Drugs
FDA has accepted for review a Biogen sNDA for a higher dose regimen of Spinraza (nusinersen) for spinal muscular atrophy (SMA). A company statement says the higher dose regimen comprises a more rapid loading regimen compared to the approved Spinraza dosing. The sNDA was based on data from the DEVOTE
Drugs
The Trump Administration’s rollback of government-wide diversity, equity and inclusion activities seems to have caught FDA in its net regarding several diversity-related initiatives and policies, including its high-profile Diversity Action Plan (DAP) draft guidance document, according to Politico’s AgencyIQ. The document has been removed from
Drugs
FDA has extended by three months its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndrome. The new user fee review action target date is 4/29. The review extension is intended to allow FDA to review supplemental information provided
Drugs
FDA has granted Zai Lab an orphan drug designation to ZL-1310, a potential first-in-class DLL3 antibody-drug conjugate (ADC) for treating small cell lung cancer (SCLC). The company says ZL-1310 has “demonstrated promising objective response rates and a favorable safety profile from the ongoing Phase 1
FDA Policy/General
Three Ropes & Gray attorneys write in their 2024 FDA Enforcement Review that while the agency’s focus may shift with the new administration, “industry should continue to invest in strong regulatory compliance and quality programs that encourage the reporting and thorough investigation of potential problems and facilitate prompt corrective
Drugs
FDA says it is adding a Boxed Warning for anaphylaxis, a rare but serious allergic reaction, to the labeling for Teva’s multiple sclerosis drug Copaxone (glatiramer acetate) and Glatopa, Sandoz’ generic version. An agency statement says the reaction can occur at any time while on treatment. “For most patients
Drugs
The U.S. Court of Federal Claims has granted the federal government’s motion for summary judgment in a case in which Vanda Pharmaceuticals alleged that FDA improperly disclosed the company’s trade secrets and confidential commercial and proprietary information to competitors seeking approval of generic drugs. In a 1/
Drugs
FDA has lifted a 2022-placed clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lilly. The agency said at the time that the hold is related to issues surrounding the trial’s protocol design,
Drugs
Patient advocacy group Friends of Cancer Research has added former principal deputy commissioner Janet Woodcock to its board of directors. Woodcock retired late 2023 after 37 years at the agency (see earlier story). She spent over two decades as CDER director until the Covid-19 pandemic saw her move to
Drugs
FDA has granted Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis. [18F]florbetaben positron emission tomography is currently approved to detect neuritic beta amyloid plaques in the brains of patients evaluated for Alzheimer’s disease
Drugs
FDA and Atara Biotherapeutics have agreed on actions needed to release the agency’s clinical holds on Ebvallo (tabelecleucel) and ATA3219. A company statement says the clinical hold on Ebvallo, being studied as monotherapy treatment for adult and pediatric patients aged two and older with Epstein-Barr virus positive post-
Drugs
A 9/26-9/29/2023 FDA inspection at Incell Corp. in San Antonio, TX, documented that the company is a contract manufacturer of a product derived from amniotic fluid. A just-released 12/12/2024 Warning Letter says the firm’s product is legally considered to be an unapproved
Drugs
FDA has issued an amended Warning Letter to Sanofi, replacing the 12/16/2024 letter addressing significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) found in a 6/12-7/9/2024 inspection at the firm’s Genzyme Corp. subsidiary in Framingham, MA. The
Drugs
FDA has approved a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants. Previously, Spravato was approved for combination use with an oral antidepressant for treating adults
Drugs
FDA has published a guidance, Bioanalytical Method Validation for Biomarkers, to help sponsors of INDs and applicants of NDAs, BLAs, sNDAs, sBLAs, and ANDAs to validate bioanalytical methods used to evaluate biomarker concentrations. The document says it can also inform the development of bioanalytical methods used to analyze biomarker concentrations
Drugs
FDA has released the form FDA-483 issued following a 12/2-12/20/2024 inspection at SCA Pharmaceuticals, a Windsor, CT, outsourcing facility. The seven inspection observations were: * failure to thoroughly review any unexplained discrepancy whether or not the batch had already been distributed; * failure to establish written procedures
Drugs
One of dozens of actions president Donald Trump took after being inaugurated 1/20 orders all government departments and agencies like FDA to end work-from-home arrangements and head back to the office “as soon as practicable.” Many FDA employees continue to work full-time from home or in
Drugs
FDA has lifted a clinical hold on an Amylyx Pharmaceuticals Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleotide targeting calpain-2 for treating amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The company plans to initiate the Phase 1 LUMINA clinical trial in Canada early
Drugs
FDA has approved Amgen’s Lumakras (sotorasib) for use with its Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The agency also approved Qiagen’s therascreen KRAS RGQ
Drugs
A new CDER guidance agenda shows that the Center is committing to issuing 11 drug quality guidance documents in 2025. Under GMP pharmaceutical quality, the agenda says the following four documents will be published: * Approaches to Meeting CGMP Requirements for Distributed Manufacturing * Laboratory Testing of Drugs Held in Interstate Commerce:
Drugs
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Drugs
An FDA update says all new neonatal incubators currently supplied in the U.S. do not show “concerning levels of airborne chemicals and therefore do not need to be run for a week before clinical use.” The agency raised concern about such devices 2/2023 and issued an alert stating