BioSpace News Archive

Policy

FDA Delays Decision for Biogen’s Alzheimer’s Drug Until June

The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.

January 29, 2021
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4 min read
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Mark Terry
Drug Development

Elevian Targets Aging to Solve Humanity’s Toughest Diseases

Elevian believes that this single protein, a key player in the circulatory system, could be a game-changer in regenerative medicine.

January 29, 2021
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6 min read
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Heather McKenzie
Novel Therapeutic May Offer Complete Response for Immuno-Inflammatory Diseases

There are severely limited therapeutic options for immuno-inflammatory diseases such as acute graft vs. host disease (aGVHD), lupus and asthma.

January 29, 2021
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5 min read
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Gail Dutton
FDA

FDA Action Alert: Adamas, Mallinckrodt and Merck

February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.

January 29, 2021
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3 min read
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Mark Terry
Job Trends

Life Sciences Companies Growing in a Pandemic-Induced Depression

While companies around the globe reduce staff amidst economic upheaval, there’s at least one industry on the rise - life sciences. Here’s who’s breaking ground on expansion projects.

January 29, 2021
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4 min read
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Kate Goodwin
Drug Development

Novavax Posts Positive First Look at Phase III COVID-19 Vaccine Results

The Phase III analysis of its COVID-19 vaccine candidate shows the medication demonstrated 89.3% efficacy in a large-scale study conducted in the U.K. that included the most common strain of the virus, as well as variants.

January 29, 2021
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4 min read
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Alex Keown
Drug Development

Vertex Moves Full Steam Ahead on Type 1 Diabetes Drug Trial With FDA’s OK

The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D).

January 29, 2021
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3 min read
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Brandon May
Drug Development

Johnson & Johnson COVID-19 Vaccine’s 66% Efficacy Rate Not the Entire Story

Overall, against moderate-severe COVID-19 infection, the vaccine was 72% effective 28 days after vaccination in the U.S., 66% in hard-hit Latin America, and bottomed out at 57% in South Africa.

January 29, 2021
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3 min read
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Heather McKenzie
Drug Development

Clinical Catch-Up: January 25-29

It was a busy week for clinical trial news. Read on for more information.

January 29, 2021
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9 min read
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Mark Terry
Drug Development

New Amivantamab Data Bolsters Janssen’s Hopes for Approval in NSCLC Subpopulation

Janssen presented additional positive data from its phase I study of its bispecific antibody amivantamab in metastatic or unresectable non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.

January 29, 2021
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2 min read
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Mark Zipkin