The Pharma Data

JUNE 1, 2022

has been appointed Senior Vice President and Head of the Company’s Vaccine Research & Development (R&D) organization effective August 1, succeeding Kathrin U. Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “I Pfizer Inc. Jansen, Ph.D., who will be retiring from Pfizer.

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PPD

OCTOBER 24, 2024

Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection. Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies.

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Drug Target Review

JULY 11, 2023

In the quest to combat and eradicate diseases, scientists and researchers are increasingly turning to the immense potential of artificial intelligence (AI) as a tool. Her focus initially consisted of preclinical development strategies , clinical development optimisation, target discovery and validation.

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Drug Target Review

SEPTEMBER 5, 2024

I was part of building up this small biopharma company and learn a lot about rare diseases, regulatory interactions and challenges related to that, challenges related to out licensing drug candidates and having new people joining the company every month as we were growing so fast.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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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

DECEMBER 3, 2020

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

MARCH 1, 2022

Astellas”) today announced that they have entered into an agreement whereby Affinivax has reacquired the exclusive worldwide rights to ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. We believe ASP3772 has significant potential to address unmet needs in this important vaccine category.

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV. About CVnCoV.

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The Pharma Data

OCTOBER 25, 2020

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., About Moderna.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Now, FDA’s CBER is setting its sights on making ambitious strides toward tackling rare diseases.

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The Pharma Data

JULY 28, 2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for avalglucosidase alfa, a long-term enzyme replacement therapy for the treatment of people with Pompe disease. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Glenn, M.D., and globally.”. and globally.”.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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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. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.

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The Pharma Data

MAY 31, 2022

billion in potential development milestones Proposed acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase II development and highly innovative, MAPS TM technology Supports development of a strong portfolio of innovative vaccines and specialty medicines. GSK to pay $2.1

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The Pharma Data

JUNE 2, 2022

Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines. The number of serotypes in current vaccines is limited due to the degree of immunological interference observed when using existing conjugation technologies.

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Drug Target Review

JULY 17, 2024

While current polyclonal antibody (pAb) therapies are derived from plasma, GigaGen has developed single-cell discovery and development platforms to produce diverse and potent recombinant pAb therapies that are made in the laboratory. It aims to clear HBsAg, to support HBV-specific immune responses and to achieve functional cure.

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The Pharma Data

AUGUST 18, 2020

The head of China’s state-owned Sinopharm has put forward a general price range for the group’s two inactivated COVID-19 vaccine candidates now in late-stage development—and it’s quite a bit higher than the amounts other shot makers have quoted so far. “An DEVELOP A UNIFIED SCIENTIFIC VOICE. Virtual Event. government.

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Drug Target Review

JULY 18, 2024

Our recent Nature Medicine publication is a good example of where liquid biopsy data was used alongside T cell responses to make decisions during a dose escalation of a new cancer vaccine candidate, ELI-002 2P 1. What is the role of liquid biopsy in oncology drug development? Reference 1 Pant, S., Wainberg, Z.A., Weekes, C.D.

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The Pharma Data

OCTOBER 28, 2020

(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., Forward-Looking Statements.

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The Pharma Data

APRIL 7, 2022

At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. Sisunatovir has been granted Fast Track designation by the U.S.

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The Pharma Data

SEPTEMBER 9, 2020

The BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within 3 days after the infection. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We Jansen, Ph.D., CEO and Co-founder of BioNTech. CEO and Co-founder of BioNTech.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization. billion doses by the end of 2021. CEO and Co-founder of BioNTech.

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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. Jansen, Ph.D.,

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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. no CMV disease (compared to 2 out of 14 cases in the placebo group).

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Drug Target Review

DECEMBER 28, 2023

Immunosurveillance and the importance of CD4 T cells in developing cancer vaccines The TRACERx data have been used to identify clonal mutations for each patient in the study by comparing a patient’s tumour DNA to their healthy DNA, thereby identifying patient-specific mutations that could be targeted by a range of novel immune therapy modalities.

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The Pharma Data

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases.

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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.

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The Pharma Data

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. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). “Our vision is to harness the power of the immune system against cancer and infectious diseases. About BioNTech.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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Drug Target Review

NOVEMBER 30, 2023

From an early age, I’ve been passionate about finding cures for difficult-to-treat diseases. I accepted and I’ve been CEO ever since; our goal, from the beginning, was to pioneer new ways to diagnose, treat and prevent neurodegenerative diseases. Food and Drug Administration for our Alzheimer’s vaccine candidate, ACI-24.060.

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The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

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Vial

APRIL 10, 2024

Moreover, IQVIA offers strategic partnership opportunities, multi-year contracts, and quick access to project managers and clinical research associates1,3. Moreover, IQVIA offers strategic partnership opportunities, multi-year contracts, and quick access to project managers and clinical research associates1,3.

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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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