Search Results for “Amgen ” – Page 3 – media

Amgen’s Lumakras shows promise in phase 3 lung cancer study

Amgen has shared positive results from a late-stage study evaluating its KRAS inhibitor, Lumakras (sotorasib), in certain lung cancer patients. The phase 3 CodeBreaK 200 trial compared Lumakras to docetaxel chemotherapy in patients with previously treated, locally advanced and unresectable or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). New data from the trial was presented at the American Society of Clinical Oncology (ASCO) annual meeting. NSCLC represents up to 85% of all lung cancer diagnoses. KRAS G12C is the most common KRAS mutation in NSCLC, Amgen reports, and patients with this mutation whose first-line treatment has failed face limited options. According to data from a post-hoc analysis of CodeBreaK 200, which included NSCLC patients with treated or stable central nervous system (CNS) lesions at baseline, Lumakras was associated with a delayed time to CNS progression and longer CNS progression-free survival (PFS) compared with docetaxel. Additionally, an assessment of CNS tumour shrinkage following ...
- Source: drugdu
- 149
- June 8, 2023
Amgen centers cancer patients’ voices in new YouTube series

Beth Snyder Bulik Senior Editor In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme. Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the ...
- Source: drugdu
- 111
- June 4, 2023
Amgen reports positive results for Otezla in psoriatic arthritis

Amgen has announced positive new research evaluating the use of its inflammatory disease medication Otezla (apremilast) in psoriatic arthritis. Psoriatic arthritis is a chronic, inflammatory form of arthritis estimated to affect nearly 38 million people worldwide. The condition can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. Otezla regulates inflammation by inhibiting an enzyme known as phosphodiesterase 4. This enzyme controls much of the inflammatory action within cells, which can affect the level of inflammation associated with psoriatic disease. The new data for the drug, being presented at the 2023 European Congress of Rheumatology (EULAR), includes results from the phase 4 MOSAIC study, which evaluated its effect on joint inflammation and structural progression of psoriatic arthritis using MRI. Results showed that patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48, ...
- Source: drugdu
- 176
- June 2, 2023
Amgen, J&J ink patent settlement

After the recent high-profile loss of exclusivity for AbbVie’s megablockbuster immunology drug Humira, industry watchers’ eyes moved to Johnson & Johnson’s Stelara as one of the next major drugs expected to face biosim competition. Tuesday, the industry got more information about when exactly that biosimilar clash might occur. In J&J’s patent case over Amgen’s proposed biosimilar to J&J’s Stelara, the companies have settled, according to a Tuesday filing in Delaware federal court. An Amgen spokesperson told Reuters the deal will allow the company to launch its Stelara biosimilar “no later than January 1st, 2025.” With that, the market exclusivity clock is ticking on J&J’s biggest drug by sales. Last year, the medicine pulled down $9.72 billion across its range of indications, including plaque psoriasis, psoriatic arthritis and Crohn’s disease. Amgen has yet to win FDA approval for its proposed biosimilar. The company filed its biosim application last November, so the ...
- Source: drugdu
- 104
- May 25, 2023
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen

After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court.The nine justices voted unanimously to uphold (PDF) a lower court ruling invalidating a pair of patents on Amgen’s PCSK9 cholesterol med Repatha. The case stretches back to 2014, when Amgen first sued Sanofi and Regeneron for allegedly treading on Amgen intellectual property with their rival PCSK9 drug Praluent, under development at the time as alirocumab. Praluent and Amgen’s Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9. In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid. Amgen took that loss to federal appeals court, where it was rejected. The company ultimately petitioned the U.S. Supreme Court to hear the case in ...
- Source: drugdu
- 120
- May 21, 2023
FTC sues to block Amgen’s $28B Horizon buy in alarming sign for biopharma M&A

Just as biopharma’s M&A prospects seemed to be improving, the U.S. antitrust watchdog is putting a damper on dealmaking. The U.S. Federal Trade Commission has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, the agency said Tuesday. By a unanimous vote among the three Democrat commissioners, the agency is seeking a temporary restraining order and preliminary injunction to prevent the transaction from closing. In an alarming sign for biopharma M&A scrutiny to come, the FTC argues Amgen could leverage its existing product portfolio to “entrench the monopoly positions” of Horizon meds for thyroid eye disease and chronic gout. The antitrust challenge marks the first time that the FTC has reached beyond specific product overlaps in its reviews and instead focused on companies’ past behaviors around drug pricing. It’s an approach that the agency has threatened to implement since 2021 but has only now reared its ...
- Source: drugdu
- 125
- May 18, 2023
Amgen and TScan Therapeutics partner to identify new Crohn’s disease targets

Amgen and TScan Therapeutics have announced a multi-year collaboration aimed at identifying new targets for Crohn’s disease. The partnership will utilise TScan’s target discovery platform, TargetScan, to identify the antigens recognised by T cells in patients with Crohn’s disease. Amgen will then develop therapeutics based on the discovered targets and will retain all global development and commercial rights. In exchange, TScan will receive an upfront payment of $30m and will be eligible for over $500m in success-based preclinical, clinical, regulatory and commercial milestones as well as tiered single-digit royalties. Under the terms of the agreement, Amgen has an option to expand the collaboration to ulcerative colitis, with each company responsible for its own research expenses. Crohn’s disease and ulcerative colitis are both inflammatory bowel diseases, characterised by chronic inflammation of the gastrointestinal tract. Nearly one in every 100 people in the US are diagnosed with IBD. Despite the availability of ...
- Source: drugdu
- 148
- May 16, 2023
Amgen faces patent infringement claims on big-selling osteoporosis drug Evenity

In developing its osteoporosis drug Evenity more than a decade ago, it is alleged in court documents that Amgen discussed forming a potential partnership with a small company from Kansas. Those discussions never amounted to a deal. Now, 11 years later, the Kansas company is suing Amgen for patent infringement. The suit, filed in U.S. District Court in Massachusetts, claims Amgen’s Evenity infringes on three of patents owned by OssiFi-Mab, including one that was granted last month. The first patent was awarded in 2012, the same year that Amgen and the Kansas company talked of a potential collaboration, according to the suit. The patents refer to the “discovery of methods of increasing bone density via administration of a sclerostin antagonist together with an antiresorptive,” the complaint says. Evenity works in part by decreasing bone resorption by inhibiting the action of sclerostin, which helps regulate bone metabolism. ...
- Source: drugdu
- 123
- May 3, 2023
Drugmakers take sides in Amgen, Regeneron fight over antibody patents

Christopher Newman Editor “This is a showdown about whether the most valuable patents in the entirety of the patent system are valid,” one law expert said. The nearly decade-long patent feud between Amgen and rivals Sanofi and Regeneron has divided the biopharmaceutical industry, with drugmakers taking different sides in a U.S. Supreme Court case that could have far-reaching effects. At issue are patents for powerful cholesterol-lowering medicines known as PCSK9 inhibitors. Regeneron and Sanofi brought the first, Praluent, to market in 2015. Amgen followed one month later with a similar medicine, called Repatha. The drugs work by boosting liver cells’ ability to hoover up LDL, or “bad,” cholesterol. Amgen has long claimed Sanofi and Regeneron infringed on patents it secured for Praluent. The fight has slowly winded its way through the U.S. legal system to reach the Supreme Court. There, judges could disrupt the $160 billion-per-year market for antibodies by deciding how broadly ...
- Source: drugdu
- 169
- April 25, 2023
Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig™ (erenumab) For Migraine Patients With Multiple Treatment Failures

The LIBERTY Trial was Conducted in Patients who Have Tried Two to Four Therapies Without Success -- a Uniquely Difficult-to-Treat Population Often Excluded From Migraine Prevention Trials Patients Taking Aimovig had Nearly Three-Fold Higher Odds of Having Their Migraine Days cut by Half or More Compared to Placebo Safety and Tolerability Were Consistent With Results Seen in the Pivotal Clinical Program; Over 97 Percent of Those Taking Aimovig Completed the Double-Blind Treatment Phase Data Selected by the American Academy of Neurology Science Committee as one of the Most Noteworthy Presentations at 2018 Annual Meeting
- Source: prnewswire
- 639
- April 20, 2018
Amgen migraine

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