At the 2022 Conference on Retroviruses and Opportunistic Infections (CROI), investigators reported on a fourth patient who has achieved HIV remission after a stem cell transplant. The patient is the first woman and the first mixed-race person to achieve HIV remission through a transplant procedure. In 2017, she was transplanted with cord blood stem cells lacking a functional CCR5 receptor, which prevents HIV from entering cells.
The U.S. Federal Circuit’s denial Feb. 11 of an en banc rehearing in a case that could undermine label carveouts and slow the launch of generics is the topic of hallway chatter at this week’s annual conference of the Association for Accessible Medicines.
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.”
New and updated preclinical and clinical data presented by biopharma firms at the ASCO Gastrointestinal Cancers Symposium, including: Abivax, Astrazeneca, Cardiff, Chimerix, Exelixis, Immunitybio, ITM, Leap, Merck, Seagen.
New and updated preclinical and clinical data presented by biopharma firms at the ASCO Gastrointestinal Cancers Symposium, including: Abivax, Astrazeneca, Cardiff Oncology, Chimerix, Exelixis, Immunitybio, ITM, Leap, Merck & Co., Seagen.
Drug sponsors should not focus on influencing legislators about how to price rare-disease and orphan therapies, Ovid Therapeutics Inc. CEO Jeremy Levin said during a panel talk at Biotech Showcase. “The game is not in Washington,” he said. “The game is on the ground in each state, where you need to convince the public, the individuals, the patients that, in fact, you are bringing value.”
Computational technology and high-quality data will help scientists to improve R&D and find better treatments for human diseases, according to experts at the Wuxi Global Forum 2022.
“There isn’t a better place to be” now than in Alzheimer’s disease (AD) drug development, said Phyllis Ferrell, global head of external engagement in AD and neurodegeneration at Eli Lilly and Co., during Biotech Showcase’s panel talk titled, “Aduhelm: Stimulating the Next Generation of AD Treatment.”
Merck & Co. Inc., building on a year-old deal with Aligos Therapeutics Inc., has moved to in-license an early stage nonalcoholic steatohepatitis (NASH) oligonucleotide program Aligos had previously advanced independently. The amended deal also gives Merck the right to add a new NASH target to the partnership, in addition to those already part of the agreement. With Aligos eligible to receive up to $460 million in development and commercialization milestones as well as tiered royalties on net sales per target, its rewards could reach $1.38 billion.
The deals continued to flow during day two of the J.P. Morgan Healthcare Conference. Privately held Arrakis Inc., which specializes in aiming at small-molecule RNA targets, primarily cancers, has signed onto a collaboration with Amgen Inc. that could bring in billions in future payments should it hit all the milestones and program options are exercised. Dren Bio Inc., meanwhile, will collaborate with Pfizer Inc. to develop bispecific antibodies for oncology targets. Dren could receive more than $1 billion in the deal that includes a $25 million in cash up-front payment from Pfizer.
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