Drugs
Three Arent Fox attorneys say that a Trump administration executive order requiring agencies to identify two existing regulations to be repealed for every new regulation they propose could cause delays in FDA efforts to implement provisions of the 21st Century Cures Act. Writing in an online blog post, the attorneys
Drugs
FDA has lifted a partial clinical hold on a Northwest Biotherapeutics Phase 3 trial of its personalized immune therapy DCVax-L for glioblastoma multiforme brain cancer. The company says that the trial has “accumulated a sufficient number of events toward the progression-free survival (PFS) endpoint, but not yet for
Drugs
FDA has delayed the effective date of a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use.” The delay, according to an FDA notice, allows the Trump Administration to review and decide whether the rule should stay
Drugs
Reps. Andy Biggs (R-AZ) and Brian Fitzpatrick (R-PA) have introduced the Right to Try Act of 2017, which would allow terminally ill patients an option to receive drugs that have passed FDA’s “basic safety testing but are still working their way through the often lengthy bureaucratic process
Drugs
Drug company executives prefer former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, as the candidate president Donald Trump should nominate for commissioner, based on a survey by Mizuho Securities USA. Gottlieb is a physician and fellow at the American Enterprise Institute whose commentaries frequently appears in
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months after neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The
Drugs
By lowering FDA regulatory standards as president Donald Trump promised pharmaceutical makers last week at the White House, many FDA watchers fear patients could be exposed to ineffective therapies until data gathered after marketing approval demonstrate effectiveness. Trump reportedly is considering several commissioner candidates that argue for quicker market access
Drugs
FDA has accepted for review an Intarcia Therapeutics NDA for ITCA 650 (exenatide) for treating Type 2 diabetes. If approved, the drug would become the first injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy, the company says. It is designed to provide consistent and continuous subcutaneous delivery
Drugs
A review of cases that president Donald Trump’s U.S. Supreme Court nominee Neil Gorsuch has decided shows that he is supportive of the federal preemption doctrine that could serve the medical product industry well when defending product liability lawsuits, according to the Drug & Device Law blog. The
Drugs
FDA has issued Charleston Laboratories and Daiichi Sankyo a complete response letter (CRL) on their NDA for CL-108 (hydrocodone, acetaminophen, promethazine), an investigational treatment for managing pain severe enough to require an opioid analgesic while preventing or reducing the associated opioid-induced nausea and vomiting when alternative treatments for
Drugs
House Energy and Commerce Committee chairman Greg Walden (R-OR) says a yet-to-be-announced health subcommittee hearing next week will take up a bill being drafted to effect lower drug prices through better generic drug competition. During a 2/2 hearing, Walden said he would push for the
Drugs
FDA has released the FDA-483 issued at the conclusion of a 1/16-1/24 inspection at Natco Pharma, Telangana, India. Specific inspection observations included: * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to follow the written stability testing program; * failing to have
Drugs
Three Akin Gump attorneys say that examples included in an FDA draft guidance on consistent communications “appear to signal a slight thawing in FDA’s approach to communications made related to drugs, particularly with respect to information about longer-term safety and efficacy, specific patient subgroups, patient-reported outcomes, and
Drugs
The pharmacist in tiny Kermit, WV (pop. 392) was making $500,000 a month selling opioids and the five drug wholesalers, including the nation’s three largest, supplying him knew it ꟷ yet they illegally looked away and kept shipping more and more, “motivated by profit and greed.” So alleges
Drugs
Biomedical ethics researchers from Canada’s McGill University say that the efficacy of drugs should be considered before they are allowed to enter first-in-human trials. Writing in a Nature commentary, the ethicists say that “more thorough assessments of clinical potential before trials begin could lower failure rates and
Drugs
FDA has accepted for priority review an AbbVie NDA for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) for treating all major genotypes of chronic hepatitis C virus (HCV). The submission is supported by data from eight registration studies in AbbVie's G/P clinical development program,
Drugs
It would be unwise to speed up drug development and approvals by reducing or eliminating Phase 2 or Phase 3 trials, according to an opinion piece in The Scientist. Written by two academics(*), the article cautions that such an approach would not test the drugs in a sufficient number of
Drugs
Impax Laboratories has filed a petition urging FDA to refuse to receive or approve any ANDA seeking approval to market a generic version of Rytary (carbidopa and levodopa) extended-release capsules unless the generic drug applicant has demonstrated bioequivalence to Rytary through scientifically appropriate methods outlined in the document. The
Drugs
A group of government scientists is warning president Trump that politics have no place in science, and any restrictions on scientific findings will lead to widespread leaks of information and embarrassment for the administration. A 1/31 letter from Public Employees for Environmental Responsibility called out the Trump administration and
Drugs
President Trump’s promise to the pharmaceutical industry to massively gut FDA’s regulations in exchange for lower drug costs for the American people would “fundamentally destroy the ability of the agency to protect patients and consumers from unsafe or ineffective medications and medical devices, hazardous foods and dietary supplements,
Drugs
Eleven House members led by Reps. Kurt Schrader (D-OR) and Gus Bilirakis (R-FL) have introduced legislation they say will lower the cost of prescription drugs by providing review voucher incentives to drug makers to develop generic drugs when competition does not already exist or when there is a
Drugs
A WilmerHale review of the False Claims Act (FCA) in 2016 predicts that FCA enforcement is likely to remain vigorous, particularly in cases involving contractors. The review notes that at his confirmation hearing, attorney general-designate Jeff Sessions said that “this government must improve its ability to protect the United