The Pharma Data

JANUARY 5, 2021

These children often miss school and social activities due to doctors’ visits or health restrictions. For the study, the researchers reviewed medical records of close to 119,000 kids, aged 4 to 17, who were treated at Texas Children’s Hospital in Houston more than once between 2011 and 2016. ” she said.

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The Pharma Data

APRIL 28, 2021

Food and Drug Administration (FDA) and for SKYRIZI ® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. “We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals.” NORTH CHICAGO, Ill.

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Agency IQ

SEPTEMBER 15, 2023

Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure. The trials assessed change in nasal congestion score over one week of treatment.

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The Pharma Data

JUNE 26, 2021

CLICK TO TWEET : @JanssenUS announces NDA submission to @US_FDA for two new potential pediatric indications for the treatment and prevention of #bloodclots. EINSTEIN-Jr is the largest pediatric study completed to date for the treatment of VTE. for use in pediatric patients. Learn more: [link].

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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.

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Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. His mother had a presentation of the disease that suggested her immune system was already on the job.

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The Pharma Data

NOVEMBER 10, 2020

Hydrogen-Oxygen Inhalation for Treatment of COVID-19, a monograph concluding China’s experience in the fight against COVID-19, reports that Hydrogen Oxygen Generator with Nebulizer is effective in treating patients with COVID-19 coronavirus. SHANGHAI , Nov.

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The Pharma Data

OCTOBER 25, 2020

Real-world effectiveness data on Oxbryta ® (voxelotor) in the treatment of sickle cell disease featured as oral presentation. Two abstracts have been accepted for presentation, including real-world effectiveness data of Oxbryta ® (voxelotor) tablets in the treatment of sickle cell disease (SCD). SOUTH SAN FRANCISCO, Calif., .

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The Pharma Data

DECEMBER 3, 2020

New preclinical data provide additional evidence of the potential for TANGO antisense oligonucleotides (ASOs) to provide a gene-specific, disease-modifying treatment for Dravet syndrome. In this study, treatment with a TANGO ASO restored Dravet syndrome mouse PV interneuron firing frequency to that of wild-type mice. Lori Isom, Ph.D.,

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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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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

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Drug & Device Law

MAY 19, 2023

In 2011 (during the Obama Administration), the FDA completed the REMS for mifepristone, mandating that it “only be prescribed by certified physicians, dispensed in certain healthcare facilities, and taken in the provider’s clinic.” That argument contravened the standing holdings of just about every other abortion case in history.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. 1 (highlights). 3d at 1247. PATDC82 I , 943 F.3d 3d at 1251.

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.

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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 ). 2011), aff’d , 741 F.3d See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. The court in Gross v.

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Drug & Device Law

MARCH 31, 2023

Criticizing attempts to sue publishers of scientific content, here in 2011, and again, here in 2013. Ridiculing a blatantly unconstitutional Missouri statute that sought to silence pharmacists critical of ivermectin and hydroxychloroquine as treatments for COVID-19, just yesterday.

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Drug & Device Law

MAY 10, 2022

The second part of the Act is likewise geared toward preventing confusion or misleading the public but by requiring certain disclosures accompany all ads concerning drugs and devices approved by the FDA: Such advertisements must include the warning: “Do not stop taking a prescribed medication without first consulting with your doctor.

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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. 2011) (no causation where “at the time of her deposition ? Schering Corp. , Accord Dietz v.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” at *3 (emphasis original).

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Drug & Device Law

DECEMBER 11, 2023

May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. July 11, 2011)); here (discussing Stone v. Defendant] does not deny that it, the doctor, and the hospital are potential joint tortfeasors. . . . Zimmer, Inc.

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Drug & Device Law

FEBRUARY 10, 2022

2011 WL 3583743, at *5 (S.D. 2011), for the proposition that a “patient’s negligent misrepresentation claim based on [a] failure to warn is not barred as a matter of law by the learned intermediary doctrine.” The court cited Mardegan v. Mylan, Inc. It seems, however, that Florida has not adopted either provision as its own.

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Drug & Device Law

OCTOBER 30, 2023

This medical causation theory was outlined in a 2011 memo authored by the defendant’s then-chief medical officer, which touched off the ensuing storm of litigation. Their “experts testified that a physician would not be expected” to change a any treatment before using the product with a low bicarbonate level patient.

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