The Pharma Data

FEBRUARY 14, 2022

Last week, Afrigen, which is part of WHO’s mRNA consortium, gained international plaudits as it announced it had developed its own version of an mRNA shot, based on the publicly available data on the composition of the Moderna COVID-19 vaccine, which will be tested in the coming months.

Vaccine 52

Vaccine Licensing Licensing Science 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). Available from: [link].

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

MARCH 29, 2022

13 People at increased risk of exposure to the SARS-CoV-2 virus could also benefit from protection with Evusheld. 1,3 The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.20.

Vaccine 52

Vaccine Virus Immune Response Trials 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 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. Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. About the VIR-7831 Clinical Development Programme.

Treatment 52

Treatment FDA Vaccine Trials 52

The Pharma Data

JANUARY 31, 2021

Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. This press release features multimedia. View the full release here: [link].

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

The Pharma Data

JANUARY 27, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of patients with Frontotemporal Dementia (FTD) with granulin (GRN) mutations. chief executive officer of Passage Bio. “FTD

Therapies 52

Therapies Treatment Clinical Trials FDA 52

The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” This brings the total number of doses to be delivered to the EU to 600 million. “We said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “To

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800. 1 Noyce RS, et al.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics is a clinical-stage emerging biotechnology company developing novel gene therapy treatments for rare, inherited metabolic diseases. Vivet’s lead program, VTX-801, is currently under clinical development. Columbus Venture Partners, Ysios Capital, Kurma Partners and Idinvest Partners.

Disease 52

Disease FDA Treatment Clinical Trials 52

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.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

JANUARY 18, 2021

Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir ® ”).

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

APRIL 1, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells.

Treatment 52

Treatment Virus Therapies FDA 52

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. Upon option exercise, Novartis would be responsible for all further development and commercialization activities.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

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.

Science 40

Science Virus Treatment Disease 40

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

Hospitals 52

Hospitals Production Clinical Trials Therapies 52

The Pharma Data

MARCH 4, 2021

vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata.” herpes zoster), were reported in clinical studies with Olumiant.

Trials 52

Trials Therapies Treatment Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. ; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc. Tonix Pharmaceuticals Holding Corp.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. The committee is tasked with supporting BeyondSpring’s business development activities related to its lead asset, Plinabulin, and other pipeline assets. BeyondSpring – BeyondSpring Inc.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

The Pharma Data

JUNE 30, 2021

Today’s results show us the potential power of cell therapy for patients with lymphoma when used earlier, and instead of standard treatment options,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. candida sepsis and aspergillus infections) and viral reactivation (e.g.,

Therapies 52

Therapies Treatment Virus Vaccine 52

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. Patient Recruitment.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

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. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

OCTOBER 29, 2020

vice president of immunology development at Lilly. “The results of this study underscore baricitinib’s potential in alopecia areata, and we look forward to continuing the clinical development program for baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA.”

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

NOVEMBER 29, 2020

3 The majority of CMV infections are not serious, and the virus can lay dormant in the body for years. HOOKIPA’s non-replicating prophylactic cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. 1 Gilbert C and Boivin G.

Vaccine 52

Vaccine Clinical Trials Disease Therapies 52

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

Licensing 40

Licensing Licensing Production Engineering 40

The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease.

Vaccine 52

Vaccine Clinical Trials RNA Trials 52

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. An update on Pfizer’s potential first-in-class maternal vaccine candidate for the prevention of respiratory syncytial virus (RSVpreF). BNT162 mRNA-based Vaccine Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production 52

Production FDA Trials FDA Approval 52

The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

AUGUST 20, 2020

“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U.

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

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.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

JULY 12, 2021

“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If About Molnupiravir. About Ridgeback Biotherapeutics.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52