Drugs
FDA has issued Amphastar Pharmaceuticals a complete response letter on an NDA for naloxone hydrochloride 2mg/0.5mL nasal spray, indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The letter, according to the company, “identifies issues including
Drugs
FDA has accepted an Ocular Therapeutix NDA resubmission for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use for treating ocular pain occurring after ophthalmic surgery. The bioresorbable intracanalicular insert is intended for administration by a physician and is designed for drug release to the ocular surface for up to
Drugs
Pharmaceutical Research and Manufacturers of America says a proposed revision to an International Council for Harmonization addendum on Clinical Investigation of Medicinal Products in the Pediatric Population “is successful in addressing the many advances in pediatric drug development” since the ICH document was first promulgated. The comment letter says the
Drugs
PhRMA (Pharmaceutical Research and Manufacturers of America) president Stephen Ubl says that when drug industry leaders met with president Donald Trump, they found that he was focused on policy changes that would allow the U.S. to continue to lead the world in drug development. “We had a positive, productive
Drugs
CDER oncology drug senior staffers Richard Pazdur and Gideon Blumenthal review FDA’s 2016 oncology drug approvals in a Clinical Oncology commentary. They note the approval of five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews, and 11 approvals of breakthrough-designated therapies. The
Drugs
FDA has accepted for priority review an NDA from the Medicines Co. for Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections (cUTIs). The submission is based on results from the pivotal Phase 3 TANGO 1 clinical trial in patients with cUTIs, which met both FDA and European Medicines Agency
Drugs
FDA has awarded contract research organization ICON a contract to validate three patient reported outcomes (PRO) instruments that will measure clinical endpoints in antibacterial drug trials. The conditions in which the endpoints will be validated are acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia and hospital-acquired
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the FDA “intended use” regulation is a root cause of the agency’s 1st Amendment problems. Writing in his firm’s FDA Law Blog, Shapiro says the issues created by an FDA 1/9 final rule that created a new “totality
Drugs
Genentech filed suit in Delaware federal court 2/20 seeking a declaratory judgment that Amgen is violating the patent dance provisions of the Biologics Price Competition and Innovation Act in connection with its proposed biosimilar of Genentech’s Avastin (bevacizumab). The complaint says that Amgen opted to participate in the
Drugs
A 6/25-7/1/15 FDA inspection at Humco Holding Group, Texarkana, TX, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 1/26 Warning Letter from the agency’s Dallas District Office. The inspection also found that the firm manufactures and distributes
Drugs
Momenta says that a Pfizer facility that is a key fill/finish supply chain partner for the company’s Glatopa (glatiramer acetate injection) products has received an FDA Warning Letter that will likely delay agency approval of a Glatopa 40 mg ANDA. The Warning Letter does not restrict production or
Drugs
Four Dechert attorneys say that life sciences companies continued to be popular targets of securities fraud class action lawsuits in 2016. In a white paper, the four report that in 2016, plaintiffs filed a total of 67 class action securities suits against life sciences companies, an increase of more than
Drugs
Vertice Pharma says FDA should not file for review any NDA or receive any ANDA for potassium chloride oral drug products unless the application includes summaries of completed risk assessment in according with an International Conference on Harmonization (ICH) Q3D guidance and appropriate controls as need for several elemental impurities
Drugs
Sarepta Therapeutics has entered into an agreement to sell to Gilead its FDA Rare Pediatric Disease Priority Review Voucher (PRV) for $125 million. Sarepta was awarded the PRV when it gained approval last year for its Duchenne muscular dystrophy drug Exondys 51. The voucher was awarded under a provision that
Drugs
FDA has approved a Perrigo ANDA for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5mg/1.5mg per 5mL, indicated for the symptomatic relief of cough in adults and children six years of age and older. Annual sales for the product are about $16 million.
Drugs
The Clinical Trials Transformation Initiative (CTTI) has released new recommendations to streamline and improve pediatric trials in antibacterial drug development. Regarding pediatric drug development planning, CTTI recommends that sponsors engage with FDA to begin pediatric studies as early in drug development as possible to ensure a clear understanding of FDA
Drugs
FDA has posted an International Council for Harmonization guideline on “Q11 Implementation Working Group Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers (regarding the selection and justification of starting materials.” The document was prepared in response to clarification requests on how to implement
Drugs
Alliance for a Stronger FDA has completed its annual agency budget analysis and has determined FDA needs $2.8 billion or 3% ($78 million) more in FY 2018 than the amount appropriated in FY 2016 and available to the agency under the FY 2017 continuing resolution. The 3% increase is
Drugs
Three staffers in the CDER Division of Bone, Reproductive, and Urologic Products say that the Center’s new structured framework for drug benefit/risk assessment “will facilitate a better understanding of the data and uncertainties underlying drug approvals and will make the information more transparent to the public.” Writing in
Drugs
FDA has granted Axsome Therapeutics fast track status for AXS-05 (bupropion and dextromethorphan in combination) for treating treatment-resistant depression. The therapy is currently being evaluated in the STRIDE-1 study, a Phase 3, randomized, double-blind, active-controlled trial. AXS-05 uses Axsome’s technology of combining the
Drugs
CDER says that it is planning to publish in this calendar year 101 new and revised guidances in 16 categories. The updated guidance agenda lists these categories, with the number of guidances to be published: Advertising (1). Biopharmaceutics (3), Biosimilarity (2), Clinical/Antimicrobial (1), Clinical/Medical (11), Clinical Pharmacology (8)
Drugs
Unger Consulting says that the routine quality system approach to auditing can frequently fail to identify data management and data integrity problems and a new approach may be needed. In an online paper, the firm suggests that auditors should first focus on data management and data integrity to establish that