The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 10:45 UTC. –( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020. 2020. for the third quarter of 2020. . for the third quarter of 2020. KENILWORTH, N.J.–(

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

JULY 21, 2021

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15 2.

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The Pharma Data

DECEMBER 21, 2020

22, 2020 07:13 UTC. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We About UV1 UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase.

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The Pharma Data

DECEMBER 10, 2020

11, 2020 02:48 UTC. –( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. CULVER CITY, Calif.–(

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The Pharma Data

OCTOBER 25, 2020

26, 2020 11:00 UTC. We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co.,

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The Pharma Data

NOVEMBER 20, 2020

. Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

JANUARY 5, 2021

COVID-19 have caused delays to submission and processing of the regulatory application to initiate clinical development in China. Due to the unforeseen delays, Targovax has extended the term of IOvaxis’s license option by 3 months, otherwise the agreement remains unchanged. OSLO, Norway , Jan.

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The Pharma Data

DECEMBER 11, 2020

Friday, December 11, 2020. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S.

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The Pharma Data

SEPTEMBER 9, 2020

The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.

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Drug Discovery World

FEBRUARY 28, 2024

With the safety of MOv18 IgE having been established in cancer patients, biotechnology company Epsilogen has licensed the drug and will continue its clinical development following this successful clinical trial.

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The Pharma Data

AUGUST 20, 2020

times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. billion doses by the end of 2021.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are pleased to work with U.S. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

DECEMBER 10, 2020

Thursday, December 10, 2020 – . Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.

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The Pharma Data

DECEMBER 1, 2020

2, 2020 07:05 UTC. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. The distribution of the vaccine in the U.K.

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The Pharma Data

OCTOBER 19, 2020

20, 2020 10:45 UTC. –( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. KENILWORTH, N.J.–(

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The Pharma Data

OCTOBER 28, 2020

29, 2020 06:00 UTC. Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., CAMBRIDGE, Mass.–(

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The Pharma Data

NOVEMBER 9, 2020

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020. Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Pfizer Inc. Today is a great day for science and humanity.

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. 30, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. . 30, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc.

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Vial

APRIL 10, 2024

With over 1,100 CROs worldwide as of 2020, choosing the appropriate partner often requires evaluating the advantages and disadvantages of large global CROs versus mid/small ones. Still in its early stages, Vial was established in 2020 and has quickly emerged as a leading CRO. increase on a reported basis and an 4.8%

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Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. vice president of immunology development at Lilly.

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The Pharma Data

NOVEMBER 23, 2020

24, 2020 07:05 UTC. OSLO, Norway–( BUSINESS WIRE )– Ultimovacs ASA (“Ultimovacs”, ticker ULTIMO), today announced that Ton Berkien will join Ultimovacs’ management team as Chief Business Officer (CBO), effective December 1, 2020. Mr. Berkien is a Dutch and Swedish citizen and is based in Sweden.

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Drug Discovery World

OCTOBER 4, 2022

billion in 2020, according to the Alliance for Regenerative Medicine’s (ARM’s): Disrupting the Status Quo report. With 3,633 advanced therapeutical medicinal products (ATMPs) currently in some form of clinical or pre- clinical development, the sector shows no signs of slowing down. billion, compared to $19.9

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Vial

MARCH 1, 2024

Recent and significant activities among these top CROs based in the US include the acquisition of Pharmaceutical Product Development (PPD), a global industry leader in clinical development and analytical services, by Thermo Fisher Scientific Inc. launched a PV platform for clinical research registries.

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The Pharma Data

JANUARY 12, 2021

On December 15, 2020 , the U.S. “The funding will enable us to execute on our breakthrough therapy designation grant and advance our lead programs in late-stage clinical development, as we are committed to bringing our treatment to patients as soon as possible.” Priyanka Belawat of HBM Partners, Jack B.

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The Pharma Data

APRIL 27, 2021

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. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients.

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The Pharma Data

JULY 28, 2021

The CHMP positive opinion and recommended indication reflect the robust data from avalglucosidase alfa’s clinical development program. The CHMP positive opinion for avalglucosidase alfa follows the EMA’s acceptance of Sanofi’s MAA at the end of 2020. About Sanofi.

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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.”. 1-3 Evusheld was generally well-tolerated in the trial.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. Accessed October 2020. Accessed October 2020. Posted: November 2020. NCT identifier: NCT04380688. Available online.

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The Pharma Data

DECEMBER 14, 2020

15, 2020 /PRNewswire/ — Cyxone (publ.), a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod.

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Apexigen, Inc. , a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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