The Pharma Data

SEPTEMBER 10, 2021

Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson’s Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% BOTOX ® Abstracts.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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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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New Drug Approvals

JULY 10, 2023

1] Zavegepant is an antagonist of the calcitonin gene-related peptide (CGRP) receptor currently in phase 3 trials in an intranasal formulation for the treatment of migraine. The clinical trial is expected to complete in September 2020. Zavegepant is indicated for the acute treatment of migraine with or without aura in adults. [1]

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The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA ® was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Through this program, the FDA can conduct periodic stability testing on select products and extend the labeled shelf life accordingly.

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The Pharma Data

NOVEMBER 4, 2020

Reaffirmed c linical trial results from study of VASCEPA in China are expected by year end 2020 : Assuming positive results from this study conducted by Amarin’s commercial partner for VASCEPA in China, regulatory submission in China could follow promptly thereafter. commercial team. “In 500 mg/dL) hypertriglyceridemia.

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Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Biotechnology Journal (2013).

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Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

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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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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

JUNE 18, 2021

2,4 This analysis included data pooled from six rheumatoid arthritis Phase 3 clinical trials and included more than 3,000 patients with over 7,000 PY of exposure of RINVOQ 15 mg, as well as data of HUMIRA and MTX. More information on this trial can be found at www.clinicaltrials.gov (NCT02629159). The approved dose for RINVOQ is 15 mg.

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The Pharma Data

JUNE 18, 2021

The GLOW study is a randomized, open label Phase 3 trial comparing progression-free survival in patients treated with either I+V or C+O as assessed by an Independent Review Committee. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Venetoclax is approved in more than 80 countries, including the U.S.

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The Pharma Data

JUNE 18, 2021

Additionally, there are other ongoing company-sponsored and investigator-initiated trials exploring the potential of ibrutinib and venetoclax in combination for CLL treatment, including the Phase 3 GLOW study. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. For more information, visit www.IMBRUVICA.com .

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New Drug Approvals

APRIL 27, 2025

octane-8,1′-azolidin-1-ium]-3-yl 2-hydroxy-2,2-diphenylacetate;chloride FDA 2024, Cobenfy 9/26/2024, To treat schizophrenia Press Release Drug Trials Snapshot Trospium chloride is a muscarinic antagonist used to treat overactive bladder. [3] Jump up to: a b FDA “Trospium chloride label” (PDF). . 4 (6): 436440.

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New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Jump up to: a b c d e f g h i j k “FDA approves imaging drug for evaluation of myocardial ischemia” U.S. Food and Drug Administration (FDA). 2013 Jan 29;61(4):469-477.

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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.

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Drug Target Review

JANUARY 16, 2025

Food and Drug Administration (FDA) approved drugs, macrocycles are used to combat a range of diseases, including cancer, viral, fungal and bacterial infections, neurodegenerative and autoimmune diseases. Phase III trials for MK-0616 commenced in the second half of 2023. Drug Discovery Today , 18(13-14):659666, 2013.

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New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2013 Jun 11;110(24):9992-7. 6] Clinical trials Phase I data indicated acoramidis achieved near-complete (>90%) TTR stabilization across the entire dosing interval at steady state. [12]

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Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. million new infections that occur globally each year. percent.

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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. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. , 4th 1261 (11th Cir. Ethicon, Inc. ,

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Drug & Device Law

DECEMBER 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. A lawyer who never loses doesn’t litigate hard cases.

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 715 F.3d

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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. For instance, in 2012, the impacts of the decision in PLIVA, Inc. Mensing , 564 U.S.

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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). 472 (2013). 2020), helped restore some sanity. Mensing , 564 U.S. Bartlett , 570 U.S.

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Drug & Device Law

JANUARY 30, 2023

472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. 483 (2013), concurrence regarding preemption concerning insurance policies of federal employees – supports preemption when the “ordinary meaning” of a federal statute “effectively repeals contrary state law” by virtue of a “direct conflict” Oneok, Inc.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. 472 (2013). (See As we discussed here , McCormack v. Hiedeman, 694 F.3d

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Drug & Device Law

MARCH 25, 2022

Just as the previous Fosamax MDL judge had back in 2013, the current Fosamax MDL judge found all of the plaintiffs’ claims (only warning claims appear now to be at issue) preempted – only this time as a matter of law under Albrecht. 472 (2013), apply to prescription drug preemption as well? 3d , 2022 WL 855853 (D.N.J. Answer: yes.

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