Amgen targets physicians with biosimilars education campaign in … – Endpoints News


With 2023 poised to be a big year for biosimilars, Amgen is marketing to doctors to help them understand the biologic drugs — and get ready for patient questions.
Why will people be asking more about biosimilars this year? The main reason is AbbVie’s megablockbuster Humira will get its first biosimilar competition in the US at the end of January, followed by a raft of other Humira biosimilars launching throughout the year. While that first Humira competitor is Amgen’s own Amjevita, its biosimilar social media campaign is educational only and does not include any mention of its own products.
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SAN FRANCISCO — If the annual JP Morgan conference is speed dating for biopharma deals, fewer eligible singles appeared to have shown up for 2023.
While attendees continued to pack the rooms for presentations, panels, networking events and happy hours, multiple people told Endpoints News that the confab felt quieter than past years.
“It’s less busy,” said Vor CEO Robert Ang. “I’d say it’s like 70%. But I think everyone’s really glad to come back.”
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Sun Pharma has enlisted the help of “Dr. Pimple Popper” dermatologist Sandra Lee to teach patients about the hormones behind their acne.
The “AH-ha! It’s Acne Hormones” campaign debuted on Wednesday, more than a year after the launch of Sun’s acne drug Winlevi. Unlike antibiotic acne treatments, Winlevi is an androgen receptor inhibitor, targeting the same hormone that can also cause hair loss.
Bristol Myers Squibb’s first campaign for Opdualag marks a second stake in the ground for the biopharma. The new work is its second immuno-oncology combo drug, direct-to-consumer (DTC) ad campaign, with both efforts now running on TV, social and digital media.
Opdualag, approved in March 2022, is a combination of Bristol Myers’ blockbuster PD-L1 Opdivo (nivolumab) and relatlimab, approved to treat advanced melanoma cancer. The second campaign is an ongoing effort for Opdivo plus Yervoy, with new creative added in December.
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The FDA and the CDC are investigating a “preliminary signal” of whether there might be an increased risk of stroke for people who got Pfizer and BioNTech’s updated Covid-19 vaccine booster.
In a statement posted on the CDC’s website, the agency said its monitoring system for vaccine side effects had been triggered to look for a potential issue with the shots in people ages 65 and older.
After more than four decades, there is still no approved HIV vaccine. And another so-called mosaic regimen has ended in disappointment.
Johnson & Johnson’s Janssen unit said Wednesday that an independent data and safety monitoring team found the Big Pharma’s regimen to be ineffective at preventing HIV infection compared to placebo. The drug developer reported no safety issues.
With that, J&J ended the Phase III Mosaico study, which enrolled 3,900 cisgender men and transgender individuals in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the US. People in the trial who contracted the virus were given “prompt HIV treatment and care,” the company said.
Merck has identified what caused levels of the nitrosamine NTTP to appear in batches of its blockbuster diabetes drugs, the company confirmed on Wednesday.
An unnamed source told Bloomberg, which first reported the news, that NTTP contamination in certain batches of its sitagliptin diabetes products Januvia and Janumet occurred during storage and manufacturing processes.
The FDA said last August that it became aware of a nitrosamine impurity in certain samples of Merck’s type 2 diabetes drug Januvia. In order to avoid a shortage of the blockbuster drug, the agency temporarily allowed higher impurity levels than the acceptable intake limit.
There’s a foot race developing for the lead of a multibillion-dollar vaccine market. And once again, Moderna $MRNA promises to be right in the thick of things as some of the biggest blockbuster players in biopharma hustle toward the finish line.
After the market closed on Tuesday, the big biotech, which has been in the vanguard of the mRNA revolution on Covid vaccines, put out word that it had aced its pivotal trial for a new RSV vaccine dubbed mRNA-1345 among older people above the age of 60. Moderna CEO Stéphane Bancel headlined the news with a clearly statistically significant effect offering 83.7% efficacy in preventing lower respiratory tract disease among people with two or more symptoms of disease.
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The FDA issued a warning letter to Optum Infusion Services last month citing a list of potential contamination concerns, including “vermin” found in a production area.
The letter, posted by the FDA on Tuesday, accuses Optum of producing sterile drug products “under insanitary conditions.” It follows a Form 483 filed back in March upon inspection of the company’s Chandler, AZ, site.
An investigator reported that Optum failed to “perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area,” and after “microbial contamination was recovered” in an aseptic processing area.
Bristol Myers Squibb, Novartis, AstraZeneca and industry group BIO are all seeking alterations to the FDA’s recent draft guidance to help sponsors measure the growth and evaluate the pubertal development in pediatric clinical trials.
The 10-page draft guidance, released last October, explains how if a drug could have an impact on the growth or pubertal development of participants in a trial, such trials should include accurate, serial measurements and recordings of growth parameters. The FDA calls on and explains how sponsors should look into participants’ changes in age, length/height, weight, head circumference in some circumstances, and more.
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