Sandoz drugs Jubbonti and Wyost are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies.
The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia. The osteoporosis drug’s black box warning follows an FDA review of Centers for Medicare & Medicaid Services studies that found Prolia led to a significant increase in the risk of severe hypocalcemia compared to treatment with an older class of medicines.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.
The Federal Trade Commission is suing to stop Amgen’s acquisition of Horizon Therapeutics. But rather than claiming product overlap, the agency contends Amgen will use its influence to keep at bay competition for Horizon’s products.
Amgen’s Lumakras became the first FDA-approved drug that addresses the elusive KRAS mutation, but Mirati believes its newly approved therapy, Krazati, could be better. The small molecule’s features include the ability to penetrate into the brain, where it can address cancer that has spread to the central nervous system.
Sanofi submitted the first unsolicited offer to acquire Horizon Therapeutics, but Amgen ultimately won what became a competitive bidding process. Amgen says Horizon's drug lineup complements its own portfolio of autoimmune and inflammatory disorder products.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
An Amgen drug led to weight loss that was sustained, clinical data that support advancing the molecule to a Phase 2 test expected to start in early 2023. While AMG 133 trails rival products from Novo Nordisk and Eli Lilly, Amgen hopes to offer patients a dosing edge.
Amgen posted positive Phase 2 data for olpasiran, further building the case for the drug's blockbuster potential in heart disease as it proceeds to a pivotal test. Arrowhead Pharmaceuticals, which originally developed olpasiran and licensed it to the big pharma company, is cashing in now by selling its royalty rights to the molecule.
Amgen said its drug Lumakras met the main goal of a Phase 3 study in non-small cell lung cancer driven by a particular genetic mutation. The pharmaceutical giant offered no specifics, but the results set the stage for an interesting regulatory race with a rival drug from Mirati Therapeutics
Amgen’s drug portfolio boasts several biologic drugs that are blockbuster sellers. In acquiring ChemoCentryx for $3.7 billion, the pharmaceutical giant gains a company entirely focused on developing small molecule alternatives to biologic medicines.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health startups navigate the regulatory process.
The American Society of Clinical Oncology’s annual meeting begins this week, including the presentation of more than 2,800 abstracts. Amgen, Roche, and Sierra Oncology are among the companies with key presentations at this year’s gathering.
How Embark® App combines a medical and digital approach to support patients in managing their Enbrel® (etanercept) treatment.
Neumora Therapeutics unveiled $500 million in capital and a research partnership with Amgen. The startup analyzes neurological data to inform its drug research and development; President and Chief Operating Officer Lori Lyons-Williams said researching psychiatric drugs and neurodegenerative drugs within the same company allows brain insights from one area to inform the other.
Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.