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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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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The Pharma Data

DECEMBER 18, 2020

J Am Soc Nephrol (2012); 23:1631-1634. Related Articles: Roxadustat FDA Approval History. National Institute of Diabetes and Digestive and Kidney Diseases. Anemia in Chronic Kidney Disease; 2014 [cited 10 December 2020]. Available from: URL: [link] 2. Babitt JL, Lin HY. Mechanisms of Anemia in CKD. Am J Kidney Dis. .

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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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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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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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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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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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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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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. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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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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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

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

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

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

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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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

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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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

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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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

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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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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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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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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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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Drug & Device Law

MAY 11, 2023

It may very well fall to a rehearing en banc and/or the Supreme Court—each stocked with mostly “conservative” jurists—to restore some sanity to the mad world where FDA approvals can be wiped out retroactively more than two decades later. Brief at 19-20 (quoting Coalition for Mercury-Free Drugs v. Sebelius , 671 F.3d

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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

JANUARY 30, 2023

387 (2012), immigration case, again rejected obstacle preemption as giving force to “judicially divined legislative purposes” Nothing in the text of federal immigration statutes “indicates that Congress intended enforcement. . . Mensing , 564 U.S. United States , 567 U.S. Albrecht , 139 S.Ct.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. The only avenue recognized in Albrecht for unilaterally changing an FDA-approved drug warning was “if the change complies with the CBE regulation.”

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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

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

FEBRUARY 2, 2023

2012 WL 956192, at *5 (S.D. March 19, 2012); Holland v. Atkinson pointed out that the main exception – fraud on the FDA − to this otherwise not easily rebutted presumption of warning adequacy is preempted. 2012) (applying Texas law). Centocor, Inc. Hamilton , 372 S.W.3d 3d 140, 165 (Tex. Long before that, In Reyes v.

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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

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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