The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. The interim findings are from phase 3 trials in the United Kingdom and Brazil that included more than 11,600 participants. © 2020 HealthDay. © 2020 HealthDay. Posted: December 2020.

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

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The Pharma Data

DECEMBER 11, 2020

The Australian government has scrapped a supply deal with CSL for 51 million doses of its COVID-19 vaccine co-developed with the University of Queensland, after trial participants falsely tested positive for HIV. Source link.

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DrugBank

JULY 18, 2024

Adjuvants are substances added to vaccines to enhance the immune response. They work by decreasing the solubility of the vaccine, which sustains the release of the drug and prolongs the immune response. Even after a vaccine is approved and distributed, the pharmaceutical industry's responsibility does not end.

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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) variants, as well as the original SARS-CoV-2 strain (WA1/2020). Additional follow-up with trial participants is currently underway.

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The Pharma Data

DECEMBER 23, 2020

24, 2020 07:00 UTC. In the context of a substantial amount of COVID-19-related research and the launch of numerous clinical trials, the French government created this steering committee to prioritize and accelerate high potential clinical trials. This Phase IIa trial follows a preliminary study conducted by Prof.

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The Pharma Data

DECEMBER 12, 2020

Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. to vaccinate on demand.

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The Pharma Data

NOVEMBER 3, 2020

Bristol Myers Squibb (BMS) has reported positive results from a late-stage trial of its investigational drug, BMS-986165 (deucravacitinib), for treating moderate-to-severe plaque psoriasis. Deucravacitinib works by inhibiting the tyrosine kinase 2 (TYK2) enzyme, which is linked to an immune response that causes skin inflammation.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon. Source link.

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The Pharma Data

NOVEMBER 18, 2020

19, 2020 /PRNewswire/ — OBI Pharma, Inc. “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.” TAIPEI, Taiwan , Nov.

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The Pharma Data

NOVEMBER 16, 2020

Johnson & Johnson (J&J) has begun the second part of its global phase 3 trial evaluating its COVID-19 vaccine candidate JNJ-78436735. Interim data from an early-stage trial indicated JNJ-78436735 delivered an immune response and was well-tolerated. Jason Scott.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon.

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The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.

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The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

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The Pharma Data

DECEMBER 31, 2020

Monthly News Roundup – December 2020. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In the Phase 3 APeX-2 trial , Orladeyo significantly reduced attacks at 24 weeks and sustained reduction through 48 weeks.

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The Pharma Data

JANUARY 25, 2021

In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Initial efficacy data are anticipated in the first quarter and the phase 2/3 trials are expected to wrap up in May.

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The Pharma Data

DECEMBER 7, 2020

7, 2020 — Scientists say they may be getting closer to creating a universal flu vaccine. In an early-stage clinical trial with 65 volunteers in the United States, an experimental vaccine triggered strong immune responses to a wide range of flu virus strains and subtypes. © 2020 HealthDay. MONDAY, Dec.

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The Pharma Data

SEPTEMBER 2, 2021

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. The results of the study enabled Pfizer to proceed to Phase 3.

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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

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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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.

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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., and Australia. About Matrix-M. About Novavax.

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The Pharma Data

NOVEMBER 24, 2020

AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose.

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Drug Target Review

OCTOBER 26, 2023

9 In addition, host immune responses further add to the complexity of developing cell-specific AAV capsids for clinical applications. It has been well established that exposure to wild-type AAV results in priming of the immune system against the virus. Nature 578 , 229-236 (2020). References Doudna JA. Ylä-Herttuala S.

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The Pharma Data

NOVEMBER 18, 2020

The Pfizer/BioNTech trial will continue to collect efficacy and safety data from participants for two years, but the vaccine appears safe so far, raising no serious safety concerns. The only notable adverse events were fatigue and headache in a small percentage of participants, 3.8 and 2 percent respectively, the companies said.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020 — Scientists are reporting early success with an experimental herpes vaccine that uses a genetically modified version of the virus. The gene edit prevents the virus from performing its normal evasive maneuver: hiding out in nervous system cells in order to elude the immune system. © 2020 HealthDay. MONDAY, Nov.

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The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above. Results of the Phase 2 trial will inform the Phase 3 protocol. About the Phase 2 study.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

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The Pharma Data

OCTOBER 16, 2020

12 to 16, 2020. 16, 2020 — A case of reinfection with severe acute respiratory syndrome coronavirus 2 is described in a study published online Oct. 14, 2020 — Enrollment in a study testing an experimental antibody therapy against COVID-19 has been paused by independent monitors. FRIDAY, Oct. THURSDAY, Oct.

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The Pharma Data

OCTOBER 21, 2020

22, 2020 (GLOBE NEWSWIRE) — Replimune Group, Inc. The offering is expected to close on October 26, 2020, subject to the satisfaction of customary closing conditions. BOSTON, Oct. Morgan Securities LLC, SVB Leerink LLC and Barclays Capital Inc. are acting as joint book-running managers for the offering.

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Creative Biolabs

JULY 12, 2020

Professor Florian Klein, the paper’s corresponding author, explained, “our goal is to better understand the immune response to SARS-CoV-2 and to identify highly potent antibodies that can be used to prevent and treat COVID-19.” They are expected to enter clinical development later this year.

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The Pharma Data

JANUARY 22, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. 24, 2020 ). Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.”.

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The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. CHENGDU, China.–(

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The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. GAITHERSBURG, Md., and globally.”. About NVX-CoV2373.

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