Drug Discovery World

SEPTEMBER 28, 2023

Probiotics offer a relatively straightforward, minimally regulated avenue to correcting dysbiosis, and a significant market exists already. However, fewer companies have pursued the avenue of regulated therapeutics. Osel is one company leading the charge to bring regulated therapeutics to market.

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Clinical Trials Regulations Trials Drug Development 163

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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FDA Approval FDA Treatment Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. That PTE application was submitted to the PTO on July 26, 2012. 6,953,787 [] for [PTE] request under 35 U.S.C. §

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). That combination therapy was designed to help CF patients with two copies of the F508del mutation.

Clinical Trials 52

Clinical Trials Small Molecule Disease Therapies 52

The Pharma Data

JUNE 18, 2021

These results were also recently published online in Rheumatology and Therapy in April 2021. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg. NORTH CHICAGO, Ill.

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Treatment Therapies Clinical Trials Disease 40

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). AMG 451 / KHK4083.

Biosimilars 52

Biosimilars Production Treatment FDA 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. PTE applications were submitted to FDA for each of U.S. To that end, 35 U.S.C. § 156(c)(4)

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