The Pharma Data

OCTOBER 19, 2020

.–( 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. among adults 65 years of age or older.

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The Pharma Data

APRIL 27, 2023

This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. There are no RSV vaccines or specific treatments currently available for older adults. Efficacy was 94.6% (95% CI, 65.9–99.9,

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The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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The Pharma Data

OCTOBER 26, 2020

FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Testing Therapies, Antivirals and Vaccines. Eli Lilly halted a separate study of its LY-COV555 antibody against COVID-19 in hospitalized patients.

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Drug Discovery World

MAY 6, 2024

The company is now investigating a promising gene therapy for Huntingdon’s disease in a Phase I/II trial, with patients already showing signs of preserved neurological function. In Paris itself, Institut Curie is a major cancer hospital, from which One Biosciences was spun-off.

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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 Discovery World

APRIL 20, 2023

Symptoms affect the brain, heart, lungs, GI tract and pancreas, are seen equally in vaccinated populations, and sometimes newly emerge after the acute infection has resolved. Alzheimer’s disease), or by initiating a new one. Acute and persistent symptoms in non-hospitalized PCR- confirmed COVID-19 patients,” Sci Rep, vol.

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The Pharma Data

DECEMBER 1, 2020

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. View the full release here: [link].

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The Pharma Data

DECEMBER 23, 2020

” Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” . PLYMOUTH MEETING, Pa. , PLYMOUTH MEETING, Pa. , mg and 2.0

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The Pharma Data

SEPTEMBER 1, 2021

Participants are not eligible for the trial if they have received the first dose of a COVID-19 vaccine more than seven days prior to enrollment, have previously had COVID-19 or are showing any signs or symptoms of COVID-19. Data from the study is expected in the second half of 2021. MOVe-AHEAD Study. About Ridgeback Biotherapeutics.

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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

MARCH 29, 2022

Spinner, MD, Consulting Physician Infectious Diseases and Pandemic Officer at the University Hospital Rechts der Isar and adjunct teaching professor at the Technical University of Munich, Munich, Germany, said: “Increasing COVID-19 cases, driven by the highly-transmissible BA.2 1-3 Evusheld was generally well-tolerated in the trial.

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The Pharma Data

AUGUST 3, 2021

. “In the interest of public health and safety, it remains a priority to provide healthcare professionals with as much information as possible about treatment options that may help improve outcomes for patients with severe disease,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines.

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The Pharma Data

APRIL 15, 2022

The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. The study also showed that, in a population with only 4.2% The FDA, an agency within the U.S.

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The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

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The Pharma Data

JUNE 7, 2022

The MITT population included all participants who were randomly assigned, received at least one dose of study drug, and were not hospitalized before the first dose of study drug. Since licensed by Ridgeback, all funds used for the development of LAGEVRIO have been provided by Merck and Ridgeback. to 51.7%]; 6.6% to 51.7%]; 6.6%

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. cancer vaccines, cardiovascular disease). Read AgencyIQ’s complete analysis of the program here.

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The Pharma Data

FEBRUARY 12, 2022

This trial was a Phase 2, randomized, clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19 who were treated with the authorized dose of bebtelovimab (175 mg) alone or together with 700 mg bamlanivimab and 1,400 mg of etesevimab. About BLAZE-4.

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Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

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Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

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Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

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The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

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The Pharma Data

APRIL 14, 2021

Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients: who are hospitalized due to COVID-19, OR. Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Some of these events required hospitalization. Adverse Events.

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. “Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S.

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The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

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The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. billion related to certain license and collaboration agreements, and certain other items. Non-GAAP EPS of $1.74 COVID-19 Research Highlights.

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The Pharma Data

APRIL 16, 2021

More than 400,000 patients have been treated with bamlanivimab – more than any other neutralizing antibody – potentially preventing more than 20,000 hospitalizations and at least 10,000 deaths during the worst of the pandemic in the U.S. Some of these events required hospitalization. Limitations of Authorized Use. Adverse Events.

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The Pharma Data

OCTOBER 29, 2020

The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte. INDIANAPOLIS , Oct.

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The Pharma Data

JULY 23, 2021

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. We also continue to identify, develop and support potential therapies which can play a role in treating the disease. The impact of COVID-19 goes beyond those who contract it.

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. 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. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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The Pharma Data

MARCH 22, 2021

1 COVID-19-related hospitalization or death through day 29. All patients in this analysis had at least one risk factor, including obesity (58%), age 50 years (51%) and cardiovascular disease, including hypertension (36%). Key results from phase III REGN-COV 2067 trial in non-hospitalised patients 1-3. 1,200 mg IV. 2,400 mg IV.

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The Pharma Data

JANUARY 26, 2021

“The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

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Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic. What’s next?

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