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Transitioning from team member to manager has its challenges, including managing ex-peers. There are a few ways you can make the change easier.
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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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Ginkgo Bioworks, the leading horizontal platform for cell programming, announced that management is scheduled to participate in a fireside chat at Jefferies Virtual Synthetic Biology Week, on March 22, 2022, at 10:00 a.m. Eastern Time.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively.
While achieving FDA approvals in rare cancers such as multiple myeloma and diffuse large B-cell lymphoma, Karyopharm’s cancer drug has a variety of scientific and market hurdles to clear.
Following a controversial Rett Syndrome trial last year, Anavex Life Sciences’ blarcamesine has claimed another clinical victory—this time in an Alzheimer’s disease Phase IIb/III study.
After nearly seven years, the company’s rare diseases arm Alexion has reached a settlement in an investors’ lawsuit over alleged unethical sales practices for its hemoglobinuria therapy Soliris.
Bristol Myers Squibb’s pipeline cuts, announced Thursday during its R&D Day, include a mid-stage drug candidate for nonalcoholic steatohepatitis and an anti-TIGIT solid tumor program.
As researchers face delayed project timelines and inflated costs, industry leaders are offering an alternative option for sourcing nonhuman primates.
The FDA has issued more than 30 guidance documents related to drug development so far this year. BioSpace takes a closer look at six of them.
AlveoGene has licensed the U.K. Respiratory Gene Therapy Consortium’s InGenuiTy platform for all uses excluding the CTFR gene, which is already licensed to Boehringer Ingelheim for cystic fibrosis.
The company declined to exercise the license option for Harpoon Therapeutics’ TriTAC HPN217 program for multiple myeloma, which targets B cell maturation antigen, or BCMA.