RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
Regulatory Focus™ > News Articles > 2020 > 8 > Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax CO

Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

Posted 07 August 2020 | By Michael Mezher 

Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA grants expedited review to Biogen's Alzheimer's drug (Reuters) (Bloomberg) (STAT)
  • Trump Signs Executive Order to Boost US Production of Essential Medicine (WSJ) (STAT)
  • Teva CEO Has Doubts About Making Generic-Drug Ingredients in the U.S. (Barron’s)
  • Moderna Backtracks to Open Covid Vaccine Trial to Those With HIV (Bloomberg)
  • Pfizer to make Gilead's COVID-19 treatment remdesivir (Reuters) (Press)
  • AbbVie pays $24m to settle lawsuit over using ‘nurse ambassadors’ to boost Humira sales (STAT)
  • 'All Bark And No Bite': Trump Holds Prescription Drug-Pricing Order In Search Of Deal (NPR)
  • Democrats try to force Trump to boost medical supplies production (The Hill)
  • Congress Fails To Reach Agreement On New COVID-19 Relief Bill (NPR)
In Focus: International
  • Japan in deals with AstraZeneca, Novavax for COVID-19 vaccines (Reuters)
  • Swiss government signs agreement with Moderna for COVID-19 vaccine (Reuters)
  • UK's Hikma making Gilead's COVID-19 drug remdesivir to increase supply (Reuters)
  • South Korea approves human trial for Genexine's coronavirus treatment drug (Reuters)
  • Italy becomes first country to require pharma to disclose public funding for R&D costs (STAT)
  • In surprising setback, combo of Roche’s Tecentriq and chemo fails to help patients with triple-negative breast cancer (Endpoints) (Press)
  • No English Funding For Lymphoma Drugs Ledaga and Poteligeo (Pink Sheet)
  • WHO asks the US to reconsider withdrawing from international group (CNBC)
Coronavirus Pandemic
  • Prices For COVID-19 Vaccines Are Starting To Come Into Focus (NPR)
  • Gates Foundation invests in $3 COVID-19 vaccine for poorer countries (The Hill)
  • Pressure mounts on FDA chief to stick with science for Covid-19 vaccine approvals (STAT) (Endpoints)
  • Preapproval Promotion? US FDA Commissioner Touts ‘Lifesaving’ Investigational Plasma For COVID-19 (Pink Sheet)
  • U.S. surpasses 160,000 coronavirus deaths as school openings near (Reuters)
  • Ohio Gov. Mike DeWine Tests Positive, Then Negative For COVID-19 (NPR)
  • University of Washington forecasts 300,000 U.S. COVID-19 deaths (Reuters)
  • MHLW Warns of COVID-Tied Cyberattacks, Urges Companies to Boost Measures (PharmaJapan)
  • Even Asymptomatic People Carry the Coronavirus in High Amounts (NYTimes)
  • Hungary ties up close to 5 million vaccine dosages in EU scheme: PM Orban (Reuters)
  • Multiple sclerosis drug to be studied for COVID-19 treatment (NBC)
  • The Coronavirus Is New, but Your Immune System Might Still Recognize It (NYTimes)
  • Coronavirus (COVID-19) Update: Daily Roundup August 6, 2020 (FDA)
Pharma & Biotech
  • AbbVie abandons a pioneering CRISPR R&D alliance with Editas as Brent Saunders' deal is cast out (Endpoints) (BioPharmaDive)
  • Biohaven adds nearly $1B in Nurtec deals with Royalty Pharma, Sixth Street (Endpoints)
  • Patient and Plan Spending after State Specialty-Drug Out-of-Pocket Spending Caps (NEJM)
  • Vizient Looks to Biosimilars to Help Contain COVID-19 Drug Price Inflation (Big Molecule Watch)
  • Hospital president wrote opinion piece critical of drug pricing efforts, but didn’t disclose role on Moderna board (STAT)
  • Perceptive fields SPAC #3 as another group of biotechs scoops up $364M in latest Nasdaq romp (Endpoints)
  • RA Capital-backed Aerovate launches with $72.6M to treat PAH with a repurposed cancer med (Endpoints)
  • Daiichi Sankyo Announces Clinical Trial Collaboration with AstraZeneca to Evaluate Patritumab Deruxtecan (U3-1402) in Combination with TAGRISSO in EGFR-Mutated Non-Small Cell Lung Cancer (Press)
Medtech
  • FDA confirms Samsung’s Galaxy Watch 3 is cleared for EKG, just like the Apple Watch (The Verge)
  • NIH launches imaging AI collaboration for COVID-19 and beyond (Fierce)
  • J&J’s Ethicon touts surgical stapler study (MassDevice)
  • Endologix wins CE Mark for Alto abdominal stent graft system (MassDevice)
  • Insulet up on Street-beating Q2, raised guidance (MassDevice)
  • InspireMD posts Street-beating Q2 results (MassDevice)
Government & Regulatory
  • Most Courts Follow 1st Circ. Generic-Delay Ruling's Standard (Law360)
  • DEA Beats Discovery Subpoenas In Opioid MDL Bellwether (Law360)
  • Pharmacies Can't Dodge Ohio Opioid MDL's 2021 Bellwether (Law360)
  • Paul Hastings Nabs Sidley Pair For FDA Regulatory Group (Law360)
  • J&J Stung by New Jersey Court Ruling Reviving Talc Cancer Claims (Bloomberg)
  • Statement on the classification of insulin products and duration of action: Notice to stakeholders (Health Canada)
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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe