UPDATED: Longtime NIH director Francis Collins resigns to make room for 'new vision' – Endpoints News

Francis Collins is stepping down from the NIH, the agency announced Tuesday morning, leaving a rich legacy of research accomplishments, initiatives as well as values.
He will leave the post by the end of the year and return to his lab at the National Human Genome Research Institute (NHGRI). A successor has not yet been named.
With a 12-year tenure spanning three presidencies, Collins, 71, has been the longest-serving NIH director. He was first appointed by President Barack Obama in 2009, after serving as director of the NHGRI — which in turn followed an illustrious career hunting for genes at the University of Michigan and leading the Human Genome Project.
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Advanced technology is supposed to help sponsors run clinical trials faster. So why are timelines getting longer?
A report from the Tufts Center for the Study of Drug Development (CSDD) found that the clinical phase of new drugs and biologics approved by the FDA between 2008 and 2013 took 83.1 months on average. Between 2014 and 2018, the clinical phase extended to an average of 89.8 months.
According to CSDD director Kenneth Getz, fragmented operating activity is one of the primary factors that contribute to growing timelines. What’s one way to limit fragmentation? Bring more clinical trial functions in-house. By making the most of internal resources, sponsors not only simplify operations, they reduce risk and operational costs.
GlaxoSmithKline is radically downsizing — and the move has nothing to do with their head count.
Spurred by the pandemic-inspired reduction in the need for office space, the pharma giant is giving up its iconic facilities in Philadelphia and Research Triangle Park, and replacing the space with new digs that require only a fraction of what they once used.
Starting early next year, GlaxoSmithKline will be shrinking its office space in Philly by 75% as the pharma leaves their bespoke building in the Navy Yard — moving to the FMC Tower in Philly’s University City district. The company is also moving its offices from RTP to downtown Durham, NC by June, the company said — a downsize of close to 90%.
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With a recent approval for lung cancer bispecific amivantamab, J&J is looking to build a franchise in that space with a growing crop of drugs in the pipeline. The drug giant has now tapped a familiar partner to drive that work ahead, and the pair is going after a well-known target.
J&J’s Janssen unit has inked a licensing deal worth $100 million in upfront cash and $25 million in equity for global licensing rights to Xencor’s CD20/CD3 bispecific antibody plamotamab currently in Phase I testing against B cell malignancies, the companies said Monday.
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Centessa Pharmaceuticals was built on the promise of scaling up Medicxi’s asset-centric model with 10 of the VC firm’s portfolio companies and their individual programs under the same roof. But the crew wasn’t going to stop there.
Instead, now that the biotech has completed its IPO, unveiled the first batch of proof-of-concept data from one of its 11 subsidiaries and — just a day ago — tapped into a fresh $300 million well of financing, Centessa has set its sights on “strategic business development opportunities.”
Canadian scientists recently withdrew an alarming pre-print manuscript that mistakenly said the incidence of the heart condition myocarditis was a lot more frequent than actually identified following vaccination with either Moderna’s or Pfizer’s mRNA shot.
“In order to avoid misleading either colleagues or the general public and press, we the authors unanimously wish to withdraw this paper on the grounds of incorrect incidence data. We thank the many peer reviewers who went out of their way to contact us and point out our error. We apologize to anyone who may have been upset or disturbed by our report,” they wrote in an update.
After more than 5 years at the helm of New Jersey-based biopharma CorMedix, Khoso Baluch is retiring, and the move has triggered a ripple of change within its executive leadership team, leading CFO Matt David to take over as interim CEO, while maintaining his current role.
The departure comes about a month after delays at a contract manufacturer led to the resubmission of a new drug application for DefenCath, an antibacterial and antifungal treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis. The drug was granted fast-track designation by the FDA, but delays at the CMO’s site led to a complete response letter.
Just a few months after a federal jury awarded $2.4 million in damages to a former AstraZeneca sales manager who alleged retaliation for whistleblowing, the pharma is back in hot water over the way it treats employees — and once again, it’s going to cost the company.
The British pharma has agreed to pay $560,000 in back pay and interest to resolve alleged race- and gender-based pay discrimination affecting 318 female and Hispanic employees.
After spending the last 4 years pushing translational research at the deep science-focused Vertex, Harold Bernstein is making the leap into the clinical world, planting both feet in drug development as BioMarin’s new SVP and chief medical officer.
Bernstein’s new role puts him in charge of clinical development at the San Francisco-based biotech where things haven’t always gone smoothly. Most notably, BioMarin’s often-touted hemophilia A gene therapy has displayed a tendency to waning efficacy, raising doubts that prompted the FDA to impose a lengthy delay on the company before any marketing decision.
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Boehringer Ingelheim on Monday joined a growing list of biopharma companies under pressure from the Biden administration’s HRSA after restricting their own participation in a hospital discount drug program because of what they claim is an excessive number of contract pharmacies.
Whether these violations are violations as HRSA contends will likely be decided in court. Meanwhile, HRSA has made its stance clear as it previously sent identical letters to AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics, explaining how the administration has determined their policies placing restrictions on 340B program pricing related to contract hospital pharmacies are in direct violation of the statute.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
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