The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% Senior Vice President and Head of Global Clinical Development at Regeneron. There was a 1.08

Virus

The Pharma Data

OCTOBER 26, 2020

Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET. AR-301 (VAP).

Pharmaceuticals

The Pharma Data

JANUARY 31, 2021

No serious adverse events related to the vaccine candidates studied were reported. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” The candidate vaccines were given in two doses, three weeks apart. For more information, visit www.dynavax.com.

Clinical Trials

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.

Vaccine

The Pharma Data

OCTOBER 15, 2020

. ASLAN appoints neurologist Professor Gavin Giovannoni as a scientific advisorto establish clinical development strategy in multiple sclerosis. Following an internal strategic review and noting changes in the AML treatment landscape, ASLAN will be focusing the future development of ASLAN003 in autoimmune disease.

Pharmaceuticals

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.” In the initial 275 patients, rates of adverse events (AEs) were similar among groups.

Hospitals

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Source link.

Clinical Trials

The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Hospitals

The Pharma Data

JANUARY 3, 2021

With the COVID-19 pandemic this year redacting the world into a state of panic, TLC aspired to make a difference, and investigated the idea of encapsulating hydroxychloroquine, which has shown antiviral effects toward the SARS-CoV-2 virus, into TLC’s proprietary liposome formulation, using only ~1% of the oral dosage needed. Source link.

Clinical Trials

The Pharma Data

JANUARY 27, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of patients with Frontotemporal Dementia (FTD) with granulin (GRN) mutations. chief executive officer of Passage Bio. “FTD

Therapies

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. LONDON and BOSTON, Jan.

Science

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800.

Vaccine

The Pharma Data

APRIL 26, 2022

No vaccine-related serious adverse events (SAEs) were observed. About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. The safety and tolerability profile observed in the 5- to 17-year age group was similar to the previously reported profile in adult participants.

Vaccine

The Pharma Data

AUGUST 20, 2020

“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U.

Vaccine

The Pharma Data

MAY 7, 2021

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine. anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

Licensing

The Pharma Data

JULY 21, 2021

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at [link].

Vaccine

The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

Vaccine

The Pharma Data

MAY 6, 2021

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

Vaccine

The Pharma Data

NOVEMBER 19, 2020

We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sosei Heptares has successfully designed three distinct series of compounds with attractive anti-viral drug-like properties and advanced the most promising molecules. Source link.

Small Molecule

The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. The study is an event-driven trial. Argentina and Brazil.

Vaccine

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). All forward-looking statements in this press release are qualified by these cautionary statements.

Licensing

The Pharma Data

DECEMBER 5, 2020

The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production

The Pharma Data

DECEMBER 11, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine.

Vaccine

Drug Target Review

JANUARY 15, 2024

Gaining access inside cells Fortunately, evolution has provided a mechanism, found in all higher vertebrates, for the immune system to monitor intracellular events. Previously, as a member of the faculty at Harvard Medical School , Dr Kavanagh was engaged in preclinical and clinical development of cellular immunotherapy and products.

Engineering

The Pharma Data

JANUARY 20, 2021

The CEC comprises clinical experts in cardiology and Intensive Care and has been established to ensure accurate and consistent assessment of the trial endpoints and/or serious adverse events. In order to ensure an unbiased endpoint assessment, members of the CEC are blinded to treatment assignment. Cardiol Therapeutics Inc. (

Hospitals

The Pharma Data

DECEMBER 27, 2020

XGEVA has also received conditional approval in China for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM), which was not eligible for 2020 NRDL considerations as it was approved after the cutoff date. In pre-clinical studies, binding to Fc?

Production

The Pharma Data

JULY 29, 2021

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Gilead presented additional lenacapavir clinical development program data at the International AIDS Society (“IAS”) 2021 Conference on HIV Science.

Science

The Pharma Data

DECEMBER 10, 2020

The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days. Rates of serious adverse events were similar between vaccine and placebo groups (0.6% kg/m2); and 21% had at least one underlying comorbidity.

Vaccine

The Pharma Data

OCTOBER 27, 2020

As part of those efforts, it has become increasingly clear that to tackle the pandemic at a global level the development of medicines that can prevent and treat the virus, in addition to the development of vaccines, will be crucial. During the clinical development stage, Molecular Partners will provide clinical supply.

Therapies

The Pharma Data

NOVEMBER 1, 2020

Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs,” stated Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

Clinical Trials

The Pharma Data

DECEMBER 29, 2020

It is important to remember that while the virology results from this analysis of hospitalized patients were robust, the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage. Senior Vice President and Head of Global Clinical Development at Regeneron. low dose, 1.4%

Hospitals

The Pharma Data

APRIL 22, 2023

It involves taking a patient’s own white blood cells, called T-cells, and modifying them so they can identify and target HIV cells to control the virus without medication. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

Clinical Trials

The Pharma Data

NOVEMBER 29, 2020

Three cases of human leukocyte antigen (HLA)-sensitization have been reported, two as serious adverse events. An archived replay will be accessible for 30 days following the event. 3 The majority of CMV infections are not serious, and the virus can lay dormant in the body for years. 1 Gilbert C and Boivin G.

Vaccine

The Premier Consulting Blog

JUNE 18, 2023

This reflects the FDA’s long history of reviewing submissions that implement CM&S across a broad range of areas, including quantitative clinical pharmacology, dose-response modeling, benefit-risk assessment, complex innovative designs and disease modeling/trial simulation.

Drug Development

The Pharma Data

JANUARY 3, 2021

Dr. Kimble Matos, the lead coordinating physician of the study, commented: “The observations made during the Clinical study did not show any adverse events.”. The clinical study enrolled a total of 39 patients with moderate to severe COVID-19 who did not require the use of a ventilator at the beginning of the study.

Clinical Trials

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. CDC, Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. Source: Moderna, Inc. .

Vaccine

The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production