Drugs
Selectively sharing information with stock analysts and not through open public disclosures after meeting with FDA on a product development issue is a “no-no.” So learns TherapeuticsMD, a pharmaceutical company headquartered in Boca Raton, FL, after being charged by the Securities and Exchange Commission (SEC) 8/20. According to
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CBER director Peter Marks tells Stat News he issued a public statement addressing Novartis’ data manipulation in the application for its Zolgensma to be sure the episode did not set back development of other gene therapies. Any case in which data are mishandled and patients are harmed could set the
Drugs
FDA has granted Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) that is seeking an indication for treating men with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is currently indicated for treating patients with castration-resistant prostate cancer. The submission is based on
Drugs
Endo International and Allergan have agreed to pay $15 million to resolve litigation brought by two Ohio counties accusing several drug companies and distributors of fueling the U.S. opioid epidemic. Reuters reports Endo will pay $10 million to the counties and provide up to $1 million worth of two
Drugs
Sen. Gary Peters (D-MI), ranking member on the Senate Homeland Security and Governmental Affairs Committee, is asking FDA acting commissioner Ned Sharpless for information about ongoing drug shortages and current and planned agency actions to address the situation. In an 8/21 letter, Peters says the number of active
Drugs
A 12/17/18-2/15/19 FDA inspection at TG United, Brooksville, FL, found current good manufacturing practice (CGMP) violations in the firm’s production of finished pharmaceuticals. An 8/1 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch
Drugs
FDA is pointing to a new Warning Letter to a Chinese drug manufacturer as evidence of its increased “oversight of over-the-counter drug manufacturing and protecting consumers from products that may put them at risk.” The Warning Letter to Ningbo Huize Commodity cited GMP violations, including data integrity issues,
Drugs
Federal Register notice: FDA has corrected a 6/8/2011 notice about the approval withdrawal of 70 NDAs and 97 ANDAs from multiple applicants. That notice contained the incorrect applicant information for NDA 018380, which has now been corrected to reflect that it belonged to Hospira. To view the notice,
Drugs
The United States Pharmacopoeia (USP) says it is updating organic impurities testing for articles subject to USP-NF (National Formulary) standards. A USP notice says the approach applies the International Conference on Harmonization (ICH) Q3A/B-based limits for identification and reporting of organic impurities and degradation products in drug
Drugs
FDA has issued a complete response letter (CRL) to Sarepta for its NDA seeking accelerated approval of golodirsen injection for treating Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping. The company says the CRL generally raises two concerns: the risk of infections related to
Drugs
Members of the FDA Pediatric Advisory Committee and Risk Management Advisory Committee will meet 9/26-27 to discuss the required pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by law. An FDA notice says the committees also will discuss pediatric data considerations for opioid
Drugs
Turner Scientific has petitioned FDA to approve and issue a proposed guidance drafted by Turner on nonclinical evaluation of ototoxicity during drug development. The petition says that Turner believes that current regulatory requirements “do not lead to adequate detection and prevention of harm to hearing and balance caused by medication
Drugs
FDA has sent Dr. Reddy’s Laboratories an eight-observation Form FDA-483 — the third inspection form in six weeks for one of its facilities in India. The current inspection ended 8/20 at the firm’s Duvvada formulations manufacturing plant in Andhra Pradesh, according to the company. On 7/
Drugs
FDA has issued Vanda Pharmaceuticals a complete response letter on a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. The letter said that “measures” contained in the NDA demonstrating improved sleep have “unclear clinical significance,” according to the company. Vanda previously reported that treated patients slept nearly three
Drugs
FDA has classified a recent inspection of Sun Pharmaceutical Industries’ troubled Halol, India plant as “no action indicated (NAI),” meaning the firm appears to have moved past GMP troubles that have been dogging it for years. According to FDA, a June inspection at the plant has been classified as NAI
Drugs
Genus Lifesciences has petitioned FDA seeking its rescission of a Lannett 505(b)(2) NDA for a cocaine hydrochloride product. Genus 12/2017 gained approval for Goprelto (cocaine hydrochloride) nasal solution, indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or
Drugs
FDA has approved a Nabriva Therapeutics NDA for Xenleta (lefamulin) for treating adults with community-acquired bacterial pneumonia. Approval was based on data from two clinical trials in 1,289 patients where Xenleta was compared to the antibiotic moxifloxacin with or without linezolid. “The trials showed that patients treated with
Drugs
FDA has approved AbbVie’s Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthritis (RA) drug Humira (adalimumab). Rinvoq is indicated for treating adults with moderately to severely active RA who have had an inadequate response or intolerance to
Drugs
A new study in Clinical Pharmacology & Therapeutics shows that FDA and European Medicines Agency (EMA) reviewers have a “high concordance” (91–98%) in approving/rejecting new drug applications, and that this suggests that “engagement and collaboration on regulatory science has a positive impact.” Conducted by officials from both agencies,
Drugs
FDA has approved a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with narcolepsy. The company says the drug is the first with this indication that is not scheduled as a controlled substance. It says that the selective histamine 3 (H) receptor antagonist/inverse
Drugs
FDA has granted accelerated approval for Genentech’s Rozlytrek (entrectinib) foe treating adult and adolescent patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. The drug also was approved for treating adults with non-small cell
Drugs
FDA has issued a guidance, Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment, with recommendations for industry use in designing nonclinical bone quality studies to support approval of drugs and biologics intended to treat osteoporosis. The document recommends that sponsors review three agency guidances before starting clinical trials of drugs