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23 March, 2026 |
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sponsored by
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Built for Speed: Integrated Early‑to‑Late Phase CDMO Solutions
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| Avid Bioservices delivers solution‑focused capabilities and the capacity biopharma innovators need to advance programs with confidence. Our new Early Phase Center of Excellence, centrally located in Costa Mesa, California, provides rapid, flexible support for early development with a direct, seamless transition into our late‑stage and commercial manufacturing facility. This integrated approach reduces handoffs, accelerates timelines, and helps keep your therapy moving efficiently toward patients. |
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The US government will get to say its piece when the Supreme Court hears arguments in a closely-watched ‘skinny label’ case. The high court on Monday granted the US solicitor general’s request to participate in the April 29 oral argument. The case is between Hikma and Amarin, but DOJ attorneys fear that a decision in Amarin’s favor could undermine a pathway commonly used to bring generic drugs to market. |
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Alexis Kramer |
Editor, Endpoints News
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by Anna Brown
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Novartis is the latest drugmaker to invest in its Chinese footprint, with a pledge of more than 3.3 billion yuan ($480 million) to bolster two manufacturing and R&D sites. The company will pour 1.5 billion yuan ($218 million) into expanding its tablets and capsules site in the Changping district of Beijing, according to a Sunday release in Chinese. Around 1.8 billion yuan ($262 million) will go to launching the "second phase" of the drugmaker’s China headquarters and R&D facility in Shanghai. It wasn't clear what that phase entailed, and Novartis didn't immediately comment before publication. Novartis joins the ranks of AstraZeneca and Eli Lilly, which have also made recent investments in China. The
pledges come at a time when Western drugmakers are looking to tap into China's early-stage research. | |
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by Zachary Brennan
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In a rare move, the FDA last week posted photographs of dilapidated buildings as part of a warning letter for a Daman, India-based drug manufacturing facility. The photographs are the latest sign that FDA Commissioner Marty Makary is taking a tougher stance on foreign drug manufacturers. Following a five-day unannounced inspection last July, the FDA warning letter issued to Patcos Cosmetics describes "insanitary conditions," particularly in the sinks in the production area that Patcos used "as a source of water for cleaning production equipment." The company's website says that it manufactures oral care and aerosols on a contract basis. The agency published the following photo of the sinks as part of the letter: | |
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by Elizabeth Cairns
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Insmed's Phase 3 trial win for Arikayce in a particular kind of lung infection sets up the drug to expand into the front-line setting — possibly giving the biotech a second projected blockbuster. The company said that Arikayce was better than placebo at both improving symptoms and reducing bacterial levels when given on top of
established antibacterials in patients with a new case of Mycobacterium avium complex (MAC) lung infection who had not received prior antibiotics. Insmed needed a hit in the study: its shares INSM are down more than 20% across 2026 so far. Subjects in the Phase 3b ENCORE trial who received Insmed’s drug for a year had a 17.8-point improvement on a score designed to measure
respiratory symptoms, which was administered a month after treatment ended. Those in the placebo group improved by 14.7 points, a statistically significant difference. | |
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by Max Bayer
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Pfizer's final-stage trial of its long-awaited Lyme disease vaccine missed its primary endpoint, but the drugmaker said it still plans to try to take the experimental shot to regulators for approval. The company said there had been too few Lyme cases to get a firm result in the trial of the vaccine, known as LB6V. That resulted in a confidence interval on one of the pre-specified analysis for which the lowest end was below 20%, missing the Phase 3 study’s primary endpoint. Confidence intervals with wide ranges suggest too little data for analysis, and Pfizer cited “fewer than anticipated Lyme disease cases” in its announcement of the results. A spokesperson for Pfizer did not say how many cases were accrued in each arm of the trial, saying more data will be released later. | |
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by Ayisha Sharma
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Apogee Therapeutics said its moderate-to-severe eczema candidate could offer much more convenient dosing over standard treatments based on its latest mid-stage results. Monday’s Phase 2 maintenance |
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