XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. Herd Immunity and Equitable Access to COVID-19 Vaccines.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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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 1 as compared to the companies’ current COVID-19 vaccine. INTERCHANGEABILITY.

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XTalks

MARCH 8, 2024

Amgen also claimed that Sandoz failed to provide information about its biosimilar manufacturing process as required by law. The company also complained that the FDA would make an approval decision on the biosimilar before patent expirations.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

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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. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. About CEPI.

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The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. and Mexico pivotal Phase 3 trial and manufacturing scale-up. . Mexico pivotal Phase 3 trial update.

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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. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

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XTalks

MARCH 13, 2023

Last year, the FDA approved four new gene therapies: Zynteglo (betibeglogene autotemcel, beti-cel), Skysona (elivaldogene autotemcel, eli-cel), Hemgenix (etranacogene dezaparvovecfor) and Adstiladrin (nadofaragene firadenovec-vncg). Another thing Dr. Xu recommended is to monitor the immune response to gene therapy products.

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The Pharma Data

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. Manufacturing and Delivery Capabilities. Germany, Turkey, South Africa, Brazil and Argentina. Pfizer is leveraging three of its U.S.

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The Pharma Data

DECEMBER 27, 2020

Our work began modestly, but we hit our stride in 2020 and reached important clinical, manufacturing, and business milestones this year, which created substantial value and advanced us toward our ultimate goal. Our goal of building Lineage into the preeminent cell therapy company is ambitious but attainable.

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The Pharma Data

DECEMBER 17, 2020

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

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The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. and Roche will develop, manufacture and distribute it outside the U.S. Yancopoulos , M.D., combined dose groups; 6.5%

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XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. At six months, 29.5

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Pharmaceutical Technology

APRIL 11, 2023

The approval enables the company to manufacture and market azithromycin to treat infections such as bronchitis, pneumonia and sexually transmitted diseases (STDs). Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Advarra

JANUARY 11, 2024

Additionally, personalized medicine tends to be more difficult to manufacture because of regulatory requirements beyond traditional drug manufacturing requirements. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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Pfizer

NOVEMBER 2, 2022

The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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The Pharma Data

DECEMBER 16, 2020

intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Initial doses are expected to be limited as manufacturing ramps up. Instead, it uses a genetic code, which tricks the body into developing an immune response to the virus.

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. ” The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. SILVER SPRING, Md. ,

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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Pfizer

OCTOBER 20, 2022

Food and Drug Administration (FDA) approved PREVNAR 20® for the prevention of invasive disease and pneumonia in adults age 18 years or older. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay.

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The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S.,

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The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. With the world watching, the biopharmaceutical community got to work.

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The Pharma Data

OCTOBER 14, 2020

Additionally, immunogenicity, duration of immune response and occurrence of symptomatic COVID-19 will be measured. agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate.

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The Pharma Data

JANUARY 29, 2021

The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations. COV2-S (SARS-CoV-2 vaccine) FDA Approval History. Janssen’s COVID-19 vaccine program has been designed to be thorough and driven by science. i] [link] [ii] The B.1.351

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XTalks

AUGUST 17, 2020

Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses. Cell-based immune therapies, including CAR-T cell therapy, have had some marked success, particularly in hematological cancers such as acute lymphocytic leukemia (ALL). Nature by Design.

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The Pharma Data

OCTOBER 26, 2020

FDA Actions. 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). News information is not all-inclusive and updates are published once a week on Tuesdays. . . Please read more here. .

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pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Full approval means it could be used routinely in future as an annual booster, much like the seasonal influenza vaccine.

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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

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XTalks

OCTOBER 16, 2020

The FDA approval is based on results from the large, multi-center clinical trial called PALM (PAmoja TuLinde Maisha) in which Inmazeb showed superiority over other antiviral investigational agents, namely ZMapp and remdesivir, with respect to mortality.

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