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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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

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The Pharma Data

AUGUST 13, 2020

With most vaccine trials ending in failure, the government is effectively hedging its bets, hoping that at least one of the vaccines it has purchased proves safe and effective. Inactivated whole virus vaccines: 60 million doses Valneva. In theory, there should be enough for everyone in the UK to get five doses.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19.

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The Pharma Data

JANUARY 27, 2021

COVID-19 Antibody Treatments Exceed Expectations in Early Trials. 27, 2021 — Promising new data on two antibody cocktails suggest these therapies can keep COVID-19 patients out of the hospital and even prevent illness altogether in some people. All tested negative for the virus but live with someone who has COVID-19.

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The Pharma Data

MARCH 3, 2022

Pfizer will publish outcomes from this clinical trial at a future date. If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus. Pfizer Inc. 8,9 For older adults in the U.S.,

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced. The trial on 10,000 people will now see if the vaccine can prevent people getting ill.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination. TAK-919 clinical trial. TAK-019 clinical trial.

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The Pharma Data

JANUARY 18, 2021

19, 2021 06:30 UTC. The first patient is expected to be enrolled in this trial in the upcoming weeks. BT-001 IS AN ONCOLYTIC VIRUS GENERATED WITH TRANSGENE’S INNOVATIVE INVIR.IO generated oncolytic virus candidate to enter clinical development” said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

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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. Respiratory syncytial virus (RSV) is a common and pervasive cause of acute respiratory illness. Burden of RSV.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. JUNE 22 , 2021. 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.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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The Pharma Data

SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September. Photo by Retha Ferguson.

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The Pharma Data

JANUARY 17, 2021

The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P, 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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The Pharma Data

NOVEMBER 27, 2020

UK firm develops solution for identifying whether patients are actually infectious from a virus or not. Iceni Diagnostics has revealed it is developing a new technology that can disclose if patients are actually infectious with a live virus or not. Read on to for the full insight.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. 2021 Apr 8:2021.04.08.438884. Although the first vaccines to receive Emergency Use Authorization by the U.S. bioRxiv [Preprint]. doi: 10.1101/2021.04.08.438884. Source link: [link].

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The Pharma Data

JANUARY 26, 2021

In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine.

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The Pharma Data

DECEMBER 8, 2020

The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University. We are hugely grateful to our trial volunteers for working with us over the past eight months to bring us to this milestone.”.

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Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. It has been well established that exposure to wild-type AAV results in priming of the immune system against the virus. Adeno-associated virus vector as a platform for gene therapy delivery.

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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. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. About Translate Bio.

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The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. billion EUR, up 5.8

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The Pharma Data

JUNE 25, 2021

The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.” More than half of the cases (57%) were caused by Variants of Concern.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — OyaGen, Inc. A Novel Ebola Virus VP40 Matrix Protein-Based Screening for Identification of Novel Candidate Medical Countermeasures.’ ’ (2021) Viruses 13:52 [link]. These findings are consistent with human clinical trials that showed that the OYA1 is safe and well tolerated in humans.

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The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Again, this was despite the fact that subjects in the trial had demonstrated durable FIX activity to this point, with a mean of 41.5%

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The Pharma Data

DECEMBER 5, 2020

.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)

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The Pharma Data

MARCH 18, 2021

Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. “We Food and Drug Administration (FDA) on 17 February 2021. Two doses of 3.75?g g of CoVLP are administered 21 days apart.

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DrugBank

JULY 18, 2024

For instance, the influenza virus is notorious for its ability to undergo antigenic drift, accumulating mutations in its surface proteins that can render existing vaccines less effective.  It commences with preclinical studies in animal models to assess safety and immunogenicity, followed by three phases of human clinical trials.

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New Drug Approvals

DECEMBER 26, 2022

1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03 Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897.gamma.1-chain), 2] [3] Nirsevimab is designed to bind to the fusion protein on the surface of the RSV virus. [4]

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The Pharma Data

JANUARY 21, 2021

Eli Lilly reported yesterday that its monoclonal antibody bamlanivimab (LY-CoV555) significantly lessened the risk of contracting COVID-19 among nursing home residents and staff, according to findings from a phase 3 trial.

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The Pharma Data

MARCH 2, 2021

(Nasdaq: GILD) today announced the upcoming presentation of new data from the company’s HIV, hepatitis C virus (HCV), and COVID-19 research and development programs at the 28th Conference on Retroviruses and Opportunistic Infections ( virtual CROI 2021) taking place from March 6-10. HIV Research. COVID-19 Research.

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The Pharma Data

DECEMBER 20, 2020

Followed by Russia , Indonesia, and Korea, the second phase of the COVID-19 clinical trial was approved in Italy on Friday, December 18, 2020. Currently, it is smoothly progressing with the approval for Phase 2 clinical trials in four countries, and it is expected to see the results sequentially starting as early as the third quarter of 2021.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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