The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

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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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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. New Haven, CT. and > 300 mg/mL at lower pH pKa 4.8

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The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health.

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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. Takeda Pharmaceutical Co. , 3d , 2023 WL 4191651 (C.D.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The G/N MDL was created in 2013 and mostly settled in 2016. Forest Pharmaceuticals, Inc.

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Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , 2013); Massa v. Luitpold Pharmaceuticals, Inc. , Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law.

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Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. FDA , 715 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

MAY 19, 2022

Mutual Pharmaceutical Co. 2466, 2475 (2013). In concluding plaintiff plausibly alleged a design defect, the court relies heavily on the “nearly 600” adverse events reported to the FDA — creating a classic case of damned if you do, damned if you don’t. Bartlett , 133 S.

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Drug & Device Law

OCTOBER 6, 2023

341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. 472 (2013), and (3) express OTC drug preemption under 21 U.S.C. Food and Drug Administration (FDA)-approved drugs (both prescription and OTC) that are part of medication abortion and emergency contraception medical treatments.

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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

AUGUST 31, 2023

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. 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. Bartlett , 570 U.S. Courts are divided.

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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. 472 (2013). (See As we discussed here , McCormack v. Hiedeman, 694 F.3d

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Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. 627, 636 (2013).

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Drug & Device Law

MARCH 25, 2022

Just as the previous Fosamax MDL judge had back in 2013, the current Fosamax MDL judge found all of the plaintiffs’ claims (only warning claims appear now to be at issue) preempted – only this time as a matter of law under Albrecht. 604 (2011), and Mutual Pharmaceutical Co. 472 (2013), apply to prescription drug preemption as well?

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Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. Bartlett , 570 U.S. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

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Drug & Device Law

FEBRUARY 22, 2024

Instead of highlighting the cognitive dissonance of the possibility that both of these theories of liability could be viable, we could be touting the creativity of the plaintiff lawyers trying different approaches to force pharmaceutical companies to play an unfun version of Simon Says.

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Drug & Device Law

MARCH 16, 2023

472 (2013). Since the appellate decisions in Wimbush and Lance , few courts have expressly recognized a “stop selling” cause of action for FDA-authorized medical products. But sue she did, so Beaver ends up as another case rejecting the silly stop selling theory of liability for an FDA-approved drug. Mensing , 564 U.S.

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Drug & Device Law

OCTOBER 13, 2023

Ortho-McNeil-Janssen Pharmaceuticals, Inc. , 2015), and the Supreme Court’s opinion in Mutual Pharmaceutical Co. 2466, 2471 (2013). It makes no difference in our view that the FDA ultimately approved TAF-based drugs. Gilead Sciences, Inc. , 18-cv-06972, 2023 WL 6390598, at *3 (N.D. 3d 281 (6th Cir.

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Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 604 (2011), and Mutual Pharmaceutical Co. 472 (2013) is worth consideration as well. It is fair to say that Bexis co-founded this blog (in 2006!) 379r(a)(1). 379r(e) product liability savings clause Id.

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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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New Drug Approvals

APRIL 27, 2025

13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] November 2013). billion in 2004. [23]

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New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Jump up to: a b c d e f g h i j k “FDA approves imaging drug for evaluation of myocardial ischemia” U.S. Food and Drug Administration (FDA). 2013 Jan 29;61(4):469-477.

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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. Pharmaceuticals , 16(7):996, 2023. Yusof I, Segall MD. Springer, 2019.

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New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2013 Jun 11;110(24):9992-7. June 2013). Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S.

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Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. 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.

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