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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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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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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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

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

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

Securities and Exchange Commission Regulation G. 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. Use of Non-GAAP Adjusted Financial Information.

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Agency IQ

MAY 3, 2024

With the new LDT final rule, FDA works to clarify what emergency response will look like going forward The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations. In the U.S. IVDs are defined at 21 CFR 809.3(a), The rule amends 21 CFR 809.3(a)

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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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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

FDA litigation that is now before the Supreme Court. 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. We were hardly alone. See AHM I , 2023 WL 2825871, at *4 n.9

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Drug & Device Law

DECEMBER 29, 2023

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. The G/N MDL was created in 2013 and mostly settled in 2016. 3d , 2023 WL 5807340 (D. Better late than never. 13) McGee v.

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. 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 ). 4th 210 (5th Cir. Gilead Sciences, Inc.

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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 , 727 F.

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Drug & Device Law

OCTOBER 10, 2023

Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” That’s the FDA’s job, not the court’s. Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Nidek Co. ,

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Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). 472 (2013) is worth consideration as well.

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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. FDA also says so, which the Supreme Court noted in Mensing. Mensing , 564 U.S.

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Drug & Device Law

MAY 11, 2023

398, 409 (2013), on the requirement of a particularized injury—but did not apply them correctly, as far as we are concerned—it did not cite Summers and account for its rejection of statistical arguments that some member of a plaintiff organization is likely to suffer a concrete injury at some point in the future. Brief at 11 n.1.

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Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. Ortho-McNeil-Janssen Pharms., 3d 281 (6th Cir. Bartlett , 570 U.S.

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Drug & Device Law

MARCH 2, 2023

Plaintiffs alleged that they had these contraceptive devices implanted between 2011 and 2013 (presumably in Georgia), and later suffered some combination of a wide range of symptoms that they attributed to “migration” of the device. That should not pass the smell test, but the court did not analyze (sniff?) as to each claim by each plaintiff.

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Drug & Device Law

JANUARY 30, 2023

472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. Levine , 555 U.S. 555 (2009), and rated only a “ cf. citation in PLIVA, Inc. Mensing , 564 U.S.

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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. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. 12 (citation and quotation marks omitted).

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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. 627, 636 (2013). The disputed regulations ostensibly regulated how health care providers and pharmacists could prescribe and/or dispense the targeted drug.

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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

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. 472 (2013), apply to prescription drug preemption as well? 3d , 2022 WL 855853 (D.N.J. Answer: yes.

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Drug & Device Law

MARCH 22, 2022

15, 2022), was 15 years old in 2013 when her mother consented to plaintiff receiving the Gardasil vaccine. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. The plaintiff in Herlth v. Merck & Co. , 2022 WL 788669 (D.

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