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Amgen, Astra launch real-time trials

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Overview
BioSpace · 6h
Amgen, AstraZeneca join FDA effort harnessing cloud for real-time clinical trials
The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the cloud—a system that could “compress drug development timelines,” Jefferies analysts said.

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Fierce Biotech · 1d
FDA unveils plan for real-time review of clinical trial data, with AstraZeneca and Amgen already on board
 · 1d
US FDA to Monitor Clinical Trial Data in Real Time in Pilot Program Aimed at Speeding Approvals
 · 1d
US FDA to monitor clinical trial data in real time in pilot program aimed at speeding approvals
Program aims to reduce trial delays, cut years off drug approval timelines

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 · 1d
FDA Announces Major Steps to Implement Real-Time Clinical Trials
STAT · 22h
FDA launches effort to speed up clinical trials, using AI
Fierce Pharma
1d

FDA turns up heat on Amgen, proposing to rescind approval of Tavneos

Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker denied the request. Now, the U.S. | The FDA has told Amgen that it is proposing to withdraw the approval of the rare disease drug Tavneos.
5h

Earnings To Watch: Amgen (AMGN) Reports Q1 Results Tomorrow

Biotech company Amgen (NASDAQ:AMGN) will be announcing earnings results this Thursday afternoon. Here’s what investors should know.
BioSpace
1d

FDA alleges ‘manipulated’ data supported approval of Amgen’s autoimmune drug

The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
2don MSN

Pharma bets a little-known form of cholesterol will underpin its next blockbuster heart drugs

Novartis, Amgen and Eli Lilly are betting that slashing levels of a particularly bad form of cholesterol could deliver the next blockbusters in cardiology.
1d

Amgen to Report Q1 Earnings: Can It Keep the Beat Streak Alive?

Amgen heads into Q1 earnings with growth from key drugs offset by pricing pressure, patent losses, and biosimilar competition.
3hon MSN

Amgen Q1 preview: What to expect

Amgen (AMGN) is projected to report a nearly 3% fall in its Q1 earnings on April 30, after the closing bell. The consensus EPS Estimate is $4.77, while the revenue estimate is $8.57B, translating to a 5.
1don MSN

FDA review panel challenges Amgen's Tavneos approval on efficacy, data grounds

The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness,
1d

FDA proposes to withdraw Amgen's drug for rare autoimmune diseases over effectiveness

The U.S. Food and Drug Administration's Center ​for Drug Evaluation ‌and Research on Monday proposed withdrawing approval of Amgen's ​drug for a ​group of rare autoimmune ⁠diseases, citing a lack ​of proven effectiveness and ​untrue statements in the application that led to its ​approval.
Labiotech.eu
16d

Amgen pipeline’s next growth cycle: replacing its old blockbusters

Delve into the pipeline strategy of major biotech Amgen, which is increasingly diversifying its growth engines.
Pacific Coast Business Times
5d

Amgen executive VP/chief tech officer retiring after 21 years

Biotech giant Amgen on April 22 announced the retirement of David Reese, executive vice president and chief technology officer, who has been with the Thousand Oaks-based company for 21 years. Reese, an M.
Morning Overview on MSN
1d

Novartis, Amgen, Lilly target Lp(a) in bid for next heart drugs

Statins cannot touch it. Neither can diet or exercise. Lipoprotein(a), a cholesterol-like particle hardwired into a person’s DNA, circulates at elevated levels in roughly one in five adults and raises the risk of heart attacks,
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