The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. (Alume) announced today that it has been awarded a $2.5M

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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The Pharma Data

DECEMBER 13, 2020

As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). billion in 2019 with a CORE EBITDA of CHF 1.6

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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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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Just as the original 1962 efficacy standard makes scientific judgment central to a determination of substantial evidence, the 1997 amendment makes scientific judgment central to a determination of what constitutes sufficient confirmatory evidence to substantiate a single adequate and well-controlled trial.

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The Pharma Data

AUGUST 9, 2021

Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

Science Translational Medicine, 2019 Researchers continue to produce impressive miniature human tissues that resemble the structure of a range of human organs, including the livers, kidneys, hearts, and even the brain. 2019 Jun 19;11(497). [2] 2] Clinical development success rates for investigational drugs.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

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The Pharma Data

DECEMBER 27, 2020

In these unprecedented times, we are especially grateful for the dedication of our research site staff and trial participants, whose commitment to EXCELLENCE facilitated the advancement of our lead program,” said George Yeh, President of TLC. “We SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

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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. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

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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. 2019 May 22;10:1078. She has established a track record as a successful leader and entrepreneur in the biotech industry. Frontiers in Immunology.

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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

JANUARY 3, 2021

InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs, such as TLC19 for the treatment of Coronavirus disease 2019 (COVID-19) as well as other programs for severe acute and chronic pulmonary diseases.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.

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The Pharma Data

OCTOBER 19, 2020

19, 2020 — A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinical trial reports. She is executive medical director of immunology clinical development for the pharmaceutical company AbbVie in North Chicago, Ill.

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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The Pharma Data

MARCH 5, 2021

The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.

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The Pharma Data

NOVEMBER 23, 2020

The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. . .

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The Pharma Data

NOVEMBER 8, 2020

The New Drug Application (NDA) for the drug is based on data from four Phase III trials in pediatric patient populations from the age of 6 to 17 years, two Phase II trials, several Phase I trials, a long-term open label extension study, preclinical testing, and drug manufacturing data. The NDA was resubmitted on May 2020.

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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. 2019 Mar 1;55:93–100. Toxicol Sci.

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AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. 7,8,9,10,11. 12,13,14,15. 12,13,14,15. Saphnelo is under regulatory review for SLE in the EU and Japan.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

DECEMBER 10, 2020

“We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

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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

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In the AG221-C-001 Phase 2 clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. WARNINGS AND PRECAUTIONS.

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The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Ton Berkien joins Ultimovacs with over 15 years of experience in strategic business development and corporate finance in the biopharmaceutical industry.

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The Pharma Data

MARCH 23, 2021

The approval of Vitrakvi in Japan is based on data from 125 patients from the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. Results analyzed from the NAVIGATE trial population showed an overall response rate (ORR) of 65.2% with a complete response (CR) rate of 16.9%

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The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. Spinal Muscular Atrophy (SMA). Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD). Roche will present five sets of data on adults living with NMOSD.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

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The Pharma Data

AUGUST 6, 2020

The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers. Outside of China, BioNTech and its partner Pfizer launched their 30,000-subject phase 3 efficacy trial last week. China has several home-grown COVID-19 vaccines in clinical development.

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The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”

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The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”.

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The Pharma Data

JANUARY 11, 2021

MediciNova intends to use the proceeds received from the private placement primarily for the following three programs: 1) To initiate a new clinical trial of MN-166 (ibudilast) for glioblastoma, which could be a pivotal trial. 3) To initiate a Phase 2 clinical trial of MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH).

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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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