Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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Disease Clinical Trials Therapies Science 112

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Vaccine FDA Approval FDA Disease 52

PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. The original approved was in 2003 to treat a type of Gaucher disease. Until today, there were no approved therapies in the US.

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Disease FDA Approval Drugs Treatment 52

The Pharma Data

OCTOBER 9, 2021

STELARA is the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, both of which play an important role in inflammation associated with immune-mediated diseases like PsA.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

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Clinical Trials DNA Trials Treatment 52

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. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). About ImmunityBio ImmunityBio, Inc.

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Vaccine Trials FDA Clinical Trials 40

The Pharma Data

APRIL 8, 2021

“Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. It is approved and commercially available as OLUMIANT in the U.S. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.

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Hospitals FDA Approval Laboratories Treatment 52

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

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Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.

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Licensing Licensing Therapies Laboratories 40

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. vice president of immunology development at Lilly.

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Therapies Treatment Disease Clinical Trials 52

The Pharma Data

MARCH 4, 2021

Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. It is approved and commercially available as OLUMIANT in the U.S. associate professor of Dermatology at Yale School of Medicine.

Trials 52

Trials Treatment Therapies Clinical Trials 52

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. Test patients for latent TB before initiating Olumiant and during therapy. See the full Prescribing Information here.

Treatment 52

Treatment Clinical Trials Drugs Therapies 52

The Pharma Data

AUGUST 3, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is also approved for the treatment of certain hospitalized patients with COVID-19 in Japan. Serious Side Effects.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

The Pharma Data

JULY 29, 2021

The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. million by 2004.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70

Drug & Device Law

SEPTEMBER 19, 2022

555 (2009) , and PLIVA, Inc. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. c)(6)(iii)(A).

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Regulations FDA Approval Drugs FDA 10