Drugs
Alliance for Pharmacy Compounding CEO Scott Brunner says FDA should give up its current efforts to draft a drug compounding memorandum of understanding (MOU) for states to sign and start with a new joint effort with the industry. Writing in a Pharmacy Times opinion post, Brunner relates the history of
Drugs
FDA and the National Institute of Health’s National Center for Advancing Translational Sciences have launched updates to the CURE ID crowd-sourcing app on drug repurposing for infectious diseases to increase usability, improve data visualization, and generate faster searches. The new version of CURE ID also includes more details
Drugs
A study by the LUNGevity Foundation analyzing the current global lung cancer-focused drug development landscape highlights “the impressive progress that has been made in the lung cancer therapy space and points to an increased need for comprehensive biomarker testing at earlier stages of the disease.” The foundation says the
Drugs
FDA has granted Mustang Bio an orphan drug designation for MB-106, a CD20-targeted, autologous CAR T cell therapy for treating Waldenstrom macroglobulinemia, a rare form of B-cell non-Hodgkin lymphoma (B-NHL). The cell therapy is being developed in a collaboration between Mustang and Fred Hutchinson Cancer
Drugs
U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) have unveiled bipartisan legislation entitled Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, which is intended to lower insulin costs. The lawmakers note that insulin is one of the most expensive categories of drugs purchased
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA proposal to require manufacturers to provide mail-back envelopes and education on the safe disposal of opioid analgesics dispensed in an outpatient setting is well-intentioned but could inadvertently lead to increased opioid theft and diversion. PhRMA’s
Devices
BD is recalling its BD intraosseous needle set kits, BD intraosseous manual driver kits, and BD intraosseous power drivers. A company statement says certain lots within the expiration dates of the products may result in: * difficulty separating the stylet from the intraosseous needle, where the increased force required to remove
Drugs
The Menarini Group has submitted an NDA for elacestrant and its use in patients with ER+/HER2 advanced or metastatic breast cancer. The company has requested a priority review. The submission is based on data from the Phase 3 EMERALD study, which it says met both primary endpoints — progression-free
Biologics
Krystal Biotech has submitted a BLA for B-Vec (beremagene geperpavec) and its use in treating patients with dystrophic epidermolysis bullosa (DEB). The topical gene therapy is designed to treat DEB at the molecular level by providing the patient’s skin cells with two copies of the COL7A1 gene to
Biologics
CBER has issued an updated agenda of guidances it plans to publish this year. The document lists eight guidances under Blood and Blood Components, eight under Tissues and Advanced Therapies, and two under Vaccines.
Drugs
Lazaro Hernandez of Miami, FL, has been arrested for allegedly distributing over $230 million in adulterated HIV drugs. The U.S. government contends that Hernandez was part of a nationwide scheme to defraud FDA. According to the indictment, he acquired large quantities of HIV medication illegally and then created false
Drugs
Attorney Michael Shumsky (Hyman, Phelps & McNamara) says FDA has changed a longstanding practice and now says a full switch to over-the-counter status through an sNDA does not create a new listed drug and thus does not create a new period of 180-day exclusivity. Writing in his
Drugs
FDA says Glicerinas Industriales, a Zapopan, Mexico, drug manufacturing facility, was advised of a planned agency inspection on 5/16-5/20 and refused to allow the inspection. A 6/13 Warning Letter says the firm supplies drug components such as glycerin to manufacturers of finished drug products that are
Drugs
The 4th Circuit Court of Appeals has upheld a West Virginia law regulating ads that solicit plaintiffs for lawsuits involving drugs or medical devices. The appeals court reversed a district court decision that struck down the law on First Amendment grounds. Writing in a Washington Legal Foundation Legal Opinion Letter,
FDA Policy/General
Federal Register notice: CBER has announced a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Electronic Submission Template and Resource (eSTAR) pilot program. It is intended to improve consistency and efficiency in both industry’s preparation and FDA’s review of such submissions. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” The document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee has voted 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanserin) for an indication to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The panel members did not find the company’s data sufficient to approve
Biologics
FDA has denied a 5/20 petition submitted by the Informed Consent Action Network relating to emergency use authorizations for and development of vaccines to prevent Covid-19. The petition asked that FDA: * revoke its 5/10/21 emergency use authorization for the use of Pfizer/BioNTech’s Covid-19
Drugs
The FDA report to Congress on Drug Shortages for CY 2021 identifies two supply chain changes that require ongoing work to help ease drug shortages. The report identifies them as: * need to gain better insight into the supply chain; and * need to increase the resilience of the supply chain. “To
Drugs
The West Health Policy Center says changes are needed to the generic drug Paragraph 4 certification process to stop innovator companies from using new patents to delay generic drug competition. As reported in Health Affairs, the analysis calls for: * Shifting the patent litigation burden from generic to brand manufacturers for
Devices
Draeger has recalled (Class 1) one lot (#LT2103) of its SafeStar 55 Breathing System Filter because a manual inspection process revealed that some defective filters, including several that may be partially obstructed, were inadvertently distributed instead of destroyed. The filter, which is used as part of a ventilator when a
Drugs
FDA has granted Paratek Pharmaceuticals a fast track designation for an oral and intravenous formulation of its broad-spectrum antibiotic Nuzyra (omadacycline) for treating pulmonary nontuberculous mycobacterial (NTM) disease caused by both Mycobacterium avium complex and Mycobacterium abscessus. The agency granted the therapy an orphan drug designation for these infections