The Pharma Data

MAY 7, 2021

FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at [link] by calling 1-800-822-7967.

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The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% There was a 1.08 REGN-COV2 was well tolerated in the trial. high dose, 1.6% low dose; 2.3%

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The Pharma Data

JANUARY 6, 2021

We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

JANUARY 29, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca . Source link.

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The Pharma Data

JANUARY 29, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Source link.

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The Pharma Data

JANUARY 31, 2021

No serious adverse events related to the vaccine candidates studied were reported. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The candidate vaccines were given in two doses, three weeks apart.

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The Pharma Data

DECEMBER 3, 2020

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

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The Pharma Data

NOVEMBER 9, 2020

Data from the event-driven trial could support global authorization and approval, including in the U.S. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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Drug Discovery World

APRIL 27, 2023

Research spotlight : In February 2023, Duke University co-investigators took a groundbreaking step in the treatment of geographic atrophy (GA), an advanced form of dry macular degeneration through the FDA approval of pegcetacoplan, the first ever FDA-approved treatment for GA.

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The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

JANUARY 12, 2021

. “Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. Yancopoulos , M.D.,

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The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. Director of the FDA’s Center for Biologics Evaluation and Research. FDA Evaluation of Available Effectiveness Data.

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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.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

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The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Many of these adverse events were serious and some resulted in death. Many of these adverse events were serious and some resulted in death.

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The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. versus placebo). WARNINGS AND PRECAUTIONS.

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The Pharma Data

JUNE 30, 2021

1-6 The most common adverse events observed in the upadacitinib groups during the 52-week study period were nasopharyngitis, exacerbation of ulcerative colitis and blood creatine phosphokinase increase. 1 The exposure-adjusted event rates of adverse events per 100 patient years were 16.0 events in the placebo group.

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The Pharma Data

JANUARY 18, 2021

Napoleone Ferrara, a member of OKYO’s Scientific Advisory Board, will be spearheading this effort at OKYO to advance chemerin and its associated analogues for the treatment of patients with SARS-CoV-2 virus and ARDS. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Many of these adverse events were serious and some resulted in death. Many of these adverse events were serious and some resulted in death.

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The Pharma Data

DECEMBER 29, 2020

It is important to remember that while the virology results from this analysis of hospitalized patients were robust, the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage. Casirivimab and imdevimab injection is not FDA approved for any use. high dose, 0.9%

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The Pharma Data

NOVEMBER 30, 2020

Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. Source link.

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The Pharma Data

NOVEMBER 16, 2020

A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. These solicited adverse events were generally short-lived. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. They are an inspiration to us all.

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The Pharma Data

APRIL 1, 2021

1 , 2 Through 24 weeks, rates of treatment-emergent adverse events (AEs) and serious AEs were similar between 15 mg of upadacitinib and 40 mg of adalimumab, but were more frequent with upadacitinib 30 mg. Adjudicated venous thrombotic events included one event of deep vein thrombosis in the placebo group (0.2

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The Pharma Data

OCTOBER 21, 2020

These findings speak to how the regimen of cabotegravir and rilpivirine may be adapted to meet the needs of people living with HIV who have events in their lives that could cause them to miss an injection appointment.”. CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is currently only approved in Canada.

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The Pharma Data

JULY 29, 2021

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. At a median follow-up of two years, Yescarta improved event free survival by 60% over the standard of care chemotherapy plus stem cell transplant.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.

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The Pharma Data

DECEMBER 5, 2020

The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 6 months of follow-up, 83% (10 of 12 patients) have ongoing responses for up to 13 months at the time of analysis.

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The Pharma Data

DECEMBER 10, 2020

The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days. Rates of serious adverse events were similar between vaccine and placebo groups (0.6% BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

SEPTEMBER 1, 2020

months, 2,039 participants (81.8%) had any treatment-emergent adverse event (TEAE), 236 (9.5%) had a serious TEAE (SAE) and 56 (2.2%) discontinued the study due to a TEAE. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Regeneron Pharmaceuticals, Inc. Schleifer , M.D., In July 2020 , the U.S.

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The Pharma Data

DECEMBER 11, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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The Pharma Data

NOVEMBER 20, 2020

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

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Codon

MAY 22, 2023

One paper estimates that the entirety of human-created mass (half of which is concrete) probably reached the total weight of Earth’s entire biomass — every tree, bacterium, virus, and whale — in 2020. Read ⚒️ In the Ether Education, resources, and events. Nature Communications. Read Engineered P.

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Codon

MAY 22, 2023

One paper estimates that the entirety of human-created mass (half of which is concrete) probably reached the total weight of Earth’s entire biomass — every tree, bacterium, virus, and whale — in 2020. Read ⚒️ In the Ether Education, resources, and events. Nature Communications. Read Engineered P.

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