Drugs
The day before the House approved (see related coverage) it 11/30, the Rules Committee denied a request by Rep. Louise Slaughter (D-NY) to add an 11th-hour amendment to the 21st Century Cures Act (see earlier story) that would have added an extra layer of adverse event reporting
Drugs
Adapt Pharma Operations has filed a citizen petition asking that FDA require sponsors of ANDAs for generic intranasal naloxone products to submit specific types of data to support the interchangeability of the generic version of its reference-listed product (Narcan). Specifically, the petition asks that FDA: * not approve a generic
Drugs
FDA has denied a Vanda Pharmaceuticals 9/7 petition asking that the agency not approve an ANDA referencing its atypical antipsychotic drug Fanapt (iloperidone) until expiration of a three-year exclusivity relating to Vanda’s clinical study of the drug for maintenance treatment of schizophrenia. The denial letter says the
Drugs
FDA has approved a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg — generic versions of Cephalon’s Nuvigil, indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder. Brand sales are over $500
Drugs
FDA has accepted for priority review an EMD Serono BLA for avelumab and its use in patients with metastatic Merkel cell carcinoma (MCC). The submission is based on tumor response results from the JAVELIN Merkel 200 trial. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and
Drugs
A 10/12-16/15 FDA inspection at Dongying Tiandong Pharmaceutical Co., Shandong, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/10 Warning Letter. Specific deviations included: * failing to adequately investigate and document out-of-specification results according to a
Drugs
A 7/11-7/21 FDA inspection at STI Pharma, Langhorne, PA, found serious violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, according to an 11/21 Warning Letter from the agency’s Philadelphia District Office. Specific violations included failing to develop adequate written procedures for the surveillance, receipt,
Drugs
The latest FDA report on the status of drug postmarketing requirements and commitments shows that industry has improved its (on-time) submission of annual status reports. Status reports must be submitted within 60 days of the anniversary date of U.S. approval of the original application or an alternate reporting
Drugs
CDER has issued a Manual of Policies and Procedures describing the organization, membership, responsibilities, and procedures of the Safety Outcomes Trials (SOT) Subcommittee of the Medical Policy Council. The document says that SOTs are typically large trials designed to assess whether a treatment increases the rate of certain clinical adverse
Drugs
Attorneys Gail Javitt and Jae Kim (DLA Piper) say the HHS final rule on expansion of the national clinical trials database (ClinicalTrials.gov) runs 177 pages and aims to improve public access to information about specified clinical trials involving FDA-regulated products. “The final rule both implements and elaborates on
Drugs
FDA has released a guidance on “Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)” that describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonization (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in
Drugs
The U.S. House of Representatives has scheduled an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in additional funding to accelerate discovery, development, and delivery of new cures and treatments. The measure would provide $4.8 billion to the National Institutes
Drugs
FDA has partially approved a Teva petition that sought tighter bioequivalence on generic copies of its skeletal muscle relaxant Amrix (cyclobenzaprine hydrochloride), 15 mg and 30 mg extended-release capsules. The agency agreed with Teva’s contentions that generic applicants must demonstrate that their proposed ANDA product is bioequivalent to
Drugs
Public Citizen and seven other consumer and government watchdog groups have told FDA that its draft guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” would allow the agency to continue inappropriately excluding advisory committee members from participating in committee meetings. The groups
Drugs
Federal Register Notice: FDA has extended the comment period on a 9/14 notice on the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals
Drugs
FDA has published a draft guidance, Submission of Quality Metrics Data, explaining and implementing the voluntary reporting phase of its new quality metrics reporting program. The document says that CBER and CDER will use submitted data and quality metrics to help ensure that their policies and practices continue to support
Drugs
Juno Therapeutics is facing another setback on pushing its CAR-T cell product candidate through the development process after the company placed its ROCKET trial on clinical hold following cerebral edema reported in two patients earlier this week. One patient died and the other is not expected to recover. In
Drugs
CDER director Janet Woodcock says that clinical trial designs, no matter how novel, “will only be as good as the knowledge that underlies them.” In presentation slides prepared for the 12th annual personalized medicine conference, she says that the full clinical development program must be considered, and not just the
Drugs
Eli Lilly says solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase 3 study in people with mild dementia due to Alzheimer’s disease. “Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=
Drugs
FDA has issued a guidance, Contract Manufacturing Arrangements for Drug: Quality Agreements, with the agency’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice requirements. In particular, the document says, “we describe how parties involved
Drugs
FDA has denied in part a Therapeutic Proteins International petition asking that it take actions to advance the use of risk-based bioequivalence testing. To the extent that the petition asks the agency to undertake activities it is already doing, the letter says, it is granted. The 2007 petition called
Drugs
Intarcia Therapeutics has submitted an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes. If approved, the drug would become the first injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy. It is designed to provide consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-