Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. IMPORTANT SAFETY INFORMATION . has a fever.

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Delveinsight

AUGUST 27, 2020

Moderna’s COVID-19 vaccine triggers an immune response in older adults. The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults.

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The Pharma Data

SEPTEMBER 8, 2021

BTK is an intracellular signaling molecule involved in innate and adaptive immune responses involved in certain immune-mediated diseases. Allergy, 75: 100-119. By inhibiting BTK, rilzabrutinib has the potential to target the underlying disease pathogenesis. Arthritis Rheumatol. 2020 Apr 9;72(9):1435–46. doi: 10.1002/art.41275.

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. has a fever.

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Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17.

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Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Food and Drug Administration for the products. 10 World Allergy Organization (WAO).

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Scienmag

SEPTEMBER 15, 2020

Scientists at Sanford Burnham Prebys Medical Discovery Institute have received a $3 million grant from the National Institutes of Health (NIH) to study how SARS-CoV-19 weakens the immune system–and identify drugs to help infected […].

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

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pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Development in peanut allergy has also been discontinued, said Sanofi in its second-quarter update.

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XTalks

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. percent in the placebo group.

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XTalks

MAY 17, 2024

Led by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), World AIDS Vaccine Day emphasizes the importance of awareness and education in the fight against HIV/AIDS. It’s a day to celebrate the scientific strides made towards a vaccine and to remember the work that still lies ahead.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 1) The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022. US Food and Drug Administration. Ann Allergy Asthma Immunol.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) are starting to pick up. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). Sarah Silbiger/Getty Images. After a start-of-the-year lull, activities at the U.S.

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pharmaphorum

JULY 12, 2022

Since then, outbreaks have occurred almost every year around the world, mainly in India and Bangladesh, and there is no approved vaccine or drug treatment to protect humans or animals at risk. “The need for a preventive Nipah virus vaccine is significant,” he added. .

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Bioengineer

JULY 15, 2021

But some patients develop resistance to current immunotherapies and others have cancers characterized by immunologically “cold” tumors, which evade or suppress the patient’s immune response against his or her cancer. Food & Drug Administration to begin testing this agent in human clinical trials.

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Pfizer

NOVEMBER 2, 2022

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. are immunocompromised or are on a medicine that affects the immune system.

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The Pharma Data

APRIL 28, 2021

About Rilzabrutinib Rilzabrutinib is an oral, reversible covalent, Bruton’s tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases. BTK is involved in innate and adaptive immune responses and is a signaling molecule in immune mediated diseases.

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Delveinsight

JANUARY 21, 2021

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The new research provides a scientific rationale to advance clinical studies of the drug combination in patients with AML. billion in total for three drugs.

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The Pharma Data

OCTOBER 26, 2020

The National Institute of Allergy and Infectious Diseases (NIAID), the study sponsor, could not verify the safety issue, but their analysis also indicated there was little likelihood the antibody would help the hospitalized patients. The approval marks the first drug approved by the U.S. The drug is an orally active caspase inhibitor.

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The Pharma Data

FEBRUARY 8, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. Allergy Cough & Cold. to €238 million, reflecting growth in the Allergy (Allegra ® and Xyzal ® ) and Digestives categories. Consumer Healthcare.

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The Pharma Data

FEBRUARY 4, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. Allergy Cough & Cold. to €238 million, reflecting growth in the Allergy (Allegra ® and Xyzal ® ) and Digestives categories. Consumer Healthcare.

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The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category.

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pharmaphorum

AUGUST 13, 2020

Bourla made Pfizer’s manufacturing capabilities available to small biotech concerns and is in talks to make large quantities of other companies’ COVID-19 drug candidates. AstraZeneca has joined forces with GSK and Sanofi to play a socially responsible role in the search for a vaccine and its rapid production.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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XTalks

JANUARY 2, 2025

The immunology drug market is a dynamic landscape driven by innovation, expanded indications and competitive strategies. From biologics to biosimilars, the top-performing drugs in this sector not only offer life-changing therapies for patients but also generate billions in revenue for pharmaceutical companies.

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The Pharma Data

DECEMBER 31, 2020

Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. Professional.

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The Pharma Data

MAY 13, 2021

Food and Drug Administration regarding the approval of the vaccine regimen in the U.S. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response. Discussions are ongoing with the U.S.

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pharmaphorum

JULY 26, 2022

With the option to medicate with pre-exposure prophylaxis (PrEP), the chance of transmitting HIV from sex or drug use through injection has also been greatly reduced. Leronlimab blocks HIV from entering immune cells due to a surface protein called CCR5.

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The Pharma Data

AUGUST 24, 2020

Some 10,000 people have volunteered for trials of the drug, but US agencies require trials involving 30,000 people for a vaccine to be authorised. In an interview with Reuters , Dr Fauci – head of the National Institute of Allergy and Infectious Diseases – warned rushing out an untested vaccine could damage other trials.

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XTalks

SEPTEMBER 14, 2020

These companies include Moderna, a US biotech company which has formed a partnership with the National Institute of Allergy and Infectious Diseases (NIAID), Oxford University who has partnered with AstraZeneca, and Johnson & Johnson, Merck and Pfizer. Drugs and Vaccines.

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