New Drug Approvals

SEPTEMBER 29, 2024

2017 ; Ilievski et al., Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. A Phase 2/3 trial (GAIN) evaluating a 48-week course of COR388 in 643 people with mild to moderate AD began in April 2019. This trial involves 93 sites in the U.S. In preclinical work from other labs, infection with P.

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The Pharma Data

AUGUST 21, 2020

According to data from the China phase 3 Orient-11 trial, Tyvyt used in tandem with Lilly’s Alimta and platinum chemo helped those lung cancer patients live a median 8.9 Lilly first licensed Tyvyt from Innovent in 2015. months without their tumors progressing, significantly longer than the 5.0 months experienced by the chemo group.

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Molecule Blog

AUGUST 6, 2021

This is happening so regularly that academia has coined the phase of research up until clinical trials the “Valley of Death”. Therefore, it is common to use license agreements to structure the terms surrounding the IP. Before and after the transaction, access to the IP and relating license agreements need to be managed by the parties.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Eur J Neurol. 2020;27(S1).

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). FDORA § 3209(a)(1).

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The Pharma Data

NOVEMBER 29, 2020

Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment. 2017, 16 , 101-114. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia , and China. 2015, 58 , 1038?1052. Lai, A. Drug Discov. Ryan P.

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The Pharma Data

JANUARY 10, 2021

In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval.

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Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Normality sensing licenses local T cells for innate-like tissue surveillance.

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New Drug Approvals

OCTOBER 24, 2023

This approval was based on favorable results obtained from Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, that investigates the efficacy of a 2-mg daily dose regimen of etrasimod, with a 32% and 26% remission rate observed in UC 52 and UC 12 trials respectively.

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The Pharma Data

MARCH 22, 2021

GENERATION HD1 is the largest clinical trial in Huntington’s disease to date and we do know that the data generated will significantly advance our understanding of huntingtin-lowering as a potential treatment approach. About tominersen and the clinical trials. said Levi Garraway, M.D.,

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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

APRIL 4, 2022

The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE ( Part A and Part B ), and data from an active long-term extension trial. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017.

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The Pharma Data

MARCH 4, 2021

Together we generated positive Phase 2 ELEKTRA study data, and as a result, soticlestat is poised to enter two pivotal trials,” said Andy Plump, M.D., President of Research and Development at Takeda. Ovid led global development of soticlestat through the successful demonstration of proof-of-concept in multiple rare epilepsies.

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The Premier Consulting Blog

JANUARY 17, 2023

However, the FDA Reauthorization Act of 2017 (FDARA) amended PREA to require timely pediatric investigations of certain new active ingredients intended for the treatment of adult cancers, even if the indication does not occur in children and/or orphan designation has been granted.

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The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017. Nuance Pharma .

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The Pharma Data

NOVEMBER 8, 2020

In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. Almirall will initiate a Phase III trial soon to demonstrate the drug’s efficacy and safety in China. 10% of its Net Sales in R&D and also invests significantly in business development and in-licensing.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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The Pharma Data

APRIL 8, 2022

Based on these studies, one of those drugs was licensed to Cantex Pharmaceuticals for the treatment of COVID-19 and other inflammatory lung diseases. Data from the research were recently included in the company’s Investigational New Drug (IND) application to the FDA to initiate a Phase 2 clinical trial for COVID-19.

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Advarra

AUGUST 10, 2023

FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions.

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The Pharma Data

NOVEMBER 11, 2020

Expect to initiate INZ-701 Phase 1/2 clinical trials for ENPP1 and ABCC6 deficiencies in first half of 2021. and European regulatory authorities, and we remain on track to initiate our planned Phase 1/2 clinical trials in the first half of 2021, subject to clearance of our regulatory applications.”. BOSTON, Nov.

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The Pharma Data

OCTOBER 14, 2020

iota is a start-up company founded in 2017 by Michel Maharbiz and Jose Carmena, each of whom has demonstrated outstanding achievement in the bioelectronics field. Clinical trials of multiple projects including those under the R&D Agreement are expected to start in the early 2020s. “I President and CEO, Astellas.

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The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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The Pharma Data

OCTOBER 26, 2020

The Company expects to initiate enrollment of the PROVIDE Phase 1/2 clinical trial of PR001 for Type 2 neuronopathic Gaucher disease patients in the second half of 2020. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA). Founder and Chief Executive Officer of Prevail.

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The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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The Pharma Data

DECEMBER 9, 2020

Aducanumab, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia. Since October 2017 Biogen and Eisai Co.,

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The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval.

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The Pharma Data

JUNE 30, 2021

Food and Drug Administration (FDA) whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency. The top-line results of the randomized ZUMA-7 trial paint the picture of a potential paradigm shift in the treatment of large B-cell lymphoma,” said Frederick L. IMPORTANT SAFETY INFORMATION.

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The Pharma Data

OCTOBER 18, 2020

Directly prior to joining AVEO, Mr. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer.

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The Pharma Data

OCTOBER 28, 2020

We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.”. The dosing regimen in the Phase 3 is the same as in the pilot trial.

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The Pharma Data

APRIL 1, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. The sBLA is supported by data from the Phase 1/2 ZUMA-3 trial, which are also being submitted for presentation at an upcoming scientific congress. 18 years old) with relapsed or refractory ALL.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson.

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The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine.

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The Pharma Data

NOVEMBER 5, 2020

Most recently, Holland served as Global Head of licensing at Lonza AG. Prior to joining Navitor, Hughes served as president and CSO of Zafgen and previously led Zafgen as CEO from 2008 to 2017. O’Day has been a principal investigator for more than 200 clinical trials. Schijns, a former professor at N.C.

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. approval was supported by the RATIONAL 302 study, which was a randomized, active comparator, open-label trial in the second-line setting.

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources. September 30, 2024 Upcoming (or overdue) legislative requirements due as of August and September Congress often asks the FDA to release or hold guidance documents, regulation, reports, meetings, hearings or pilot programs as of specific dates.

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The Pharma Data

OCTOBER 27, 2020

The growth in Orenitram revenues resulted primarily from an increase in quantities sold, as the number of patients being treated with Orenitram grew following the update to Orenitram’s labeling to reflect the FREEDOM-EV clinical trial results, partially offset by the impact of the Excess Order. 2020. .

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The Pharma Data

OCTOBER 28, 2020

GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. GeneTx was launched by FAST, a patient advocacy organization and the largest non-governmental funder of Angelman syndrome research. About Ultragenyx.

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