Drugs
FDA has accepted a Nabriva Therapeutics NDA and granted a priority review for Contepo (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The agency has set a 6/30 review action target date. The 505(b)(2) submission is supported by data from the Phase
Devices
Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol. The company is recalling all existing inventory data, and use under the protocol will first be pre-screened by a panel
Drugs
Verrica Pharmaceuticals says it is planning an NDA submission in the second half of the year for VP-102 for treating molluscum contagiosum, a highly contagious skin disease affecting primarily children. The submission will be based on just-reported data from the company’s Phase 3 CAMP-1 and CAMP-
Devices
Akonni Biosystems has filed a 510(k) to market the TruDiagnosis system, its proprietary microarray-based technology. The company says the in vitro diagnostic device is intended for genotyping multiple genes in a DNA sample using on-slide polymerase chain reaction gel-drop microarray technology to help detect clinically relevant
Drugs
FDA and the American Society for Clinical Pharmacology and Therapeutics are co-sponsoring a 3/13 conference on “PBPK Modeling for the Development and Approval of Locally Acting Drug Products.” In announcing the conference, the agency says “recent advancement of physiologically-based PK (PBPK) models for drugs delivered directly to
Drugs
FDA has approved a StemCyte IND to conduct a Phase 2 trial of its Allogeneic Human Leukocyte Antigen-Matched Umbilical Cord Blood Mononuclear Stem Cells (MC001) for treating spinal cord injury. The regenerative cell therapy drug is designed to regenerate neurons in patients who suffered chronic, severe, stable spinal cord
Devices
FDA has cleared a Tivic Health Systems 510(k) for the ClearUP Sinus Pain Relief, a bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever). The over-the-counter handheld device uses microcurrent waveforms to provide sinus pain relief. Tivic Health says it is intended to glide along
Drugs
FDA has asked the DC federal court to continue a stay of Endo’s suit against the agency over bulk compounding of drugs including vasopressin until the government shutdown ends and agency and Justice Department employees are permitted to work again. The suit previously was stayed until 12/31/18
Drugs
seven-year market exclusivity granted by FDA to orphan drugs intended to treat rare diseases is working as intended. “In nearly every case,” NORD says, “orphan exclusivity did not inappropriately prevent generics and biosimilars from entering the market. Instead, the lack of generic competitors can be credited to their prospective
Drugs
Some drug companies started 2019 with price increases on more than 250 prescription drugs, with more likely to come, according to multiple media reports. Relying on data from Rx Savings Solutions, which helps health plans and employers find lower cost prescription drugs, Reuters reports that Allergan raised prices on more
Drugs
A study (REDUCE-IT) funded by Amarin Pharma shows that among patients with elevated triglyceride levels despite use of statins, the risk of ischemic events, including cardiovascular death, is significantly lower among those receiving 2 g of icosapent ethyl twice daily than among those receiving placebo. Researchers from Harvard Medical
Drugs
The Supreme Court will hear oral arguments 1/7 as part of Merck’s appeal of a 3rd Circuit Court of Appeals ruling that allowed hundreds of state-based liability claims involving alleged failure to adequately warn of fracture risk associated with Fosamax (alendronate sodium) to go to trial. Chemical
Devices
FDA has granted Bruin Biometrics de novo clearance to market the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for pressure ulcers. The device is designed to objectively alert clinicians to
Drugs
FDA has chosen a Phase 2/3 efficacy and safety trial for Wave Life Science’s Duchenne muscular dystrophy (DMD) drug suvodirsen to be part of the agency’s pilot program for complex innovative trial designs. Suvodirsen is an investigational therapy for boys with DMD who are amenable to exon
Drugs
FDA has approved an expanded indication for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include treating pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Approval is based on data from the Phase 2 study, CA180-
FDA Policy/General
Below are the FDA Warning Letters published during our annual end-of-year holiday break. Cao Medical Equipment Co. Hebei, China (11/30/2018): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to perform, for each batch of drug
Drugs
FDA has approved a Slayback Pharma ANDA for hydroxyprogesterone caproate injection 1,250 mg/5mL, a generic form of Amag Pharmaceuticals’ Makena, indicated to reduce the risk of preterm birth in some women. The company says it will soon launch its generic product, which is the only Makena generic approved
Drugs
FDA has released the FDA-483 issued following a 9/10-10/12/18 inspection at Intact Pharmaceuticals, an outsourcing facility in New Milford, CT. The 11 inspection observations were: * aseptic processing areas are deficient regarding systems for maintaining any equipment used to control aseptic conditions; * aseptic processing areas are
Drugs
Adamis Pharmaceuticals has submitted a 505(b)(2) NDA for its naloxone pre-filled single dose syringe product candidate, indicated for treating opioid overdose. Naloxone works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness, the company says. Adamis recently gained
Drugs
FDA has approved Alexion Pharmaceuticals’ Ultomiris (ravulizumab) to treat adult patients with paroxysmal hemoglobinuria (PNH). An agency announcement says PNH is a rare acquired disorder that leads to the rupture or destruction of red blood cells (hemolysis). Ultomiris is described as a long-acting complement inhibitor that prevents hemolysis. Its
Drugs
FDA says Torrent Pharmaceuticals has recalled two lots of losartan potassium 100 mg tablets due to presence of N-nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs. An agency notice says that not all Torrent losartan-containing medications distributed in the U.S. are being recalled,
Biologics
A 6/18-6/22/18 FDA inspection at a Genetech facility located in San Diego, CA, found multiple violations in the firm’s processing of human umbilical cord blood derived cellular products that are distributed to Liveyon LLC, Yorba Linda, CA. An 11/29/18 Warning Letter says the