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Illustration of antibodies attacking neurons
Immune

Allogene’s ALLO-329 gains IND clearance for autoimmune diseases

Jan. 29, 2025
Allogene Therapeutics Inc. has obtained IND clearance from the FDA for a rheumatology basket study of ALLO-329.
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Insider trades on sales data result in US SEC settlement

Jan. 28, 2025
A former regional sales director at Lantheus Holdings Inc. is the latest biopharma official to settle insider trading charges with the U.S. SEC. As part of the settlement, John Heropoulos agreed to disgorge nearly $61,000, an equal amount in civil penalties and more than $10,000 in prejudgment interest, according to the SEC.
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Red wooden approved stamp

TGA clears CSL’s garadacimab to prevent hereditary angioedema

Jan. 28, 2025
By Tamra Sami
Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.
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Gavel and vials

FCA cases reach new high in 2024, but value of recoveries no outlier

Jan. 28, 2025
By Mark McCarty
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts.
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Biohaven’s pre-acquisition deeds lead to $60M payout for Pfizer

Jan. 27, 2025
By Mari Serebrov
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
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MHRA logo

UK’s postmarket monitoring mandates to take force in June

Jan. 27, 2025
By Mark McCarty
The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.
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US flag, gavel, book

Bard agrees to pay $17M to settle FCA allegations

Jan. 27, 2025
By Mark McCarty
Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.
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Colorized transmission electron micrograph of SARS-CoV-2.
Immune

Ocugen’s OCU-500 inhaled mucosal vaccine for COVID-19 gains IND clearance

Jan. 27, 2025
Ocugen Inc. has received IND clearance from the FDA for OCU-500, an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct a phase I trial of OCU-500 administered via inhalation into the lungs and intranasally as a spray.
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Gavel and pill blister packs

US Claims Court rules Vanda’s trade secrets not so secret

Jan. 24, 2025
By Mari Serebrov
A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
Read More
Abbott sign

PFA update: Abbott to launch in EU, J&J hold indefinite

Jan. 24, 2025
By Annette Boyle
A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.
Read More
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