The Pharma Data

NOVEMBER 18, 2020

. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients.

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The Pharma Data

OCTOBER 18, 2020

Berk completed his internship, residency, and fellowship in internal medicine, hematology, and medical oncology at the Weill Cornell Medical College and New York Presbyterian Hospital, where he also served as a faculty member. Inflection Biosciences Ltd is developing small molecule therapeutics for the treatment of cancer.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer.

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The Pharma Data

JANUARY 17, 2021

The NDA was built on data from the Phase III VICTORIA trial. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. HFrEF was formerly known as systolic heart failure.

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Drug Discovery World

MAY 11, 2023

An ovarian cancer drug, which targets the alpha folate receptor (FRα), is set to enter Phase II trials. The drug has already shown particular promise in ovarian cancer in a first-in-human, Phase I trial led by researchers at the ICR and The Royal Marsden NHS Foundation Trust. Cancer Research UK also helped to fund earlier research.

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The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. International Immunol. (11):1583 The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. WO 2021/001458 A1. Structure.

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The Pharma Data

MAY 6, 2021

The IOC and International Paralympics Committee (IPC) have made it clear that vaccination is not mandatory in order for athletes to participate in the Olympic and Paralympic Games, and that any vaccination program must be conducted in full respect of national vaccination priorities.

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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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., “I would like to thank Ovid for their thoughtful and productive collaboration. President of Research and Development at Takeda. selective GABA A receptor agonist.

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As CEO and Co-founder of BioNTech. About the Phase 2/3 Study. billion doses by the end of 2021.

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? and whether a molecule’s pharmacology can help to mitigate safety risk. Human and mouse genetics can inform not only efficacy but also safety. in liver, in CNS)?

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The Pharma Data

OCTOBER 26, 2020

I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”. billion related to certain license and collaboration agreements, and certain other items.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. the United States.

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Drug Discovery World

AUGUST 5, 2022

One of these may be lack of internal resources to carry out particular tasks. In return, they will become as invested professionally as any internal team member. Companies can grow organically, recruiting and building internal teams which is both distracting and time consuming. A strategic partnership.

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Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

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The Pharma Data

AUGUST 3, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HLE BiTE ® molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 LUMAKRAS received accelerated approval based on overall response rate and duration of response. Tezepelumab.

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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. Oral, Small Molecules.

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The Pharma Data

NOVEMBER 8, 2020

We have done this by both internal talent development as well as by external hires. 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. Guidance for FY 2020.

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The Pharma Data

FEBRUARY 4, 2021

Net Revenues of $4.305 Billion and International Profit Sharing of $1.009 Billion; Global Venclexta Net Revenues Were $1.337 Billion. net revenues of $1.165 billion and international profit sharing of $259 million. . – Full-Year Global Net Revenues from the Immunology Portfolio Were $22.153 Billion, an Increase of 13.2

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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

OCTOBER 14, 2020

International Dial-in Number: (210) 874-7715. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. Conference Call Information : Date : Thursday, November 5, 2020. Time : 4:30 p.m. Domestic Dial-in Number : (866) 913-8546.

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The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Aubagio ® sales decreased 1.1%

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The Pharma Data

DECEMBER 27, 2020

Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

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The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

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