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BioWorld - Monday, May 18, 2026
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Feet and scale

Pfizer M&A prospect Metsera heads to phase III with lead GLP-1

Sep. 30, 2025
By Karen Carey
No Comments
Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion.
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US Capitol at night

HHS rolls the numbers as shutdown looms for US government

Sep. 30, 2025
By Mari Serebrov
No Comments
Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills.
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100 percentage illustration

Trump hits drug imports with 100% tariffs, starting Oct. 1

Sep. 30, 2025
By Nuala Moran and Karen Carey
No Comments
The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”
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Pacbio Revio sequencing plate

Pacbio’s Puretarget simplifies carrier screening

Sep. 29, 2025
By Annette Boyle
Up to 71% of people carry at least one pathogenic variant that could contribute to development of a heritable disorder in offspring, but until now, prospective parents often had to undergo multiple tests to understand their risks. Pacific Biosciences of California Inc. (Pacbio)’s expanded Puretarget portfolio provides a quicker and more streamlined solution as it covers all challenging tier 3 genes identified in the American College of Medical Genetics technical standard.
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Decorative scales of justice in a courtroom

Bard caught in FCA case directed toward Semler Scientific

Sep. 29, 2025
By Mark McCarty
Bard Peripheral Vascular Inc., agreed to pay $7.2 million to settle allegations that two photoplethysmography products it distributed were the subject of illicit Medicare claims, a problem the company inherited when it decided to do business with Semler Scientific Inc. of Campbell, Calif.
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Generic injection pens

Larimar above par in FA despite anaphylaxis penalty

Sep. 29, 2025
By Randy Osborne
No Comments
Anaphylaxis rates caused Larimar Therapeutics Inc.’s stock (NASDAQ:LRMR) to take a hit on the latest data from an open-label study with nomlabofusp in the neuromuscular disease Friedreich’s ataxia (FA), but the company is targeting a BLA submission to seek accelerated approval in the second quarter of next year.
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Financial chart, downward arrow

Moonlake shares crash on phase III sonelokimab data for HS

Sep. 29, 2025
By Nuala Moran
No Comments

Bar what it described as a “placebo wobble,” Moonlake Therapeutics AG turned in positive results from the phase III trials of sonelokimab in treating hidradenitis suppurativa (HS), only to see its share price take a complete battering. The stock (Nasdaq:MLTX) fell 90%, or $55.75, to close Sept. 29 at $6.24, after the Zug Switzerland-based company published 16-week data from two identical trials, Vela-1 and Vela-2.


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Red and blue bispecific antibodies

Genmab adding late-stage bispecific in $8B Merus acquisition

Sep. 29, 2025
By Jennifer Boggs
No Comments
Genmab A/S is paying $8 billion to acquire Merus NV, gaining rights to the latter’s phase III-stage petosemtamab, a bispecific antibody initially in development for head and neck cancer, and continuing the firm’s strategy to transition from a royalty-based operation to a fully integrated biopharma.
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DNA in drug capsules

FDA continues to build regenerative medicine pathway

Sep. 26, 2025
By Mari Serebrov
No Comments
The U.S. FDA released a trio of draft guidances to help sponsors in developing and monitoring cell and gene therapies, as well as other regenerative medicine therapies.
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Prescription bottle with dollar sign shadow

MFN pricing model under White House review

Sep. 26, 2025
By Mari Serebrov
No Comments
As President Donald Trump promised again in a Sept. 23 media briefing, most-favored-nation (MFN) prescription drug pricing could soon come to America.
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