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Regulatory Focus™ > News Articles > 2020 > 6 > Recon: Emergent lands $628M contract to boost COVID-19 vaccine capacity; Congo declares new Ebola ou

Recon: Emergent lands $628M contract to boost COVID-19 vaccine capacity; Congo declares new Ebola outbreak

Posted 01 June 2020 | By Michael Mezher 

Recon: Emergent lands $628M contract to boost COVID-19 vaccine capacity; Congo declares new Ebola outbreak

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump announces US withdrawal from the World Health Organization (Politico) (Reuters)
  • US awards new $628 million contract to boost output of potential COVID-19 vaccine (Reuters)
  • Drugs standards group nixes plan to kick pharma's crab blood habit (Reuters 1, 2) (The Guardian) (USP)
  • FDA approves Roche immunotherapy cocktail in liver cancer (Reuters) (Endpoints) (FDA)
  • Eli Lilly begins first human tests of an antibody drug against Covid-19 (STAT) (Reuters)
  • Lilly's Cyramza, after split decision from FDA advisers, wins first-line lung cancer nod (Fierce) (FDA)
  • AstraZeneca's heart drug gets FDA nod (Reuters)
  • Gilead trades that made millions on COVID-19 drug news raise eyebrows (Reuters)
  • Gilead remdesivir results mixed in moderate COVID-19 patients (Reuters) (STAT) (Endpoints)
  • Moderna starts dosing patients in mid-stage coronavirus vaccine study (Reuters)
  • FDA approves Abbvie's drug to control menstrual bleeding due to fibroids (Reuters) (FDA)
  • AbbVie pens cancer pact with U.S.-China biotech Jacobio (Fierce) (Press)
In Focus: International
  • Congo declares new Ebola epidemic, 1,000 km from eastern outbreak (Reuters)
  • Chinese vaccine could be ready by year-end, government body says (Reuters)
  • US sends Brazil malaria drug unproven for COVID-19 treatment (AP)
  • Russia Approves Flu Drug’s Use Against Covid-19 (WSJ) (Reuters)
  • Russia plans coronavirus vaccine clinical trials in two weeks: report (Reuters)
  • South Korea's Celltrion aims to start in-human COVID-19 drug trial in July (Reuters)
  • Taiwan approves Gilead's remdesivir to treat COVID-19 (Reuters)
  • Oxford Biomedica hires French pharma veteran after signing vaccine deal (Reuters)
  • Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials (Reuters)
  • UK hospitals to trial five new drugs in search for coronavirus treatment (The Guardian)
  • US pharma giant seeks marketing authorisation from India for remdesivir (Economic Times)
  • Medical Journal Issues Correction on Study of Covid-19 and Antimalarial Drugs (WSJ) (NYTimes)
  • UK's Post-Brexit Medicine Plans Under Pressure (Pink Sheet)
  • Record number of countries contribute data revealing disturbing rates of antimicrobial resistance (WHO)
Coronavirus Pandemic
  • Coronavirus started spreading in the U.S. in January, CDC says (NCB)
  • FDA approves emergency use of Abiomed heart pump for COVID-19 patients (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020 (FDA)
  • FDA greenlights Quest, LetsGetChecked home-based coronavirus tests (Fierce)
Pharma & Biotech
  • Coronavirus Continues to Disrupt Prescription Drug Supplies (NYTimes)
  • In a stinging setback, Pfizer’s cancer blockbuster Ibrance flops in key adjuvant setting (Endpoints)
  • COVID-19 could slow progress in reducing cancer death, NCI head warns (BioPharmaDive)
  • ASCO: Has AstraZeneca finally found a place for long-plagued I-O candidate tremelimumab? (Fierce)
  • ASCO: Merck, Eisai pad case for liver cancer nod with Keytruda-Lenvima combo data (Fierce)
  • New research offers hope for a way through the blood-brain barrier, ‘the final frontier for drug delivery’ (STAT)
  • Incentives And Risks From OTC Drug Monograph Revamp (Law360)
  • Iterum's future looks uncertain, after lead antibiotic fails consecutive pivotal studies (Endpoints)
  • The big money: Poised to make drug R&D history, a China biotech unveils unicorn racing ambitions in a bid to raise $350M-plus on Nasdaq (Endpoints)
  • IPOs abound in the time of coronavirus, as Forma Therapeutics pencils in $150M Nasdaq debut (Endpoints)
  • Versant-backed, Bristol Myers-stamped Repare Therapeutics guns for $100M IPO (Endpoints)
  • Myovant’s relugolix wins a pivotal prostate cancer showdown with an old standard — coming down to the wire on approvals (Endpoints)
  • Eyes on hemophilia prize, Regeneron adds a $100M wager on joint development campaign with Intellia (Endpoints)
  • BioMarin holds the line on bleeds with 4-year valrox update on hemophilia A — but what's this about another decline in Factor 8 levels? (Endpoints)
Medtech
  • Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures (FDA)
  • Gynesonics lands FDA clearance for fibroid-removal system (MassDevice)
  • How 3 smaller medtechs are navigating COVID-19 (MedtechDive)
Government & Regulatory
  • Genentech Must Face Claims It Shorted Providers on Cancer Drug (Bloomberg)
  • 10th Circ. Revives Genentech Cancer Drug Dosage Suit (Law360)
  • Mylan Gets More Sanofi Insulin Pen Patents Nixed At PTAB (Law360)
  • PTAB Takes Up 1 Of 2 Gilead Challenges To State Univ. Patent (Law360)
  • Pharma Suppliers Appeal CMA Action Over UK Market Rig (Law360)
  • Action taken to halt sales of fingerprick coronavirus (COVID-19) antibody testing kits (MHRA)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

Tags: US, worldwide

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