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Regulatory
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Integra reports removal of Cerelink systems due to electromagnetic compatibility issues

Aug. 25, 2022
By Mark McCarty
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
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US Tax Court steers middle path between Medtronic, appeals court in royalty determination

Aug. 25, 2022
By Mark McCarty
Litigation over how to assign royalties for intellectual property with an offshore subsidiary doesn’t consume the kind of billable attorney hours that patent disputes do, but the question can affect a multinational corporation’s bottom line in significant ways. The U.S. Tax Court recently decided on a method for assigning royalties to a Medtronic plc subsidiary located in Puerto Rico that fell between the rate sought by Medtronic and the rate sought by an appeals court, but that ultimate rate was close to that preferred by Medtronic, handing the company a better outcome than it might have predicted when the IRS filed suit.
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U.S. Securities and Exchange Commission

After 12 years, SEC issues ‘pay-vs.-performance’ rule

Aug. 25, 2022
By Mari Serebrov
A dozen years after the Dodd-Frank Act was signed into U.S. law, the SEC adopted a final rule Aug. 25 implementing the law’s so-called “pay-vs.-performance” provisions related to executive compensation.
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Pills in blister packs

EC revises guidance on manufacturing sterile drugs

Aug. 25, 2022
In an effort to keep up with the advances being made in manufacturing technologies, the European Commission (EC) is updating its 2007 technical guidance on good manufacturing practices for sterile drugs.
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Time to identify notorious markets selling counterfeits

Aug. 25, 2022
By Mari Serebrov
It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy. While it’s not exhaustive, the annual list is composed of online and physical markets around the world that deal in commercial-scale counterfeiting and piracy across all sectors, including biopharma and med tech.
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FDA Approved stamp with blister pack

Fewer filings? Pandemic ripple effect? FDA approvals way down

Aug. 25, 2022
By Karen Carey
U.S. FDA approvals in 2022 are down by more than 30%, while new molecular entity approvals have been cut in half. So far this year, the U.S. FDA has approved 93 drugs and biologics, including expansions into new indications. In comparison with each of the last three years, it is a significant drop. There were 136 approvals in 2021, 143 in 2020 and 134 in 2019 announced by the end of August.
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Regulatory actions for Aug. 25, 2022

Aug. 25, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight.
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Man scratching arm

Rolling the bones in psoriasis, Dice advances oral IL-17 therapy

Aug. 25, 2022
By Randy Osborne
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
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Regulatory actions for Aug. 25, 2022

Aug. 25, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ainos, Can-Fite, Enlivex, Innocare, Janssen, Keymed, Moderna, Pfizer, Tachyon, Valneva.
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Brainspec

Brainspec receives FDA breakthrough device designation for virtual brain biopsy technology

Aug. 24, 2022
By Annette Boyle
The U.S. FDA granted breakthrough device designation to startup Brainspec Inc. for its non-invasive virtual brain biopsy system. The company uses standard magnetic resonance imaging equipment to measure brain chemistry rather than to create images, providing a more detailed view of pathophysiology involved in a range of neurological disorders.
Read More
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