Drugs
Senator Patrick Leahy (D-VT) has introduced legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block lower-cost generic drugs from entering the market. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act aims to put an end to brand-name
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FDA has released a three-item Form 483 after an inspection at Lupin’s Goa, India drug manufacturing facility found GMP problems. For example, the agency said the firm failed to thoroughly review any unexplained discrepancy and the failure of a batch to meet any of its specifications. The company
Drugs
FDA has approved a Radius Health NDA for Tymlos (abaloparatide) injection for treating postmenopausal women with osteoporosis at high risk for fracture. In such women, Tymlos reduces the risk of vertebral and nonvertebral fractures. Approval was based on data from an 18-month trial called ACTIVE and the first six
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FDA has expanded the use of Bayer’s Stivarga (regorafinib) to include treating patients with hepatocellular carcinoma (liver cancer) who have been previously treated with the drug sorafenib. This is the first agency-approved treatment for a liver cancer in almost a decade, an FDA release says. Stivarga is a
Drugs
In more than an hour of oral arguments 4/26, representatives of Amgen and Sandoz highlighted their differing interpretations of the requirements in the Biologics Price Competition and Innovation Act before the Supreme Court. Media accounts indicate that the principal issues argued included whether FDA can approve a biosimilar before
Drugs
The Corporate Whistleblower Center, a self-described advocate for whistleblowers in the U.S., is asking drug company employees to report to it instances of unsanitary conditions on a drug manufacturing line. “The reason this is such a big deal,” the center says in a news statement, “is because drugs
Drugs
FDA has approved label changes on the use of general anesthetic and sedation medicines in children younger than three years. These changes include: * A new Warning stating that exposure to these medicines for long periods or over multiple surgeries or procedures may negatively affect brain development. * Addition of information about
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Attorney Michelle Yeary (Reed Smith) says a Louisiana federal judge erred in determining that Xarelto (rivoroxaban) multi-district litigation claiming that the drug was unreasonably dangerous due to a design defect was not preempted under the Supreme Court’s Bartlett decision. Writing in an online blog post, Yeary says that
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FDA has cleared a Reapplix 510(k) for its 3C Patch System including the 3C Patch Centrifuge. The device is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma gel from a small sample of a patient’s own peripheral blood.
Drugs
Six CDER staffers say the Center is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitted to CDER. Writing online in Nature Nanotechnology (subscription or purchase required), the six say that data from more than 350 products show an
Drugs
Reps. Ann Kuster (D-NH) and Mimi Walters (R-CA) have introduced HR 2144 that would require FDA to implement an efficient, streamlined process for classifying medical device accessories. In announcing support for the measure, the Advanced Medical Technology Association (AdvaMed) said it would “establish a new procedural mechanism for
Drugs
FDA has granted in part and denied in part an Adapt Pharma Operations 11/23/16 petition asking that the agency not approve any ANDA referencing Adapt’s Narcan (naloxone hydrochloride) nasal spray that does not provide specific pharmacokinetic, device, stability, and chemistry, manufacturing, and controls data. FDA’s response
Drugs
Matrix Global Advisors says there are ways the next FDA commissioner can address drug prices by promoting competition. In a white paper, the consulting group says the “widespread public frustration over drug prices is an indication that competition must begin receiving attention at FDA comparable to what has been focused
Drugs
FDA has approved Inspirion Delivery Sciences’ RoxyBond (oxycodone hydrochloride) tablets, indicated for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company describes RoxyBond as the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties, consistent with the
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Federal Register notice: FDA is seeking comments on an information collection extension on “Radioactive Drug Research Committees OMB Control Number 0910–0053.” The committees are required to prepare minutes for each meeting, and an annual report. To view the notice, click here.
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Bristol-Myers Squibb and Transgene have entered into a clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) plus standard chemotherapy as a first-line treatment for advanced non-squamous non-small cell
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Professors from Columbia University and the University of Massachusetts medical school say that new federal rules on the protection of human research participants calling for use of a central or single institutional review board in multisite research funded by the National Institutes of Health raise questions that must be resolved.
Drugs
The Tatia Oden French Memorial Foundation is petitioning FDA to conduct a Sentinel query to assess rates and severity of adverse reactions associated with the unapproved use of misoprostol (Cytotec and others) for cervical ripening and induction of labor to determine whether regulatory action is needed to assure patient and
Drugs
A 11/26-12/6/16 FDA inspection at Divi’s Laboratories, Andhra Pradesh, India, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 4/13 Warning Letter. The agency also documented that the firm limited and/or refused an FDA inspection, the letter
Drugs
A 9/26-9/29 FDA inspection at Teva Pharmaceutical and Chemical (Hangzhou), Zhejiang, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 4/5 Warning Letter. Specific deviations cited in the letter include: * failing to establish written procedures to monitor the progress
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FDA says it has sent Warning Letters to 14 U.S.-based companies for “illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer.” An agency news release says the products are marketed and sold without agency approval, often on Web sites or social
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FDA has issued a draft guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, to provide guidance to government stakeholders on testing to extend the shelf life of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. The document