U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
The FDA’s attempts to thwart the use of electrostimulation devices for self-injurious and aggressive behavior came up short in an appeals court hearing of Rotenberg v. FDA, largely because the FDA’s approach suggested the agency would control the practice of medicine.
The whopper June buyout of by Morphosys AG of Constellation Pharmaceuticals Inc. brought renewed attention to myelofibrosis (MF) and other players in the space, such as Sierra Oncology Inc.
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice.
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs.
The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.
The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
An exome sequencing study of more than 600,000 individuals of European and mixed American ancestry has identified more than a dozen genes, including five brain-expressed G protein-coupled receptors, that were associated with body mass index.
Looking to allow customers to directly purchase its diagnostics system that runs a full panel of blood tests, Babson Diagnostics Inc. raised $31 million in new series B financing. The proceeds will be used to scale the Austin, Texas-based company to bring its finger-prick blood microsampling system to retail locations across the country.
Neuropace Inc. nabbed $9 million in the form of a five-year NIH grant as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The grant will support the study of the Mountain View, Calif.-based company’s Responsive Neurostimulation (RNS) system in patients with Lennox-Gastuat syndrome (LGS), a debilitating form of epilepsy.
RSS
