BioSpace News Archive

FDA

Takeda Closes in on Potential Approval for NSCLC Drug, Mobocertinib

Takeda’s non-small cell lung cancer treatment Mobocertinib is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.

April 28, 2021
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2 min read
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Alex Keown
BioMidwest

Alpha 9, Engage Tech Raise Funds for Cancer Therapeutics, Improved Patient Journey

Alpha-9 Theranostics announced the closing of an $11 million Series A financing today, while Engage Technologies also announced it has raised money in a Series A round, funding that came in at a tune of $15 million.

April 28, 2021
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2 min read
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Brandon May
Genetown

Less than 18 Months After Launch, Ohana Biosciences Closes Its Doors

Launched in January 2020 by Flagship Pioneering, Ohana was being dubbed a “first-in-category reproductive health company” focused on the industry’s first sperm biology platform.

April 28, 2021
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3 min read
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Mark Terry
Biotech Bay

Preparing a Pandemic Plan for Whatever Comes Our Way Next

According to Teo, the definition of the next pandemic depends a lot on one’s perspective.

April 28, 2021
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7 min read
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Heather McKenzie
FDA

Genentech’s Tecentriq Survives FDA Accelerated Approval Vote in mTNBC

A U.S. FDA committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with mTNBC.

April 28, 2021
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2 min read
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Alex Keown
Business

Developing ‘Antennae’ for Drug Regulation and Policy: A Conversation with Geoffrey Levitt

Levitt has practiced law for over 20 years in the FDA regulatory space. Previously chief regulatory counsel for Pfizer Inc., Levitt has had extensive experience working with an interdisciplinary team of scientists, executives and lawyers to push a candidate to market.

April 28, 2021
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5 min read
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Maggie Chen
Biotech Beach

Cutting-Edge Biotechs Raise Investors’ Hopes: Exscientia and Boundless Bio

Investors are still hungry for cutting-edge biotech companies that can make a difference in people’s lives with the hope of a big return on investment. Here’s a look at two recent big funding rounds.

April 28, 2021
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4 min read
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Mark Terry
FDA

Houston’s Hope BioSciences Highlights Texas’ Hotbed Status

Texas is quickly becoming a hotbed of biopharmaceutical activities, with Houston being one of the two top cities in the state that is leading the way.

April 28, 2021
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3 min read
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Brandon May
Drug Development

Pfizer Expands Presence in Antimicrobials with Amplyx Acquisition

Pfizer is expanding its presence in infectious diseases with the acquisition of San Diego-based Amplyx Pharmaceuticals and its lead antifungal compound Fosmanogepix.

April 28, 2021
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2 min read
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Alex Keown
Drug Development

Companies Betting Oral Vaccines, Therapies Will Boost Fight Against COVID-19

Researchers are continuing to develop next-generation therapeutics and oral vaccines that could overcome some vaccine hesitancy. Here are some of the top producers.

April 28, 2021
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4 min read
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Alex Keown