Zenas Biopharma’s obexelimab achieved a statistically significant and clinically meaningful reduction in signs and symptoms of immunoglobulin G4-related disease, but not to the extent shown by Amgen’s Uplizna in its pivotal study. Still, Zenas points to features of its drug that could make it competitive as a maintenance therapy for the rare autoimmune disorder.

The post Zenas Bio Inflammation Drug Meets Phase 3 Goals, But Is It Enough to Compete With Amgen? appeared first on MedCity News.

September has seen a wide range of executive hires, exits, promotions and layoffs across the healthcare industry. For example, Medtronic, Amgen and Kaiser Permanente welcomed new executives. There were also layoffs at organizations including Novo Nordisk and Seattle Children’s.

The post Healthcare Moves: A Monthly Summary of Hires, Exits and Layoffs appeared first on MedCity News.

Amgen’s experimental obesity drug, MariTide, led to an average 20% reduction in weight in a Phase 2 clinical trial. While investors hoped for greater weight loss, some analysts say less burdensome monthly dosing of MariTide could make it competitive against weekly injectable weight drugs Zepbound and Wegovy.

The post Weight Loss With Amgen Drug in Line With Eli Lilly Med, But Dosing Could Be Differentiator appeared first on MedCity News.

Harvard spinout GRO Biosciences has a platform technology for engineering therapeutic proteins that won’t prompt an immune response against them. The startup’s lead program is a potential competitor to an Amgen gout drug acquired in a multi-billion dollar deal.

The post Aiming to Top Amgen in Gout, Startup GRObio Gets $60M to Enter the Clinic appeared first on MedCity News.

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen drug will become a blockbuster seller.

The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.

Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1.

The post Amgen Puts Its Weight Behind Obesity Drug With Potential Edge Over Lilly, Novo Nordisk Meds appeared first on MedCity News.

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 post FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs appeared first on MedCity News.

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.

The post Amgen Osteoporosis Drug Prolia Is Hit With FDA’s Strictest Warning appeared first on MedCity News.

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 post Amgen, FTC Settlement Allows $28B Horizon Acquisition to Move Forward appeared first on MedCity News.

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.

The post FTC Files Suit to Block Amgen’s $28B Buyout of Horizon Therapeutics appeared first on MedCity News.

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.

The post FDA Approval of Mirati Lung Cancer Drug Sets Stage for Competition With Amgen appeared first on MedCity News.

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.  

The post Amgen to Buy Horizon Therapeutics for $28B, Edging Out Sanofi in Bidding War appeared first on MedCity News.

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.

The post Amgen Weighs In to Chase Rival Obesity Drugs From Novo Nordisk and Eli Lilly appeared first on MedCity News.

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.

The post Arrowhead Gets $250M in Royalty Deal for Cardio Drug Heading to Phase 3 appeared first on MedCity News.

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

The post Amgen’s Phase 3 win in lung cancer puts pressure on Mirati bid for speedy FDA nod appeared first on MedCity News.

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.

The post Amgen’s $3.7B ChemoCentryx acquisition adds a new piece to autoimmune strategy appeared first on MedCity News.

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.

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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.

The post ASCO 2022 ahead: Clinical trial updates and data readouts to watch for appeared first on MedCity News.

[Sponsored] How Embark® App combines a medical and digital approach to support patients in managing their Enbrel® (etanercept) treatment.

The post Speaking the latest language of healthcare: Digital health tech appeared first on MedCity News.

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.

The post Allied with Amgen and backed by $500M, Neumora brings data science to brain drugs appeared first on MedCity News.

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.

The post Amgen adds antibody assets and R&D tech with $900M Teneobio acquisition appeared first on MedCity News.

Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.

The post Eying eczema, Amgen pays $400M to co-develop Phase 3-ready Kyowa Kirin drug appeared first on MedCity News.

FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.

The post Amgen lands first FDA approval for drug targeting elusive mutation in lung cancer appeared first on MedCity News.

The acquisition brings Amgen a novel Phase 3-ready drug for gastric cancers. For Five Prime Therapeutics, the deal is a lifeline following a series of clinical and financial setbacks that left much of the biotech’s fortunes resting on its lead antibody drug.

The post Amgen’s $1.9B Five Prime deal adds to cancer drug pipeline and Asia strategy appeared first on MedCity News.

In its report released last Tuesday, a nonprofit drug pricing research group claims that seven drugs have prices that do not align with any newly discovered increase in clinical benefit, leading to over $1.2 billion in excess drug spending in 2019, alone.

The post Drug price hikes without new evidence upped spending by $1.2B, ICER says appeared first on MedCity News.

The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……

The post Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target appeared first on MedCity News.

Sotorasib, a KRAS G12C inhibitor, showed an overall response rate and duration of response that analysts called approvable, but they noted the results have waned over time, and combinations may be the way forward.

The post Amgen publishes, presents data on therapy with ‘undruggable’ target appeared first on MedCity News.

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

The post Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients appeared first on MedCity News.

A federal appeals court upheld two key patents covering Amgen’s Enbrel, thus further preventing Novartis’ generics unit from launching its biosimilar. However, an analyst wrote that the probability of Sandoz overturning the decision is low.

The post Sandoz loses challenge to patent on Amgen’s $5.2B autoimmune drug, may appeal to Supreme Court appeared first on MedCity News.

An investigator in the Phase I/II trial of Amgen’s AMG 510 said that while data for colorectal cancer indicated low activity as a single agent, it nevertheless represented a doubling in progression-free survival over what is seen from currently available treatments.

The post Combinations seen as preferable for Amgen drug whose ASCO data got ‘meh’ reception appeared first on MedCity News.