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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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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Drug Target Review

NOVEMBER 30, 2023

From an early age, I’ve been passionate about finding cures for difficult-to-treat diseases. Then I was approached to co-found AC Immune in 2003. I accepted and I’ve been CEO ever since; our goal, from the beginning, was to pioneer new ways to diagnose, treat and prevent neurodegenerative diseases.

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The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

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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

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. It is designed for use in a broad infant population, including all infants experiencing their first RSV season and infants with congenital heart disease or chronic lung disease entering their first and second RSV season.

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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

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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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

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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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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