INDUSTRY NEWS

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U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

February 3, 2022

CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of…

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

February 3, 2022

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…

Opinion: Biden risks killing his cancer moonshot on the launchpad

February 3, 2022

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…

Neogen, 3M announce blockbuster merger to create ‘global leader’ in food safety

February 3, 2022

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…

FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

February 3, 2022

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…

New Report Outlines Best Practices in Bioscience Economic Development Initiatives

February 3, 2022

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…

CMS’ Attempt to Restrict Patient Access to Alzheimer’s Drug Sets “Dangerous and Far-Reaching” Precedent

February 3, 2022

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…

MichBio Opposes Criminalization of Fetal Tissue Research

December 14, 2021

HB 5558, sponsored by Rep. Albert and others, was recently introduced and seeks that “Research shall not knowingly be performed on an organ, tissue, or cell taken from a dead embryo, fetus, or neonate obtained from an abortion.” This legislation is the latest attempt to criminalize and restrict fetal tissue research conducted legally and ethically.…

Creation of Rare Disease Advisory Council Proposed

December 14, 2021

HB 4654, legislation to establish a Rare Disease Advisory Council (RDAC) within the Department of Health & Human Services has moved to the Senate for their consideration. Substitute language was introduced at the House Health Policy Committee that accommodated changes sought by MichBio. These included expanding the RDAC membership to include greater representation from the…

Letter to President Biden Regarding Mexico Treatment of Agricultural Biotechnology

December 14, 2021

MichBio joined other state and federal partners in a letter to President Biden ahead of his recent meeting with the leaders of Mexico and Canada. It requested that the U.S. government engage the Government of Mexico at the highest levels to address its recent actions affecting agricultural biotechnology and trade of U.S. agricultural products produced…

Build Back Better Act to Impact Bio-Industry Negatively

December 14, 2021

The U.S. House on November 19 voted 220 to 212 to pass the “Build Back Better” Act (BBBA) reconciliation bill (H.R. 5376) that includes more than $1.5 trillion in business, international, and individual tax increase provisions. The legislation is now being debated in the Senate, initially by the Finance Committee It includes several drug pricing…

uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B

December 10, 2021

~ 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…

New Federal Vaccine Mandate Details Issued – What Employers Must Know

November 5, 2021

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…

Delphinus Receives FDA Approval for its SoftVue 3D Whole Breast Ultrasound Tomography System

November 2, 2021

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…

Praxis Bioresearch Seeks Regulatory Strategy Support from MMS Holdings to Develop Therapeutics for Alzheimer’s Disease

November 2, 2021

SACRAMENTO, Calif. 10/28/2021 – MMS Holdings (MMS) – a data-focused CRO – provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company’s lead development candidate, PRX-P4-003. Experts at MMS provided regulatory…