European Pharmaceutical Review

MARCH 7, 2024

Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024. He then worked at BCG from 2004 to 2011, where he developed expertise in the energy, engineering, and high-tech sectors.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. This t-AI would be used for ≤12 months.

Food and Drug Administration 87

Food and Drug Administration Pharmaceutical FDA Medicine 87

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings. Tecfidera was approved in 2013 to treat MS, and in August 2020, Mylan launched its first FDA-approved dimethyl fumarate generic to the market.

Government 59

Government Specialization Physicians Education 59

PM360

APRIL 7, 2023

a company from the University of Illinois at Chicago will be building upon 19 years of research and the first-in-human pilot clinical trial of immunoglobulin drops, while Grifols , a global leader in plasma-derived therapies, committed to funding the development though FDA approval and commercialization. Selagine, Inc. ,

Healthcare 52

Healthcare Healthcare Government Consulting 52

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

FDA 52

FDA Patients Sales Marketing 52

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

World of DTC Marketing

MARCH 17, 2022

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. American Cancer Society’s ACS ).

Food and Drug Administration 255

Food and Drug Administration Medical Ethics Patients 255

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. While Zolgensma is also being investigated in the form of an injection, the MOA currently approved by the FDA is a single infusion.

Food and Drug Administration 69

Food and Drug Administration Government Healthcare Healthcare 69

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma 122

Pharma Food and Drug Administration Manufacturing Medicine 122

World of DTC Marketing

MAY 2, 2022

The work for Purdue began in 2004 and continued for 15 years as opioid-related deaths surged. Still, they said nothing about the CEO, who will take home over $18 million in compensation, or the fact that the drug should never have been submitted to the FDA without a lot more data. Will MBA spreadsheet marketers sink pharma more?

Consulting 234

Consulting Doctors Pharma Sales 234

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. The FDA’s Modernization Act 2.0

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

Cadensee

JULY 20, 2021

When he was going through his cancer, he died in 2004. So, you see on one side, there's a special body of the FDA trying to listen to patients to find new targets for health and for pharmaceutical technology. There're much more paved roads than, let's say 6 or 7 years ago, when the FDA didn't know how to improve it.

Food and Drug Administration 52

Food and Drug Administration Doctors Healthcare Healthcare 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

Pharmaceutical 97

Pharmaceutical Doctors Healthcare Provider Prescription 97