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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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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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

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]. 2012 Jul 6;337(6090):100-104. [4] 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial. Novo Nordisk. 2016 March 4. [5]

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NIH Director's Blog: Drug Development

JULY 20, 2017

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). About 30,000 Americans have CF. As exciting as that was, we knew it represented just the first step on a challenging road to helping all people with CF.

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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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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2012 Apr 30;11(5):349-50. Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023. DOI: 10.1101/2023.02.07.23285407. Ochoa D, Karim M, Ghoussaini M, Hulcoop DG, McDonagh EM, Dunham I. Nat Rev Drug Discov. 2022 Aug;21(8):551. PMID: 35804044.

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The Pharma Data

NOVEMBER 26, 2020

Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix’s unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc.

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Codon

AUGUST 26, 2024

In 2012, a research group at MIT isolated the major components of mucus from pig stomachs (“porcine gastric mucins”) and tested its ability to inhibit infections caused by human papillomavirus, influenza virus, and Merkel cell polyomavirus. PCANS can be freely purchased online. A look inside Panoplia Laboratories.

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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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Agency IQ

JUNE 7, 2024

One is Prevagen (Apoaequorin; Quincy), a dietary supplement marketed as a memory enhancer, which received a denial in 2012. Although this product has received continued scrutiny because of its advertising claims, its presence on the market despite a denied NDIN has never resulted in action from the FDA.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. 110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub.

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The Pharma Data

DECEMBER 29, 2020

Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries.

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Agency IQ

JULY 8, 2024

Six years later with the reauthorization of several FDA-industry user fee programs in 2012, Congress took the opportunity to set a series of policy changes into motion. FDASIA also addressed a challenge cited by then-CDER Director JANET WOODCOCK when she testified before Congress in March 2012 on medical gases.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. “Globocan 2012: Prostate Cancer: Incidence, Mortality and Prevalence Worldwide, 2012.” 2 ERLEADA ® received U.S. Accessed February 2021. iii] World Health Organization.

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Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. Stimulant use disorder is acknowledged in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with severity levels ranging from mild to severe.

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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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Agency IQ

JUNE 16, 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. The rule, will also, if finalized, address communication with State boards of pharmacy.

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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

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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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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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. Tax Petition. In July 2021, we filed a petition in the U.S.

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The Pharma Data

OCTOBER 21, 2020

Shionogi joined in October 2012. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Such factors include, but are not limited to, those described under Item 3.D Source: GSK . Posted: October 2020. Source link.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. 2012 Feb;26(1):147-56. 2 In August 2019 , RINVOQ received U.S. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. Duarte G.V.,

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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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The Pharma Data

OCTOBER 9, 2021

Currently there are no FDA-approved treatments for EoE. Amgen collaboration In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for tezepelumab. Patients are often treated with corticosteroids to manage inflammation. In EoE, a Phase III trial is planned.

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The Pharma Data

AUGUST 22, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. FDA-APPROVED INDICATIONS. Rheumatoid Arthritis.

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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. It’s a history of gene therapy told through the voices of the patients, families, researchers, and clinicians behind the first FDA approvals, which didn’t come until 2017.

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PLOS: DNA Science

FEBRUARY 27, 2025

.” I’ve attended Rare Disease Day celebrations, and befriended many families while and since writing The Forever Fix: Gene Therapy and the Boy Who Saved It , published in 2012. DNA Science has covered Rare Disease Day for years – links are at the end of this post.

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Drug Target Review

JANUARY 16, 2025

Food and Drug Administration (FDA) approved drugs, macrocycles are used to combat a range of diseases, including cancer, viral, fungal and bacterial infections, neurodegenerative and autoimmune diseases. Advanced Drug Delivery Reviews , 64:417, 2012. 5 Macrocycles as drugs Despite accounting for just four percent of the U.S.

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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. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.

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Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. Hamilton , 372 S.W.3d

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Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. For instance, in 2012, the impacts of the decision in PLIVA, Inc. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. Mensing , 564 U.S.

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Drug & Device Law

JULY 24, 2023

Apparently, plaintiff’s statistician, in considering the post-2011 decline in Actos sales, did not deem it important that generic versions became available in August 2012. We searched PATDC82 II for the word “generic” – it does not appear. The data were then rotely applied to all the earlier years.

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Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

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