BioSpace News Archive

FDA

Avadel Sues HHS and FDA for Not Approving Narcolepsy Drug

The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.

July 25, 2022
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3 min read
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Mark Terry
Business

Replay Launches with $55M In Seed Funding To Author Genomic Medicine

Replay features next-generation genomic medicine technologies in its portfolio to address the needs of diseases that have large unmet needs.

July 25, 2022
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2 min read
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Vanessa Doctor, RN
Drug Development

Opposing Role of T-Cells in Promoting and Preventing Colorectal Cancers

A study published this month in Science discusses data that may support a devious alter ego of T-cells present within colorectal cancers that appear to inhibit and promote tumor progression.

July 25, 2022
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2 min read
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Jazmine Colatriano
Drug Development

FDA Hands Out Regulatory Nods to Novartis, AstraZeneca, HOOKIPA

Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted

July 25, 2022
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4 min read
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Tristan Manalac
Business

Zymergen Cuts 80 More Jobs Following Buyout by Ginkgo BioWorks - Updated

The transaction, Ginkgo’s largest acquisition to date, is expected to close by the first quarter of 2023, subject to regulatory approval and other closing conditions.

July 25, 2022
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2 min read
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Vanessa Doctor, RN
Drug Development

Global Biotech News: Rona and Sanofi, Genuine Bio, and NEOsphere Bio

Here’s a look at global biopharma company news stories including Rona Therapeutics, Genuine Bio and NEOsphere Bio.

July 25, 2022
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3 min read
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Mark Terry
Drug Development

WHO Declares Monkeypox a Public Health Emergency

The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.

July 25, 2022
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4 min read
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Mark Terry
Deals

Biotech’s Prospects Transition from Hero to Zero and – Maybe – Back Again

The biotech industry is facing what some consider the worst times since its inception. Several market analysts recently shared their thoughts.

July 25, 2022
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4 min read
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Gail Dutton
eHealth Devices Market, 2031 | Witness significant Growth Opportunities in the Global Healthcare Industry

Novel workflow automation approaches are likely to create new opportunities in the eHealth devices market across the forecast period of 2021-2031.

July 25, 2022
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6 min read
Micro Guide Catheters Market Key Growth Factors, Analysis, and Potential Opportunities

Wilmington, Delaware, United States, Transparency Market Research Inc.: Micro Guide Catheters Market Catheters refer to a device fitted with a thin medical device that is produced from high graded substance.

July 25, 2022
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7 min read