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.
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care.
Some favorable and some not-so-great results from separate midstage trials testing the anti-dickkopf homolog 1 antibody sirexatamab in combo regimens for two types of gastrointestinal tumors vexed Leap Therapeutics Inc. (NASDAQ:LPTX), shares of which ended Jan. 28 at 66 cents, down $1.60, or 71%.
Lantheus Holdings Inc. is making waves in M&A with its second big deal of the month – and year – the acquisition of Evergreen Theragnostics Inc. for $250 million in cash up front and up to an additional $752.5 million in contingent payments. The transaction follows announcement of a definitive agreement to acquire Life Molecular Imaging Ltd., a subsidiary of Life Healthcare Group Holdings Ltd., on Jan. 13 for $350 million in cash at closing and a further $400 million in milestone payments.
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.
Litigation against companies in the life sciences has far too often covered those who were not injured by the device or drug, but there are signs that this tide is shifting.
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.
What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71.
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.
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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