Citing an "atypical FDA review process and corporate greed" ahead of the controversial approval of Biogen Inc.'s Aduhelm (aducanumab), Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) called for "corrective actions" at the agency to "re-earn the trust of the American people." Pallone's comments prefaced a report drawn from 18 months of investigation around the regulatory review and approval process for the Alzheimer's disease drug, as well as Biogen’s pricing strategy.
Magenta Therapeutics Inc., the developer of an antibody-drug conjugate intended to help prep certain relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome patients for stem cell transplant or gene therapy, has stopped dosing the drug in part of an ongoing trial after observing two cases of serious adverse events (SAEs) possibly related to the candidate.
Gossamer Bio Inc. shares (NASDAQ:GOSS) fell 74.6% to $2.36 Dec. 6 after the disclosure of phase II results that, while meeting the study's primary endpoint of reducing pulmonary vascular resistance vs. placebo, failed to show the company's pulmonary arterial hypertension (PAH) candidate, seralutinib, holding its own against the performance of Merck & Co. Inc.'s PAH candidate, sotatercept, in separate PAH studies.
Theratechnologies Inc. paused enrollment of a phase I trial testing TH-1902, its lead peptide-drug conjugate for sortilin-expressing cancers, after finding efficacy "not convincing enough" nor outweighing adverse events in some participants, an undisclosed number of which experienced neuropathy and eye toxicity, the company said.
A diverse group of government and academic researchers, marking World AIDS Day 2022, have published details of an investigational vaccine they said safely induced broadly neutralizing antibody-precursors against HIV in nearly all participants in a small phase I trial.
Horizon Therapeutics plc shares (NASDAQ:HZNP) jumped 27.3% to $100.29 after the company disclosed being in "highly preliminary" discussions about takeover interests expressed by Amgen Inc., Janssen Global Services LLC and Sanofi SA. The companies have until Jan. 10, 2023, to report whether they intend to make an offer or not.
Cajal Neuroscience Inc., a startup seeking new targets to use in medicines for neurodegeneration, has launched with the completion of a $96 million series A financing led by The Column Group and Lux Capital. The company, inspired by the pioneering work of Santiago Ramón y Cajal, is focused on the "mechanistic, spatial and temporal complexity of neurodegeneration" to determine "how, where and when different mechanisms contribute to disease."
Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval.
An investigational dendritic cell vaccine from Northwest Biotherapeutics Inc., administered with standard of care, extended both median overall survival (OS) and "the ‘long tail' of the survival curve" vs. matched external controls in newly diagnosed and recurrent glioblastoma multiforme brain cancer patients, according to results published Nov. 17 in JAMA Oncology.
Conditionally active antibody specialist Cytomx Therapeutics Inc. has agreed to work with Regeneron Pharmaceuticals Inc. to discover and develop new bispecific antibodies with what the partners said is the potential to "widen the therapeutic window and help minimize off-target effects."
