The Pharma Data

MAY 4, 2021

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS. Tue, 05/04/2021 – 06:45. Tuesday, May 04, 2021 – 06:45am. <!–*/. First-Quarter 2021 Revenues of $14.6 First-Quarter 2021 Reported Diluted EPS (1) of $0.86, Adjusted Diluted EPS (2) of $0.93. Anonymous (not verified). –*/. <!–*/.q4default.bwalignc

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

Vaccine 52

Vaccine Production FDA Disease 52

The Pharma Data

MARCH 16, 2021

It included the option to acquire additional doses in 2021. The Company also has a separate agreement to supply the DoD with 100,000 doses, bringing potential US supplies of AZD7442 to 700,000 in 2021. The combination of LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus and its variants.

Treatment 52

Treatment Virus Trials Government 52

The Pharma Data

NOVEMBER 17, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. Data on File Number: REF-131228, 10 November, 2021. Available at: [link] [Accessed August 2021] 6.

Vaccine 52

Vaccine Clinical Trials Virus Licensing 52

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. About TicoVac (TBE vaccine, whole virus inactivated). This release contains forward?

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

AUGUST 22, 2021

AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. 2021 [link]. 2021.02.037.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

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.,

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

SEPTEMBER 30, 2021

That’s how easy it’s for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. As prior work with other respiratory pathogens like influenza has shown, sterilizing immunity to virus re-infection requires adaptive immune responses within the tract and therefore the lung. Breathe in, exhale. doi: 10.1016/j.isci.2021.103037.

Vaccine 52

Vaccine Disease Immune Response Virus 52

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.

Trials 52

Trials Virus Long-Term Care Facilities Government 52

The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. © 2021 Sorrento Therapeutics, Inc. SAN DIEGO, Jan.

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

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.

Therapies 52

Therapies Virus Disease Licensing 52

The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. 2021 group guidance³ confirmed, noting Sandoz sales expected to decline low to mid single digit. Net income declined -7% (cc, -5% USD) , mainly due to lower operating income. Free cash flow¹ of USD 1.6 Operating income.

Production 40

Production Licensing Licensing Clinical Trials 40

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Laboratories 52

Laboratories Clinical Trials Virus Trials 52

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.

Virus 40

Virus Trials Clinical Trials Production 40

Agency IQ

MARCH 7, 2024

BY AMANDA CONTI | MAR 6, 2024 8:46 PM CST AgencyIQ’s quick primer on the influenza virus and how annual vaccine strains are selected Influenza viruses have caused untold illness and death through human history. A key part of the influenza virus’ ability to infect humans is hemagglutinin (HA), a glycoprotein found on the surface of the virus.

Vaccine 40

Vaccine FDA Virus Licensing 40

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.

Licensing 40

Licensing Licensing Therapies Laboratories 40

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

FEBRUARY 14, 2022

For most of 2021, limited global vaccine supply led to huge disparities in COVID-19 vaccine access, leaving billions of people – especially in low- and middle-income countries – unprotected against serious disease and death from COVID-19. We are opening the door to better health and wellbeing for our people.”. “At

Vaccine 52

Vaccine Licensing Licensing Science 52

The Pharma Data

JUNE 26, 2021

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. We look forward to evaluating the potential of these mRNA influenza vaccine candidates in this Phase 1 clinical trial.”.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1).

Therapies 52

Therapies FDA Treatment Clinical Trials 52

The Pharma Data

MARCH 26, 2021

Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalisation or death due to COVID-19.

Treatment 52

Treatment FDA Vaccine Trials 52

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.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

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.

FDA Approval 52

FDA Approval FDA Vaccine Pharmacy 52

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.

Vaccine 52

Vaccine Clinical Trials Trials Virus 52

The Pharma Data

OCTOBER 12, 2021

On 5 October 2021, the Company blazoned that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19. Paraphernalia included 903 actors in a 11 randomisation AZD7442 to placebo. The primary analysis was grounded on 822 actors.

Trials 52

Trials Treatment Virus Disease 52

The Pharma Data

JANUARY 31, 2021

1, 2021 11:00 UTC. Our preclinical work at Gritstone developing our powerful prime-boost vaccine technology utilized simian immunodeficiency virus (SIV) derived antigens as model antigens, which are very similar to HIV-1. FOSTER CITY, Calif. & & EMERYVILLE, Calif.–( –( BUSINESS WIRE )– Gilead Sciences, Inc.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

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.

Clinical Trials 52

Clinical Trials Virus Trials FDA 52

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).

Vaccine 52

Vaccine Virus Trials Immune Response 52

The Pharma Data

DECEMBER 30, 2020

31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing.

Virus 40

Virus International Trials Clinical Trials 40

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.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

MARCH 11, 2021

Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17 and March 6, 2021, when the Pfizer-BioNTech COVID-19 Vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 The information contained in this release is as of March 11, 2021.

Vaccine 52

Vaccine Clinical Trials Hospitals Licensing 52

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.

Doctors 52

Doctors Pharmacy Vaccine Licensing 52

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.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

The Pharma Data

JANUARY 6, 2021

6, 2021– Moderna, Inc. The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. “I CAMBRIDGE, Mass.–(BUSINESS Authorized Use.

Vaccine 52

Vaccine RNA FDA Clinical Trials 52

The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. We are encouraged that more than 85% of our employees in the U.S.

Clinical Trials 52

Clinical Trials Vaccine Virus Trials 52