The Pharma Data

MARCH 24, 2021

76% vaccine efficacy against symptomatic COVID-19. Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021. 100% efficacy against severe or critical disease and hospitalisation.

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The Pharma Data

MARCH 22, 2021

79% vaccine efficacy at preventing symptomatic COVID-19. 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.

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pharmaphorum

OCTOBER 5, 2022

Furthermore, VIR-2482 could have the potential to overcome the limitations of current flu vaccines and result in higher levels of protection, given it does not rely on an individual to create their own protective antibody response.

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The Pharma Data

DECEMBER 23, 2020

” Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” . PLYMOUTH MEETING, Pa. , The participants were enrolled into 1.0

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The Pharma Data

NOVEMBER 18, 2020

. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. ” COVID Vaccines Move Closer to Emergency Use Approval. Meanwhile, Moderna Inc.

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The Pharma Data

NOVEMBER 20, 2020

Though talk of two highly effective vaccines came this week, they will not be widely available until spring of 2021. COVID Vaccines Move Closer to Emergency Use Approval. Pfizer and the German firm BioNTech announced Thursday that their vaccine is 95 percent effective and they will apply for emergency use approval Friday.

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The Pharma Data

MARCH 25, 2022

People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld. This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). W911QY-21-9-0001.

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The Pharma Data

MARCH 29, 2022

Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure.”. 1 It is also authorised for use and being supplied in several other countries around the world.

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The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

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The Pharma Data

JUNE 26, 2021

All current COVID-19 vaccines and antibody-based therapeutics were designed to disrupt this route into cells, which requires a receptor called ACE2. The ability to use an alternative entry pathway opens up the possibility of evading COVID-19 antibodies or vaccines, but the researchers did not find evidence of such evasion.

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XTalks

MARCH 10, 2021

Along with COVID-19 vaccine authorizations, the US Food and Drug Administration (FDA) remains committed to increasing access to COVID-19 tests and supporting their development, having authorized three new tests recently for emergency use. The products encompass molecular, antigen and T cell-based testing approaches.

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The Pharma Data

MARCH 16, 2021

Pascal Soriot, Chief Executive Officer, said: “The long-acting antibody combination has the potential to offer almost immediate protection to those who are not able to be vaccinated, to both prevent infection or treat the disease in patients already infected with the virus.

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The Pharma Data

NOVEMBER 18, 2021

About 2 of the global population is considered at increased threat of an shy response to a COVID-19 vaccine.1 Importantly, six months of protection was maintained despite the swell of the Delta variant among these high- threat actors who may not respond adequately to vaccination.”. W911QY-21-9-0001.

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The Pharma Data

APRIL 15, 2022

director of the FDA’s Center for Devices and Radiological Health. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. for the next public health emergency.”.

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The Pharma Data

DECEMBER 23, 2020

At this time there does not appear to be evidence that the mutations are enough for the viruses to dodge the currently authorized vaccines by Pfizer-BioNTech and Moderna, which focus on parts of the S protein. It is also the primary focus of the vaccines developed by Pfizer-BioNTech and Moderna and other companies.

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The Pharma Data

NOVEMBER 9, 2021

government has chosen to buy further than 3 million courses of molnupiravir, our promising oral antiviral, so that molnupiravir, if authorized, will be among the vaccines and drugs available to fight COVID-19 as part of our collaborative sweats to bring this epidemic to an end. We ’re recognized that theU.S.

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The Pharma Data

JUNE 25, 2021

While COVID-19 vaccination efforts have been successful, there is still a significant need for prevention and treatment options for certain populations, including those unable to be vaccinated or those who may have an inadequate response to vaccination.”. The PROVENT trial will give us more clarity in this patient population.

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Bioengineer

JULY 15, 2021

“Treating with low-dose radiotherapy and immunotherapy eradicated their cancer, and it also acted as a sort of anti-cancer vaccine, preventing the mice from getting this type of cancer again,” Patel said. In addition to the mouse studies, the physician-scientists worked together with David Vail, D.V.M.,

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The Pharma Data

APRIL 20, 2022

director of the FDA’s Center for Devices and Radiological Health. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA, an agency within the U.S.

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The Pharma Data

NOVEMBER 17, 2020

director of FDA’s Center for Devices and Radiological Health. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. . .

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Delveinsight

SEPTEMBER 2, 2021

New mandates from governments and businesses specify the need for periodic testing for those who cannot or chose not to be vaccinated. The BD Veritor At-Home COVID-19 Test is an easy-to-use test with definitive digital results, ideal for use in the home, as said by Dave Hickey, president of Life Sciences for BD.

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The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of mortal and veterinary medicines, vaccines and other natural products for mortal use, and medical bias. The FDA, an agency within theU.S.

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The Pharma Data

NOVEMBER 6, 2020

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. The FDA, an agency within the U.S. .

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The Pharma Data

APRIL 7, 2023

The primary endpoint is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives will evaluate additional efficacy endpoints and safety. Targeting components of this pathway could potentially inhibit unchecked tumor growth and proliferation caused by BRAF mutations.(5)

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The Pharma Data

APRIL 17, 2021

Biogen currently has more than 25 MS clinical trials underway including research on considerations around COVID-19 vaccination for people with MS. No Difference in Radiologic Outcomes for Natalizumab Patients on Extended Interval Dosing Compared with Standard Interval Dosing in MS PATHS – P15.210.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Paul Sax, clinical director of infectious diseases at the Brigham and Women’s Hospital, shared an analysis on nirmatrelvir and ritonavir (NMV-r, Paxlovid Rx) in high-risk vaccinated outpatients showing a strong link between treatment and improved outcomes. Experts have stated that under-vaccination is the reason behind the surge in polio.

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The Pharma Data

OCTOBER 6, 2021

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said” Vulnerable populations suchlike as the immunocompromised hourly are n’t suitable to mount a self-protective response following vaccination and continue to be at trouble of developing COVID-19. AZD7442 was well- let. W911QY-21-9-0001.

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The Pharma Data

FEBRUARY 23, 2022

director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, Ph.D.,

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine. The price of that prize is incalculable.

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The Pharma Data

MAY 3, 2021

Feds rethink vaccination strategy as slowing demand reveals stark divide ( Politico ). US to launch trade talks on COVID-19 vaccine distribution ( AP ) ( CNBC ). Next Generation of Covid-19 Vaccines Could Be Pill or Spray ( WSJ ). In Focus: US. In Focus: International.

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FDA Law Blog

NOVEMBER 18, 2024

Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023. He has equated vaccination to the Holocaust and argued that COVID-19 was “ethnically targeted” to spare Ashkenazi Jews and the Chinese.

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