The Pharma Data

JUNE 18, 2021

14 In August 2019 , RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg. RINVOQ ® (upadacitinib) [Package Insert]. ClinicalTrials.gov. AbbVie Inc. .

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The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

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The Pharma Data

JANUARY 21, 2021

Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression.

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FDA Approval Treatment RNA FDA 52

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

AUGUST 6, 2020

Otezla® Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. All comparisons are made versus the same period in 2019 unless otherwise stated. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019. Second Quarter. . .

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Production International Licensing Licensing 52

The Pharma Data

OCTOBER 28, 2020

As in the earlier analysis, patients with higher viral load at baseline and/or no detectable antibodies at baseline (suggesting their bodies had not yet mounted an effective immune response), derived greater benefit from REGN-COV2 therapy. combined dose groups; 6.5% placebo; p=0.024).

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Regeneron Pharmaceuticals, Inc.

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FDA Clinical Trials Hospitals Government 40

The Pharma Data

JUNE 18, 2021

“Combining our novel therapies to deliver a new potential treatment is an example of AbbVie’s innovative approach to identify options for difficult-to-treat blood cancers, like CLL,” said Mohamed Zaki , M.D., IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

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The Pharma Data

JUNE 18, 2021

Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41). “We are encouraged by these results, which further support the efficacy of these two well-established therapies,” said Mohamed Zaki, M.D., IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

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Treatment Therapies FDA FDA Approval 52

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

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Engineering Vaccine Production RNA 85

Agency IQ

OCTOBER 27, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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FDA Science Regulations Production 40

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval 52

FDA Approval FDA Production Vaccine 52

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Malaria mortality from 2000 (left) to 2019 (right). Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do? Twitter thread.

Vaccine 52

Vaccine DNA Virus Engineering 52

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Malaria mortality from 2000 (left) to 2019 (right). Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do? Twitter thread.

Vaccine 52

Vaccine DNA Virus Engineering 52