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. That PTE application was submitted to the PTO on July 26, 2012.

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Eye on FDA

JANUARY 16, 2023

In 2012 there were 35 meetings held by FDA for the purpose of considering new drug approval which is almost 3 meetings a month. Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. So that is one – albeit small – way in which AdComms have changed.

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The Pharma Data

DECEMBER 18, 2020

AstraZeneca in CVRM Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. J Am Soc Nephrol (2012); 23:1631-1634. Related Articles: Roxadustat FDA Approval History. National Institute of Diabetes and Digestive and Kidney Diseases.

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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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NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. Furthermore, the next-gen, combo therapies were generally well tolerated and served to improve sweat chloride levels.

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The Pharma Data

DECEMBER 30, 2020

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: December 2020.

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The Pharma Data

NOVEMBER 26, 2020

. As previously announced, the FDA accepted the BLA, granted Priority Review designation under FDA’s Accelerated Approval pathway, and indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. About Pegunigalsidase Alfa.

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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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NIH Director's Blog: Drug Development

JUNE 14, 2016

The study, which analyzed vast troves of genomic and clinical data collected over many years from more than 50,000 people with and without diabetes, indicates that anti-diabetes therapies that lower glucose by targeting the product of a specific gene, called GLP1R , are unlikely to boost the risk of cardiovascular disease. December 2008. [2]

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Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. While stimulant use disorder is increasing, there are currently no FDA-approved medications.

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The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. percent of patients in the combination arm versus 56.2 10 months. [iv]

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The Pharma Data

DECEMBER 29, 2020

Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

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Codon

MARCH 24, 2024

In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease. Kanuma, their FDA-approved protein product for rare lysosomal diseases, is “purified from the egg white of transgenic hens.”

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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). Tax Petition.

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Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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Agency IQ

OCTOBER 27, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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The Pharma Data

OCTOBER 21, 2020

In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days. Source: GSK .

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The Pharma Data

AUGUST 22, 2021

today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

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PLOS: DNA Science

DECEMBER 21, 2023

Martin’s Press was about to publish my book about gene therapy in 2012, my agent urged me to start blogging. The book that kickstarted DNA Science was The Forever Fix: Gene Therapy and the Boy Who Saved It. Was I Overly Hopeful About Gene Therapy? FDA has approved only a handful. Results can vary.

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Agency IQ

DECEMBER 1, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Venclexta, an oral B-cell lymphoma-2 (BCL-2) inhibitor, was previously granted provisional approval in Nov.

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