Drugs
Juno Therapeutics has submitted a complete response to FDA to address concerns after a clinical hold was ordered on a Phase 2 clinical trial (ROCKET) involving JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the hold on the trila after three patient
Drugs
FDA has granted Merrimack Pharmaceuticals fast track status for MM-121 (seribantumab) for treating patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Currently, Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with
Drugs
After an unexplained gestation period of nine years, FDA has denied a 7/28/97 Luitpold Pharmaceuticals petition asking the agency to withdraw its approval of the intramuscular route of administration for INFeD, an injectable iron dextran product that at the time of the petition was manufactured by Schein Pharmaceutical.
Drugs
Boehringer Ingelheim says that while the main purpose of an FDA draft guidance on chemistry, manufacturing, and controls information in comparability protocols for human drugs and biologics is well stated in the draft’s introduction and background sections, it loses focus in its content recommendations. The company’s comment letter
Drugs
FDA has granted AbbVie a rare pediatric disease designation for ABT-414, an investigational antibody drug conjugate targeting the epidermal growth factor receptor (EGFR) for treating pediatric patients with EGFR-amplified diffuse intrinsic pontine glioma (DIPG). The highly aggressive and difficult to treat brain tumors are found at the base
Drugs
An FDA statement says that the agency is changing its procedure for inspections of entities that are seeking to compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (human drug compounders not registered with FDA as section 503B outsourcing facilities). As of 8/1, it says,
Drugs
An 8th Circuit Court of Appeals panel voted 2-1 to uphold a district court ruling imposing three-month prison sentences and $100,000 fines on the owner and COO of Quality Egg under the Park (responsible corporate officer) doctrine. Attorneys Jennifer Thomas and John Fleder (Hyman, Phelps & McNamara)
Drugs
FDA has approved Galderma Laboratories’ Differin Gel 0.1% (adapalene), a once-daily topical gel for over-the-counter treatment of acne in people age 12 and older. An agency statement says Differin Gel is the first retinoid to be made available OTC for treating acne. FDA also says the
Drugs
FDA says it is supporting President Obama’s Precision Medicine Initiative through release of two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. An agency statement (contains links to both
Drugs
FDA has issued a draft guidance, Updating ANDA Labeling After the Marketing Application for the Reference-Listed Drug Has Been Withdrawn, to describe a process for updating labeling for ANDAs in cases when FDA has withdrawn approval of the NDA for the reference-listed drug (RLD) for reasons other than
Drugs
A 7/20-24/15 FDA inspection at Guangzhou Haishi Biological Technology, Guangzhou, Guangdong, China, found significant violations of current good manufacturing practice for finished pharmaceuticals, according to a just-released 6/22 Warning Letter. Specific violations included: * failing to test finished batches of drug products for the identity and
Drugs
AstraZeneca has filed a motion seeking a temporary restraining order (TRO) to block FDA from approving generic copies of the company’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium) if they are approved with a labeling “carve-out” that omits marketing exclusivity-protected pediatric labeling. The TRO request follows last month’
Drugs
The Federal Circuit Court of Appeals has affirmed a lower court decision granting Amgen a preliminary injunction blocking Apotex from launching its biosimilar pegfilgrastim for 180 days after receiving FDA approval and giving notice of commercial marketing. Apotex had argued that because the two parties completed the Biologics Price Competition
Drugs
The National Cancer Institute (NCI) says it is working with three organizations in England and the Netherlands to develop the Human Cancer Models Initiative that will bring together expertise from around the world to make about 1,000 cancer cell models. “Using new techniques to grow cells, scientists can make
Drugs
Mallinckrodt is asking FDA to designate Inomax (nitric oxide) 800 ppm for inhalation and its 510(k)-cleared specialized delivery system as a drug-device combination product. A 6/30 citizen petition says that Inomax is approved for use in treating neonates greater than 34 weeks gestational age suffering from
Drugs
FDA reviewers are backing a Sandoz BLA (GP2015) for a biosimilar copy of Amgen’s Enbrel (etanercept) for treating arthritis. The agency’s Arthritis Drugs Advisory Committee is meeting 7/13 to review and vote on the submission. “In considering the totality of the evidence submitted, the data submitted by
Drugs
Collegium Pharmaceutical has petitioned FDA for a block on other extended-release oxycodone drug products unless they bear abuse-deterrent labeling based on premarket studies. Earlier this year, the agency approved the company’s NDA for Xtampza ER (oxycodone) extended-release capsules with abuse-deterrent labeling based on premarket studies
Drugs
FDA has issued two draft guidances describing its plans to implement legal provisions that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The guidances apply to pharmacies, doctors, federal facilities, and outsourcing facilities. An agency statement reasserts longstanding policy, saying that taking
Drugs
Adapt, the the manufacturer of Narcan (naloxone) Nasal Spray, 4 mg, indicated for treating opioid overdose, has petitioned FDA asking that it publish a guidance for all naloxone products to identify the “optimal fixed initial dose for each route of administration as well as the required exposure levels to achieve
Drugs
The International Council for Harmonization (ICH)says it increased its “global reach,” by formally adding last month two new members and 14 observers. ICH welcomed the following as new observers: * · Association of Southeast Asian Nations * · Biotechnology Innovation Organisation * · Central Drugs Standard Control Organization * · Council for International Organizations of Medical Sciences
Drugs
FDA has told Pain Therapeutics that an advisory committee meeting for the third NDA submission for Remoxy (oxycodone), an extended-release capsule in an abuse-deterrent formulation for treating pain, is unnecessary and will not be held. The panel meeting had been tentatively scheduled for 8/5. Remoxy was previously
Drugs
FDA has issued a guidance, Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing and Control Information, to assist IND sponsors with submissions for early clinical trials with live biotherapeutic products (LBP), including those lawfully marketed in the U.S. as foods, such as conventional foods and dietary supplements. The