FDA Law Blog: Biosimilars

MAY 11, 2023

If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.” Plainly, the Government brief states “The decision below is incorrect.

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Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. The drugs work by blocking a protein, PD-1 — which helps keep immune responses in check — and stimulating the immune system to attack tumors.

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The Pharma Data

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”

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The Pharma Data

AUGUST 17, 2021

On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C. Jazz believes that FDA precedent precludes that position and thus FDA departed from established policy, which FDA denied ever existed.

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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Nature 477 , 220–224 (2011). 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

SEPTEMBER 8, 2021

On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

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Codon

AUGUST 26, 2024

In 2011, research groups at the MIT Lincoln Laboratory and Boston University fused together two different proteins to make broad antivirals: one protein binds to double-stranded RNA, and the other triggers apoptosis, or cell death. As a result, it is classified as a “drug-free” product and does not require FDA approval.

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Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability.

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Agency IQ

OCTOBER 6, 2023

Earlier this year, the FDA reported that, for FY 2021, 31% of all required post-marketing studies had not yet been completed and were off-schedule for future completion. Despite the growing controversy, the number of products granted accelerated approval increased in FY 2023. of all NME approvals this year.

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Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. ZYTIGA ® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), approved by the U.S.

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Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

DNA 52

DNA Engineering Science Trials 52

The Pharma Data

OCTOBER 25, 2020

FDA approval. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tax Petition. In July 2021, we filed a petition in the U.S.

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The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. In 2011, through a collaboration agreement with Ono Pharmaceutical Co.,

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The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. In 2011, through a collaboration agreement with Ono Pharmaceutical Co.,

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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. In short, all studies found no significant difference between phenylephrine and placebo.

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The Pharma Data

DECEMBER 21, 2020

2011:29;2121-27. Related Articles: Tagrisso (osimertinib) FDA Approval History. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy.

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The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. WHAT IS XARELTO ® (rivaroxaban)?

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Broad Institute

NOVEMBER 6, 2024

Kerry Reynolds: The first immune checkpoint inhibitor was FDA-approved in 2011 to treat melanoma, with nearly a dozen more ICIs approved for various cancers since then. How big of a problem are these complications from cancer immunotherapy? These are home-run, breakthrough therapies, and quite an amazing success story.

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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

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. See 2023 Mich.

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Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

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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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Drug & Device Law

SEPTEMBER 22, 2023

604 (2011), and Mutual Pharmaceutical Co. 379r(e) product liability savings clause Id. at 1283-87. The second is that OTC monographs impose federal requirements—including labeling requirements—on the drugs they cover, and manufacturers are not free to unilaterally change them. As a result, implied preemption derived from PLIVA, Inc.

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Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. We—truly in the plural sense—will continue to trash bad decisions and amplify good decisions in our little niche of the legal world. Mensing , 564 U.S.

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Drug & Device Law

JULY 24, 2023

To put that in context, the Actos label also carries the FDA’s most serious type of warning – a boxed warning – but for congestive heart failure, not bladder cancer. precipitously” after the 2011 label change adding the bladder cancer language, a “significant number” of claims would not have been reimbursed by TPPs nationwide.

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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. 2011), aff’d , 741 F.3d Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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Drug & Device Law

MARCH 16, 2023

604 (2011), and Mutual Pharm. Since the appellate decisions in Wimbush and Lance , few courts have expressly recognized a “stop selling” cause of action for FDA-authorized medical products. But sue she did, so Beaver ends up as another case rejecting the silly stop selling theory of liability for an FDA-approved drug.

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Drug & Device Law

MARCH 2, 2023

Plaintiffs alleged that they had these contraceptive devices implanted between 2011 and 2013 (presumably in Georgia), and later suffered some combination of a wide range of symptoms that they attributed to “migration” of the device. That should not pass the smell test, but the court did not analyze (sniff?) as to each claim by each plaintiff.

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Drug & Device Law

FEBRUARY 28, 2023

FDA regulations draw important distinctions between brand drugs and generic drugs. A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials. Once approved, that drug becomes the reference list drug. 604 (2011). Mensing , 564 U.S.

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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

JANUARY 30, 2023

Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf. citation in PLIVA, Inc. Mensing , 564 U.S. Drown , 556 U.S. Mazda Motor, Inc. , Mazda Motor, Inc. , Mensing , 564 U.S. Albrecht , 139 S.Ct.

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Drug & Device Law

SEPTEMBER 19, 2022

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. 555 (2009) , and PLIVA, Inc. c)(6)(iii)(A).

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Drug & Device Law

SEPTEMBER 12, 2022

Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. c)(6-7), and, as to this drug, the defendant itself filed a CBE supplement in 2011 and was allowed to add depression as an adverse reaction. 12 (citation and quotation marks omitted). 13-14 (citation omitted). “No

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