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Roche's O'Day becomes Gilead CEO; Neurocrine calms investors on drug trial miss


Essential IR Insights Newsletter Fall - 2023

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Roche's O'Day becomes Gilead CEO; Neurocrine calms investors on drug trial miss

Here are the editors' top picks for the week ended Dec. 14.

Roche's O'Day takes oncology experience to Gilead as its new CEO

Daniel O'Day, the highly regarded head of Roche Holding AG's pharmaceutical business, is leaving the Basel, Switzerland-based company after 31 years to land at U.S. biotechnology giant Gilead Sciences Inc.

CEO: Neurocrine's Ingrezza miss in Tourette syndrome no reason to 'panic'

Neurocrine Biosciences Inc.'s phase 2b trial assessing valbenazine did not meet its goal of reducing the tic symptoms of Tourette syndrome in children, such as facial grimacing and repeating words and phrases.

US FDA withdraws generic drugs safety labeling proposal after industry pushback

U.S. regulators withdrew a proposal that would have permitted generic drug companies to independently revise their product labeling with new safety updates before being reviewed or approved like brand-name manufacturers already can do.

US patent board clears path for Mylan to launch version of Sanofi's Lantus

The U.S. Patent and Trademark Appeal Board has ruled in favor of Mylan NV in a patent dispute brought by Sanofi over the vial form of the long-acting insulin Lantus.

WuXi AppTec closes at issuance price in Hong Kong on 1st trading day

The Shanghai-based company issued approximately 116 million shares for the listing on the main board in Hong Kong to receive net proceeds of about HK$7.55 billion, not including the overallotment option.

Senate health chief wants to abandon 'loser' coverage debate as ACA sign-ups lag

The Republican head of the Senate health committee said he wants to pivot away from trying to get anything done on fixing the individual healthcare insurance market and focus instead on reining in costs.

Arkansas offers more reporting options for Medicaid work requirements program

The Arkansas Department of Human Services expanded the reporting options for the state's controversial work requirements program. Medicaid enrollees can now report their hours over the phone, seven days a week.

Johnson & Johnson's Tremfya tops Novartis' Cosentyx in psoriasis trial

Johnson & Johnson's plaque psoriasis drug Tremfya was more successful than Novartis AG's Cosentyx in treating the disease in a head-to-head late-stage trial.

Bill to stop pharma gaming of Medicaid hitches ride to speed through House

A bill aimed at stopping biopharmaceutical companies from gaming the Medicaid drug rebate program hitched a ride on a broader piece of legislation that sped its way through the U.S. House on Dec. 11.

Of Mice Not Men: Seeking a preventative malaria treatment; space mice

A team of scientists are searching for a preventative malaria treatment by lighting up cells from mosquitoes like fireflies, and researchers have developed a higher resolution brain-imaging system for mice. Also, space mice.

Zai Lab launches ovarian cancer drug in Hong Kong

The Nasdaq-listed company aims to release the drug in mainland China before 2020.

US FDA sets stage for bringing lower-cost biosimilar insulins to market

U.S. regulators took new steps to incentivize drugmakers to develop lower-cost versions of insulin, a product that is essential for diabetes patients and that has grown substantially more expensive in recent years.

US FDA's Scott Gottlieb says real-world data is 'top strategic priority'

U.S. Food and Drug Administration commissioner Scott Gottlieb announced that the agency would begin taking a more active role in applying patient data outside of clinical trials, known as real-world data, to help inform decisions in drug regulation and approval.

Boehringer holds ground in challenge of AbbVie's Humira drug patent 'thicket'

One biosimilar maker, Germany's Boehringer Ingelheim GmbH, is making the argument against AbbVie Inc. in district court that Humira holds a "thicket" of patents that serves as a barrier to litigation, forcing a monopoly.

China unveils list of drugs targeted in cost-cutting measures

The new policy, which allows hospitals in 11 cities to team up to get cheaper prices for 25 drugs, is part of regulators' efforts to cut prices. The list includes Monopril by Bristol-Myers Squibb Co. and AstraZeneca PLC's Iressa.

Capitol Checkup: ACA sign-ups lag; drug pricing czar named; NIH flies to space

Democrats demanded answers about why the Trump administration is not defending the Affordable Care Act; enrollment in ACA plans continued to lag; a well-known venture capitalist was sentenced to prison; and a new drug pricing czar was appointed.