Biologics
FDA has published one draft foundation guidance and five immediately effective guidances covering specific disease agents and diseases to assist establishments that make eligibility determinations for donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps) to understand the regulations governing donor eligibility. The draft foundation guidance,
Drugs
FDA has accepted for review a Verastem Oncology NDA for avutometinib, an oral RAF/MEK clamp for use in combination with defactinib, an oral FAK inhibitor, for treating adult patients with recurrent low-grade serous ovarian cancer (LGSOC) who received at least one prior systemic therapy and have a KRAS
Biologics
An FDA summary report on clinical study diversity action plans for FY 2023 and FY 2024 shows that submission of the action plans to the agency is going up, even though such submissions are not yet required. The report shows that CDER received 124 plans in FY 2023 and 161
Drugs
A 1/3-1/5/2024 FDA inspection at XO Biologix in Austin, TX, determined that the company markets and distributes a product derived from amniotic fluid under a redacted contract. A just-released 12/12/2024 Warning Letter says the company’s MaviX product is an unapproved new drug
Drugs
FDA has granted fast-track designation for Johnson & Johnson’s posdinemab which is being investigated in the Phase 2b AuTonomy study to treat patients with early Alzheimer’s disease. A company statement says posdinemab is a phosphorylate tau-directed monoclonal antibody that was discovered internally and has shown the
Drugs
First-cycle NDA approvals fell in 2024 to 74% (37 of the 50 novel drugs approved) from 84% (46 of the 55 novel approvals) in 2023, according to CDER’s annual new drug approvals report. In contrast, CDER approved 28 of the 37 (76%) novel drugs on the first cycle
Drugs
The FDA Anesthetic and Analgesic Drug Products Advisory Committee will discuss 1/10 the challenges FDA has identified in a Seikagaku BLA for condoliase with a proposed indication to treat radicular leg pain associated with confirmed nerve root impingement caused by lumbar disc herniation in adults. An agency briefing document
Drugs
Vanda Pharmaceuticals is criticizing FDA for failing to approve the company’s NDA for tradipitant to treat the symptoms of gastroparesis. In 9/2024, FDA issued a complete response letter that the company said was “conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional
Devices
The UK-based maker of Anne’s Daye Tampons says it is pulling its CBD-coated tampons intended to relieve menstrual pain from the U.S. market following receipt of an FDA Warning Letter. The letter said the adulterated products were not approved for sale in the U.S. and
Drugs
FDA has published a draft guidance, Developing Drugs for Optical Imaging, with recommendations for sponsors about clinical trial design features that support the development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as
Drugs
FDA has accepted for priority review biopharmaceutical firm Dizal’s NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) whose disease has progressed on or after platinum-based
Drugs
A 7/16-7/26/2024 FDA inspection at the Indoco Remedies drug manufacturing facility in Goa, India, found repeat significant violations of current good manufacturing practice (CGMP) regulations. A just-released 12/16/2024 Warning Letter says the specific violations were: * failure to record and justify any deviations from
Drugs
FDA has published a draft guidance, Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction, with recommendations to industry about developing drugs and biologics regulated by CDER intended for reduction and long-term maintenance of body weight in patients with obesity and those with a body mass index
Biologics
FDA has approved a guidance, Communications from Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers, to reassure firms that if they provide communications that are consistent with the guidance’s recommendations, the agency will not consider the dissemination of such
Drugs
Johnson & Johnson is announcing positive topline results from the Phase 3 MARIPOSA study showing that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a statistically significant and clinically meaningful improvement in overall survival versus standard-of-care osimertinib (AstraZeneca’s Taggrisso) as a first-line therapy for patients with
FDA Policy/General
Federal Register notice: FDA is correcting a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilson Jiao). The new notice indicates that Jiao is debarred for five years from importing or offering for import any drug into the U.S. FDA bases the
Drugs
Two eukaryotic initiation factor 2B (eIF2B) activator drugs from Denali Therapeutics and Calico Life Sciences each failed to meet primary and secondary endpoints in an innovative platform trial studying their safety and effectiveness in treating amyotrophic lateral sclerosis (ALS; also known as Lou Gerig’s Disease), according to company statements.
Devices
FDA has published a draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, providing lifecycle management and marketing submission recommendations consistent with a total product lifecycle (TPLC) approach for AI-enabled devices. The document has recommendations on the contents of marketing submissions for devices that
Biologics
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for increasing the number of females in clinical trials and non-interventional studies to help ensure the generalizability of results. The document says it also has recommendations for analyzing and interpreting
Biologics
An FDA alert says the agency has required safety labeling changes about Guillain-Barré syndrome risks for Pfizer’s Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline Biologicals’ Arexvy (respiratory syncytial virus vaccine, adjuvanted). Guillain-Barré syndrome is a rare disorder in which the body’s immune system damages nerve cells,
Drugs
FDA has approved Ionis’ Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA). An agency statement says FDA worked closely with Ionis during development to help design and implement the analysis upon which the approval was based. Spinraza’s efficacy was evaluated in
Devices
FDA has released a final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” Agency regulations require device makers to notify FDA during or in advance of a public health emergency about any permanent discontinuance