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Clinical Trials › Innovation › Prescription Drugs

Morgan Lewis - As Prescribed

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

Morgan Lewis - As Prescribed on

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

American Conference Institute (ACI) on

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Smart & Biggar

Agile licensing amendments registered

Smart & Biggar on

Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more

Haug Partners LLP

Next-Generation Antibodies: Antibody-Drug Conjugates

Haug Partners LLP on

Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more

Wilson Sonsini Goodrich & Rosati

2020 Life Sciences Securities Litigation Roundup

Wilson Sonsini Goodrich & Rosati on

2020 Filings While there was a more than 20 percent decline in the number of securities class actions filed in 2020 (approximately 330 cases) as compared to 2019 (approximately 430 cases), the percentage of cases filed...more

Patrick Malone & Associates P.C. | DC Injury...

FDA reviews go faster — but with less proof drugs are safer or more effective

Patrick Malone & Associates P.C. | DC Injury... on

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more

Troutman Pepper Locke

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper Locke on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

Knobbe Martens

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

Skadden, Arps, Slate, Meagher & Flom LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

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