Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Food and Drug Administration (FDA) approval. The FDA Since 1983.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Waterworth notes that the findings come on the heels of early results released in March from a clinical trial testing the cardiovascular safety of the GLP1R-targeted drug Victoza® (liraglutide), which confirm the newly reported genetic findings [4]. 2016 Jun 1;8(341):341ra76. [3] 2016 March 4. [5] December 2008. [2]

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Codon

NOVEMBER 3, 2024

Still, while these developments provide cause for hope, each drug or vaccine faces a variety of challenges, ranging from financial incentives for clinical trials to the difficulty of discovering new antimicrobials that pass safety and efficacy tests. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 was submitted on December 8, 2016 (Docket No.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

In their trial run of PRISM, the researchers uniquely barcoded more than 100 cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved. 2016 Feb 29. Nat Biotechnol.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. About 30,000 Americans have CF.

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. This compound, since renamed ‘branaplam’, is in clinical trials in SMA patients.

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The Pharma Data

FEBRUARY 13, 2022

The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.

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The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Data on File, Allergan, 2016; Clinical Study Report Satisfaction Table. . . .

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The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. Small Molecule Inhibitors. The maximum achievable ACR CRISS score is 1.0.

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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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Codon

MARCH 24, 2024

by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial. In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease.

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Codon

MARCH 28, 2023

There was nothing left over for human trials, until an opportune call came from Elon Musk’s secretary. The money was earmarked for human trials and, afterward, to develop a neural prosthesis that could augment memories in healthy adults. The meeting took place before the launch of Neuralink, in July 2016.

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Codon

JUNE 18, 2024

By 2016, Shapiro had set up a research laboratory at the California Institute of Technology in Pasadena and began to devote his attention entirely to gas vesicles. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. This latest expanded use approval gives laboratories access to the complete Roche Cervical Cancer Portfolio offering in the U.S.,

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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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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 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. EINSTEIN-Jr. About the EINSTEIN-Jr.

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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. UNIVERSE was conducted in two parts.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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The Pharma Data

SEPTEMBER 10, 2021

The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Founded in 2016, we have two FDA-approved products. ORGOVYX® (relugolix) was approved by the U.S.

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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. But by 2016, we started to see an increasing number of patients admitted to our hospital with adverse events after having these novel therapies.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children. It has also been approved for newborns of mothers who have tested positive for Ebola. during the 2014 to 2016 epidemic. In 2019, the FDA approved an Ebola vaccine, Merck’s Ervebo. “We

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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

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. Danco Labs., See 21 U.S.C.§

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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). 2016), and In re Zantac (Ranitidine) Prods. Wyeth , 85 A.3d 3d 434 (Pa. 3d 281 (6thCir.

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Drug & Device Law

JANUARY 30, 2023

Learjet, Inc. , Liberty Mutual Insurance Co. , Albrecht , 139 S.Ct.

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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. She sued in 2017 with a bunch of the typical claims for medical device cases.

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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. Genzyme Corp. ,

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Drug & Device Law

MAY 26, 2022

When the court denied a plaintiff motion for a new trial after a defense verdict, we found the reasoning a bit shaky and the leeway plaintiff had received along the way excessive. About three and a half years after that, she complained of new pain in her left hip, was worked up, and had a left hip revision surgery in December 2016.

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Drug & Device Law

APRIL 18, 2022

2016), “ Probably the Best Wisconsin Law Decision We’ve Ever Seen.” make clear that Wisconsin adopts the doctrine, as consistently predicted by Wisconsin federal courts since 2016. at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval.

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