Search Results for “Amgen” – Page 11 – media

Johnson & Johnson inks another Stelara patent settlement, this time with Alvotech and Teva

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
- Source: drugdu
- 123
- June 14, 2023
Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
- Source: drugdu
- 118
- June 11, 2023
Study reveals first genetic locus for voice pitch

In a paper published in Science Advances, an international team led by deCODE genetics, a subsidiary of Amgen, reveals the discovery of sequence variants in the gene ABCC9 that influence the pitch of voices. Speaking is one of the most characteristic human behaviors, and yet the genetic underpinnings of voice and speech are largely unknown. In the first study of its kind, the scientists combined speech recordings from almost 13,000 Icelanders with data, in the sequence of the genome, to search for common variants in ABCC9 that are associated with a higher-pitched voice. The scientists found that ABCC9 variants associate with higher voice pitch in both men and women. The same sequence variants are also linked to higher pulse pressure, a cardiovascular risk factor, highlighting links between voice pitch and health-related traits. In addition to voice pitch, the study investigated the genetics of vowel acoustics. While vowel sounds such as ...
- Source: drugdu
- 107
- June 11, 2023
Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
- 200
- June 9, 2023
Lawmakers look to crack down on Big Pharma tax breaks

Drug pricing crackdowns aren’t the only way lawmakers are looking to reign in pharma’s business practices. With scrutiny of the industry intensifying on Capitol Hill, a Senate committee is now shining a spotlight on how Big Pharma is paying taxes, too. Earlier this month, Senate Finance Committee Chair Ron Wyden, D-Ore., released a memo revealing the latest findings of an ongoing investigation into how the industry has used a Trump-era law to reap massive decreases in tax rates. “Big Pharma gets us coming and going — they charge Americans sky-high prices and they pay absolute rock-bottom taxes,” Wyden said in a statement. According to Wyden, the industry has been leveraging a 2017 law that triggered a 40% reduction in the industry’s tax rate since it was enacted. All told, Wyden’s investigation found that in 2019 and 2020, the industry paid an effective tax rate of 11.6%, down from 19.6% on ...
- Source: drugdu
- 162
- June 3, 2023
Bristol Myers’ $4B plan for Reblozyl takes shape in blood cancer anemia—with one caveat

Bristol Myers Squibb’s Reblozyl could be an effective initial treatment for anemia patients who are suffering from a group of blood cancers called myelodysplastic syndromes (MDS) and are at a relatively lower risk of progression. That’s the conclusion reached by Olatoyosi Odenike, M.D., from the University of Chicago Medical Center, after she reviewed data from the phase 3 COMMANDS trial that are slated to be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Odenike is an invited ASCO expert and an opinion leader in the MDS field. The COMMANDS trial is the first study in decades that has shown a benefit for a new agent against erythropoiesis-stimulating agents (ESAs) in low- to intermediate-risk MDS, Noah Berkowitz, M.D., Ph.D., senior vice president of hematology development at BMS, said in an interview with Fierce Pharma. If the FDA eventually agrees with Odenike’s finding, Reblozyl could move from behind ...
- Source: drugdu
- 260
- May 29, 2023
In a new look at Novo’s Wegovy data, researchers spell out weight loss for teens

Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
- Source: drugdu
- 101
- May 21, 2023
Pfizer to raise $31 billion in debt offering to fund Seagen acquisition, SEC filing shows

Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drug maker Seagen, for what would be its largest takeover since 2009, according to a new filing with the Securities and Exchange Commission. Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024. The debt offering is expected to close Friday, according to a prospectus supplement New York-based Pfizer filed with the SEC late Tuesday. The pharma giant’s debt offering would be the biggest since CVS Health sold $40 billion of bonds in 2018 to finance its acquisition of health insurer Aetna. Pfizer’s move comes as other corporations including Apple, T-Mobile and Merck rush to tap the U.S. bond market ahead of a potential spike in borrowing costs sparked by the debt ceiling standoff. Pfizer’s stock price dropped slightly on Wednesday. The company said it will secure ...
- Source: drugdu
- 127
- May 19, 2023
Mirati’s KRAS drug beats estimates in Q1, but Keytruda combo plan remains unclear

Just as Amgen’s KRAS contender Lumakras suffered a sequential sales decline, Mirati Therapeutics’ rival drug Krazati has surprised analysts in its first full quarter on the market. But investors remain more interested in Mirati’s plan for newly diagnosed lung cancer patients. After an FDA approval in KRAS-mutated non-small cell lung cancer (NSCLC) in December, Krazati generated $6.3 million in the first three months of 2023, coming in ahead of Wall Street’s expectation of $3.4 million. Krazati delivered that beat just as Lumakras’ sales in the U.S. slumped by $14 million, or 23% lower than its haul in the fourth quarter of 2022. In a sign of early interest in the therapy, Krazati has captured a third of new patient starts, Mirati’s chief commercial officer Ben Hickey told investors during a call Tuesday. Among the top 50 doctors that Mirati is targeting with its awareness efforts, 80% have prescribed Krazati, he ...
- Source: drugdu
- 370
- May 13, 2023
BMS, after last year’s West Coast purge, lays off 48 in New Jersey

While smaller biotech outfits have certainly taken the brunt, the layoff deluge of the past year hasn’t spared big pharmas either. Now, after unveiling more than 250 job cuts in San Diego in September, Bristol Myers Squibb is turning its staff reduction campaign northeast. Starting at the end of May, BMS will roll out job cuts for 48 employees in Princeton, New Jersey, according to a new Worker Adjustment and Retraining Notification (WARN) alert filed with the state. The BMS site in question is a 650,000-square-foot facility that houses employees from the commercial team, plus commercialization and late-stage development partners from the R&D unit. The plant also hosts members of BMS’ global product development and supply teams, according to the company’s website. It’s not immediately clear what types of roles will be affected. Putting the cuts into context, Bristol’s business model is “evolving to support our mission to discover, develop and deliver innovative ...
- Source: drugdu
- 203
- May 11, 2023

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