Vanda Pharmaceuticals Inc.'s antisense oligonucleotide (ASO) VCA-894A has been awarded orphan drug designation by the FDA for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within IGHMBP2.
If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.
The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the National Institutes of Health or the FDA, two programs of intense interest for companies in the life sciences.
Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.
The U.S. FDA has granted 510(k) clearance to GE Healthcare Technologies Inc. for its Precision DL for PET/CT, an artificial intelligence (AI) and deep learning (DL)-powered software designed to sharpen quality and improve efficiencies in medical imaging. Part of the company’s Effortless Recon DL portfolio, the technology is available on GE’s Omni Legend PET/CT digital scanner.
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
With rising rates of disease and established guidelines for treatment, officials at Lexicon Pharmaceuticals Inc. have “the wind at our backs” as they go about commercializing Inpefa (sotagliflozin) for heart failure (HF), after the drug was cleared late May 26 by the U.S. FDA, said CEO Lonnel Coats. Shares of The Woodlands, Texas-based Lexicon (NASDAQ:LXRX), which had risen significantly after hours on word of the Inpefa go-ahead, closed May 30 at $2.90, down 28 cents. Regulators gave their nod to the inhibitor of renal sodium-glucose co-transporter 2 (SGLT2) and intestinal SGLT1 with a broad label across the full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes.
U.S. FDA approvals had a modest increase during the first four months of 2023 compared to last year, but still fall short of the peaks seen in 2019 and 2021.
Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.
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