For the first time ever, the FDA on Wednesday green-lighted an interchangeable biosimilar, capping a decade-long quest for such an approval since the pathway was opened up by Obamacare. The announcement means that Mylan’s new Lantus biosimilar may be substituted for Sanofi’s reference product without the intervention of a prescriber.

The US is the only country in the world to use these congressionally-created, so-called “interchangeable” designations. The US still fails to adopt biosimilars as quickly or as consistently as its European counterparts, where all biosimilars are considered interchangeable.

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Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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As the US House of Representatives is expected to vote this evening on a deal that would raise the nation’s debt ceiling, some biopharma industry advocates worry about how proposed budget restrictions could affect drug research.

The proposed budget deal includes relatively flat funding for non-defense spending over the next fiscal year, and a 1% increase in fiscal year 2025, which the Association for Clinical Oncology said on Wednesday would “considerably restrict potential resources for the National Institutes of Health (NIH) and National Cancer Institute (NCI) at a time when scientists are on the cusp of so many promising cancer discoveries.”

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After Covid-related delays that forced the FDA to delay its China-based inspections, Coherus BioSciences said today that its China-based partner Junshi Biosciences has now successfully completed the required pre-approval inspection for its PD-1 toripalimab, which is being made at a site in China, with three observations.

“The Company believes that the three observations received at the close of the FDA inspection are readily addressable and, together with Junshi Biosciences, plans to submit the response to the FDA in early June,” Coherus said in an SEC filing. The company did not disclose the observations, but Coherus’ stock price $CHRS fell by almost 8% on Wednesday.

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Although not as well-known as the pediatric-focused Make-A-Wish organization, the Dream Foundation has been making wishes come true for adults diagnosed with a terminal illness for decades. Kyowa Kirin began supporting the group six years ago, and now is doubling down on its commitment and extending its pledge through next year.

The financial support of Kyowa Kirin and on-the-ground work by its employees have directly led to 100 final dreams for people across the US and Puerto Rico. The Dream Foundation overall grants 2,500 requests each year to people who have a prognosis of 12 months or less to live. The wishes fulfilled range from family trips to places such as Disneyland or beach destinations to professional sports games to meet a sports hero.

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Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus.

The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024.

Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.”

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