Drugs
Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Azar said 10/26 that HHS is steadfast with the Trump Administration’s plans to change the way Medicare pays for costly physician-administered drugs. Currently, these drugs are reimbursed at the
Drugs
Attorneys Deborah Livornese, JP Ellison, and Josephine Torrente (Hyman, Phelps & McNamara) say CDER should change its current process and provide access to complete agency drug reviews to sponsors who are issued a complete response letter (CRL) advising them of the reasons the agency cannot approve an application in its
Drugs
FDA has issued a draft International Conference for Harmonization guidance, M9 Biopharmaceutics Classification System-Based Biowaivers, with recommendations to support the biopharmaceutics classification of drug substances and the BCS (biopharmaceutics classification system)-based biowaiver of bioequivalence studies for drug products. The document says biowaivers may be used to demonstrate bioequivalence,
Drugs
FDA commissioner Scott Gottlieb says the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, recently signed by the President, gives FDA new authorities “that we believe will meaningfully advance our efforts, and the agency will take immediate steps to implement this legislation
Drugs
FDA has cleared a Masimo 510(k) for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry that is intended to provide improved SpO2 (peripheral capillary oxygen saturation) accuracy specifications for all patients greater than 3 kg. RD SET single-patient-use sensors with
Drugs
A White House Council of Economic Advisors report praises efforts by HHS and FDA to respond to the problem of high drug costs. “FDA regulations intended to guarantee safety and efficacy can constitute barriers to price competition for drugs,” the report says. “In few other industries do firms spend over
Drugs
FDA has published a draft guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, to give the agency’s of the law’s requirements for verification systems. The document includes recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products,
Drugs
FDA has approved an updated label for Novo Nordisk’s weight management drug Saxenda (liraglutide) injection 3 mg to add data from the LEADER trial showing that liraglutide 1.8 mg in another product did not increase the risk of major cardiovascular (CV) events in adults with Type 2 diabetes
Drugs
Pfizer and Lilly say a Phase 3 study of the efficacy and safety of subcutaneous administration of their investigational humanized monoclonal antibody tanezumab in patients with osteoarthritis pain met all three co-primary efficacy endpoints. The companies say that in patients with moderate-to-severe osteoarthritis pain of the knee
Drugs
FDA has approved Genentech’s Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and older. The first-in-class drug works by inhibiting polymerase acidic endonuclease, an enzyme essential for viral replication, the company says. “Xofluza has demonstrated efficacy against a wide range of
Drugs
A new study has concluded that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and resulted reported on ClinicalTrials.gov. The study, published in Trials Journal, examined trials that supported FDA approval of new drugs for neuropsychiatric indications, found that “reporting results on
Drugs
FDA has issued a draft guidance, Testicular Toxicity: Evaluation During Drug Development, to assist sponsors who are developing drug products that may have potential adverse effects on the testes, referred to by FDA as testicular toxicity, based on findings in non-clinical studies. The document discusses: * non-clinical findings that
Drugs
A 6/13-6/29/17 FDA inspection at Auro Pharmacies, a La Habra, CA, outsourcing facility, found that the drug products produced there failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify
Drugs
The FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet 12/17-18 to consider various options for increasing access to naloxone. FDA commissioner Scott Gottlieb says the advisors “will help us weigh logistical, economic, and harm reduction aspects of different strategies. And
Drugs
FDA has released the FDA-483 issued following a 9/24-9/28 inspection at Cipla Limited, a Goa, India, drug manufacturer. The two inspection observations were: * batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing;
Drugs
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee will meet 10/24-25 to discuss the agency’s 2008 guidance “Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” An agency briefing document distributed in advance of the session says that concerns were
Drugs
Several companies have responded to an FDA request for comment on issues surrounding orphan drug exclusivity for Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride) in light of a federal court order reversing an FDA decision that Bendeka was not entitled to orphan drug exclusivity because it was not clinically superior to existing
Drugs
A Tennessee federal judge has entered a consent decree sought by FDA against Keystone Laboratories, Memphis, TN, and its owner and president, barring them from selling over-the-counter drug products until the firm complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the decree.
Drugs
Working with international regulatory and law enforcement agencies in Operation Pangea XI, the 11th annual International Internet Week of Action, FDA says it targeted 465 Web sites that illegally sell potentially dangerous, unapproved versions of opioid, oncology, and antiviral prescription drugs to U.S. consumers. An agency statement says the
Drugs
FDA has extended by three months its review of a Bristol-Myers Squibb supplemental BLA for an indication in metastatic first-line non-small cell lung cancer for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden (TMB) greater or equal to 10 mutations/megabase. The
Drugs
FDA has approved Regeneron’s Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent works by inhibiting the overactive signaling of interleukin-4 and interleukin-13, two key
Drugs
Experts have varying opinions on the legality and potential effectiveness of a Trump administration proposal to lower drug prices by requiring manufacturers to include pricing information in television ads. That’s the conclusion drawn from a Bloomberg Law online post. Under the proposal announced 10/15, the HHS Centers for