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At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.
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To drive true innovation in drug development, executives must not let excitement about the latest shiny object obscure ultimate outcomes.
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
Therapies from industry leaders BioMarin and Ascendis Pharma supply a key hormone that promotes bone growth. In order to move the field forward, challengers are looking to address the underlying cause of the rare, genetic disease.
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AbbVie (NYSE: ABBV) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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Despite disappointing third-quarter results for Regeneron’s high-dose Eylea injection, analysts continued to be cautiously optimistic about the company’s promising cancer, immunology and genetic medicines pipeline.
While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external experts found that the company did not provide enough data to support its drug application.
Bristol Myers Squibb’s third-quarter results benefited from sales of its legacy brands Eliquis and Revlimid, as well as growth portfolio products such as Abecma, Breyanzi and Reblozyl.
In another delay for the psychedelic treatment space, Compass Pathways announced adjusted timelines for two Phase III trials of its psilocybin to address treatment-resistant depression.
Offsetting Merck’s growth in the third quarter were disappointing revenues from its HPV vaccine Gardasil and type 2 diabetes pill Januvia, with the company on Thursday narrowing its 2024 sales and adjusted profit outlooks.
AbbVie’s Humira missed Wall Street’s expectations in the third quarter but Skyrizi and Rinvoq’s continuing outperformance demonstrated the overall strength of its immunology franchise.
While Amgen’s third-quarter financial results on Wednesday were “somewhat uneventful,” investors continue to be focused on the highly anticipated MariTide Phase II results slated for late 2024, according to BMO Capital Markets analyst Evan Seigerman.
Candidates looking to enter biotech should focus on cultivating key skills, thoughtfully crafting their resumes and putting their best, most authentic foot forward in interviews. An internship, co-op or fellowship won’t hurt, either.
Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs.
Following disappointing results for an antibiotic candidate whose development program is now being suspended, Spero Therapeutics is looking to extend its cash runway while it focuses on other assets in its pipeline.