The Pharma Data

OCTOBER 27, 2020

27, 2020 /PRNewswire/ — Mirati Therapeutics, Inc. The offering is expected to close on or about October 30, 2020 , subject to customary closing conditions. SAN DIEGO , Oct. Nasdaq: MRTX) today announced the pricing of an underwritten public offering of 4,335,397 shares of its common stock at a price to the public of $202.00

Small Molecule

The Pharma Data

APRIL 15, 2022

Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow. Each serum was tested simultaneously for its neutralizing titer against recombinant SARS-CoV-2 (with USA-WA-1/2020 genetic backbone) bearing the wild-type SARS-CoV-2 spike protein and theOmicron spike.

Immune Response

Broad Institute

OCTOBER 4, 2023

Cancer immunotherapy drugs called PD-1 inhibitors are widely used to stimulate the immune system to fight cancer, but many patients either don’t respond or develop resistance to them. A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy.

Small Molecule

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. ” Previous clinical trials of the vaccine had found that the vaccine triggers antibody and T-cell immune responses, and is safe in people aged 18 and older. © 2020 HealthDay. Posted: December 2020.

Vaccine

NIH Director's Blog: Drug Development

OCTOBER 27, 2020

Science, 2020 One way to fight COVID-19 is with drugs that directly target SARS-CoV-2, the novel coronavirus that causes the disease. That’s the strategy employed by remdesivir , the only antiviral drug currently authorized by the U.S. Food and Drug Administration to treat COVID-19. Credit: DE Gordon et al.,

Drug Development

The Pharma Data

DECEMBER 16, 2020

16, 2020 (GLOBE NEWSWIRE) — Novavax , Inc. Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. GAITHERSBURG, Md., About Novavax. Novavax, Inc.?(Nasdaq:

Vaccine

The Pharma Data

DECEMBER 28, 2020

29, 2020 /PRNewswire/ — Moleculin Biotech , Inc., 29, 2020 /PRNewswire/ — Moleculin Biotech , Inc., ” The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. .

FDA

The Pharma Data

DECEMBER 18, 2020

18, 2020 — Allergic reactions to vaccines are generally rare and people with common allergies are not more likely to have a reaction to the Pfizer-BioNTech COVID-19 vaccine, according to guidance released by the American College of Allergy, Asthma & Immunology (ACAAI). Food and Drug Administration on Dec. © 2020 HealthDay.

Vaccine

The Pharma Data

MAY 6, 2021

This donation of the vaccine is another tool in our toolbox of measures to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure for all participants and to show solidarity with our gracious Japanese hosts,” said IOC President Thomas Bach. “We This press release features multimedia. View the full release here: [link].

Vaccine

The Pharma Data

DECEMBER 22, 2020

22, 2020 — In very rare cases, some people have had severe allergic reactions after receiving the new COVID-19 vaccines, leading the American College of Allergy , Asthma, and Immunology (ACAAI) to issue updated guidance for Americans with allergies. © 2020 HealthDay. Posted: December 2020. TUESDAY, Dec. Source link.

Vaccine

Drug Target Review

FEBRUARY 28, 2024

These include engineering the cells to express cytokines that promote their maturation and/or differentiation, and engineering drug-resistant γδ T cells that can be combined with chemotherapies, which stress cancer cells but would otherwise also deplete the T-cell population. Cells 9(40):800 (2020). Cell Mol Immunol 17:925-939 (2020).

Therapies

The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. A global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK’s pandemic adjuvant system is expected to begin in December 2020. CHENGDU, China.–(

Vaccine

The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Posted: November 2020. GAITHERSBURG, Md., NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. Source link.

Vaccine

The Pharma Data

NOVEMBER 22, 2020

23, 2020 10:10 UTC. Pandion focuses on the development of innovative modular therapeutics using its TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform. The TALON effector modules are based on immunomodulatory molecules that act as regulatory control points within the immune system.

Immune Response

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. The drug is a first-in-class, off-the-shelf AdenoVerse immunotherapy. In January 2020, it raised $69 million in Series D, bringing the then-total up to $150 million. It filed for a U.S.

Immune Response

The Pharma Data

SEPTEMBER 8, 2021

BTK is an intracellular signaling molecule involved in innate and adaptive immune responses involved in certain immune-mediated diseases. Rilzabrutinib was granted FDA Fast Track Designation for ITP in November 2020 and for pemphigus vulgaris in May 2021. 2020 Apr 9;72(9):1435–46. Arthritis Rheumatol.

Immune Response

The Pharma Data

DECEMBER 10, 2020

11, 2020 02:48 UTC. The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

Vaccine

The Pharma Data

DECEMBER 13, 2020

14, 2020 /PRNewswire/ — Synlogic, Inc. SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response.

Immune Response

The Pharma Data

NOVEMBER 30, 2020

30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Posted: November 2020. GAITHERSBURG, Md., Additional clinical data from the Phase 2 trial conducted in the U.S.

Clinical Development

The Pharma Data

NOVEMBER 9, 2020

10, 2020 06:00 UTC. Combining ICIs with radiation therapy is emerging as a valuable strategy to “prime” an immune response and thereby increase the response rate, however the efficacy of radiation therapy is limited by toxicities related to the exposure of healthy tissues. PARIS & CAMBRIDGE, Mass.–(

Immune Response

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The Pfizer?BioNTech

Vaccine

The Pharma Data

OCTOBER 19, 2020

20, 2020 10:45 UTC. Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. KENILWORTH, N.J.–(

Vaccine

The Pharma Data

JANUARY 19, 2021

On January 19, its investigational new drug (IND) for GC019F, a FasTCAR-enabled CAR-T therapy in relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL) was approved by China’s National Medical Products Administration (NMPA). In January 2020, it raised $69 million in Series D, bringing the then-total up to $150 million.

Small Molecule

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

Vaccine

The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration (FDA) and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today. Likely EUA Date: December 10, 2020. Likely EUA Date: December 10, 2020. As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. Type: mRNA.

Vaccine

The Pharma Data

OCTOBER 21, 2020

22, 2020 (GLOBE NEWSWIRE) — Adicet Bio, Inc. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (??) “We are particularly excited to advance on our goal to exploit the therapeutic potential of our first in class engineered CAR ??

FDA

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? billion doses by the end of 2021. Pfizer Disclosure Notice.

Vaccine

The Pharma Data

AUGUST 20, 2020

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission. The information contained in this release is as of August 20, 2020.

Vaccine

The Pharma Data

SEPTEMBER 9, 2020

The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.

Vaccine

The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. Gilead Forward-Looking Statements. Securities and Exchange Commission.

Vaccine

The Pharma Data

DECEMBER 11, 2020

Friday, December 11, 2020. Government to supply doses in 2020 & 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. immediately. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccine

The Pharma Data

OCTOBER 25, 2020

26, 2020 11:00 UTC. The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. CAMBRIDGE, Mass.–(

Vaccine

The Pharma Data

OCTOBER 20, 2020

21, 2020 /PRNewswire/ — Moleculin Biotech , Inc., That presentation included findings from preliminary animal studies demonstrating that Moleculin’s drug candidate Annamycin, a more potent and non-cardiotoxic anthracycline, was capable of accumulating in the lungs of mice at up to 6-fold higher concentrations than doxorubicin.

Clinical Trials

The Pharma Data

DECEMBER 15, 2020

Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. In late 2020, the effort received $200,000 in seed funding from the Baker Department of Cardiometabolic Health at the University of Melbourne’s medical school. Antigen-Specific Drugs.

Disease

The Pharma Data

NOVEMBER 10, 2020

Recently, Tiziana announced positive results from its Phase 1 study showing that oral treatment with Foralumab was well-tolerated in healthy volunteers, with no drug-related safety issues even at the highest dose of 5 mg 2. Tiziana Life Sciences January 9, 2020 Press Release ( [link] ). Billion by 2025. NEW YORK and LONDON, Nov.

Clinical Trials

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication. CHATHAM, N.J.,

Vaccine

The Pharma Data

OCTOBER 28, 2020

28, 2020 /PRNewswire/ — . “The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. . TARRYTOWN, N.Y. , combined dose groups; 6.5%

Virus