Drugs
FDA has accepted for priority review a Bristol Myers Squibb NDA for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI) for treating patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The agency has set a review action target date of 11/27. The submission
Drugs
FDA has approved Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent. The company is seeking an indication for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial
Drugs
Hyman, Phelps & McNamara says a client that develops drugs intended to treat neovascular age-related macular degeneration (nAMD) has concerns about an FDA draft guidance on developing drugs to treat nAMD. The firm’s comment letter says the areas of concern are the guidance recommendations for the comparator arm,
Drugs
Janssen has submitted an NDA to FDA for an investigational single-tablet combination of macitentan (Janssen’s Opsumit) 10 mg and tadalafil (Lilly’s Cialis and others) 40 mg for the long-term treatment of pulmonary arterial hypertension in some specified adult patients. A company statement says the NDA is
Drugs
Pfizer says that its investigational hemophilia drug marstacimab met its primary endpoints in the Phase 3 BASIS trial, demonstrating statistically significant and clinically meaningful effects. A company statement says marstacimab is an investigational anti-tissue factor pathway inhibitor being studied to treat hemophilia A or B for people without inhibitors
Drugs
CDER’s Office of New Drugs has denied an Akebia Therapeutics dispute resolution request following its receipt of a 3/22 complete response letter (CRL) for vadadustat, but the company says it was offered a “path forward” to resubmit the NDA, indicated for treating anemia due to chronic kidney disease
Drugs
The National Organization for Rare Disorders says it appreciates FDA efforts in a draft guidance on clinical trial considerations to support accelerated approval of oncology drugs “since the guidance, when finalized, will likely have far-reaching impacts on rare disease drug development well beyond oncology products.” The comment letter recommends:
Drugs
Bristol Myers Squibb says its Breyanzi (lisocabtagene maraleucel) showed “deep and durable efficacy” in the Phase 1/2 TRANSCEND CLL 004 study of adults with relapsed or refractory lymphocytic leukemia or small lymphocytic lymphoma. A company statement says Breyanzi delivered statistically significant complete response rates, the primary endpoint, in 18.
Drugs
AstraZeneca says the Phase 3 DUO-E trial showed statistically significant and clinically meaningful improvement in progression-free survival of advanced endometrial cancer when its Imfinzi (durvalumab) was used in combination with platinum-based chemotherapy and followed by Imfinzi plus Lynparza (olaparib) or Imfinzi alone as maintenance therapy. A company
Drugs
FDA has released the form FDA-483 issued following a 4/17-4/21 inspection at the UCB Pharma drug manufacturing facility in Braine-l’Alleud, Belgium. The three inspection observations were: * failure of the quality unit to establish adequate document control of the forms used for good manufacturing practice
Drugs
FDA says it is requiring updates to the Boxed Warning and other information for prescription stimulants to ensure the prescribing information is consistent across the entire class of drugs, The drugs are used to treat attention deficit/hyperactivity disorder, binge-eating disorder, and narcolepsy. An agency notice says the current
Drugs
FDA has accepted for priority review a Takeda and Hutchmed NDA for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for treating adult patients with previously treated metastatic colorectal cancer (CRC). If approved, the companies say fruquintinib will be the
Drugs
FDA has approved a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The
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Mirati Therapeutics says the Phase 3 SAPPHIRE study that evaluated sitravatinib with Bristol-Myer Squibb’s Opdivo (nivolumab) versus docetaxel in select patients with second- or third-line advanced non-squamous non-small cell lung cancer failed to meet its primary endpoint of overall survival at the final analysis. The
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FDA has published a guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, with current agency recommendations on adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. The document provides recommendations for using covariates in the analysis of randomized parallel
Drugs
Drug recalls surged by 53.2% from 94 in the fourth quarter of 2022 to 144 in the first quarter of 2023, according to the Sedgwick first quarter recall index. The report says current good manufacturing practice deviations dominated the recall activity, accounting for 70 events and 33.2 million
Drugs
FDA has granted Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary membranous nephropathy (PMN). The monoclonal antibody is designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies, the company says. PMN is a rare
Drugs
The 13 House members from Michigan have sent a bipartisan letter to FDA commissioner Robert Califf urging the agency to take immediate action to mitigate the effects of a nationwide shortage of chemotherapy drugs. Led by Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI), the delegation letter says
Drugs
FDA has approved a Pfizer NDA for its antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets) for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. Paxlovid was granted an emergency use authorization (EUA) 12/2021, which is
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say they commend FDA for publishing a framework to guide the use of digital health technology (DHT)-derived data in regulatory decision-making for drug and biological products. The associations’ joint letter recommends that the agency consider
Drugs
Phathom Pharmaceuticals says it has resubmitted to FDA an NDA for vonoprazan, a novel first-in-class potassium-competitive acid blocker to treat erosive gastroesophageal reflux disease (erosive esophagitis). The company says the resubmission responds to an agency 2/2023 complete response letter relating to specifications and controls for a
Drugs
FDA has published a draft guidance, Generally Accepted Scientific Knowledge in Applications for Drug and Biological Product: Nonclinical Information, describing instances in which it may be appropriate to rely on GASK (generally accepted scientific knowledge) to meet certain nonclinical safety requirements for NDAs and BLAs. The document says the information