The Pharma Data

NOVEMBER 18, 2020

Food and Drug Administration on Tuesday. “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. WEDNESDAY, Nov. Meanwhile, Moderna Inc.

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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

NOVEMBER 9, 2021

million fresh courses of molnupiravir, an investigational oral antiviral drug, if the drug is granted Exigency Use Authorization (EUA) or blessing by theU.S. Food and Drug Administration (FDA), for roughly$ 1 billion. With these exercised options, theU.S. government has now committed to buy a aggregate of roughly3.1

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The Pharma Data

APRIL 20, 2022

Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). director of the FDA’s Center for Devices and Radiological Health.

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Delveinsight

SEPTEMBER 2, 2021

On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques. Helius Medical Technologies, Inc.

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The Pharma Data

NOVEMBER 12, 2021

Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S.

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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. Food & Drug Administration to begin testing this agent in human clinical trials. ” ###.

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The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Food and Drug Administration. .

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Delveinsight

DECEMBER 10, 2020

AstraZeneca’s COVID-19 vaccine data suggest single-dose efficacy. The full data from late-phase trials of AstraZeneca’s COVID-19 vaccine have pointed to the potential for AZD1222 to work after a single dose and limit asymptomatic cases; however, missed main questions regarding the efficacy of the candidate.

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Drug Discovery World

APRIL 16, 2023

DDW’s Megan Thomas rounds up highlights from Sunday 16 April at AACR 2023, from promising trial results for a personalised mRNA-based cancer vaccine to winners of lifetime achievement awards. The post Sunday 16 April at AACR Annual Meeting 2023 appeared first on Drug Discovery World (DDW). Read more about AACR award winners here.

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Pfizer Inc. announced that the U.S.

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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. Source link: [link].

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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. Food and Drug Administration this week. COVID Vaccines Move Closer to Emergency Use Approval. The vaccine’s efficacy was consistent across age, race and ethnicity, the companies said.

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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. Financial considerations.

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The Pharma Data

NOVEMBER 17, 2020

Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. director of FDA’s Center for Devices and Radiological Health. Food and Drug Administration. SILVER SPRING, Md. , .

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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

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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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

OCTOBER 6, 2021

AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Juncture Use Authorization (EUA) for AZD7442, its long- production antibody (LAAB) combination, for prophylaxis of proper COVID-19. Notwithstanding, AZD7442 would be the first LAAB to take an EUA for COVID-19 precluding, If granted. AZD7442 was well- let.

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Antibody In-Vitro Trials Vaccination 52

The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

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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 ). Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). In Focus: US.

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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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