Drugs
FDA has finalized a guidance on “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document provides information on FDA’s current thinking on interpreting Section 505(q) of the Food, Drug, and Cosmetic Act, which governs
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FDA has granted an orphan drug designation for its novel gene therapy (OCU400) for treating the CEP290 mutation-associated retinal disease. Inherited retinal diseases are caused by genetic mutations that are passed down within families and lead to visual impairment and blindness. Mutations in CEP290 have been associated with different
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to develop a benefit/risk framework for approving prescription opioid medicines that accounts for public health concerns. In its comment on an agency draft guidance, PhRMA proposes: * FDA revise the draft to state more clearly that under the
Drugs
Attorney James Beck (Reed Smith) says drug companies and their attorneys involved in failure-to-warn suits “should closely examine all allegations of ‘inadequate’ warnings to determine whether such claims would create inconsistencies with Highlights information [in the drug’s label], and adjust their preemption strategy accordingly.” Writing in a
Drugs
Legislation awaiting signature by California’s governor does not prohibit pay-for-delay settlements between branded and generic drug companies but presumes an anticompetitive effect if, as part of a Paragraph 4 litigation settlement, an ANDA sponsor receives anything of value in exchange for limiting or foregoing entry of a
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking the DC Court of Appeals to overturn an FDA decision refusing to approve its Roxicodone, a new opioid capsule the company says is intended to deter abuse through a novel combination of physical properties and labeling changes. The company says the Roxicodone label
Drugs
A 10/22-10/30/18 FDA inspection at SC Johnson Professional (formerly Deb USA), Stanley, NC, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and requirements for registration and listing of drug products. A just-released 6/11 Warning Letter says specific CGMP violations
Drugs
FDA says it has taken its first regulatory actions under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among its international partners. Under the project, FDA, the Australian Therapeutic Goods Administration and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous
Drugs
GlaxoSmithKline says that while it agrees with FDA’s need to have access to additional supportive files in population pharmacokinetics analyses, the current portal for submissions makes the process challenging. Its comment letter says that very few file types are supported and most of the file formats routinely used by
Drugs
The new FDA Knowledge-aided Assessment & Structured Application (KASA) system “will promote issued-based quality assessment using structured data and information to improve the efficiency, consistency, and objectivity of regulatory actions,” according to six CDER staffers writing in the International Journal of Pharmaceutics. The article says the agency recognized
Drugs
Takeda Pharmaceutical Co. has recalled all doses of Natpara (parathyroid hormone) for injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg) due to a potential issue related to rubber particulates originating from the rubber septum of the product’s cartridge. During a typical 14-day Natpara treatment period, the
Drugs
FDA has awarded three grants under a pilot program to support developing publicly available clinical outcome assessments (COAs) and related endpoints for specific disease indications (RFA-FD-19-006). “These awards will provide avenues to advance the use of patient input as an important part of drug development that can
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthritis. The human monoclonal antibody was approved originally 7/2017 for treating adult patients with moderate to severe plaque psoriasis. Janssen says the sBLA is based on results from the Phase 3 DISCOVER-
Drugs
FDA has posted a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspection of the drug outsourcing manufacturer. For example, the company’s procedures designed to prevent microbiological contamination of its drug products did not include adequate validation of the aseptic
Drugs
Former FDA Commissioner Scott Gottlieb has been appointed to the FasterCures advisory board. As a board member, Gottlieb will “leverage decades of experience to provide counsel to the FasterCures team in a variety of areas, including how to best engage patients in research, creating new pathways to innovation through novel
Drugs
Concerns about an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has now spread to some ranitidine heartburn drugs, including the brand-name drug Zantac, according to an FDA safety alert. The agency says that a nitrosamine impurity called N-nitrosodimethylamine (NDMA), which has been detected
Drugs
FDA says it will develop bioanalytical “best practices” for biosimilar biological product development. Writing in the recent American Association of Pharmaceutical Scientists Journal, a team of CDER officials said they examined 28 biosimilar biologic license applications that had been submitted up to 12/2018, which showed a “diversity of the
Drugs
FDA is warning that Pfizer’s Ibrance (palbociclib), Novartis’ Kisqali (ribociclib), and Eli Lilly’s Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause a rare and severe inflammation in the lungs. “We have approved new warnings about this risk to the prescribing information and patient
Drugs
KRS Global Biotechnology has recalled all lots of unexpired human and animal drugs due to sterility concerns. “Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening,” a recall notice (XXINSRT LINKXXX) says. The company says it
Drugs
Researchers from several universities around the world say that the size of therapeutic effects in alternative methods of FDA evaluation of breakthrough therapy drugs correlates with FDA approval without requiring randomized clinical trials. Writing in an open access article posted online, the researchers say the magnitude of treatment effects was
Drugs
FDA has granted EMD Serono a breakthrough therapy designation for its investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) that exhibit MET exon 14 skipping alterations and who have progressed following platinum-based cancer therapy. The designation was based on data showing that tepotinib
Drugs
Federal Register notice: FDA has announced an 11/14 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amarin Pharma supplemental NDA for Vascepa (icosapent ethyl) capsules for oral administration for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult