Drugs
FDA has issued Camden, NJ-based contract testing laboratory Sure-Biochem Laboratories a just-posted Warning Letter after a 10/2022 inspection cited significant GMP violations associated with the firm’s microbial testing of finished drug products. For example, the agency letter says the testing lab “failed to follow required
FDA Policy/General
FDA and the Veterans Health Administration (VHA) are announcing a new memorandum of understanding (MOU) to help increase medical product manufacturing capacity and flexibility, and “improve resilience of domestic supply chains during emergencies, shortages, and pandemics. The MOU is intended to develop requirements for “trusted networks needed to enable the
Drugs
Despite testimony from three already convicted cooperating witnesses, a Miami federal jury 5/18 acquitted Tellus Clinical Research CEO Fidalgis Font and clinical study coordinator Julio Lopez in their alleged role of falsifying research data. Jurors also acquitted physician Martin Valdes of conspiracy, fraud and money laundering charges, but they
Drugs
FDA has agreed to a PolyPid Ltd. Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal colorectal surgical site infections (SSIs). The revised trial will recruit patients undergoing colorectal resection surgery with large incisions (greater than 20 cm), according to the company. Recruitment into
Drugs
FDA has denied a Public Citizen petition urging the agency to require a Boxed Warning for all sodium-glucose cotransporter-2 (SGLT-2) inhibitor drugs contraindicating their use in patients with Type 1 diabetes. “There is irrefutable evidence from multiple randomized clinical trials that the SGLT-2 inhibitors canagliflozin (Janssen’
Devices
FDA has updated its CDRH Portal to allow users to track the progress of pre-submissions. Device premarket submission types may be uploaded to the CDRH Portal at any stage of the review process, according to an agency notice. “Official correspondents do not need to send a physical cover letter
Drugs
FDA has approved a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis (ISM). The rare hematologic disorder can lead to several debilitating symptoms across multiple organ systems, according to the company. The drug was designed to potently and selectively inhibit KIT D816V, the primary underlying
Drugs
Novo Nordisk says it will seek FDA approval for obesity drug semaglutide 50 mg tablets after announcing that the Phase 3a OASIS 1 trial met its primary endpoint — demonstrating a statistically significant and superior weight loss at week 68 versus placebo. Injectabe semaglutide (Wegovy) was approved in 2021 for treating
Drugs
Rain Oncology says it will not pursue further development of milademetan in dedifferentiated liposarcoma after reporting disappointing topline data from its pivotal Phase 3 MANTRA trial. The trial did not meet its primary endpoint of progression free survival (PFS). In the study, the median PFS for milademetan was 3.6
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of Abbott’s NDA for Cyclert (pemoline) tablets, indicated for treating attention-deficit/hyperactivity disorder. The company stopped marketing the product in 2005 in response to an agency safety alert about liver toxicity. The NDA was never officially withdrawn and Abbott is now
Drugs
FDA has approved an Opiant Pharmaceuticals NDA for Opvee (nalmefene HCl) nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. “On the heels of the FDA’s recent approval of the first over-the-counter opioid
Drugs
FDA 5/19 issued Aurobindo Pharma a four-observation Form FDA-483 after concluding a five-day inspection of the firm’s Unit XIV active pharmaceutical ingredient (non-antibiotic) manufacturing facility at Paravada Industrial Area in Andhra Pradesh, India. “The observations are procedural in nature,” the company says, adding that
FDA Policy/General
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDA submissions. To view the notice, click here.
Drugs
New FDA research on direct-to-consumer (DTC) television ads found that study subjects have trouble differentiating progression-free survival and overall response rate from overall survival. The agency says research has suggested that disclosures can help consumers stop conflating overall survival with other endpoints. Such disclosures specifically state that
Devices
Abiomed has recalled (Class 1) its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patient’s circulatory system. The recall was decided after the company experienced a “heightened complaint rate for purge leaks,” according to a recall notice. FDA says the problem was
Devices
The Justice Department has resolved civil claims requiring Zoll Medical to pay $400,000 for selling Chinese-made products to the federal government that were required by law to have been made in America. The FDA-investigated case resolves allegations that between 1/2019 and 11/2022 Zoll sold electrocardiogram
Drugs
FDA has granted Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B‑cell lymphoma after two or more lines of systemic therapy. DLBCLs are the most common type of
Biologics
FDA has approved a Krystal Biotech BLA for Vyjuvek, a herpes-simplex virus Type 1 vector-based gene therapy for treating wounds in patients six months of age and older with dystrophic epidermolysis bullosa (DEB). The topical gene therapy is designed to treat DEB at the molecular level by providing
Devices
FDA has cleared a Beta Bionics 510(k) for the iLet ACE Pump and the iLet Dosing Decision Software for treating Type 1 diabetes in patients aged six years and older. “These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system
Drugs
Vanda Pharmaceuticals is asking FDA to revoke its approval of an MSN Pharmaceuticals ANDA for generic Hetlioz (tasimelteon) capsules and order a recall of any product that has been distributed under the ANDA. The Vanda petition says MSN failed to satisfy bioequivalence requirements in its ANDA. Hetlioz is indicated for
Drugs
FDA has released the form FDA-483 issued following an 11/8-12/2/22 inspection at the Nephron Pharmaceuticals warehouse in Murray, KY. The four inspection observations were: * failing to have a quality control unit; * failing to examine visually at least once a year reserve samples from representative sample
Drugs
FDA has approved AbbVie’s Rinvoq (upadacitinib) for treating adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Previously, Rinvoq was approved as a treatment for rheumatoid arthritis, active psoriatic arthritis and active ankylosing