The Pharma Data

JUNE 24, 2021

“With the introduction of PARP inhibitors in the metastatic castration-resistant prostate cancer setting, it is important to explore how a combination approach may impact outcomes for men with metastatic castration-sensitive disease,” said Neeraj Agarwal, M.D., Talazoparib is not approved for the treatment of prostate cancer.

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The Pharma Data

MARCH 4, 2021

AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. There are currently no FDA-approved treatments for AA. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”

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The Pharma Data

AUGUST 3, 2021

. “In the interest of public health and safety, it remains a priority to provide healthcare professionals with as much information as possible about treatment options that may help improve outcomes for patients with severe disease,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. Serious Side Effects.

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The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. “Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. scalp hair loss, or 14.5%

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The Pharma Data

OCTOBER 29, 2020

The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1. INDIANAPOLIS , Oct.

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The Pharma Data

OCTOBER 21, 2020

These findings were presented today at the 2020 Infectious Diseases Society of America (IDSA) IDWeek. CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is currently only approved in Canada. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Kimberly Smith, M.D.,

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The Pharma Data

JULY 29, 2021

The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. Baricitinib is not recommended for patients who are on dialysis, have end-stage renal disease, or have acute kidney injury.

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The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

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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. Reported infections include: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease.

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The Pharma Data

MAY 4, 2021

Baricitinib is an oral medication currently registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.

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The Pharma Data

OCTOBER 14, 2020

is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. 2009 Sep;16(9):673-82. Epub 2009 Feb 20. About ImmunityBio ImmunityBio, Inc. PMID: 23624851; PMCID: PMC3732790. iv Osada T, et al. Cancer Gene Ther.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Codon

JANUARY 26, 2025

Astrologers of the time believed that the disease’s periodic return was influenced by the location of the stars. By contrast, smallpox and measles vaccines are more than 95 percent effective at preventing disease, a level sufficient to have eradicated smallpox entirely. Formaldehyde had precedent in medicine.

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Codon

FEBRUARY 23, 2025

When tests showed that zidovudine did not work against cancer, though, Horwitz set it aside — but told his peers that this molecule, as well as similar DNA base mimics, were “a very interesting set of compounds that were waiting for the right disease.” Jerome Horwitz and Wolfram Ostertag.

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Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. This is not the first time we have written about litigation related to this shortage.

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Drug & Device Law

JULY 24, 2023

at *6 (plaintiff “has documents and formularies reaching back to only 2009”). Without any consideration of what actual doctors did for actual patients with actual diseases, all that was proven was the maxim “garbage in, garbage out.” First, the class plaintiff got away with destruction of evidence.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. Changing tack after the fact did not work.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp.

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