BioSpace News Archive

FDA

Gout Disease Control Suffered After FDA-Driven Price Hike: Study

Colchicine, a drug used to treat gout, saw a 16-fold price increase since the FDA changed its policy toward single-ingredient oral colchicine products, which had previously been available generically.

May 11, 2023
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4 min read
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Lisa Munger
FDA

FDA Advisory Panel Strongly Backs Perrigo’s OTC Birth Control Pill

The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.

May 11, 2023
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2 min read
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Tristan Manalac
FDA

Pharma, PBMs Blame Each Other Under Intense Scrutiny from Sanders’ Health Committee

As insulin prices skyrocket, pharmas and PBMs faced pointed critique from the Senate HELP Committee, led by Sen. Bernie Sanders (I-VT).

May 11, 2023
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4 min read
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Lisa Munger
Deals

Convicted ‘Pharma Bro’ Shkreli’s Vyera Files for Bankruptcy

The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.

May 11, 2023
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2 min read
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Tristan Manalac
Drug Development

FDA Action Alert: Krystal, Genmab/AbbVie, Pfizer and Intercept

The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.

May 11, 2023
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5 min read
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Tristan Manalac
FDA

Merck’s Gardasil Under Legal Scrutiny Despite Lack of Evidence to Support Suits

A federal judge compelled Merck to release confidential information on its HPV vaccine as a part of discovery in a series of lawsuits spanning states dating back to 2020.

May 11, 2023
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6 min read
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Lisa Munger
Policy

FDA Rejects ImmunityBio’s Bladder Cancer Therapy, Sends Stock Tumbling

The regulator in a Complete Response Letter rejected ImmunityBio’s bladder cancer hopeful due to deficiencies with the company’s third-party contract manufacturer.

May 11, 2023
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2 min read
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Kate Goodwin
Deals

Walgreens Boots Alliance Sells Shares of AmerisourceBergen Corporation for $694 Million of Initial Proceeds

Walgreens Boots Alliance, Inc. announced that it has sold shares of AmerisourceBergen Corporation common stock pursuant to variable prepaid forward transactions executed in reliance on Rule 144 of the Securities Act of 1933, as amended, for current proceeds of approximately $644 million.

May 11, 2023
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4 min read
Business

Nona Biosciences Announces Strategic Collaboration Agreement with PharmaEssentia Innovation Research Center

Nona Biosciences announced today it has entered into a strategic collaboration agreement with Massachusetts-based PharmaEssentia Innovation Research Center (PIRC) on Nona’s proprietary Harbour Mice® fully human antibody transgenic mice platform.

May 11, 2023
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2 min read
Business

Cyclerion Announces Corporate Updates and Q1 2023 Financial Results

Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced corporate updates and first quarter 2023 financial results.

May 11, 2023
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9 min read