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15 April, 2026 |
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My quote of the week comes from Zachary Brennan's interview with former CDER director Richard Pazdur. "There really was a firewall between the Commissioner’s Office and the review divisions, and obviously that has been breached,” Pazdur said. Read more on what the longtime cancer drug reviewer had to say about what he thinks should be done to prevent that from carrying on into future administrations. |
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Lydia Ramsey Pflanzer |
Deputy Editor, Endpoints News
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Former CDER Director Richard Pazdur |
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by Zachary Brennan
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Richard Pazdur doesn't regret resigning back in December as director of the FDA's drug center, just weeks after taking the role. Pazdur, who spent more than two decades leading the agency's cancer drug reviews, left the post of Center for Drug Evaluation and Research director abruptly. In an interview with Endpoints News, he pointed to several issues with FDA Commissioner Marty Makary's priorities and specifically highlighted the unprecedented political interference in the FDA's drug reviews. The firewall between each administration's political appointees like Makary and the federal employees carrying out the drug reviews has
cemented the FDA as the leading regulator in the world. But since the second Trump administration took office, Pazdur said, political appointees have expanded from the commissioner level to the center director level. Political appointees are now more commonly overruling review teams. Pazdur noted that this is the first time in his FDA career in which a commissioner called him to discuss a specific application. | |
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by Max Bayer
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The FDA is taking the first step toward potentially backing popular peptides, convening advisors to discuss whether a handful of products should be given the go-ahead for compounding in the US. A meeting of the agency’s Pharmacy Compounding Advisory Committee has been scheduled for July 23 and 24, according to a
Federal Register notice released Wednesday morning. The committee will discuss whether some bulk substances should be added to a list that compounding pharmacies are required to stick to when making drug products. Two of the peptides under discussion — BPC-157 and TB-500 — are among the most well-known. The combination is called the “Wolverine stack” and has been billed as a treatment to help with
recovery, repair and inflammation. According to the federal notice, the advisory committee will discuss compounding of BPC-157 to treat ulcerative colitis and TB-500 for wound healing. | |
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by Tom Randall
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Biotech stocks are back at it. The XBI is up more than 30% in the last six months, outpacing the broader S&P 500 by more than 24 percentage points — one of the sharpest stretches of outperformance in a decade. Today's chart shows the market emerging from a month of uncertainty driven by the war in Iran. Biotech stocks, with their
outsized sensitivity to investor sentiment, fell almost 7% after the US and Israel started their bombing campaign in Iran on Feb. 28. But those losses reversed on March 31, following reports that the US was seeking to wind down military hostilities. Since then, the XBI is up 14%. | |
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The start of 2026 has shaped up as an extension of the solid performance we tracked with DealForma’s Chris Dokomajilar through the second half of last year. Dealmaking continued apace, venture capital is recovering, and Asia stayed out front as the leading region for licensing pacts. Chinese biotechs, which seized the spotlight on deals last year, started out
2026 hotter than ever. Pharma companies eager to expand their pipelines have taken advantage of China's drug labs, which have been quick to follow R&D trends. VCs, meanwhile, regrouped around later-stage assets, chasing the windfall returns that shape R&D in many respects. |
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by Max Gelman
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Revolution Medicines is capitalizing on its recent clinical trial success, putting together the biotech industry’s largest public raise since the Covid-19 pandemic. The company priced its stock and debt offering at $2 billion, doubling the amount it expected to raise after a Phase 3 win in pancreatic cancer. The colossal figure comes as the XBI, biotech’s closely watched industry barometer, topped $135 on Tuesday — its highest point since the summer of 2021, when pandemic-era vibes still dominated. Over the last six months, the XBI has risen 29.1%, compared to a 4.9% increase in the S&P 500. It's been powered by a wave of public offerings and heightened M&A activity. Along with Revolution, Spyre Therapeutics and Allogene Therapeutics also put together raises this week, pricing theirs at $403 million and $175 million, respectively. | |
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