The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. ENSPRYNG treatment is administered every four weeks after an initial loading dose. Basel, 17 August 2020.

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The Pharma Data

MAY 14, 2021

Billions of Rubles were spent in this “think-tank” of Olympic Coaches, Special Forces Trainers, Psycho-Physiologists and Biomechanics Researcher Doctors. When you do get out of breath, faster than even a world-class fighter, you’ll recovery your heart rate and amaze your doctors! relaxed and awaken totally refreshed!

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Codon

OCTOBER 22, 2024

However, I think caution is warranted when drawing sweeping conclusions from these studies because they were each conducted over only a decade (between 1998 and 2008) in just two medical journals (the British Medical Journal and The Annals of Emergency Medicine.) These numbers are quite low and do not inspire confidence.

Science 108

Science Research Government Cell Biology 108

Codon

APRIL 9, 2024

In response to the precipitous rise in incidence, governments on both sides of the Pacific began a systematized search for antimalarial treatments. Over the course of 12 years, the Walter Reed Army Institute of Research (WRAIR) screened more than 250,000 compounds in search of an efficacious treatment. Nobody had an answer.

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PLOS: DNA Science

FEBRUARY 3, 2025

Her doctor said this was because she was 6 months pregnant. Karen died on November 16, 2008 – coincidentally, the same date that Dr. Liebman’s father had died 28 years earlier, at age 66, from a presumed heart attack. That is, a genetic disorder is valuable to detect if treatment is possible. Her heart had stopped.

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Disease DNA Doctors Science 84

Alta Sciences

MARCH 4, 2025

Despite having a final FDA guidance issued in 2017 , evolving drug development and treatment modalities continue to prompt important dialogue to adapt existing methods. One example is the recent interest in psychedelics for the treatment of psychiatric disorders, including major depressive disorder.

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Clinical Trials FDA Drug Development Trials 52

Drug & Device Law

DECEMBER 11, 2023

Defendant] does not deny that it, the doctor, and the hospital are potential joint tortfeasors. . . . GlaxoSmithKline , 2008 WL 11515533, at *3 n.10 June 5, 2008) (all finding medical malpractice defendants dispensable in prescription product liability litigation litigation in non-removal situations). Synthes Corp. ,

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Drug & Device Law

DECEMBER 4, 2023

Abuse of substantive law as a weapon to force settlement occurs so frequently in multidistrict litigation (“MDL”), that we’ve given it a name – “the MDL treatment.” The linchpin of the MDL treatment is that plaintiffs are allowed to take way more liberties with state law than the Erie doctrine allows. Sinclair v. Merck & Co. ,

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Drug & Device Law

JULY 27, 2023

Second, so long as one recognizes that the relevant actor is not the patient but the patient’s doctor, the failure-to-read doctrine , under which there can be no proximate causation unless the label is read, applies with equal force in the drug and device context. citing Witt v. Stryker Corp. , App’x 867, 871 (11th Cir. 2016); Bailey v.

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Drug & Device Law

OCTOBER 10, 2022

The drug at issue is the only FDA-approved pharmaceutical treatment for ATTR-CM (although off-label use of other drugs, and organ transplant, are sometimes used as treatments). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

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Drug & Device Law

JUNE 28, 2022

However, one state’s attempt to prohibit doctors in that state from prescribing an FDA-approved opioid did produce interesting precedent (which we previously discussed here and here ). 22, 2008)), aff’d , 919 F.3d See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. 3d 699 (2d Cir.

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FDA Approval FDA Drugs Regulations 116

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. 2008) (applying Texas law and discussed here ), several times. Schering Corp. ,

Testimonials 59

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries. Today we examine it in more detail. at *3 (emphasis original).

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Drug & Device Law

FEBRUARY 21, 2022

11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.”

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