Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that additional clarify and increased consistency from FDA on the bridging of information approaches for drug-device and biologic-device single entity and co-packaged combination products promote efficiency in the development process that can lead to timely access to
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Biogen says it is delaying a BLA for aducanumab, an anti-amyloid beta antibody candidate for the potential treatment of Alzheimer’s disease that it is developing in collaboration with Eisai Co. The company has a rolling BLA planned and has started to submit modules of the filing. Biogen has
Drugs
Braun Medical has recalled one lot of ceftazidime for injection (2g) and dextrose for injection (50 ml) in its duplex container after stability test results were found to exceed the specification limits for high molecular weight polymers at the product’s 19 month stability interval. “Elevated levels of high molecular
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FDA commissioner Stephen Hahn, CBER director Peter Marks, and CDER director Janet Woodcock say the agency has streamlined its review and advice process to get studies of potential Covid-19 treatments started as quickly as possible. Writing in an online FDA Voices post, the three say that under the agency’
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BakerHostetler attorneys say that in this time of a Covid-19 pandemic, pharmaceutical companies should be making specific CGMP adjustments. “This includes conducting internal audits of CGMP compliance and increased scrutiny in specific areas that may relate to Covid-19,” the company says in an online post. As an example,
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A new study shows that the malaria drug hydroxychloroquine, which has been touted by president Trump and his allies for treating coronavirus patients, did not reduce the risk of mechanical ventilation in patients hospitalized with the infection. The study was conducted in all U.S. Veterans Health Administration medical centers
Drugs
Researchers from Yale School of Medicine and other academic centers and hospitals say that more recent FDA approvals of new drugs and biologics were based on fewer pivotal trials which, when aggregated by indication, had less rigorous designs but longer trial durations. Writing online at JAMA Network Open, the authors
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FDA has approved an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The submission was based on data from the Phase 3 E1912 study, which was sponsored by the National Cancer Institute. The
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FDA has released a guidance on “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the Covid-19 Public Health Emergency.” The agency says the policy is intended to help address reports related to increased demand and supply interruptions involving
Drugs
Avet Pharmaceuticals has recalled several lots of tetracycline HCl capsules, 250 mg and 500 mg, 100-count bottles due to low out-of-specification dissolution test results. Low dissolution results in less tetracycline available in the body to fight infection, which can lead to treatment failures, a recall notice says.
Drugs
FDA has sent Nova Botanix a Warning Letter after reviewing the company’s Web site and determining that its CBD products were being marketed for unapproved drug uses in treating or preventing Covid-19. The Web site included claims like “Five ways CBD can Boost Your Immune System during the
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FDA has approved an Incyte Corp. NDA for Pemazyre (pemigatinib) for treating adults with certain types of previously treated, advanced cholangiocarcinoma, a rare cancer that forms in bile ducts. “At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery,
Drugs
Fresenius Kabi has recalled 13 lots of ketorolac tromethamine injection, 30 mg/ml, and ketorolac tromethamine injection 60 mg/2 ml due to the presence of particulate matter, which was identified as carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials, a recall notice says.
Drugs
International Laboratories has recalled one lot (Lot# 117099A) of clopidogrel tablets 75 mg due to a mislabeling. The product may contain clopidogrel 75mg or simvastatin Tablets 10 mg, according to a recall notice. Missed doses of clopidogrel increases the risk of heart attack and stroke, while unintentional ingestion of simvastatin,
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CDER has revised a Manual of Policies and Procedures (MAPP 5700.1, Rev.1) entitled “ANDA Amendments and Supplements Reviewed by the Division of Filing Review.” The document outlines policies and procedures for the Center to determine whether an amendment or supplement should be reviewed by OGD’s Division of
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FDA has added content to a question-and-answer appendix for its guidance on “Conduct of Clinical Trials of Medical Products during Covid-19 Public Health Emergency.” The amended appendix includes new discussions on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document
Drugs
FDA has granted Hutchison China MediTech two fast track designations for surufatinib for treating both advanced and progressive pancreatic neuroendocrine tumors (NET) and non-pancreatic NET in patients who are not amenable for surgery. The company describes surufatinib as a novel, oral angio-immuno kinase inhibitor that “selectively inhibits the
Drugs
NIH, FDA, CDC and the European Medicines Agency are looking to develop an international strategy for a coordinated research response to the Covid-19 pandemic. The planned “Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials,
Drugs
FDA has approved a Seattle Genetics NDA for Tukysa (tucatinib) for use in combination with chemotherapy (trastuzumab and capecitabine) for treating adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain,
Drugs
A southern Florida federal judge has entered an emergency temporary restraining order and a preliminary injunction against Genesis II Church of Health and Healing (Genesis) and four individuals, requiring them to immediately stop distributing “Miracle Mineral Solution” (MMS), an unapproved and potentially harmful treatment offered for sale to treat coronavirus
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Harvard Medical School researchers say the current search for treatments for Covid-19 “represent fundamental threats to the U.S. drug development process.” Writing in the New England Journal of Medicine, the researchers say it is a false dichotomy to suggest it is necessary to choose between rapid deployment of
Drugs
FDA has issued an immediately-in-effect guidance describing its intention to exercise enforcement discretion regarding outsourcing facilities compounding some drugs on the agency drug shortage list for use by hospitalized patients. The document says that while the agency generally tries to address potential and actual drug shortages by working