FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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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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The Pharma Data

NOVEMBER 4, 2020

“The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. 500 mg/dL) hypertriglyceridemia.

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

MAY 13, 2021

WITHOUT doctors, physical therapists or chiropractors. Our Unique Solution Has Been Featured All Over The Media, From Hallmark, The Doctors, Atlanta Live & Arizona Midday…. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm.

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Agency IQ

JUNE 17, 2024

In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue Two lower courts had articulated a Rube Goldberg-esque theory of “standing” – the right of a person or organization to sue another entity – based on the idea that doctors not prescribing mifepristone or treating patients who had taken it had experienced economic harms.

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The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products. January 29, 2024).

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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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. .

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The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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Codon

NOVEMBER 24, 2024

2 Along the way, they argue that political polarization around IVF has prevented federal-level regulation, resulting in a “ Wild West ” of reproductive technology — a state of affairs that has enabled some abuses (and ineffectual fertility treatments), but allows for greater innovative freedom overall.

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Drug & Device Law

MARCH 19, 2024

Plaintiff did not allege that the design of the clips deviated from the FDA approved design. Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA. The court answered that question affirmatively for plaintiff’s design defect and manufacturing defect claims.

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Drug & Device Law

FEBRUARY 16, 2024

First up was preemption of the design defect claim, and the court made short work of this: [I]t is uncontroverted that Cialis is an FDA-approved prescription medication which, under federal law, Defendant is prohibited from altering its formulation without prior FDA approval. Allied Mut. 2d 262, 266 (9th Cir.

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Drug & Device Law

FEBRUARY 14, 2024

In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss. Lastly, the OPLA (bless it) bars punitive damages against FDA-approved products. Alcon Laboratories, Inc. 2024 Ohio Misc. LEXIS 2 (Ohio Ct.

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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. Studnicki J, Harrison D.J., Longbons T.,

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Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. at *48-*50. at *31, *32.

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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. Adequate directions for use were something given to doctors by manufacturers, not by doctors to anyone else.

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Drug & Device Law

SEPTEMBER 26, 2023

The court’s decision to take judicial notice of defendant’s FDA-approved labeling has not changed. Prescription drug failure to warn claims are preempted unless plaintiff pleads a labeling deficiency that could have been changed via the Changes Being Effected (“CBE”) regulation. Meaning they don’t fit the bill.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F. That’s why Buckman Co. 1, 6 (D.D.C.

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Drug & Device Law

AUGUST 28, 2023

It has generally been assumed that such plaintiffs, while free to seek an advisory opinion from the FDA, may not collaterally attack FDA decisions in other litigation. FDA , 727 F. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. E.g. , Estee Lauder, Inc. 1, 6 (D.D.C.

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Drug & Device Law

AUGUST 3, 2023

To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. Dear Doctor letters are labeling, according to post- Mensing cases and the regulation defining what written communications can create liability for “mislabeling.” LEXIS 18721, *8 n.10.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. The most prominent litigation in this space these days relates to reproductive rights. Ogden , 22 U.S.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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Drug & Device Law

APRIL 20, 2023

This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions. The identified injuries were even more unusual in light of the lack of standing to challenge approval. That is unusual.

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Drug & Device Law

APRIL 17, 2023

Allegations that FDA-approved drug warnings are inadequate justify taking judicial notice of those warnings on a motion to dismiss. Plaintiff included only boilerplate: “lack of adequate warnings proximately caused Plaintiff’s injuries” and had Defendant “adequately warned Plaintiff or his doctors. . .

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Drug & Device Law

APRIL 14, 2023

The only cases the defendant cited in support of its preemption argument were cases in which courts held that plaintiffs’ labeling claims related to Class II devices were preempted because the FDA “had specifically defined the content required to the devices label through a regulation or a specific requirement in a special controls document.”

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Drug & Device Law

NOVEMBER 17, 2022

The complaint did “not allege that the warnings Defendants provided deviated in any way from the language and warnings that the FDA approved. Nor could she claim that defendants “were required to give any warning or instruction beyond the labeling the FDA approved.” emphasis original). Bye-bye warning claims.

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Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. You read that correctly. This is not a new idea.

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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. The disputed regulations ostensibly regulated how health care providers and pharmacists could prescribe and/or dispense the targeted drug. 2022 WL 2276808 (U.S.

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Drug & Device Law

MARCH 22, 2022

The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. Therefore, plaintiff’s failure to warn claim is preempted unless “she has pleaded a labeling deficiency that [defendant] cold have unilaterally changed in accordance with the requirements of the CBE regulation.”

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