The Pharma Data

MARCH 8, 2021

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

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The Pharma Data

AUGUST 16, 2021

Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus. In the U.S.,

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Monitor patients for TB during Olumiant treatment.

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Drug Target Review

JULY 19, 2023

Translating these insights into a licensed vaccine (RTS,S, made by GlaxoSmithKline) took nearly five decades – a glacial pace compared to the recent COVID-19 vaccines. Essentially, Lumen’s antigen design is very similar to RTS,S and R21: a virus-like particle that presents the NANP repeat antigen to the host immune system.

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The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. MUNICH, Germany, Jan.

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The Pharma Data

SEPTEMBER 1, 2021

Data from the study is expected in the second half of 2021. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Wayne and Wendy Holman and Merck. MOVe-AHEAD Study. About Molnupiravir. in collaboration with Ridgeback Biotherapeutics. About Ridgeback Biotherapeutics.

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The Pharma Data

MARCH 11, 2021

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. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. About the Phase 1/2 clinical trial. About Translate Bio.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. In June 2021, uniQure provided another regulatory update , announcing that FDA was requiring a demonstration of “durability of effect” based on data from patients followed for at least 52 weeks after FIX levels achieve steady state, which occurs by 26 weeks.

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The Pharma Data

APRIL 27, 2021

All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.

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The Pharma Data

JULY 12, 2021

In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. Since licensed by Ridgeback, all funds used for the development of EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and Merck. This press release features multimedia.

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. We will disclose the Fiscal Year 2022 forecast at the Fiscal Year 2021 financial results announcement scheduled in May 2022. TAK-019 Clinical Trial. ml dose of TAK-019 at both vaccinations.

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The Pharma Data

MARCH 25, 2022

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(10) and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function. 2-4 Evusheld was generally well-tolerated in the trial.(2-4).

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Agency IQ

JANUARY 19, 2024

This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The rate of negative opinions over the last three years has remained relatively stable, with three each in 2023 and 2022 and five in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

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The Pharma Data

OCTOBER 25, 2020

The UK government’s COVID-19 Vaccine Taskforce and a contract research company called Open Orphan announced a $13 million (£10 million) plan to test investigational COVID-19 vaccines in volunteers who are then intentionally exposed to SARS-CoV-2, the virus that causes COVID-19. They will require regulatory and ethical approval.

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The Pharma Data

MAY 13, 2021

Posted 13 May 2021 | By Michael Mezher . Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection ( FDA ). In Focus: US. Medtech.

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The Pharma Data

MARCH 22, 2021

Basel, 23 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). .” As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work.

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The Pharma Data

JANUARY 13, 2021

GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. We are developing the manufacturing processes for TNX-1500 and expect Good Manufacturing Practice (GMP) TNX-1500 to be available in the third quarter of 2021.

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The Pharma Data

JANUARY 5, 2021

5, 2021 — In late December, Dr. Ada Stewart asked her staff to check on a patient who had missed an appointment. Besides giving telemedicine a boost, the pandemic has also fostered the rise of innovative medical services, everything from getting prescriptions by mail to drive-through virus testing and pharmacy-based vaccinations.

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The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 6, 2021. This press release features multimedia. View the full release here: [link]. Pfizer Disclosure Notice.

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The Pharma Data

JULY 21, 2021

Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer Disclosure Notice.

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.

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The Pharma Data

FEBRUARY 12, 2022

Early in 2021, prior to the identification of the Omicron variant, Lilly scientists were already working to develop bebtelovimab as a broadly neutralizing antibody that could be used to fight a highly mutated variant, should one emerge,” said Daniel Skovronsky, M.D.,

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The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. VANCOUVER, Jan. For further information please visit www.abetterlifepharma.com.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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The Pharma Data

APRIL 6, 2021

The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021. ” This extension does not affect Lilly’s previously-issued financial guidance for 2021. . ” This extension does not affect Lilly’s previously-issued financial guidance for 2021.

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The Pharma Data

MARCH 2, 2021

It is licensed for commercial use by Ecología y Protección Agricola (EPA) in Valencia and provides 400 days of pest control. The launch of Vynyty Citrus ® at this year’s SHE2021 event coincides with 2021 being designated as the International Year of Fruits and Vegetables by the United Nations.

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The Pharma Data

DECEMBER 19, 2020

Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. Under Operation Warp Speed, the U.S. W911QY-20-C-0100.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

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The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. In the U.S.,

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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The Pharma Data

JANUARY 12, 2021

12, 2021 /PRNewswire/ — . Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. .

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Drug Discovery World

SEPTEMBER 6, 2022

Unsurprisingly, oncology remains the biggest focus for cell and gene therapy developers, accounting for 52% of clinical activity in 2021, according to ARM’s Regenerative Medicine: Disrupting the Status Quo report. Cancer is king . New indications . Carlo Russo, CEO of Genenta.? . Workforce .

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The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. In the U.S.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. LONDON and BOSTON, Jan. LONDON and BOSTON, Jan.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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