BioSpace News Archive

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
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
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
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

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
Business

Zealand Pharma Announces Financial Results for the First Quarter of 2023

Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced the interim report for the three months ended March 31, 2023 and provided a corporate update.

May 11, 2023
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11 min read
Sensorion Will Present Two Posters At The American Society Of Cell And Gene Therapy (ASGCT) 26th Annual Meeting

Sensorion a pioneering clinical-stage biotechnology company which specializes in gene therapies in the ear, is pleased to announce its participation in the ASGCT Annual Meeting taking place on May 16-20, 2023, in Los Angeles, USA.

May 11, 2023
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3 min read
Drug Development

Nagasaki University Presented Results Of a Specified Clinical Trial On The Use of L. lactis strain Plasma For Patients With COVID-19

Nagasaki University presented the results of a specified clinical trial on patients with COVID-19 using Lactococcus.

May 11, 2023
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6 min read