| | | |   | Hello, all. Damian here with a preview of the year to come, a look at clinical trial diversity, and the first major move from Biogen's new CEO. | | | What does 2023 have in store for biotech? How can the FDA win back trust? And who came up with “XBB.1.5”?
We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we delve into a sweeping congressional investigation into the FDA’s approval of the last treatment for Alzheimer’s disease and what it means for the next one. We also preview the upcoming J.P. Morgan Healthcare Conference and the biggest biotech events of 2023.
Listen here. | The plot to end an antibiotic drought A pharma-funded effort to combat antibiotic resistance has invested about $100 million into biotech companies doing the work major firms have largely abandoned, and it’s expecting to pick up the pace in the years to come.
As STAT’s Ed Silverman reports, the AMR Action Fund is providing $7.5 million to BioVersys, a private company developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitalized patients. The deal follows last year’s investments in Venatorx Pharmaceuticals and Adaptive Phage Therapeutics, two companies taking various approaches toward developing therapies that can fight drug-resistant infections.
The goal is to generate four new antibiotics in a decade. And AMR — which counts Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, and Pfizer among its founders — has about $1 billion to do it.
Read more. | New hope for patients as science advances in allogeneic CAR T The introduction of autologous CAR T therapy revolutionized the treatment of certain late-stage blood cancers. This major step forward in oncology was life changing for many patients, but its success created a CAR T access bottleneck. As thousands of U.S. patients wait for access, new off-the-shelf CAR T investigational products are showing clinical promise. Read more. | Pharma’s trial diversity report card Very few clinical trials in oncology included enough non-white or older patients to qualify as truly representative, according to a scorecard published in BMJ Medicine showing how well pharma companies diversify research studies.
Researchers at the nonprofit Bioethics International looked at 64 pivotal trials conducted by 25 pharma companies, studying novel cancer therapeutics approved by the FDA between 2012-2017, to see how inclusive those studies were — and how transparent companies were in reporting participant demographics.
Among the findings, more than half of the companies included adequate numbers of women, and 25% adequately included older adults, but just 16% adequately represented patients who were not white. And while nearly half the companies adequately represented Asian patients in their studies, just 16% adequately represented Black patients, and no company adequately represented Hispanic patients.
The authors ranked companies according to a new metric called “fair inclusion,” which combines both diversity and transparency. Here’s how the companies stacked up:
 | Biogen shifts its approach to research In the first major move under its new CEO, Biogen is reorganizing its R&D division, splitting a key job in two and making an interim appointment permanent.
As STAT’s Allison DeAngelis reports, Biogen will no longer employ a head of R&D. Instead, Priya Singhal, who filled the job on an interim basis after the departure of Al Sandrock, will be head of development. The company is now searching for a research leader to work alongside her. Both positions will report directly to new CEO Chris Viehbacher.
The change comes as Biogen works to shift the narrative after a rocky few years of drug development. The company’s core business of medicines for multiple sclerosis is shrinking under the weight of competition, and its powerful treatment for the rare disorder spinal muscular atrophy appears to have plateaued. Biogen’s pipeline of novel treatments for neurological diseases has received little notice from Wall Street analysts, who have long criticized the company for betting heavily on high-risk science.
Read more. | More reads - China's CanSino: 'positive' interim data on COVID mRNA vaccine booster trial, Reuters
- Continuous manufacturing can help pharma companies save time, money, and more, STAT
| Thanks for reading! Until next week,  | | | |
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