Codon

AUGUST 26, 2024

One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. PCANS, for example, is made entirely from components listed on the FDA’s Inactive Ingredients Database and Generally Recognized as Safe list, meaning that its components do not raise safety concerns.

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The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Are drug targets with genetic support twice as likely to be approved?

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The Pharma Data

DECEMBER 21, 2020

DFS results in the overall trial population of patients with Stage IB-IIIA disease showed Tagrisso reduced the risk of disease recurrence or death by 80% (HR 0.20; 95% CI 0.15-0.27; The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting. 0.23; p<0.0001).

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The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

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The Pharma Data

SEPTEMBER 8, 2021

CheckMate -743 remains the only Phase 3 trial to show a survival benefit with first-line immunotherapy treatment in patients with MPM. First-line nivolumab + cabozantinib vs sunitinib in patients (pts) with advanced renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy in the CheckMate 9ER trial. Dr. Camillo Porta.

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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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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

Verve already started a Phase 1b trial in New Zealand last July. halted a Verve trial in the U.S. Read A chikungunya vaccine induced high levels of neutralizing antibodies in a phase II trial. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin.

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Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. Three drugs were approved based on no pivotal trials (such as in cases where an approval leveraged literature on use of the drug).

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Codon

MAY 22, 2023

Verve already started a Phase 1b trial in New Zealand last July. halted a Verve trial in the U.S. Read A chikungunya vaccine induced high levels of neutralizing antibodies in a phase II trial. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin.

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The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. All rights reserved.

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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. Finally, the committee came up with a list of recommendations for the structure of additional trials, listed in the meeting minutes.

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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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The Pharma Data

OCTOBER 25, 2020

FDA approval. In a sample of charts from 56 patients with SCD, voxelotor increased hemoglobin by more than 1 g/dL on average and decreased hemolysis markers to a degree consistent with the randomized controlled HOPE trial results. .

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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. AMG 451 / KHK4083. Tax Petition. billion, plus interest.

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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. We can’t just empirically be pulling treatments — they need to be evidence-based from randomized clinical trials. We also need better diagnostics.

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Drug Patent Watch

JANUARY 7, 2025

Explain the FDA Approval Process Many patients are unaware of the rigorous approval process generic drugs must undergo. Educate them about the FDA’s role in ensuring the safety and efficacy of generic medications. ” Health Affairs, 2011. ” WHO.int, 2020. Shrank, W.H.,

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Codon

JANUARY 26, 2025

They ran extensive trials and experiments to inoculate people against this perennial killer. Even in good years, such as 2010-2011, the vaccine tops out at about 60 percent efficacy. Researchers at the Mount Sinai School of Medicine have tested a chimeric vaccine in a Phase I trial , and it has now moved into Phase 2.

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Drug & Device Law

FEBRUARY 22, 2024

In particular, plaintiffs trying to force clinical trial sponsors to continue providing free drug after the end of the trial—something clinical trial participants are told is not a guaranty—have floundered. 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

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Thus, CEH turned on implied impossibility preemption, specifically an application of Mensing ( 2011+1 ) independence principle. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. , 4th 1261 (11th Cir.

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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

AUGUST 3, 2023

It turns out that our first post ended up describing the second worst case of the year. It also turns out the we were prescient, because the Louisiana Supreme Court ended up reversing the trial verdict for a number of the reasons we flagged. 604 (2011), were still playing out. Mensing , 564 U.S. Bartlett , 570 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

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 604 (2011), and Mutual Pharm. Wyeth Ayerst Pharms. , 3d 364 (1st Cir. 3d 1034 (S.D.

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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

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” ? 604 (2011), and Mutual Pharmaceutical Co. The decision is 87 pages long, but well worth the read.

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