The Pharma Data

DECEMBER 21, 2020

2013:6;2800-12. 2013:66;79-89. Related Articles: Tagrisso (osimertinib) FDA Approval History. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. Keedy VL, et al. J Clin Pathol.

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The Pharma Data

JANUARY 6, 2021

Professor in the School of Medicine in the Department of Molecular and Cellular Physiology, and in Neurology, Psychiatry and Behavioral Sciences at Stanford University, a 2013 Nobel Prize winner in Physiology/ Medicine, a Howard Hughes Medical Institute investigator, and Chair of CytoDel’s Scientific Advisory Board. “We Südhof, M.D.,

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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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Vial

JUNE 12, 2024

To improve how it assesses the benefit of positive PROs in HF, for example, the FDA works with academia to explore how previously developed PRO instruments may be modified to capture outcomes of diverse patient groups adequately. Use of PRO assessments Specifically for oncology drugs, Moore et al.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Advarra

JULY 19, 2022

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? A: It depends, but the answer is usually yes. of this guidance. of this guidance.

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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. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

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Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

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Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

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The Pharma Data

OCTOBER 14, 2020

Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges. 2013 Aug;62(8):1293-301. Epub 2013 Apr 30. Cancer Immunol Immunother. doi: 10.1007/s00262-013-1400-3. iv Osada T, et al.

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The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) . Atlas of MS 2013. Adv Studies Pharm.

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Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. BTK signaling is needed by specific cancer cells to multiply and spread.

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The Pharma Data

SEPTEMBER 10, 2021

Overview of the Population of Patients with Advanced Parkinson’s Disease (aPD) Initiating Therapy with Levodopa-Carbidopa Intestinal Gel (LCIG): POMPE-PARK Study on French Health Insurance Data (2013-2017). BOTOX ® Abstracts. OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. BTK signaling is needed by specific cancer cells to multiply and spread.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Through this program, the FDA can conduct periodic stability testing on select products and extend the labeled shelf life accordingly.

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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. 10, October 2013 , pp 1600–1607. 3 In August 2019 , RINVOQ received U.S. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Data on File, ABVRRTI64959.

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The Pharma Data

NOVEMBER 4, 2020

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. 500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times.

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New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

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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. Drug Discovery Today , 18(13-14):659666, 2013. 5 Macrocycles as drugs Despite accounting for just four percent of the U.S.

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Agency IQ

MAY 3, 2024

As described in the guidance, the FDA “intends to look at the testing needs of the emergency response,” including “the number of, and access to, FDA-approved/authorized tests available and how time sensitive the need for a test is.” Factor 1: Need.

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Codon

NOVEMBER 1, 2024

This technique " opens large windows into the cell’s interior ," according to a 2013 review, allowing visualization of hidden structures that can’t be easily extracted or crystallized. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. Credit: SIngh U.S.

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Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

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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. Cartridge Co. ,

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Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. FDA , 715 F.3d 2013) (Kavanaugh, J.). Cytori Therapeutics, Inc. 3d 922, 927 (D.C.

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Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 13) McGee v.

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Drug & Device Law

DECEMBER 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. A lawyer who never loses doesn’t litigate hard cases.

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Drug & Device Law

NOVEMBER 2, 2023

Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. The defendant in Zyla is a qualifying compounding pharmacy that sells without FDA approval a compounded product containing the active ingredient found in the plaintiff manufacturer’s FDA-approved product. Mukasey , 536 F.3d

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 715 F.3d

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Drug & Device Law

OCTOBER 13, 2023

2466, 2471 (2013). It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is undisputed that, at the time the FDA approved the first TDF-based drug, the plaintiff’s proposed “alternative” was not approved, and would not be approved for another 10+ years.

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Drug & Device Law

OCTOBER 10, 2023

2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Nidek Co. , 3d 1109, 1119 (9 th Cir.

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Drug & Device Law

OCTOBER 6, 2023

472 (2013), and (3) express OTC drug preemption under 21 U.S.C. 379r, should preclude some (but hardly all) state abortion-related bans – particularly when states purport to target the availability of FDA-approved drugs for their FDA-approved indications. Plaintiffs Legal Committee , 531 U.S. Bartlett , 570 U.S.

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Drug & Device Law

SEPTEMBER 22, 2023

472 (2013) is worth consideration as well. 379r(e) product liability savings clause Id. at 1283-87. The second is that OTC monographs impose federal requirements—including labeling requirements—on the drugs they cover, and manufacturers are not free to unilaterally change them. As a result, implied preemption derived from PLIVA, Inc.

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Drug & Device Law

AUGUST 31, 2023

472 (2013), because “[i]t would be impossible for [the manufacturer] to comply with both its state duty to change the composition of [the biologic] and its duty under 21 C.F.R. b)(2) not to make such a change without first obtaining FDA approval.” Bartlett , 570 U.S. 2023 WL 5437356 at *7­. Note, however, the caveat.

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Drug & Device Law

AUGUST 3, 2023

472 (2013), had not arrived and plaintiffs had not stopped suing over alleged injuries from generic drugs. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. For instance, in 2012, the impacts of the decision in PLIVA, Inc. Mensing , 564 U.S.

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