Codon

AUGUST 27, 2024

Doctors in training are told that when they hear hoofbeats, they should think horses, not zebras; rare diseases are the exception, not the rule. Nevertheless, the costs of DNA sequencing have dropped since 2001 , and since 2008 have decreased at a pace more rapid than that which Moore’s Law predicts for computing power.

DNA 87

DNA Laboratories Hospitals Virus 87

The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022.

Science 40

Science Doctors Government Pharmaceuticals 40

PLOS: DNA Science

OCTOBER 5, 2023

Listen to doctors, do research, then finally decide. A 2008 study exonerated the Stockholm subway from causing lung cancer in men. I took the most drastic action – I had reason to believe my case was worse than the others. The car was a hotbed of benzene but the subway car not so bad.

DNA 96

DNA Treatment Science Doctors 96

Drug Target Review

MAY 21, 2024

As an undergraduate and as a doctoral candidate, I studied intestinal biology in a lab that used mostly animal models, because they were the only appropriate models that were available at the time. Vicky’s journey started with a PhD from Cardiff University in 2008, focusing on cancer genetics.

Doctors 59

Doctors Science Research Cell Biology 59

Conversations in Drug Development Trends

NOVEMBER 13, 2024

Despite another kidney infection in the first year, I graduated early in December 2008. I always kept up with my doctor’s appointments and insulin. Then in 2019, my doctor suggested a continuous glucose monitor (CGM) for better control. Still, I refused to let diabetes define me.

Hospitals 64

Hospitals Clinical Trials Doctors Nurses 64

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!

Packaging 52

Packaging Production Doctors International 52

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 96

Science Research Government Cell Biology 96

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. The same considerations ring true for OTC drugs. FDA, for years, has been concerned with overwarning.

FDA Approval 40

FDA Approval FDA Production Drugs 40

The Pharma Data

MAY 15, 2021

And the doctors? I started doing things with my body that not only shocked the hell out of the doctors who told me my best days were behind me… but gave my “glory days” a run for their money. Most programs seemed to be created for young, able bodies. And most trainers didn’t know what to do with a body that had limitations.

Production 52

Production Packaging Doctors Science 52

The Pharma Data

JUNE 28, 2021

The filing of this application in the US is an important step in helping to address the burden of venous thromboembolism and provide doctors with body weight-based dosing options in pediatric patients,” said Dr Christian Rommel, Head of Research and Development and Member of the Executive Committee at Bayer Pharmaceuticals.

FDA 52

FDA Clinical Trials Treatment Therapies 52

The Pharma Data

AUGUST 16, 2020

“We are very optimistic the addition of this new approved treatment option will make a meaningful difference for those living with NMOSD, those who love and support them and the doctors who treat them,” said Victoria Jackson, founder, The Guthy-Jackson Charitable Foundation.

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 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. ,

Production 102

Production Hospitals Pharmaceuticals Doctors 102

Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 2008) (applying the rule; rejecting distinction that “this is a ‘no warning’ case as opposed to an inadequate warning case”), aff’d , 321 F. Sinclair v. Merck & Co. , 2d 587, 595 (N.J.

Production 52

Production Trials Treatment Pharmaceuticals 52

Drug & Device Law

AUGUST 29, 2023

Essentially, all the things doctors and medical device manufacturers do – collaborate on product development and education. 312 (2008). The “conspiracy” was based on the surgeons doing things like attending manufacturer sponsored events, consulting for the manufacturer, and receiving grants and sponsorships. Medtronic, Inc. ,

FDA 59

FDA Doctors Production Marketing 59

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.

Doctors 52

Doctors Production Drugs Treatment 52

Drug & Device Law

OCTOBER 10, 2022

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. , In Ruan , the Supreme Court examined the case of two doctors who were convicted of violating the Controlled Substances Act (“CSA”), 21 U.S.C. § Not so, said the court. 124, 131 n.3

Drugs 52

Drugs FDA Approval FDA Disease 52

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.

FDA Approval 116

FDA Approval FDA Drugs Regulations 116

Drug & Device Law

JUNE 6, 2022

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” 2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal. Schering Corp. , 2d 1140, 1148 (N.J. 1993) (dissenting opinion).

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

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. Our 2008 post discussed Ackermann v. There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries. 2d 1084 (Ariz.

Testimonials 59

Testimonials Doctors Production Laboratories 59

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.”

Testimonials 59

Testimonials Clinical Trials Production Trials 59