FDA Law Blog: Biosimilars

JANUARY 18, 2024

At that time, the Agency allowed it to stay on the market under a program that tested edible portions of pigs, a method FDA now claims is not sufficient. The EU prohibited it in 1999, almost immediately after FDA approved the testing methods at issue here, and Canada banned it in 2006.

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. Before 1983, only 38 orphan drugs had received U.S.

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Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Usually at this point in a post we would identify the date of approval of the relevant NDA. But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ?

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NIH Director's Blog: Drug Development

JUNE 14, 2016

That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. 2016 Jun 1;8(341):341ra76. [3] 2016 March 4. [5] December 2008. [2] Scott RA, Freitag DF, Li L, Chu AY, Ehm MG, Wareham NJ, Waterworth DM, et al. Sci Transl Med. Novo Nordisk.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved. 2016 Feb 29. With PRISM, it’s now feasible to screen entire small molecule libraries across large panels of cancer cell lines. Nat Biotechnol.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 was submitted on December 8, 2016 (Docket No.

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Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

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NIH Director's Blog: Drug Development

JULY 20, 2017

Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. The first major advance in molecularly targeted drug treatment for the disease came in 2012, when the Food and Drug Administration (FDA) approved ivacaftor (Kalydeco). People with CF have a misspelling of both copies of the CFTR gene, one inherited from each parent.

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The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. UNIVERSE was conducted in two parts.

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The Pharma Data

JANUARY 31, 2021

Having raised more than USD $350 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Data on File, Allergan, 2016; Clinical Study Report Satisfaction Table. . . .

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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The Pharma Data

DECEMBER 3, 2020

Having raised more than USD $350 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag © technology platform to develop novel biologics targeting trimerization-dependent pathways. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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The Pharma Data

AUGUST 30, 2021

In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities.

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Codon

MARCH 28, 2023

The meeting took place before the launch of Neuralink, in July 2016. DARPA invested more than $200 million in support of the White House’s Brain Research through Advancing Innovative Neurotechnologies ( BRAIN ) Initiative between 2014 and 2016 alone. The company was not publicly unveiled until the following year.)

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The Pharma Data

DECEMBER 15, 2020

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Four comments were submitted to the docket established for the 2015 Petition.

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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2016 May;34(5):531-8. Epub 2016 Apr 11. 2016 May;135(5):477-483. Epub 2016 Mar 11. 2016 Nov 4;354(6312):aag0839. Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023. DOI: 10.1101/2023.02.07.23285407. PMID: 35804044.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. § at 53,700; 81 Fed.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

DEA and HHS last considered rescheduling cannabis in 2016. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. The 2016 review concluding that cannabis remain in schedule I was dependent on several factors.

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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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Broad Institute

APRIL 25, 2024

Christian Happi Christian Happi However, in other parts of West Africa , Ebola was spreading, infecting nearly 29,000 people and killing more than 11,000 before the outbreak was contained in 2016. This year they began testing for 19 bloodborne pathogens such as Ebola, yellow fever, Lassa, and HIV.

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FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. A different therapeutic modality was pursued by Avexis, working with Novartis.

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The Pharma Data

DECEMBER 30, 2020

billion in cash to gain control of FDA-approved Palforzia , a first-of-its-kind treatment for patients with peanut allergies. Nestlé has been a longtime partner of Aimmune, first investing in the company in 2016. Nestlé and Peanut Allergies – In August, Nestlé Health Science acquired the outstanding stakes of Aimmune for $2.6

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Molecular Design

OCTOBER 14, 2018

I've included some photos to break up the text a bit and these are from a 2016 visit to the north of Vietnam. The first was reported in 2014 by AstraZeneca( 16 ) and the second in 2016 by academic researchers and called Badapple.( I'll start with this one taken from the western shore of Hoan Kiem Lake the night after the supermoon.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study.

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The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. UNIVERSE was conducted in two parts.

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The Pharma Data

FEBRUARY 13, 2022

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years). About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

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The Pharma Data

DECEMBER 21, 2020

2016:8;S494-S497. Related Articles: Tagrisso (osimertinib) FDA Approval History. LUNGevity Foundation. Types of Lung Cancer. Available at [link] Accessed August 2020. Sethi S, et al. Incidental Nodule Management – Should There Be a Formal Process? Journal of Thorac Onc. LUNGevity Foundation. Screening and Early Detection.

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Codon

JUNE 18, 2024

By 2016, Shapiro had set up a research laboratory at the California Institute of Technology in Pasadena and began to devote his attention entirely to gas vesicles. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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Agency IQ

JULY 8, 2024

During a House Energy and Commerce (E&C) Health Subcommittee meeting , Woodcock explained that certain medical gases have been used for so long in medicine that they actually predate the establishment of the FDA’s review practice and thus, were technically being used without any sort of FDA approval.

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Agency IQ

OCTOBER 27, 2023

December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

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