Devices
A 5/8-6/15 FDA inspection at the Diasol facility in Phillipsburg, NJ, found Quality System Regulation violations in the firm’s work manufacturing Dryasol liquid acid concentrates and Dryasol powder mixes, and repacking CitriSol Concentrate, liquid Diasol acid concentrates, and liquid and powder sodium bicarbonate. A 9/28
Drugs
Novo Nordisk is asking FDA not to approve any ANDA referencing any of the company’s liraglutide-containing drugs as the reference-listed drug. The company’s 10/2 petition also asks that the agency: * not approve any 505(b)(2) NDA that references any of the company’s liraglutide-
Drugs
Pfizer says there may be conflicts between an FDA draft guidance on chemistry, manufacturing, and controls postapproval manufacturing changes for specified biological products to be documented in annual reports, and other guidance documents. In its comment letter on the draft, the company says it is difficult to determine which guidance
Drugs
FDA has accepted an Allergan NDA for ulipristal acetate, an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids. Ulipristal acetate is a selective progesterone receptor modulator that acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary
Biologics
FDA has issued a complete response letter for Mylan´s BLA for MYL-1401H, a proposed biosimilar of Amgen’s Neulasta (pegfilgrastim). The letter relates to a “pending update of the BLA with certain [chemistry, manufacturing and controls] data from facility requalification activities post recent plant modifications,” according to the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Diasol Inc. San Fernando, CA (9/28): FDA inspected the firm in June and cited GMP deficiencies with Dryasol liquid acid concentrates, Dryasol powder mixes, CitriSol concentrate, liquid Diasol
Biologics
FDA has accepted for priority review an Ultragenyx Pharmaceutical and Kyowa BLA for burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia (XLH). The agency has set a user fee review action target date of 4/17/2018. FDA previously designated burosumab as a “rare pediatric disease” that
Drugs
FDA medical reviewers are posing tough questions for members of the Cellular, Tissue, and Gene Therapies Advisory Committee when they meet 10/12 to consider a BLA submitted by Spark Therapeutics for Luxturna (voretigene neparvovec) for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Devices
Reps. Susan Brooks (R-IN) and David Trott (R-MI) have introduced the Internet of Medical Things Resilience Partnership Act to create a public-private partnership for a cybersecurity framework to protect Americans’ sensitive healthcare information from cyberattacks. The two say the legislation creates a stakeholder partnership to collect and
Drugs
In its fourth major decision since May for drug products aimed at non-small cell lung cancer (NSCLC), FDA has accepted for priority review a Boehringer Ingelheim supplemental NDA for Gilotrif (afatinib) that seeks an indication for first-line treatment of certain patients with metastatic NSCLC whose tumors have epidermal
Devices
Federal Register correction: FDA is correcting a final order entitled “Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator” that appeared in the 7/28 Federal Register. The order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket
Drugs
FDA has approved a Respicardia PMA for the Remed System as a treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The implantable device stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing, according
Drugs
FDA has cleared a Roche 510(k) for the Cobas C-diff Nucleic acid test for detecting the toxin B (tcdB) gene of toxigenic Clostridium difficile. The automated qualitative in vitro diagnostic test uses real-time polymerase chain reaction to detect the tcdB gene in soft or liquid stool specimens
Drugs
FDA has accepted an Amgen supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis. The agency has set a user fee review action target date of 5/28/2018. The submission is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid
Drugs
FDA has granted AstraZeneca a breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The designation was based on data from the Phase 3 FLAURA trial of Tagrisso versus standard-of-
Drugs
FDA has awarded six new research grants ($6.3 million) for natural history studies in rare diseases that are intended to evaluate how they progress over time. “One potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in
FDA Policy/General
Federal Register notice: FDA has announced a 11/2 public meeting entitled “Animal Generic Drug User Fee Act.” The meeting will discuss proposed recommendations for reauthorizing the Animal Generic Drug User Fee Act. To view the notice, click here.
Drugs
FDA has cleared a Game Ready 510(k) for its orthopedic rehabilitation device, the Med4 Elite. The device is controlled by an intuitive touchscreen computer interface to deliver iceless cold therapy, heat therapy, rapid contrast (alternating heat and cold) therapy and intermittent pneumatic compression therapy, the company says. It is
FDA Policy/General
Federal Register notice: FDA has announced a 11/2 public meeting entitled “Animal Drug User Fee Act.” The meeting will discuss proposed recommendations for reauthorizing the Animal Drug User Fee Act (ADUFA IV). To view the notice, click here.
FDA Policy/General
Avara Pharmaceutical Services has agreed to acquire an AstraZeneca manufacturing and distribution facility in Reims, France. Norwalk, CT-based Avara is a contract manufacturing and technical services organization providing both active pharmaceutical ingredient formulation and manufacturing, along with secondary formulation, manufacturing, packaging and distribution of small molecule drugs, including highly
FDA Policy/General
Regulatory Review Period Determined for Impella 2.5 System Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System. 10/06/2017 Regulatory Review Period Determined for Bayer’s Kovaltry Federal Register notice: FDA determines the regulatory review period
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Bayer’s Kovaltry (antihemophilic factor (recombinant)) is 2,478 days — of this, 2,021 days occurred during the testing phase and 457 days occurred during the approval phase. To view the notice, click here.