Devices
FDA has cleared a Tyber Medical 510(k) for TyFix, an all-in-one extremity joint fixation system. The device is designed to eliminate the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction, according to the company. In addition, the all-in-
Devices
FDA has cleared a Royal Philips 510(k) for the Philips BlueControl wearable light therapy device to treat mild psoriasis. “Clinical studies have demonstrated that the UV-free blue LED light emitted by Philips’ BlueControl wearable device induces natural, drug-free processes in the skin to significantly reduce symptoms of
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 10-0 to support approval of a Novartis BLA for CTL019 (tisagenlecleucel-T), a chimeric antigen receptor T-cell (CAR-T) for treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. CAR-T therapies are different
Drugs
Although FDA encourages development of abuse-deterrent formulations (ADF) for opioid drugs, lack of a consistent regulatory policy may hinder innovation in the area, according to a roundtable of pharmaceutical experts convened by the Tufts Center for the Study of Drug Development. The experts’ assessment of the clinical development, regulatory,
Drugs
FDA has accepted for review a Pfizer supplemental NDA for Xeljanz (tofacitinib citrate) for treating adult patients with moderately to severely active ulcerative colitis (UC). Tofacitinib citrate is a Janus kinase inhibitor currently approved for treating adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work
FDA Policy/General
The Trump Administration has renewed its call for Congress to double user fees paid by industry to help with the government’s budgetary activities. In a statement following House passage (see story) of a user fee reauthorization bill (HR 2430), the White House said that to “better support FDA’s
Drugs
FDA has cleared a TechLab 510(k) for the Tri-Combo Parasite Screen test for detecting Giardia, Cryptosporidium, and Entamoeba histolytica, the three most common intestinal protozoan parasites. The enzyme immunoassay simultaneously detects the parasites in human fecal specimens, according to the company. It is indicated as an aid in
Drugs
FDA has granted Allena Pharmaceuticals an orphan drug designation for ALLN-177, an oral formulation of oxalate decarboxylase for treating primary hyperoxaluria. The rare genetic disorder is caused by endogenous overproduction of oxalate by the liver that can result in kidney stone disease, kidney damage, and kidney failure. Oxalate decarboxylase
Devices
FDA has released the FDA-483 issued after a 5/10-6/29 inspection at Magellan Diagnostics, North Billerica, MA. The company was the subject of a 5/17 agency warning that Magellan Diagnostics LeadCare tests systems performed on blood drawn from a vein may provide inaccurate results. An agency
Drugs
FDA says it wants feedback on 34 product-specific guidances that describe the agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs (RLDs). The 21 new and 13 revised product-specific guidances are listed with the docket soliciting feedback.
Drugs
Public Citizen says that hydroxyethyl starch (HES) solutions that are used mainly in hospitals should be removed from the market because they cause life-threatening side effects and there are safer, equally effective IV solutions readily available. A news release from the advocacy group (containing a link to a petition
Drugs
Four Hogan Lovells attorneys write that a recent Office of New Drugs Manual of Policies and Procedures (MAPP) outlining policy goals, roles, and responsibilities with respect to financial disclosures in NDAs, BLAs, and NDA/BLA supplements is a “potential sign of renewed interest in financial ties between industry and clinical
Drugs
Attorney James Beck (Reed Smith) writes in an online post that while a Missouri court last year held that an FDA-approved Boxed Warning was not only inadequate but so poor as to be worthy of punitive damages, most courts have found that Boxed Warnings are adequate as a matter
Drugs
The 10th Circuit Court of Appeals has upheld a Utah federal court finding that a branded drug company cannot be held liable for failing to warn consumers about alleged birth defect risks when FDA previously rejected a petition seeking the same warnings. Four Morrison & Foerster attorneys write in an
Drugs
FDA assistant commissioner of international programs Leslie Ball and two colleagues recently participated in a two-day joint training workshop for Indian regulators, academic representatives, and the drug industry on scientific and ethical standards for clinical trials in Mumbai, India. Ball and the other FDAers report on their experiences in
Drugs
The Oncologic Drugs Advisory Committee voted 6-1 on 7/11 to recommend to FDA that Pfizer’s Mylotarg (gemtuzumab ozogamicin) 3 mg/m2 in combination with chemotherapy has a favorable risk/benefit profile for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML). Mylotarg was originally approved under
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of two new animal drug applications at the sponsor’s request because these products are no longer manufactured or marketed. The products, which were marketed by Zoetis, Inc., are NADA 065–291 for bulk dihydrostreptomycin sulfate and NADA 065–324 for bulk streptomycin
Drugs
FDA has issued a second complete response letter to Ocular Therapeutix on an NDA for Dextenza (dexamethasone insert) 0.4mg for treating ocular pain following ophthalmic surgery. The letter cites deficiencies in manufacturing processes and analytical testing related to manufacturing the drug product for commercial production identified during a pre-
Drugs
Andropharm has recalled all lots of Sten Z and M1 Alpha capsules because they contain derivatives of anabolic steroids, which makes them unapproved drugs. “Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men,” a recall notice
Drugs
The Justice Department says that Mallinckrodt will pay $35 million to resolve allegations that it failed to report suspicious orders of pharmaceutical drugs and for recordkeeping violations. A department news release says this is the first settlement of its magnitude with a manufacturer of pharmaceuticals resolving nationwide claims that the
Devices
A North Carolina federal court has ruled that a case involving Bayer’s Essure birth control medical device is preempted. Attorney Michelle Yeary (Dechert) writes in an online blog post that the plaintiff tried to get around traditional failure-to-warn preemption by arguing that the failure to warn was
Drugs
FDA has accepted for priority review an Eli Lilly NDA for abemaciclib, a cyclin-dependent kinase 4 & 6 inhibitor for two indications — monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for