NIH Director's Blog: Drug Development

MAY 21, 2020

Science, 2020 We now know that the immune system of nearly everyone who recovers from COVID-19 produces antibodies against SARS-CoV-2, the novel coronavirus that causes this easily transmitted respiratory disease [1]. In the U.S. Stay tuned for more information about these potentially significant advances in the next few months. 2020 May 18.

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The Pharma Data

FEBRUARY 12, 2022

Belimumab is also approved in China for five-year-old and older patients with active, autoantibody-positive SLE with high disease activity (e.g., positive anti-double-stranded DNA and low complement, and an objective assessment of overall disease activity using SELENA-SLEDAI score ? 8) in combination with standard of care. About lupus.

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The Pharma Data

MARCH 26, 2021

It causes inflammation in the kidneys and can lead to end-stage kidney disease which may require dialysis or a transplant. 2] LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Approximately 20% of patients with LN progress to end-stage kidney disease within 10 years of diagnosis. [5].

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Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. 10 Proteasome inhibitors Since the approval of Bortezomib in 2003, 11 new proteasome inhibitors have emerged with reduced side effects.

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The Pharma Data

DECEMBER 23, 2020

AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – but who now demonstrate post-acute infection chronic fatigue-like symptoms. See: PLOS ONE ). AIM CEO Thomas K.

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Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines.

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The Pharma Data

MAY 5, 2021

Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.”. 2] LN can lead to end-stage kidney disease, which could require dialysis or a kidney transplant.

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NIH Director's Blog: Drug Development

MARCH 18, 2021

He uses these fundamental insights to guide the design of vaccines and therapeutics, including promising monoclonal antibodies. He’s also a member of the international research team that identified a human antibody, called S309, from a person who’d been infected with SARS in 2003.

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The Pharma Data

AUGUST 19, 2021

Gorsky’s leadership has been oncology, with the Company’s sales in this area growing from approximately $2 billion in 2011 to over $12 billion in 2020, while acquisitions have included Actelion, the largest in the Company’s history, which significantly expanded Johnson & Johnson’s Pharmaceutical segment portfolio of rare-disease treatments.

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Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people.

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The Pharma Data

AUGUST 24, 2020

There is no cure but the polio vaccine protects children for life. The disease is now only found in Afghanistan and Pakistan. A polio vaccine was developed in 1952. Now only the vaccine-derived polio virus remains in Africa. Since 1996 nine billion oral polio vaccines have been provided, averting an estimated 1.8

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Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

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Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.

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