The Pharma Data

NOVEMBER 12, 2020

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019. Related Articles: Calquence (acalabrutinib) FDA Approval History.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Hammami et al.,

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Hammami et al.,

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The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada.

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The Pharma Data

SEPTEMBER 9, 2020

The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, Roche’s Chief Medical Officer and Head of Global Product Development. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.

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The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus).

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The Pharma Data

JANUARY 18, 2021

Dr. Ferrara commented: “We are very excited to be working with our collaborating industry and academic partners to develop this promising addition to the COVID-19 therapeutic armamentarium and, of course, to expedite evaluation in patients as soon as possible.

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The Pharma Data

NOVEMBER 30, 2020

It showcases our ability to advance strategically important candidates against specific disease targets through early development to become attractive partnering opportunities in parallel with the multi-target deals we have established. ” Abbreviations used: CGRP – calcitonin gene-related peptide. About Sosei Heptares.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

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The Pharma Data

SEPTEMBER 1, 2020

Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Presentation Topic: Disease Modifying Therapies – Risk Management. Presentation Topic: Disease Modifying Therapies – Mechanism of Action. FDA-APPROVED INDICATION FOR ZEPOSIA.

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The Pharma Data

APRIL 11, 2021

” In May 2020, Lilly’s first-in-class selective RET inhibitor Retevmo received Accelerated Approval from the U.S. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50

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The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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Drug Discovery World

JULY 13, 2023

There are various schemes in force that allow patients access to unlicensed medicines that are in the late stages of clinical development (i.e., Schemes to allow expanded access to unlicensed therapies can also be open to abuse.

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The Pharma Data

JANUARY 15, 2021

Enhertu is also approved in Japan for HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy based on the DESTINY-Gastric01 trial. Enhertu previously received Priority Review and Breakthrough Therapy Designation (BTD) in the U.S. mg/kg) is also approved in the U.S. Enhertu (6.4

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Senior Vice President and Head of Global Clinical Development at Regeneron. In the U.S.

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Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4. 21 In a recent publication, Silvestri et al.,

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The Pharma Data

DECEMBER 10, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Source: Pfizer Inc. .

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The Pharma Data

NOVEMBER 20, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Source: Pfizer Inc. .

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The Pharma Data

DECEMBER 11, 2020

AUTHORIZED USE: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2. SARSCoV2) in individuals 16 years of age and older.

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The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

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The Pharma Data

NOVEMBER 9, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Source: Pfizer, inc.

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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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. The meeting’s outcome did not receive a rave review from former FDA Commissioner Scott Gottlieb, who led the agency between 2017 and 2019.

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The Pharma Data

OCTOBER 28, 2020

As in the earlier analysis, patients with higher viral load at baseline and/or no detectable antibodies at baseline (suggesting their bodies had not yet mounted an effective immune response), derived greater benefit from REGN-COV2 therapy. Senior Vice President and Head of Global Clinical Development at Regeneron.

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Drug Discovery World

DECEMBER 13, 2023

Anti-idiotype antibodies are critical for the development and validation of antibody-based biologics, CAR therapies including CAR T cells, and VHH. Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

OCTOBER 25, 2020

FDA approval. 28 Abstract Session: New Therapies Real-World Effectiveness of Voxelotor for the Treatment of Sickle Cell Disease: A Chart Review Study Presenter: Kenneth Bridges, M.D., 25, 2019, Oxbryta received U.S. Details of the ASCAT presentations are as follows: Wednesday , Oct. 4 – 7.

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Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. in July 2019, who have recently initiated a Phase 1 study with their formulation.

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The Pharma Data

JUNE 26, 2021

The EC also approved Libtayo in advanced basal cell carcinoma, the first treatment to be indicated for those patients who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). The extensive clinical program for Libtayo is focused on difficult-to-treat cancers.

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The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. EINSTEIN-Jr is the largest pediatric study completed to date for the treatment of VTE.

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The Pharma Data

OCTOBER 26, 2020

Responses were observed in all primary tumor types and across all lines of prior therapy. Responses were observed in all primary tumor types and across all lines of prior therapy. In particular, in the patient with CR, lesions disappearance was accompanied by the development of a strong T-cell response against E6 and E7.

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Codon

MARCH 24, 2024

A 2019 report from RethinkX, an independent research group, states that the “cost to produce a single molecule using [precision fermentation] has fallen from $1 million per kilogram in 2000, to about $100 today.” The real cost is clinical development. Why rock the boat?

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The Pharma Data

OCTOBER 28, 2020

Our R&D Engine continued to advance our Wave 1 pipeline, with 7 new regulatory filings anticipated within the next 12 months, and we expanded our cell therapy capabilities, both of which will help drive Takeda’s future growth. billion cash received for Xiidra® in July 2019. Further de-leveraging in H1 led to a 3.7x

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The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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