The third of Johnson & Johnson’s four Innovation Centers, designed to give the behemoth company access and proximity to early-stage scientific innovation, opened June 27 in Boston. Concurrently, the company backed two VC-funded young start-ups , as well as a hospital alliance and a laboratory initiative.
The newly-opened Boston office ofJohnson & Johnson’s reorganized investment and business development operation has funded a pair of start-ups in tandem with local venture firms.
Epigenetics company Rodin Therapeutics and microbiome specialist Vedanta Biosciences Inc. received support from J&J’s Boston Innovation Center, one of...
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Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.
Manufacturers who succeed in treating several patients with bespoke therapies could leverage platform data to gain marketing approval for similar products in additional conditions, FDA leaders say in a NEJM article that describes five prerequisites for use of the new pathway.
Demonstration could bring unprecedented transparency into international net prices, at least to CMS.
The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.
New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.
US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.
The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.
