Drug Discovery World

MAY 29, 2024

AAV purification The question of adeno-associated virus (AAV) vectors, according to Hummersone, is interesting for several reasons. Looking over the last five to eight years, he reflects on the handful of FDA approvals and CGTs that really work well. Firstly, AAV is a delicate vector.

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The Pharma Data

DECEMBER 11, 2020

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval. Doctors say this reflects India’s younger and leaner population. Initially, a shipment of 2.9 and Troy, Mich. —

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The Pharma Data

APRIL 1, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. 2-12 In August 2019 , RINVOQ received U.S.

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. This DNA Science post from 2018 traces the history of the efforts.

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The Pharma Data

OCTOBER 24, 2020

That’s just not possible when the virus is surging everywhere,” Eleanor Murray, an epidemiologist at Boston University, told the Post. The winter’s cold, dry air will also help the virus stay stable longer, just as people start to spend more time indoors where ventilation may be poor.

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The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

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The Pharma Data

JANUARY 26, 2021

In November, Lilly submitted a request to the FDA for emergency use authorization (EUA) for bamlanivimab and etesevimab together as another treatment for mild to moderate COVID-19 in high-risk patients. It remains under review by the FDA. Bamlanivimab FDA Approval History. Securities and Exchange Commission.

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The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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The Pharma Data

OCTOBER 27, 2020

” Antibodies are proteins the body makes when an infection invades the body ; they attach to a virus and help eliminate it. Remdesivir gets full FDA approval to treat COVID-19. The antiviral drug remdesivir has received full approval from the U.S. Food and Drug Administration.

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The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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The Pharma Data

NOVEMBER 23, 2020

23, 2020 – Americans were greeted with possible advances against coronavirus as Thanksgiving week began: A third vaccine candidate shows good results in shielding recipients against the virus, and an antibody therapy used by President Donald Trump against COVID-19 got emergency use approval by the U.S. MONDAY, Nov. Meanwhile, U.S.

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Drug & Device Law

JANUARY 12, 2024

The defendant in Gilead has developed multiple drugs used to treat or prevent infection with the AIDS virus, including several containing tenofovir disoproxil fumarate (“TDF”). The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. at *48-*50. at *31, *32. That is important.

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