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Regulatory Focus™ > News Articles > 2020 > 8 > Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

Posted 04 August 2020 | By Kari Oakes 

Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Generic drug approvals still winning the pandemic at US FDA (Pink Sheet)
  • BARDA Begins Stockpiling APIs For Critical Drugs (Pink Sheet)
  • Report: GoodRx files for IPO (MedCity News)
  • CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis (Global Genes)
  • BARDA drafts Fujifilm Diosynth into its vaccine production effort, offering to also accelerate capacity expansion (BioPharma Reporter)
  • AbbVie cans Voyager Alzheimer’s, Parkinson’s gene therapy pacts (Fierce Biotech)
 
In Focus: International
  • MYR Pharmaceuticals gains conditional EC approval for Hepcludex (Pharmaletter)
  • Ono reports positive Phase III data for Opdivo combo (Parmaletter)
  • Coronavirus compounds trouble for Bayer (Pharmaletter)
  • Rerouting Drug Supplies ‘A Priority’ After Brexit Transition Ends (Pink Sheet)
  • EU Orphan Law Under Attack Over ‘Flawed Incentives’ (Pink Sheet)
  • Indian excipients industry should get govt support to become self-reliant: Experts (Pharmabiz)
  • IBM deal to provide the NHS with quicker to access cloud services (Healthcare IT News)
  • Sun Pharma latest to sell COVID-19 drug favipiravir in India (Economic Times)
 
Coronavirus Pandemic
  • 4 former FDA commissioners: Blood plasma might be the covid-19 treatment we need (WaPo)
  • Exposure to common cold coronaviruses can teach the immune system to recognize SARS-CoV-2: Study (Science)
  • UK increases COVID-19 vaccine manufacturing capacity (PharmaTimes)
  • Gilead faces renewed pressure to pursue remdesivir-like compound to fight Covid-19 (STAT)
  • Most Americans support single, national strategy to combat COVID-19 (Ipsos)
  • Fauci warns of 'really bad situation' if daily coronavirus cases don't drop to 10K by September (The Hill)
  • Fauci: Masking Needs To Be Consistent To Beat Covid-19 (Forbes)
  • UK government reserves Wockhardt production line to fill finish COVID-19 vaccines (EPR)
  • Covid-19 vaccine trials worry US minority communities (Financial Times)
  • Healthcare workers at greater risk of COVID-19 despite 'adequate' PPE, finds research (Pharmaceutical Journal)
  • I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials (Forbes)
 
 
Pharma & Biotech
  • Medidata: COVID-19 forcing trials to adapt (Outsourcing-Pharma)
  • Oxford Biomedica and Beam Therapeutics sign CAR-T deal (PharmaTimes)
  • Immodulon, Champalimaud Foundation team up on ‘difficult to treat’ cancers (PharmaTimes)
  • Resistance Is Futile: Is This Herpes Treatment the Future for Antivirals? (Forbes)
  • What Ever Happened to NIH’s “Fair Pricing” Clause? (Harvard Law/Petrie Flom)
  • Merck bags J&J castoff from Hanmi to expand NASH pipeline (Fierce Biotech)
  • Sangamo and Novartis partner on gene therapies for autism (BioPharma-Reporter)
  • Novartis’ Ilaris [canakinumab] unexpectedly slashes need for joint replacements from osteoarthritis in key study (Fierce Biotech)
 
Medtech
  • Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay (MedTechDive)
  • Medtronic Ups Its Game in Sacral Neuromodulation for Bowel and Bladder Control (MD+DI) (MedTechDive)
  • Natera's Signatera ctDNA Test Shows Immunotherapy Response Prediction Capability in Advanced Cancer (360Dx)
  • Ancestry relaunches DNA health offerings employing Quest’s next-gen sequencing (Fierce Biotech)
 
Government & Regulatory
  • Bausch Health to pay $45M to settle US charges over Valeant-era accounting (BioPharmaDive)
  • No Evidence FDA Sabotaged $375K-A-Year Drug, Judge Says (Law360)
  • Judge Recommends Throwing Out Catalyst’s Suit Against FDA (FDA News)
  • Sandoz Warns Federal Circuit Enbrel Ruling Invites Patent Abuse (Law360)
  • Federal Circuit Trims Bio-Rad IP Win, But $24M Verdict Stays (Law360)
  • Full Federal Circuit Won't Revisit Save Of Illumina DNA Patents (Law360)
 
 
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: EMA, EU, FDA, US

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