was in Italy (Reuters)
• First Dutch coronavirus infection confirmed: health authorities (Reuters)
• German states report total of 22 new coronavirus cases (Reuters)
• Number of cases of coronavirus double in France, tally at 38 (Reuters)
• British region of Northern Ireland confirms first coronavirus case (Reuters)
• Swiss coronavirus cases rise to nine as children placed in precautionary quarantine (Reuters)
• New Zealand confirms first case of the new coronavirus (Reuters)
• Azerbaijan reports first case of coronavirus – Ifax (Reuters)
• Lebanon bars travel for-non residents from countries with coronavirus (Reuters)
• Italian with coronavirus in Nigeria was not isolated for almost 48 hours (Reuters)
• Singapore claims first use of antibody test to track coronavirus infections (ScienceMag)