Drugs
FDA has approved an expanded indication for Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children six weeks through 17 years of age. The vaccine is indicated for preventing invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
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
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
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,
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
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
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
Drugs
The Federal Trade Commission says it is ramping up enforcement against any illegal bribes and rebate schemes that impede patients’ access to competing lower-cost drugs. Drug companies use rebates to have their drugs placed on formularies or on preferred tiers of formularies to ensure those drugs are covered. FTC
Drugs
FDA’s National Center for Toxicological Research (NCTR) has announced the publication of three International Test Method Standards in Nanotechnology by the American Society for Testing and Materials International. The NCTR Nanocore team conducted research that supported consensus standards-development for liposomes, the agency says. The standards are intended to
Drugs
Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC) 6/17 introduced bipartisan legislation that would establish a task force between the U.S. Patent and Trademark Office (USPTO) and FDA to improve communication and coordination in
Drugs
FDA has updated its list of off-patent, off-exclusivity drugs without an approved generic. The list, which is updated every six months, includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of each update and for which the agency has not
Drugs
FDA has released the FDA-483 issued following a 2/14-2/25 inspection at Central Admixture Pharmacy Services, a Phoenix, AZ, outsourcing facility. The six inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic
Drugs
FDA has accepted for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II or IIIA non-small cell lung cancer following complete surgical resection. The submission is based on data from the pivotal Phase 3 KEYNOTE-091 trial. Merck