Drugs
FDA 1/4 sent Akorn a Warning Letter related to a month-long inspection at its Decatur, IL manufacturing facility that was conducted in April and May last year. In disclosing the letter, the company says it will work collaboratively with FDA to resolve all issues cited, and it will
Drugs
HHS secretary Alex Azar says he and President Donald Trump won’t stop pressuring drug companies until the list prices of drugs come down. Fox Business reports that Azar told the network that the administration will “roll out more regulatory and legislative proposals and we will work with Democrats and
Drugs
FDA has denied an 8/21/13 Public Citizen petition asking that it require a Boxed Warning on labeling for clopidogrel tablets (Bristol-Myers Squibb’s Plavix) addressing the “increased risk of major and minor bleeding with use beyond 12 months following implantation of a drug-eluting coronary artery stents.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should exercise caution in implementing any format changes for the National Drug Code (NDC). In a 1/5 comment letter, the trade group says that any changes to the NDC “will require a substantial amount of time and resources to revise
Drugs
FDA commissioner Scott Gottlieb unveiled agency plans 1/8 to create a new Office of Drug Evaluation Science to modernize the drug review process. “We envision a world where we’re going to move toward a much more structured review process where the data will be available in a cloud-
Drugs
In an FDA Voices online report, CDER director Janet Woodcock describes many of the agency’s activities to ensure that drugs it approves are not only effective, but safe. “Safety is a priority both before and after approval, and maintaining the safety of drugs that Americans rely on is a
Drugs
While the U.S. continues to lead worldwide drug research and development, China, India, and South Korea are emerging as important players on the global R&D stage, according to an analysis of new active substances reported in the latest Tufts Center for the Study of Drug Development Impact
Drugs
FDA has granted Novartis a breakthrough therapy designation for crizanlizumab (SEG101) for use in preventing vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease. The company says VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic complications. They happen when
Drugs
FDA has granted Awak Technologies a breakthrough designation for its Awak Peritoneal Dialysis device, a wearable and ultra-portable peritoneal dialysis system that uses the company’s patented sorbent technology. The device is intended to allow dialysis to be performed “on-the-go,” overcoming the challenge of long hours of
Drugs
U.S. Supreme Court justices 1/7 appeared to be leaning in Merck’s favor in its arguments for reversing 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
Drugs
Lupin Pharmaceuticals has recalled five lots of ceftriaxone for injection (250mg), 10 lots of ceftriaxone for injection (500mg), 24 lots of ceftriaxone for injection (1g) and three lots of ceftriaxone for injection (2g) because the products have been found to contain visual grey particulate matter in reconstituted vials. “Improper piercing
Drugs
CDER saw a 28% increase in novel new drug approvals last year — jumping from 46 approvals in 2017 to 59 in 2018. In contrast, over the past ten years CDER has averaged about 33 novel drug approvals per year, according to a just-released report. A close look at the
Drugs
FDA has granted Rainier Therapeutics a fast track designation for its targeted antibody vofatamab for treating patients with advanced or metastatic urothelial cell carcinoma (bladder cancer) that is positive for FGFR3 mutation or fusion. Vofatamab (B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3)
Drugs
FDA has granted CRISPR Therapeutics and Vertex Pharmaceuticals a fast track designation for CTX001 for treating sickle cell disease. The companies are developing the investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies. Late last year, they filed an IND for a Phase 1/2
Drugs
Torrent Pharmaceuticals has expanded an earlier recall from two lots of hypertension drug losartan potassium tablets USP to a total of 10 lots due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs. Torrent is only recalling lots of
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
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-
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
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