The Pharma Data

MARCH 17, 2021

Clyburn joined Merck in 2008 and has had responsibility for numerous global pharmaceutical franchises, including diabetes, cardiovascular and women’s health, as well as leadership of marketing and sales teams. Ireland and Sweden markets as well a variety of roles in commercial operations, business development and investor relations.

Research Laboratories

Agency IQ

APRIL 8, 2024

While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines. To contact the author of this item, please email Rachel Coe ( rcoe@agencyiq.com ).

FDA

The Pharma Data

AUGUST 19, 2021

Gorsky then left the Company in 2004 to join Novartis Pharmaceuticals Corporation, where he served as head of the North American pharmaceuticals business before returning to Johnson & Johnson in 2008 as Company Group Chairman and Worldwide Franchise Chairman for Ethicon in the medical devices business.

Pharmaceuticals

Agency IQ

JUNE 21, 2024

Regulation (EC) No 1234/2008 (Variations Regulation) provides the procedures for implementing the different types of variations. A quick note on annual updates for influenza and coronavirus vaccine: The procedure for submission and assessment of annual human influenza vaccine updates remains the same.

Regulations

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Things got so bad that Congress acted to shield vaccine manufacturers from liability in order to ensure sufficient availability of vaccines. The same considerations ring true for OTC drugs. FDA, for years, has been concerned with overwarning. billion in damages were brought between 1980 and 1986.

FDA Approval

Agency IQ

JUNE 2, 2023

Some exemptions: Vaccine manufacturers are likely to benefit from the FDA’s proposed rule. That’s because FDA states that with “few anticipated exceptions, we propose to exclude manufacturers of preventive vaccines that do not have a Medication Guide from the requirement to create and distribute PMI.”

FDA

Codon

AUGUST 27, 2024

New Yorkers wait to receive a monkeypox vaccine. 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. When an anomaly is detected, a technician comes to remove the filter and analyze the data.

DNA

National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

In 2008, the Mental Health Parity and Addiction Equity Act required insurers to provide benefits for substance use treatment to the same extent they cover other forms of mental health care.

Science

The Pharma Data

DECEMBER 1, 2020

The authors performed an observational analysis of the Boston Birth Cohort between 2008 and 2016 and found that the prevalence of cardiovascular risk factors was higher in U.S.-born AHA: Young Adults With CVD Have Low Flu Vaccination Rates. Garima Sharma, M.D., born Black women. born Black women compared with foreign-born Black women.

Hospitals

The Pharma Data

OCTOBER 6, 2021

In 2008, she spent six months working inpost-conflict Liberia with Population Services International (PSI), anon-governmental order (NGO) that uses social marketing to promote health gestes. Outside of her creative work, Yvonne is saved to her charitable whiles.

Vaccine

Agency IQ

NOVEMBER 20, 2023

The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA). There are two pilots – automated negative control identification and vaccine effectiveness. Following a series of “mini-Sentinel” pilots, the FDA fully launched the system in 2016.

Science

The Pharma Data

MAY 15, 2021

Human Factor Research Group. Grossman, Dave, and Christensen, Loren. On Combat: The Psychology and Physiology of Deadly Conflict in War and in Peace. Warrior Science Publications. ClickBank is the retailer of products on this site. CLICKBANK® is a registered trademark of Click Sales Inc., a Delaware corporation located at 1444 S. Entertainment Ave.,

Production

The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

FDA

The Pharma Data

MAY 13, 2021

2008 Nov 4;105(44):17145-50. DOI: 10.1007/ s10620-016-4054-0. . Solinas M, Chauvet C, Thiriet N, El Rawas R, Jaber M. Reversal of cocaine addiction by environmental enrichment. Proc Natl Acad Sci U S A. DOI: 10.1073/ pnas.0806889105. 0806889105. . Solinas M1, Thiriet N, El Rawas R, Lardeux V, Jaber M.

Disease

Drug & Device Law

DECEMBER 21, 2023

Remember Riegel ( 2008+1 )? We also thought long and hard whether In re Zostavax (Zoster Vaccine Live) Products Liability Litigation , 2023 WL 5044944 (E.D. There was, of course, no California state appellate authority for any of these novel Erie predictions at the time Holley was decided, which is another black mark.

FDA Approval

Codon

AUGUST 10, 2023

Nature Reviews Molecular Cell Biology (2008). Drug Discovery Today: Disease Models (2008). PNAS (2008). Molecular Systems Biology (2008). Craig Venter Higher Animals: Vaccines, Synthetic Biology, and the Future of Life , by Michael Specter What’s Your Bio Strategy? , & Shamir R. Artificial Life (2018).

DNA

The Pharma Data

JANUARY 13, 2021

In May 2020, she temporarily stepped away from her CDER duties to assist Operation Warp Speed and the federal government’s efforts to rapidly develop vaccines against the novel coronavirus. As a career regulator, Woodcock will be seen as a steady hand for the agency until the Biden administration can name a new commissioner.

FDA

Drug & Device Law

MAY 30, 2022

This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. 1981) (applying Virginia law), both of which involved vaccines. Our 2008 post discussed Ackermann v. 2004) (another case we discussed in 2008 ), because the plaintiff failed to “produce[] evidence that the risk. . .

Testimonials

Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

FDA

Codon

APRIL 28, 2025

While initially overlooked, GFP later revolutionized biology and medicine, earning Shimomura a share of the 2008 Nobel Prize in Chemistry. By enabling researchers to “light-up” living cells, GFP has played an indispensable role in neuroscience, cancer research, and even vaccine development.

DNA