Drugs
FDA has granted AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. Traditional approval was also granted for acalabrutinib’s use as a single agent for adults with previously treated MCL.
Drugs
Boehringer Ingelheim says its Phase 3 CONNEX clinical trial program evaluating iclepertin in cognitive impairment in adults with schizophrenia did not meet primary and key secondary endpoints. “Overall, no statistically significant effects on cognition or functioning were observed in patients treated with iclepertin versus placebo at six months,” it says,
Drugs
An FDA alert is warning healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, FL, and Endo USA, in Malvern, PA. The alert says healthcare professionals have confused these products with FDA-approved injectable epinephrine products for intravenous use. “BPI Labs and Endo
Drugs
FDA has issued Atara Biotherapeutics a complete response letter on its BLA for Ebvallo (tabelecleucel), a monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease, who have received at least one prior therapy including an anti-CD20
Drugs
FDA has published a draft guidance, Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology, with recommendations to sponsors for the clinical development of drug and biological products intended to prevent and treat chemotherapy-induced peripheral neuropathy (CIPN) in oncology patients. The document pertains
Drugs
The Department of Justice (DoJ) says a former McKinsey & Company senior partner pleaded guilty 1/10 to obstructing justice related to his work on opioids with Purdue Pharma. A department statement says Martin Elling, an American citizen who lives in Bangkok, Thailand, pleaded guilty to a one-count information
Drugs
FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn’s disease in adults. Omvoh was originally approved 10/2023 as a first-in-class treatment for moderately to severely active ulcerative colitis in adults. The new approval is based on data from the
Drugs
Getinge and its subsidiary Maquet Cardiovascular are recalling (Class 1 instructions for use update) the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the possibility of two failure modes being experienced during use. A recall notice describes the failures as a bent or detached
Drugs
FDA has published a Federal Register notice indicating its intention to deny the Vanda Pharmaceuticals NDA for tradipitant capsules, 85 mg, in its present form and offering the company the opportunity to request a hearing with the commissioner. The notice says the NDA seeks an indication for “the treatment of
Drugs
FDA has accepted for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug-releasing system for treating patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, with or without papillary tumors. The company says the submission
Drugs
The HHS Office of Inspector General (OIG) says its review of a sample of 24 drugs approved via the FDA Accelerated Approval pathway identified concerns with three of the approvals. The OIG report says that because accelerated approval does not require that a drug demonstrate a clinical benefit before it
Drugs
FDA says the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine an acceptable intake (AI) limit for N-nitrosamine impurities in drugs has expedited the regulatory review of drug safety assessments submitted by drug companies as an AI limit can be identified more efficiently and with greater transparency
Drugs
The Association for Accessible Medicines (AAM) says FDA should publish guidance for oligonucleotide product development for ANDAs, particularly for topics not included in product-specific guidances such as recommendations for immunogenicity and inflammation risk assessments and for demonstration of comparability of impurities. The request is included in AAM’s comments
Drugs
FDA has accepted for review an Eisai BLA for Leqembi (lecanemab-irmb) subcutaneous autoinjector weekly maintenance dosing for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. The submission is based on data from the Clarity AD (Study 301) open-label extension and
Drugs
FDA has accepted for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior systemic therapies. The user fee review action date is expected during the
Drugs
FDA has granted Rigel Pharmaceuticals an orphan drug designation for R289 and its use in treating myelodysplastic syndromes (MDS). The “potent and selective” dual inhibitor of IRAK1 and IRAK4 is being studied in an ongoing Phase 1b study evaluating the safety, tolerability, pharmacokinetics and preliminary activity in patients with lower-
Drugs
CDER’s senior leadership is in turmoil ahead of president-elect Donald Trump’s 1/20 inauguration as director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new administration takes hold. “Leaving CDER was an extremely difficult decision, but the time has come for me to
Drugs
FDA has accepted for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. The submission has been granted priority review and a user fee action date of 6/30.
Drugs
Tenpoint Therapeutics is reporting positive topline results from BRIO-II, the company’s second Phase 3 pivotal trial evaluating Brimochol PF (brimonidine), a pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia. BRIO-II met its pre-specified primary endpoints, demonstrating statistically significant improvements in
Drugs
Pfizer is announcing positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody, for combination use with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer. The
Drugs
FDA has accepted for review an Agios Pharmaceuticals sNDA for Pyrukynd (mitapivat) to treat adults with non-transfusion-dependent alpha- or beta-thalassemia. The agency set a PDUFA review goal date of 9/7. A company statement says the sNDA is based on results from the ENERGIZE and ENERGIZE-T
Drugs
FDA has granted fast track designation for Marengo Therapeutics’ invikafusp alfa to treat unresectable, locally advanced, or metastatic colorectal cancers with high tumor mutational burden. A company statement says the designation was informed by encouraging results from Marengo’s first-in-human clinical study of invikafusp alfa in heavily pretreated