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. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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The Pharma Data

NOVEMBER 9, 2021

FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Malice, and Thrombosis. Marketing authorization for the treatment of rehabilitated cases with COVID-19 has been granted for OLUMIANT in multiple countries. See the full Prescribing Information then.

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The Pharma Data

NOVEMBER 10, 2020

FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (“PMX”). PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. ” About Spectral and Dialco. Spectral is a Phase III company seeking U.S.

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The Pharma Data

JUNE 24, 2021

Talazoparib is currently approved under the brand name TALZENNA ® for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Selection of patients for therapy is based on an FDA-approved companion diagnostic for TALZENNA.

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Codon

MARCH 28, 2023

In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall. The first project, REMIND, began in 2009. View our database of DARPA neurotechnology projects online. “I am a brain, Watson.

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The Pharma Data

MARCH 27, 2022

FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for OLUMIANT in multiple countries. See the full Prescribing Information here.

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The Pharma Data

APRIL 8, 2021

in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Additional information regarding baricitinib for its FDA-approved indication, including safety information, may be found in the full? Warnings and Precautions ?in

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The Pharma Data

AUGUST 3, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is also approved for the treatment of certain hospitalized patients with COVID-19 in Japan. Serious Side Effects.

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The Pharma Data

OCTOBER 21, 2020

CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is currently only approved in Canada. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. About ViiV Healthcare. Such factors include, but are not limited to, those described under Item 3.D Source: GSK . Source link.

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Agency IQ

JUNE 2, 2023

In 2007, the FDA held a public workshop to hear from the public about the Medication Guides system; per the agency , “the public testified that the Medication Guides distribution processes needed improvement” and that it should be “shorter and easier to read.” After all, companies already have FDA-approved labels.

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The Pharma Data

JULY 29, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is also approved for the treatment of certain hospitalized patients with COVID-19 in Japan. Serious Side Effects.

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The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. associate professor of Dermatology at Yale School of Medicine.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2009 Nov 27;326(5957):1231-5. Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023. DOI: 10.1101/2023.02.07.23285407. Ochoa D, Karim M, Ghoussaini M, Hulcoop DG, McDonagh EM, Dunham I. Nat Rev Drug Discov. 2022 Aug;21(8):551. PMID: 35804044.

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The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. See the full Prescribing Information here.

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The Pharma Data

OCTOBER 14, 2020

Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges. 2009 Sep;16(9):673-82. Epub 2009 Feb 20. PMID: 23624851; PMCID: PMC3732790. iv Osada T, et al. Cancer Gene Ther.

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The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Drug & Device Law

JULY 24, 2023

at *6 (plaintiff “has documents and formularies reaching back to only 2009”). First, the class plaintiff got away with destruction of evidence. It preserved no records for nine of the eleven years of the class period.

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Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 555 (2009), concurring in the 6-3 no-preemption result. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. citation in PLIVA, Inc. Mensing , 564 U.S. Dow Agrosciences LLC , 544 U.S. Levine , 555 U.S.

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Drug & Device Law

SEPTEMBER 19, 2022

555 (2009) , and PLIVA, Inc. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. c)(6)(iii)(A).

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Drug & Device Law

MAY 11, 2023

488, 495 (2009), where it said expanding standing as proposed would “make a mockery” of Article III. It may very well fall to a rehearing en banc and/or the Supreme Court—each stocked with mostly “conservative” jurists—to restore some sanity to the mad world where FDA approvals can be wiped out retroactively more than two decades later.

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? 555 (2009). The decision is 87 pages long, but well worth the read. femur fractures. Levine , 555 U.S.

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Drug & Device Law

FEBRUARY 16, 2023

But FDA clearance/approval is an absolute prerequisite to the legal marketing of a prescription medical product in this country, so no go. “FDA FDA approval is required to show availability.” A device must be approved or cleared by the FDA before it can be sold in the United States. 3d 760 (Tex.

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Drug & Device Law

APRIL 14, 2023

The court denied the defendant’s motion, however, to the extent that the plaintiff’s claims were based on the defendant’s alleged failure to report adverse events associated with the device to the FDA. Contrary to the Second Circuit’s adherence to Erie conservatism in predicting state law, e.g. Runner v. New York Stock Exchange, Inc. ,

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. The only avenue recognized in Albrecht for unilaterally changing an FDA-approved drug warning was “if the change complies with the CBE regulation.”

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. Changing tack after the fact did not work.

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Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. In examining the law applicable to OTC drugs, ASH-ADHD ignored what the applicable FDA regulations state, in favor of what they don’t state.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp.

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Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Saigh , 769 N.W.2d

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Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

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Drug & Device Law

AUGUST 31, 2023

b)(2) not to make such a change without first obtaining FDA approval.” As construed by the court, the complaint alleged that the biologic approved by the FDA is defective as a matter of state law. Bartlett , 570 U.S. 2023 WL 5437356 at *7­. Note, however, the caveat. 2023 WL 5437356 at *7­. Courts are divided.

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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.

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Drug & Device Law

NOVEMBER 2, 2023

Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. The defendant in Zyla is a qualifying compounding pharmacy that sells without FDA approval a compounded product containing the active ingredient found in the plaintiff manufacturer’s FDA-approved product. Mukasey , 536 F.3d

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