The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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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. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Within the RAISE trial, it will allow clinicians to rapidly establish a diagnosis of nonconvulsive SE in the absence of immediate availability of conventional EEG. About the RAISE Trial. RADNOR, Pa.–(

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

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Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. in North America) in late 2017. She has established a track record as a successful leader and entrepreneur in the biotech industry.

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Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. 2017 Jan;155(1):234–47.

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The Pharma Data

MARCH 1, 2022

We are excited to regain exclusive, worldwide rights to ASP3772, our MAPS vaccine candidate for Streptococcus pneumoniae that has achieved positive Phase 2 clinical trial results and received FDA Breakthrough Therapy designation. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Let’s go O’s!

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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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The Pharma Data

JANUARY 3, 2021

The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. NEW YORK and LONDON, Jan.

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The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. Clinical Data Expected by End of Year. The clinical data from this trial is expected to available by the end of this year. Brazil has reported almost 5.5M

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The Pharma Data

DECEMBER 18, 2020

Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anaemia in Chronic Kidney Disease.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

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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 8, 2021

We are excited to be part of the Lyme disease vaccine development program with Valneva. Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva commented , “This trial initiation marks an important step in the development of VLA15 toward a potential licensure. Food and Drug Administration (FDA) in July 2017 3.

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The Pharma Data

OCTOBER 29, 2020

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions. “We About Avance Clinical www.avancecro.com.

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The Pharma Data

JULY 29, 2021

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

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Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Several bioanalytical strategies for the quantitation of ASOs are available at Altasciences.

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The Pharma Data

APRIL 29, 2022

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Food and Drug Administration in 2017. No infant who gained the ability to sit without support lost this ability after three years of treatment.

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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

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Nuance Pharma .

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The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Food and Drug Administration in 2017.

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The Pharma Data

JUNE 25, 2021

The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety.

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LifeSciVC

APRIL 27, 2023

By the time Chapter 1 was nearing its end, Project Troubled Water, then Nimbus Discovery, became Nimbus Therapeutics as we took a further step to forward integrate into clinical development. In 2017 we formed a classic Celgene option deal with our two most advanced programs, TYK2 and STING.

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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. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval.

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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. Founder and Chief Executive Officer of Prevail.

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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.

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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.”.

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The Pharma Data

APRIL 1, 2021

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. In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. IMPORTANT SAFETY INFORMATION.

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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. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., Before that, Ms. About MultiStem ®.

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Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.” What’s ahead? Putting policy into practice.

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The Pharma Data

MARCH 11, 2021

In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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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

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Prior to joining Navitor, Hughes served as president and CSO of Zafgen and previously led Zafgen as CEO from 2008 to 2017. Before GSK, Rosén was senior vice president, U.S.

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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. Almirall expects to make an option exercise decision in Q1 2021.

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The Pharma Data

JULY 23, 2021

Opdivo was first granted this indication in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

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Agency IQ

AUGUST 18, 2023

BY COREY JASEPH, MS, RACAUG 11, 2023 4:47 PM CDT Quick refresher on the European regulations Europe enacted the medical device and IVD regulations in May 2017 but gave manufacturers and other stakeholders, including the regulators themselves, time to implement them.

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