Drugs
FDA has accepted for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation. The company says the minimally-systemic small molecule is designed to act locally in the gastrointestinal tract to inhibit the sodium transporter NHE3 and reduce sodium uptake from the gut. The
Biologics
A 1/16-1/26 FDA inspection at StemGenex Biologic Laboratories, San Diego, CA, determined that the company processes adipose tissue from donors for autologous use and also processes stromal vascular fraction (SVF) that is administered in a variety of ways. A 10/31 Warning Letter says the company says
Drugs
The Stericycle Recall Index for the third quarter of 2018 shows that drug recalls increased 19% to 92, although recalled units declined 56% to just over seven million, lower than in 10 of the last 13 quarters. The report says that failed specifications were the top reason based on recalls
Drugs
FDA has approved a PolyPid Ltd. IND for it to proceed with a Phase 3 clinical trial involving lead candidate D-Plex[100] for preventing post-cardiac surgery sternal infections. The novel product is designed to provide local anti-bacterial activity directly at the surgical site to prevent surgical site
Drugs
The Tufts Center for the Study of Drug Development says the global biotech revolution that launched in the early 1980s is continuing, “offering the promise of a cornucopia of novel products to treat a wide range of diseases.” Using data from the center’s Comprehensive Biotech Data Book to be
Drugs
FDA has issued a draft guidance, Nonmetastatic, Castration-Resistant Prostate Cancer; Considerations for Metastasis-Free Survival Endpoint in Clinical Trials, for drug or biological product development programs regulated by CDER and CBER. The document says issues involving metastasis-free survival were discussed at a 2011 Oncologic Drugs Advisory Committee meeting
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. StemGenex Biologic Laboratories San Diego, CA (10/31): FDA inspected the firm in January and cited it for illegally marketing an unapproved cellular product manufactured in a facility with
Drugs
FDA has accepted for review a Shire supplemental NDA to expand the indication of Gattex (teduglutide [rDNA origin]) for injection to pediatric patients (aged 1-17 years old) with short bowel syndrome (SBS) who are dependent on parenteral nutrition support. The drug is currently indicated for treating adult patients with
Drugs
FDA says it wants to amend its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. If finalized, the proposed rule would allow
Drugs
FDA has accepted for review a Retrophin NDA for a new formulation of its Thiola (tiopronin) tablets for treating cystinuria. The agency has set a user fee review action target date of 6/30/2019. The 505(b)(2) NDA was submitted by the company’s partner, Mission Pharmacal. Thiola
Drugs
FDA has accepted for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) 150 mg tablets twice daily as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated advanced ovarian cancer who are in complete or partial response following first-line standard platinum-based chemotherapy. A user
Drugs
FDA has granted Palvella Therapeutics a fast track designation for its lead product candidate PTX-022 (rapamycin topical formulation) for treating pachyonychia congenita (PC), a rare, chronically debilitating and lifelong monogenic disease. With PC, mutations of genes responsible for keratin production lead to dysregulated keratinocyte proliferation, increased skin fragility and
Drugs
Pain Therapeutics has appealed an August-issued FDA complete response letter (CRL) for Remoxy, an abuse-deterrent, extended-release form of oxycodone. The agency and the company have agreed to meet 1/31/2019 to discuss the action. According to the company, the CRL said data submitted in the company’
Drugs
U.S. Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) have sent a letter to the President urging him to support legislation to limit anticompetitive “pay-for-delay” pharmaceutical settlements between brand and generic drug makers as part of the Administration’s effort to bring down prescription drug
Drugs
After several years of planning, FDA says it implementing its “New Inspection Protocol Project (NIPP)” to modernize inspections with a “new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products. FDA commissioner Scott Gottlieb says the “new tool is being applied
Drugs
Sandoz has recalled one lot of losartan potassium and hydrochlorothiazide after an impurity, NDEA (N-nitrosodiethylamine), was detected in the active pharmaceutical ingredient. The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen
Drugs
FDA approved a record number of generic drugs in October as part of its efforts to improve patient access to lower cost drugs. It approved 110 generic drugs and tentatively approved 18 others, for a total of 128 approval actions. This included 23 first generics for brands that lacked competition
Drugs
On FDA’s orders, U.S. marshals have conducted a mass seizure of FDA-regulated products that the agency says were being held under insanitary conditions that exposed them to widespread rodent, insect and live animal infestation. The 11/7-8 seizure at J and L Grocery (Alma, AK) included
Drugs
FDA has approved a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The long-acting muscarinic antagonist is the first once-daily, nebulized bronchodilator approved for treating COPD, according to the companies. Approval was based on
Drugs
FDA has approved a new over-the-counter (OTC) version of Primatene Mist, a metered-dose inhaler indicated for providing temporary relief of symptoms of mild intermittent asthma. An earlier OTC version of the drug was withdrawn from the market in 2011 because it contained chlorofluorocarbon propellants, which are known
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA regulation of some medical devices as drugs violates the distinction Congress has drawn between the two regulatory schemes. “FDA’s position that it may regulate devices as drugs is plainly not authorized under the Federal Food, Drug, and Cosmetic Act (FFDCA)
Drugs
FDA has granted Korea-based Vivozon a fast track designation for VVZ-149, a non-opioid pain killer. The new mechanism-based non-narcotic and non-NSAID analgesic, according to the company, has demonstrated robust pain-suppressing efficacy in a panel of in vivo models (post-operative, formalin-induced, or