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.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Vaccine 52

Vaccine Trials Virus Treatment 52

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.

Virus 52

Virus Vaccine International Immune Response 52

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].

Vaccine 52

Vaccine Virus Immune Response Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Vaccine 52

Vaccine Trials Immune Response Virus 52

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.

Virus 40

Virus Clinical Trials Government Laboratories 40

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%

Therapies 119

Therapies FDA FDA Approval Treatment 119

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

Virus 40

Virus Trials Clinical Trials Production 40

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?)

Clinical Trials 52

Clinical Trials Trials Small Molecule Treatment 52

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.

Vaccine 52

Vaccine Trials Clinical Trials FDA 52

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.

Nurses 52

Nurses Research Laboratories Laboratories Virus 52

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.

Virus 40

Virus Treatment Science Trials 40

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.

Clinical Trials 40

Clinical Trials Treatment Trials Hospitals 40

The Pharma Data

JANUARY 6, 2021

Process development and quality control will begin in 2021, and full manufacturing capabilities at the 88,000-square-foot facility will be available in 2023. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021. Oncorus’ stock opened at $32.45

Virus 52

Virus FDA Approval Clinical Trials Trials 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

Vaccine 40

Vaccine Trials Clinical Trials Immune Response 40

The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Clinical Research 52

The Pharma Data

SEPTEMBER 5, 2021

Under the agreement, AstraZeneca commits to deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. Legal proceedings by the European Commission against AstraZeneca were initiated in Brussels on 21 April 2021.

Vaccine 52

Vaccine Virus Clinical Trials Trials 52

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. The DMC letter is available here: [link].

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 23, 2020

It is an mRNA vaccine that codes for the virus’s spike protein and is encapsulated in a lipid nanoparticle. Once injected, the cells churn out the spike protein, triggering the body’s immune system to recognize the virus. In Phase III trials, it demonstrated 95% efficacy. Likely EUA Date: Possibly March or April 2021.

Vaccine 52

Vaccine Virus Immune Response Trials 52

The Pharma Data

NOVEMBER 17, 2021

2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. Available at: [link] [Accessed August 2021] 6.

Vaccine 52

Vaccine Clinical Trials Virus Licensing 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — Senhwa Biosciences, Inc. Senhwa’s Silmitasertib is an oral medication, targeting the host protein kinase CK2 (casein kinase 2), where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy. Dr. Recknor’s trial enrolled their first patient on December 3, 2020.

Trials 40

Trials Treatment Small Molecule Hospitals 40

The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

Vaccine 52

Vaccine Virus Trials Regulations 52

The Pharma Data

AUGUST 16, 2021

During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages. Clearance of the virus in the lungs and nasal passages of the animals was tested following challenge infection with the original virus.

Immune Response 52

Immune Response Vaccine Virus RNA 52

The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021. Variant Virus Strains.

Vaccine 40

Vaccine Trials Disease Immune Response 40

The Pharma Data

JULY 28, 2021

There are many reasons that an intranasal vaccine against the SARS-CoV-2 virus would be helpful in the fight against COVID-19 infections, University of Alabama at Birmingham immunologists Fran Lund, Ph.D., Science 23 Jul 2021. and Troy Randall, Ph.D., write in a viewpoint article in the journal Science. Scent of a vaccine.

Vaccine 52

Vaccine Virus Clinical Trials Science 52

The Pharma Data

MAY 17, 2021

The adjuvanted vaccine suffered a serious setback in December when a phase 1/2 trial showed the candidate delivered only a weak response in older adults ( DID , Dec. 2 virus and the variant first identified in South Africa. Preliminary results from that trial are expected in the third quarter ( DID , March 15 ). ? 14, 2020 ).

Vaccine 40

Vaccine Immune Response RNA Virus 40

The Pharma Data

MAY 16, 2021

The Phase 3 trial is expected to enrol more than 35,000 adult participants from a broad range of countries and will assess the efficacy of two vaccine formulations including the D614 (Wuhan) and B.1.351 Pending positive Phase 3 outcomes and regulatory reviews, the vaccine is expected to be approved in the fourth quarter of 2021.

Immune Response 52

Immune Response Vaccine Trials Treatment 52

The Pharma Data

NOVEMBER 23, 2020

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine.

Vaccine 52

Vaccine Virus Trials Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A candidate vaccine, Ad26.COV2.S, 13, 2021 — A candidate vaccine, Ad26.COV2.S, from Janssen Vaccines and Prevention in Leiden, Netherlands, and colleagues conducted a phase 1-2a trial involving healthy adults ages 18 to 55 years (cohort 1) and 65 years or older (cohort 3). © 2021 HealthDay.

Vaccine 52

Vaccine Virus Trials Research 52

The Pharma Data

JANUARY 14, 2021

14, 2021 — Folks who’ve gotten through a COVID-19 infection might naturally question whether they need to get a coronavirus vaccination when their turn comes. “We know it’s safe because a number of people who had COVID were in both the Pfizer and Moderna trials, and in the AstraZeneca trial,” Beyrer said.

Vaccine 52

Vaccine Trials Virus Hospitals 52

The Pharma Data

DECEMBER 3, 2020

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. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

Immune Response 52

Immune Response Vaccine Clinical Trials Virus 52

The Pharma Data

NOVEMBER 9, 2020

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. and globally.”. About NVX-CoV2373. and Australia. billion from the U.S. government.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52