BioSpace News Archive

Policy

FDA Rejects Amneal’s Extended-Release Parkinson’s Drug

Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.

July 5, 2023
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2 min read
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Tristan Manalac
Aroga Biosciences Recognized as Top 10 Medical Writing Services Provider by Life Sciences Review

The regulatory medical writing firm is being acknowledged by industry for outstanding service and specialized commitment to its biotechnology and pharmaceutical partners.

July 5, 2023
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2 min read
Policy

Amgen, Horizon Hit Back at FTC Lawsuit Seeking to Block Merger

The companies have filed their own suit against the Federal Trade Commission, claiming the FTC’s attempt to legally block their $28 billion merger is unconstitutional.

July 5, 2023
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2 min read
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Tristan Manalac
Business

Pfizer Inks Manufacturing Deals with Samsung Biologics Worth Nearly $900M

The pharmaceutical giant is tapping the world’s largest biomanufacturing facility operated by Samsung Biologics for biosimilar production.

July 5, 2023
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2 min read
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Tristan Manalac
Editorial: Gen Z Works for the Money—And You Should, Too

The youngest generation to enter the workforce has mastered working to live, not living to work. Adopting this mindset made me not only more fulfilled, but more successful in my career.

July 5, 2023
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5 min read
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Rosemary Scott
Business

Moderna Signs $1B Deal to Develop mRNA Drugs for China

The company has signed a memorandum of understanding and land collaboration agreement to develop medicines exclusively for Chinese use.

July 5, 2023
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2 min read
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Connor Lynch
Adolore Biotherapeutics to Participate in the Virtual Investor Summer Spotlight Series

Adolore Biotherapeutics today announced that Roelof Rongen, CEO and Roy Levitt, MD, Founder and Executive Chairman of Adolore, will participate in the Virtual Investor Summer Spotlight Series on Tuesday, July 11, 2023.

July 5, 2023
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1 min read
Business

Scilex Holding Company Generates Record Monthly Revenue In June 2023 And Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The One Month Ended June 2023, Quarter Ended June 2023, & Year-To-Date As Of June 2023

Scilex Holding Company announces record revenue for the month of June 2023 and is providing certain preliminary unaudited financial results for the month ended June 30, 2023, quarter ended June 30, 2023, and year-to-date as of June 30, 2023, based on currently available information.

July 5, 2023
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9 min read
CMS Establishes HCPCS code for Ultromics EchoGo® Heart Failure, Accelerating Access to Precision HFpEF Detection

Ultromics, a leading health technology company advancing a novel approach for detecting heart failure and its phenotypes, announced today the assignment of a new outpatient code by the Centers for Medicare and Medicaid Services (CMS), for its flagship product, EchoGo® Heart Failure.

July 5, 2023
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3 min read
Deals

H.C. Wainwright Reiterates Buy Rating For Agile Therapeutics (NASDAQ: AGRX), Citing Growing Demand For Twirla, A Weekly Low Dose Birth Control Patch

H.C. Wainwright & Co, reiterated its buy rating on Agile Therapeutics, Inc. (NASDAQ:AGRX) this month, setting a price target of $12 per share.

July 5, 2023
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3 min read