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August 02, 2024 | Corporate Counsel

Fast-Growing Madrigal Pharma Names Veteran Health Care Lawyer Legal Chief

The Pennsylvania-based company promoted Shannon Kelley to her first general counsel post, just months after the successful launch of a drug to treat liver disease
3 minute read
August 01, 2024 | Corporate Counsel

Myriad Genetics Hires NIH Scientist-Turned-Biopharma Lawyer as Legal Chief

In a statement, Myriad Genetics CEO Paul Diaz praised incoming legal chief Jennifer Fox's experience and expertise, which "combined with her integrity, practical insight, and operational excellence, will be essential in guiding our legal strategy."
4 minute read
July 30, 2024 | The Legal Intelligencer

OIG Responds Favorably to an Arrangement for Pharmaceutical Company's Payment of Travel Expenses

The opinion concludes that although the proposed arrangement would generate prohibited remuneration under the AKS (if the requisite intent were present), the OIG would not impose administrative sanctions on the requestor; and the arrangement does not generate prohibited remuneration under the beneficiary inducements CMP.
12 minute read
July 25, 2024 | New Jersey Law Journal

Gibbons on the Case: New Jersey Firm Launches 15 Suits for Drug Company

The suits stem from defendants' submission to the U.S. Food and Drug Administration of Abbreviated New Drug Applications [ANDA] seeking permission to manufacture generic versions of American Regent's selenious acid products before their patents expire.
2 minute read
July 24, 2024 | National Law Journal

FTC's Regulatory Approach Could Conflict With Other Agencies, States, Say Ex-Agency Officials, Attorneys

"I don't know that there's that same sensitivity between jurisdictional overlap between the agencies," said attorney Nina Frant.
4 minute read
Law Journal Press | Digital Book Anatomy of a Merger: Strategies and Techniques for Negotiating Corporate Acquisitions Authors: James C. Freund View this Book

View more book results for the query "U.S. Food and Drug Administration"

July 18, 2024 | Connecticut Law Tribune

More Trouble for CooperSurgical? Product Liability Suits Proceed to Trial

In the U.S. District Court for the Middle District of Alabama, CooperSurgical and Femcare denied the allegations, and argued that the claims are preempted by the Medical Device Amendments to the Food, Drug & Cosmetic Act, U.S. Food and Drug Administration regulations and federal laws under the Supremacy Clause of the U.S. Constitution.
3 minute read
July 16, 2024 | National Law Journal

DLA Piper, Eversheds, Troutman, Polsinelli Among Latest Firms to Hire DC-Area Laterals

Partner hiring focused on intellectual property, insurance regulatory, corporate and investment management practices in D.C. and Baltimore this past week.
3 minute read
July 16, 2024 | National Law Journal

FTC, FDA Warn Hemp Shops About Selling THC Products Resembling Kid's Food

"Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk," said Samuel Levine, director of the FTC's Bureau of Consumer Protection.
4 minute read
July 16, 2024 | New Jersey Law Journal

Joint Effort: How Cannabis Legalization Is Shaping New Jersey's Psychedelics Legislation

"The legislative evolution from cannabis to psilocybin in New Jersey reflects a growing recognition of the need for evidence-based drug policy reform," write Guillermo Artiles and Ryan M. Magee of McCarter & English.
9 minute read
July 15, 2024 | Connecticut Law Tribune

BioXcel Securities Class Action Dismissed

"By framing the risk of third-party noncompliance as a mere possibility when they knew the FDA had issued a Form 483 observing such noncompliance at its audit, Defendants did not provide complete information to reasonable investors; thus, the statement was misleading and is actionable," the court said.
3 minute read

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