Drugs
FDA has approved Genentech’s Avastin (bevacizumab) for use in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Approval is based on data from the pivotal Phase 3 GOG-0218
Drugs
FDA has accepted for review a Sunovion NDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease. The agency has set a user fee review action target date of 1/29/2019. The company says apomorphine sublingual film is
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The document provides information on implementing the limited population pathway provision of the 21st Century Cures Act for such products. To view the notice, click here.
Drugs
At the 4/10 GDUFA 2 quarterly implementation meeting, industry representatives discussed challenges facing the generic drugs industry, including threats to sustainable competition and drug shortages. The industry representatives noted that drug shortages within the generic market may also occur due to the consolidation of buyers and discussed the market
Drugs
The 4th Circuit Court of Appeals has upheld a lower federal court ruling granting summary judgment to Pfizer in multi-district litigation claiming that the company’s Lipitor led to patients developing diabetes. Washington Legal Foundation (WLF), which filed an amicus brief urging vindication of the district court’s application
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test. The indication was given accelerated approval based on tumor response
Drugs
FDA has granted Chiesi USA an orphan drug designation for GPLSCD01, ex-vivo expanded autologous human corneal epithelial cells containing stem cells, for treating limbal stem cell deficiency. The rare and seriously debilitating condition affects one or both eyes due to physical or chemical ocular burns, inflammatory diseases, and hereditary
Drugs
As part of its response to efforts to rein in prescription drug costs, FDA has issued two updated final guidances to provide greater clarity about its thinking and recommendations for certain medical product communications. The first guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions
Drugs
Based on disappointing data, Eli Lilly and AstraZeneca are discontinuing global Phase 3 clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor for treating Alzheimer’s disease. Recommendations by an independent data monitoring committee concluded that both the AMARANTH trial, in early Alzheimer’s patients, and the
Drugs
A 9/1-9/11/17 FDA inspection at Taiwan Biotech Company, Taoyuan City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/31 Warning Letter. Specific violations cited in the letter were: * failing to establish an adequate system for monitoring
Biologics
Public Citizen says HHS has made substantive changes to the protocol and consent forms for a National Institutes of Health clinical trial that the advocacy group said had potentially serious ethical violations. In an 8/1/17 letter, Public Citizen called for immediate suspension of the Myocardial Ischemia and Transfusion
Drugs
The DC federal court has ordered FDA to grant seven years of orphan drug exclusivity to Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride injection), described as a liquid, low-volume, and short-time 10-minute infusion formulation of bendamustine hydrochloride. The company says that due to the court’s ruling, FDA will
Drugs
FDA has approved an Amgen supplemental NDA to add positive overall survival data from the Phase 3 ASPIRE trial to the prescribing information for Kyprolis (carfilzomib). The new data show that Kyprolis, lenalidomide and dexamethasone significantly reduced the risk of death by 21% and extended overall survival by 7.9
Drugs
FDA has approved a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis. The trial of CK0801 will begin in the third quarter at the
Drugs
Federal Register notice: FDA has announced the renewal of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years. The new charter will be in effect until 5/30/2020. To view the notice, click here.
Drugs
A northern Mississippi judge 6/8 entered a consent decree of permanent injunction against Delta Pharma (Ripley, MS) and two company officials for failing to correct promised deficiencies at the firm’s drug compounding operation. The decree prohibits Delta Pharma and the other defendants from manufacturing, processing, packing, holding or
Drugs
FDA has approved a Celixir IND for Heartcel, an immuno-modulatory progenitor (iMP) cell therapy for treating adult heart failure. The tissue-engineered product comprises allogeneic (off-the-shelf) iMP cells, which are a novel cell type engineered to reduce heart scarring and regenerate the heart in patients with heart
Drugs
CDER director Janet Woodcock says management of the Center’s formal dispute resolution (FDR) program is being transitioned from the immediate office of the Office of New Drugs to the Office of Executive Programs. “This transition allows Center-level management of the FDR program, which is not only used by
Drugs
FDA commissioner Scott Gottlieb says that a Biotech Working Group named last month is preparing an action plan with steps the agency will take to ensure it has a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation. Gottlieb made the comment
Drugs
The HHS Office of Inspector General (OIG) says FDA computed PDUFA rates paid by drug companies accurately. An OIG audit report says the office obtained and reviewed documentation from FDA such as policies and procedures and financial records to determine whether it accurately computed prescription drug user fee rates. It
Drugs
The Association for Accessible Medicines (AAM) and its Biosimilars Council says FDA should take a case-by-case approach in determining whether a 505(b)(2) biological product is deemed to be a 351(a) or 351(k) biologic. AAM says this should be an administrative transition so products can
Drugs
FDA has accepted for priority review a Pfizer NDA for talazoparib for use in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in this patient population. The user