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12 May 2024, 9:03 pm by News Desk
Warning letters often are not issued until a company has been given months to years to correct problems. [read post]
15 Mar 2024, 12:35 pm by Aaron Mackey
  Online services have even less ability to read through the millions (or sometimes billions) of pieces of content on their services than a bookseller or distributor In Bantam Books, Inc. v. [read post]
13 Mar 2024, 7:24 pm by Kurt R. Karst
§ 1.750, applicant is required to submit the following to the USPTO: Evidence that Biogen MA Inc. is expressly authorized to rely upon the regulatory review activities by Biogen, Inc., the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. [read post]
13 Feb 2024, 9:05 pm by renholding
They begin with rules on Universal Proxy (11/17/21), implementation of the Holding Foreign Companies Accountable Act (12/2/21), and Proxy Advisors (7/13/22), and end with rules on Conflicts in Securitizations (11/27/23), Treasury Market Clearing (12/13/23), and SPACs (1/24/24). [read post]
4 Jan 2024, 2:00 am by Kelly Fitzsimmons
” Other human factors such as hiring, training, coverage for sick days or PTO, and drug testing requirements would be eliminated by ATs. [read post]
20 Dec 2023, 5:00 am by Timothy Bonis
Whether Amgen will be good or bad for established drug companies or startups remains unclear. [read post]
7 Dec 2023, 1:47 pm by Dennis Crouch
Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1333 (Fed. [read post]
30 Oct 2023, 8:51 am by jonathanturley
  The packaging makes it easy for homeowners to confuse packages and give out drugged candy. [read post]
19 Jul 2023, 10:30 am by Tom Lamb
We are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who developed occlusive retinal vasculitis, eye inflammation, vision loss, or blindness after receiving Syfovre injections. [read post]
9 Jun 2023, 8:36 am by Ashwin Varma
The  commission believes that Amgen will be able to offer discounts on its existing portfolio of blockbuster products in order to secure quasi-exclusive “preferred placement” on insurance-company formularies, thereby blocking potential rivals to Horizon’s new rare-disease drugs from entering the market. [read post]
9 Jun 2023, 8:36 am by Ashwin Varma
The  commission believes that Amgen will be able to offer discounts on its existing portfolio of blockbuster products in order to secure quasi-exclusive “preferred placement” on insurance-company formularies, thereby blocking potential rivals to Horizon’s new rare-disease drugs from entering the market. [read post]
26 May 2023, 9:08 am by Zak Gowen
Federal Trade Commission has filed a lawsuit to stop Amgen Inc’s $27.8 billion acquisition of Horizon Therapeutics Plc in a rare move to block a large pharmaceutical deal. [read post]
19 May 2023, 9:45 am by Eric M. Fraser
ShareThe Supreme Court on Thursday ruled against the drug company Amgen, which had sued Sanofi for infringing Amgen’s patent on antibodies that lower LDL cholesterol, sometimes called “bad” cholesterol. [read post]
18 May 2023, 11:12 am by Eugene Volokh
{Plaintiffs have not presented any case holding such a company liable for merely failing to block such criminals despite knowing that they used the company's services. [read post]
1 May 2023, 2:06 pm by Coral Beach
Food and Drug Administration confirmed for Food Safety News that some of the recalled flour had been sent in bulk to food-producing companies. [read post]
8 Apr 2023, 8:16 am by Bruce Clark
The Food and Drug Administration says enoki mushrooms distributed by Utopia Foods Inc. of Glendale, NY, and imported from China, and enoki mushrooms labeled as “Producer: Shandong Youhe Biotechnology, Co. [read post]
7 Apr 2023, 9:06 pm by Coral Beach
The Food and Drug Administration says enoki mushrooms distributed by Utopia Foods Inc. of Glendale, NY, and imported from China, and enoki mushrooms labeled as “Producer: Shandong Youhe Biotechnology, Co. [read post]
2 Apr 2023, 9:01 pm by News Desk
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]