FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. 2003) , and Biogen lnt’l v. Another case of same-day (and same-time) FDA approvals!

FDA Approval

The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals. .” Recently, the U.S. References.

Trials

FDA Law Blog: Biosimilars

MARCH 12, 2024

Both Congress and FTC seem to have spun this tale that the named drug companies have been intentionally abusing the Orange Book patent listing requirements by including device patents in the Orange Book, but it’s really important to note that until FTC took the unusual step of requesting delisting in Fall 2023, FDA not only had provided no guidance (..)

Drugs

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The meeting’s outcome did not receive a rave review from former FDA Commissioner Scott Gottlieb, who led the agency between 2017 and 2019.

Science

PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. The original approved was in 2003 to treat a type of Gaucher disease. Until today, there were no approved therapies in the US.

Disease

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

Clinical Trials

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

Regulations

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c).

FDA Approval

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. 644 (2003), but not to Pike. Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.

Regulations

Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). 2003); Birdsong v.

Vaccine

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA

Drug & Device Law

JANUARY 30, 2023

Moran , 536 U.S. Walsh , 538 U.S. Albrecht , 139 S.Ct.

FDA

Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2003 WL 1785795, at *13 (D. Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. 3d 203 (5th Cir. 2008); Herzog v.

Testimonials

New Drug Approvals

APRIL 22, 2025

R*)))- FDA APPROVED sulopenem etzadroxil, probenecid, 10/25/2024, To treat uncomplicated urinary tract infections (uUTI) Drug Trial Snapshot Sulopenem ( CP-70,429 ) is a thiopenem antibiotic derivative from the penem family, which unlike most related drugs is orally active. . Hamilton-Miller JM (November 2003). PMC 188011.

FDA Approval

New Drug Approvals

APRIL 27, 2025

12] Chemistry Anticholinergic drugs used to treat overactive bladder were all amines as of 2003. 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets.

FDA Approval

LifeSciVC

MAY 28, 2025

Further, the pace of fast follower drugs is striking relative the past: according to PhRMAs recent report on innovation , the average time for a drug class to have three FDA approvals in it went from ~15 years in 1990-2003 to ~2 years in 2013-2021.

Production