Topic
FDA Approval
198 published works
Life Sciences Securities Litigation
Ninth Circuit Affirms Dismissal of Action Regarding Statements Concerning Likelihood of FDA Premarket Approval of Aneurysm Sealing Device
By Anne Johnson Palmer, Nicole Horowitz, Emily Smit
Nguyen v. Endologix, Inc., 2020 WL 3069776 (9th Cir. June 10, 2020) On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action brought…
Life Sciences Securities Litigation
District of New Jersey Dismisses Action Regarding Company’s Statements Concerning Drug Delivery System’s Safety
By Gregg Weiner, Adam Harris, Emily Smit
Smith v. Antares Pharma, Inc., 2020 WL 2041752 (D.N.J. Apr. 28, 2020) Judge Michael A. Shipp of the District of New Jersey dismissed a putative class action complaint filed against…
Big Molecule Watch
Oral Argument Scheduled for June 3 in Bevacizumab Preliminary Injunction Appeal
We previously reported on the bevacizumab preliminary injunction appeal in Genentech v. Immunex Rhode Island Corp., Fed. Cir. Case No. 19-2155. The notice of oral argument was posted today and…
China Law Insight
【疫情防控】新冠肺炎“特效药”距离我们还远吗？——简析加快药品注册上市及药品临床使用的若干制度
By King & Wood
2020年2月19日，国家卫生健康委员会发布了《新型冠状病毒肺炎诊疗方案（试行第六版）》（“《第六版诊疗方案》”），其中提到α-干扰素、洛匹那韦/利托那韦、利巴韦林、磷酸氯喹、阿比朵尔等药物（以下合称“试用药物”）可作为抗病毒治疗的试用药物。
Global IP & Technology Law Blog
Delaware Provides More Insight into the Scope of the Rights Derived by a Patent Term Extension
In a recent district court decision, Judge Stark (D. Del.) further clarified the scope of the rights derived from a Patent Term Extension (PTE) during the extension period. On January…
The Daily Intake
FDA Approves Drug to Treat Peanut Allergy in Children
On January 31, FDA approved the first drug to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. The drug, Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp]…
Big Molecule Watch
Congress Adopts Biosimilar Related Provisions in the 2020 Appropriations Act
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA,…
DC Medical Malpractice & Patient Safety Blog
FDA reviews go faster — but with less proof drugs are safer or more effective
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…
The Daily Intake
Senate Confirms Dr. Stephen Hahn as New FDA Commissioner
On December 12, the U.S. Senate confirmed Dr. Stephen Hahn to be the next FDA Commissioner. Dr. Hahn will take over for Admiral Brett Giroir, Assistant Secretary for Health within…
Legal Profession Blog
The Pedal Extremity
A medical malpractice claim must be tried according to a recent decision of the New York Appellate Division for the First Judicial DepartmentIn this medical malpractice action, plaintiff testified that…