Drugs
FDA has approved an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. “Hallucinations or delusions can occur in as many as 50% of patients with Parkinson’s disease at some time
FDA Policy/General
Regen BioPharma has entered into a non-exclusive license agreement with Pan Am Cancer Treatment Center in Tijuana, Mexico to test HemaXellerate in a first-in-human proof of concept study. According to the company, HemaXellerate is comprised of cells extracted from the patient’s own fat tissue and processed
FDA Policy/General
BIOLOGICS CBER Releases eSubmitter Program for Vaccine AERS Federal Register Notice: CBER is making available a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. It is a free software
FDA Policy/General
FDA is developing a new genomics project called Sequencing Quality Control Phase 2 (SEQC2) that aims to develop quality control metrics and benchmark bioinformatics approaches for analyzing whole genome sequencing and targeted gene sequencing data. The project is also designed to achieve best practices, to develop standard analysis protocols, and
Drugs
FDA has approved a Watson Pharmaceuticals ANDA for a generic copy of AstraZeneca’s cholesterol-lowering Crestor (rosuvastatin calcium) tablets. This is the first generic version of the blockbuster drug, and it is approved for the following uses: in combination with diet for treating high triglycerides in adults;in combination
Drugs
In a move to curb lower federal courts from hearing Racketeer Influenced and Corrupt Organizations Act (RICO) cases against pharmaceutical manufacturers for alleged inaccuracies in their marketing concerning the safety and efficacy of their prescription drugs, the Washington Legal Foundation (WLF) has filed a brief with the U.S. Supreme
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period and requesting public input on possible modifications to the current review processes for new animal drug applications for the use of multiple new animal drugs in combination drug medicated feeds. FDA is also making available a Center for Veterinary Medicine recommendations
Devices
FDA has granted Quest Diagnostics an Emergency Use Authorization for the Zika Virus RNA Qualitative Real-Time RT-PCR test. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals, according to the company. The authorization allows
Drugs
FDA has approved a Tract Therapeutics proposed Phase 2 trial to investigate the efficacy and safety of its novel therapy for kidney transplant recipients, which uses a patient’s own cells that are expanded in a laboratory and infused back into the patient after an organ transplant in order to
Drugs
FDA has approved a Teva Pharmaceutical Industries supplemental NDA for ProAir RespiClick (albuterol sulfate) Inhalation Powder for treating or preventing bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for preventing exercise-induced bronchospasm. The product was originally approved in 2015 for patients 12
Drugs
A Florida federal judge has entered a consent decree against Paul W. Franck of Ocala, FL that prohibits his drug compounding operations from making sterile drug products until they comply with GMPs. According to the decree, Franck manufactured and distributed drug products that were adulterated and misbranded. “Mr. Franck risked
FDA Policy/General
Federal Register Notice: CBER is making available a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. It is a free software program for voluntary use that is intended to
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period for a 3/9 Federal Register notice of a public workshop on the use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices in the clinical laboratory. Comments should be submitted by 6/2. To view this notice,
Devices
Patient group Essure Problems and Ennis & Ennis Law have written Congressman Jason Chaffetz (R-UT) urging a congressional investigation and hearing request over FDA’s approval of Bayer’s Essure contraceptive and alleged injuries caused by the device. Chaffetz is chairman of the House Committee on Oversight and Government
Drugs
FDA says that Merck has failed to meet its Pediatric Research Equity Act (PREA) study requirement for Cubicin (daptomycin for injection) that was due 8/31/15. In a 3/3 letter to the company, the agency notes that Merck had requested a deferral extension and that FDA had determined
Drugs
Eagle Pharmaceuticals is asking the DC federal court to order FDA to grant seven-year orphan drug exclusivity for its Bendeka (bendamustine HCl), an IV chemotherapy agent. The suit says that the agency granted Bendeka orphan drug designation 7/2/14 and approved it 12/7/15. However, it denied
Drugs
FDA and industry negotiations for Biosimilars User Fee Act 2 reauthorization started considering 3/31 an agency application review enhancement proposal based on a model followed by CDER under the Prescription Drug User Fee Act. Meeting minutes show that agency representatives said that such a model could promote the efficiency
FDA Policy/General
Public Citizen has filed a Freedom of Information Act suit against FDA asking that the agency post unredacted copies of the curricula vitae (CVs) of advisory committee members on its Web site. A news release from the advocacy group says that despite the fact that the CVs are created for
Drugs
FDA has granted Novartis three breakthrough therapy designations for Ilaris (canakinumab) to treat three rare types of Periodic Fever Syndromes, which are also known as Hereditary Periodic Fevers. The autoinflammatory diseases cause disabling and recurrent fevers, which may be accompanied by joint pain and swelling, muscle pain and skin rashes.
Drugs
FDA has granted Therabron Therapeutics fast track status for rhCC10 (recombinant human club cell 10 kDa protein) and its use in preventing chronic lung disease related to premature birth. The company says the investigational drug has potent anti-inflammatory properties for a variety of respiratory diseases. The drug is currently
Drugs
FDA has accepted for review an OPKO Health NDA resubmission for Rayaldee (calcifediol) for treating secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The filing addresses a 3/29 complete response letter (CRL) that indicated the NDA could not be approved due
Devices
FDA has cleared an AtriCure 510(k) for its AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System that is designed for “increased functionality” than its previous model when occluding the LAA during surgical procedures. The device features an “ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation