Drugs
CDER regulatory counsel Heather Messick, who was lead on the European Union’s General Data Protection Regulation (GDPR) when she worked in the FDA Europe Office as an international policy analyst, says the GDPR poses several concerns for FDA. Writing in an online From a Global Perspective post, she says
Drugs
FDA has issued CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The letter said the submission cannot be approved until inspection deficiencies at the company’s contract manufacturing
Drugs
Reata Pharmaceuticals says its May-submitted NDA for omaveloxolone, indicated for treating patients with Friedreich’s ataxia, is facing FDA scrutiny about the submission’s “strength” of efficacy evidence. The agency’s concern was expressed in a mid-cycle communication meeting, which the company says did not raise any clinical
Drugs
FDA has granted Attralus an orphan drug designation for 124 I-AT-01 iodine (evuzamitide) as a diagnostic for managing transthyretin amyloidosis (ATTR). The company says the product utilizes its pan-amyloid binding peptide as an amyloid-specific imaging agent to detect and quantify amyloid in multiple types of systemic
Drugs
FDA has approved Myovant Sciences/Pfizer’s Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy (treatment duration up to 24 months) for managing moderate to severe pain associated with endometriosis in pre-menopausal women. Previously, the drug
Drugs
A collaboration between FDA, the National Cancer Institute, patient advocacy group LUNGevity Foundation, and industry representatives has developed a forthcoming draft guidance that is intended to modernize and streamline eligibility criteria recommendations to allow more patients to easily enroll in lung cancer clinical trials. Efforts are underway to replicate the
Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable or metastatic HER2-low breast cancer. “This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative
Drugs
FDA has issued Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The letter recommended the company conduct an additional trial in ADP. “While the FDA stated that Study 019 demonstrated a statistically
Drugs
Merck says it will file a response in the first half of 2023 to an FDA complete response letter it received in January on an NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refractory chronic cough or unexplained chronic cough in adults. The company says it
Drugs
Regenxbio says it will file a BLA with FDA using the accelerated approval pathway for its RGX-121 to treat mucopolysaccharidosis type 2, also known as Hunter Syndrome. The company says its pivotal trial for RGX-121 is active and enrolling patients. Regenxbio describes RGX-121 as an investigational, one-
Drugs
FDA has issued a Form FDA 483 to Aurobindo Pharma that cites three observations after investigators inspected (7/25 to 8/2) the firm’s Unit XI, an active pharmaceutical ingredient manufacturing facility in Pydibhimavaram, a district of Andhra Pradesh, India. “At the end of the inspection, we have been
Drugs
The 7th Circuit Court of Appeals has affirmed the decision of an Illinois federal court to dismiss a suit alleging that AbbVie violated the Sherman Antitrust Act when it obtained 132 additional patents for its Humira following the 2016 expiration of the biologic’s primary patent. The suit was brought
Drugs
Former CDER combination products team leader Jay Jariwala has joined Sidley as senior director, regulatory compliance, in the firm’s food, drug, and medical device compliance and enforcement practice. The Sidley announcement says Jariwala worked in CDER, CDRH, and the Office of the Commissioner. He also was the assistant country
Drugs
Merck and Eisai say the Phase 3 LEAP-002 trial investigating Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) versus Lenvima as monotherapy in patients with unresectable hepatocellular carcinoma did not meet the dual primary endpoints of overall survival and progression-free survival. The combination is currently approved by
Drugs
Some 99 organizations that represent patients with rare diseases and other acute or chronic health conditions are urging congressional leadership to “resume negotiations to develop a comprehensive FDA user fee package.” In an 8/1 letter, the organizations say they are “deeply concerned about the impact that a delay in
Drugs
Pfizer says it is discontinuing the development of PF-07265803 in patients with symptomatic dilated cardiomyopathy (DCM) after an interim futility analysis of the global Phase 3 trial REALM-DCM indicated that it is unlikely to meet the primary endpoint upon completion. The trial was designed to evaluate the investigational
Drugs
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as the only interchangeable biosimilar to Genentech’s Lucentis for all five indications, with 12 months of interchangeability exclusivity. Coherus says Cimerli belongs to the anti-VEGF therapy class of biologics that has been “revolutionary” in helping retinal patients maintain or gain vision.
Drugs
Alnylam Pharmaceuticals says it is planning an NDA submission late this year for patisiran, indicated for treating transthyretin-mediated amyloidosis with cardiomyopathy after reporting positive data from the APOLLO-B Phase 3 study. The study met the primary endpoint of change from baseline in the Six-Minute Walk Test at
Drugs
A 9/7-9/9/21 FDA inspection at the DSP Skin Care drug manufacturing facility in Los Angeles, CA, found significant violations of current good manufacturing practice (CGMP) requirements for finished pharmaceuticals and multiple other violations. A 7/19 Warning Letter lists specific violations as: * failing to have for
Drugs
Allarity Therapeutics says its board has ordered a refocus of the company’s oncology drug pipeline away from monotherapies and toward combination drugs. One reason for the shift, it says, is information from a meeting with FDA on a potential Phase 3 clinical development path for dovitinib as a monotherapy
Drugs
FDA has published a draft guidance, Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies, containing instructions for the electronic submission of expedited individual case safety reports (ICSRs) from IND-exempt bioavailability/bioequivalence studies through the FDA adverse event reporting system database. The document says an ICSR
Drugs
An Amgen analysis published in Therapeutic Innovation & Regulatory Science, says the FDA accelerated approval program for drugs “has been largely successful, with half of accelerated approvals converted to traditional approval in a median time of 3.2 years.” The researchers say recent FDA actions show the agency is appropriately