Industry News
Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request From U.S. FDA
With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to address the urgent public health need Companies plan to submit additional data on…
Read MoreOpinion: Biden risks killing his cancer moonshot on the launchpad
Original Source For personal and political reasons, I strongly supported Joe Biden for president. He never wavered on climate change, women’s rights, immigration or other issues I care about. Paul Hastings is CEO of Nkarta Therapeutics in San Francisco and chairman of the Biotechnology Innovation Organization, a biotech trade group. Perhaps most compelling, though, was his…
Read MoreNeogen, 3M announce blockbuster merger to create ‘global leader’ in food safety
Original Source Lansing-based food and animal safety products manufacturer Neogen Corp. plans to combine with conglomerate 3M’s food safety business. The two companies say they signed a definitive agreement for a deal to create a new global food safety and security company valued at $9.3 billion. Shareholders at Neogen (Nasdaq: NEOG) would hold about 49.9 percent of the…
Read MoreFDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year
Original Source Ad hoc announcement pursuant to Art. 53 LR With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1 Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease (ASCVD) on…
Read MoreNew Report Outlines Best Practices in Bioscience Economic Development Initiatives
Original Source Today, the Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released a new report on bioscience economic development best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” Now in its sixth edition, the report serves as…
Read MoreCMS’ Attempt to Restrict Patient Access to Alzheimer’s Drug Sets “Dangerous and Far-Reaching” Precedent
Original Source Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s: “The announcement by CMS sets a dangerous and far-reaching…
Read MoreuniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single dose of etranacogene dezaparvovec ~ ~ Etranacogene dezaparvovec also achieved secondary endpoint demonstrating statistical superiority in reduction of annualized bleeding rate compared to baseline…
Read MoreNew Federal Vaccine Mandate Details Issued – What Employers Must Know
UPDATE On Nov. 6, the U.S. Court of Appeals for Fifth Circuit issued an order staying implementation of the OSHA Emergency Temporary Standard (ETS) requiring mandatory vaccination or weekly testing requirements for employers with 100 or more workers. While the decision is stayed, employers do not have to comply with its terms. However, that stay…
Read MoreDelphinus Receives FDA Approval for its SoftVue 3D Whole Breast Ultrasound Tomography System
The SoftVue™ 3D Whole Breast Ultrasound Tomography System from Delphinus Medical Technologies, Inc. is indicated for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially…
Read MoreFDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11
Original Source The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children. Before the vaccine becomes widely available, it will also need to be recommended…
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