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Home » Keywords » Amgen Inc.

Items Tagged with 'Amgen Inc.'

ARTICLES

Red blood cells in an artery with cholesterol

In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

June 9, 2025
By Lee Landenberger
No Comments
In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication.
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Digital globe illustrating pharma trade, tariffs

Navigating the Trump tariffs, part two: Amgen, Biogen, others

May 9, 2025
By BioWorld staff
No Comments
As biopharma companies continue to roll out their first-quarter  earnings, Trump administration tariffs remain at the top of investors’ minds. While executives offer their various strategies to appease concerns, the uncertainty prevails, making it difficult to clearly satisfy all of the questions.
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Cassidy calls on US Congress to fix longstanding 340B flaws

April 25, 2025
By Mari Serebrov
It’s time for the U.S. Congress to finally put some guardrails on the 340B prescription drug discount program it created more than 30 years ago as a way to help fund health care for low-income patients. That’s the overall conclusion of a majority staff report from the Senate Health, Education, Labor and Pensions Committee that follows a years-long investigation into the program.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 15, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 9, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
Read More
Heart scientific overlay

For nearly $2B, Jiangsu Hengrui licenses heart drug to Merck

March 25, 2025
By Lee Landenberger
In a deal that could reach nearly $2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. has licensed a small molecule for treating cardiovascular disease to Merck & Co. Inc., dropping the China-based company into a space with lots of competitors in varying stages of development.
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UK trade association says drug rebate hurting industry

March 20, 2025
By Nuala Moran
Pharma companies in the U.K. said the rebate they are required to make on drug sales is making the country “un-investible,” prompting staff cuts and leading clinical research partnerships to be unwound. Rather than the 15.3% rebate on branded drugs companies expected to pay this year, the rate has leapt to 22.9%. That has left the Voluntary Scheme for Branded Medicine Pricing and Access “in crisis,” according to the Association of the British Pharmaceutical Industries.
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Celltrion wins FDA approval of denosumab, omalizumab biosimilars

March 18, 2025
By Marian (YoonJee) Chu
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
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China accepts NDA of influenza tablet, clears Tepezza biosimilar

March 18, 2025
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
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Celltrion wins FDA approval of denosumab, omalizumab biosimilars

March 12, 2025
By Marian (YoonJee) Chu
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Read More
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