The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization in all infants. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results.

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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

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

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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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. Nature 578 , 229-236 (2020). Nature Reviews Genetics 21 , 255-272 (2020).

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The Pharma Data

DECEMBER 8, 2020

8 December 2020 — Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.

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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 20, 2020

BT-001 is a best-in-class oncolytic Vaccinia virus. platform and its patented large-capacity VV cop TK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR ® /F.I.R.S.T LUND, Sweden and STRASBOURG, France , Dec.

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The Pharma Data

JANUARY 18, 2021

This announcement follows the approval received in December 2020 from the Belgian health authorities. This announcement follows the approval received in December 2020 from the Belgian health authorities. The first patient is expected to be enrolled in this trial in the upcoming weeks. BT-001 is based on the patented Invir.IO

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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

DECEMBER 31, 2020

Monthly News Roundup – December 2020. The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. 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. Posted: December 2020. .

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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

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

DECEMBER 23, 2020

23, 2020 — Because COVID-19 is known to raise the odds for dangerous blood clots, blood thinners have quickly become part of routine care for many hospitalized patients. The three trials are being conducted on four continents. © 2020 HealthDay. WEDNESDAY, Dec.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. 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.” SAN JOSE, Calif. , AR-711 (COVID-19). AR-201 (RSV infection). AR-201 (RSV infection).

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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The Pharma Data

MARCH 22, 2021

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.

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The Pharma Data

MARCH 3, 2021

(Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial.

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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?) CAMBRIDGE, Mass.–(BUSINESS

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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

NOVEMBER 2, 2020

GWACHEON, KOREA, November 02, 2020 /24-7PressRelease/ — The trial of Shincheonji Church of Jesus Chairman Man Hee Lee continued on October 21st as the court discussed the alleged violation of the Infectious Disease Prevention Act earlier this year. More trials of Chairman Lee are currently underway. # # #.

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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. It could also be given to immunocompromised patients for whom the vaccination isn’t indicated. BARCELONA, Spain , Jan.

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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. Expected to enroll 415 participants; interim results expected in Q3 2021.

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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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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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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

NOVEMBER 16, 2020

17, 2020 11:00 UTC. has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial.

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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].

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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. In particular, two COVID-19 pneumonia patients administered at Seoul National University Hospital became virus-free within 10 days by administering hzVSF-v13 twice or three times.

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NIH Director's Blog: Drug Development

MARCH 18, 2021

With support from a 2020 NIH Director’s Pioneer Award, Veesler will study members of the order Chiroptera. These days, the Veesler lab has been hard at work to understand SARS-CoV-2 and the human immune response to the virus. Or, more colloquially, bats. Veesler says bats are remarkable creatures.

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The Pharma Data

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “It

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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The Pharma Data

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

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The Pharma Data

JANUARY 6, 2021

The announcement, following a $98 million IPO in October 2020, comes as the company advances several programs through its pipeline. 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 Monday, up $0.28

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The Pharma Data

JULY 21, 2021

(NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.

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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. Posted: December 2020.

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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), 2020) Dosage regimens for and compositions including anti-rsv antibodies. 2020/0347120 A1).

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