Drugs
Lilly says its tirzepatide achieved superior weight loss compared to placebo in the 72-week Phase 3 SURMOUNT-1 study. A company statement says the drug met both co-primary endpoints of superior mean percent change in body weight from baseline and a greater percentage of participants achieving body weight
Drugs
FDA has lifted a clinical hold on Pfizer’s mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD). The company is now planning to resume a Phase 3 study evaluating the therapy. The global study, CIFFREO, had been ongoing in 11 countries and was paused
Drugs
Consulting firm McKinsey and Co. came under intense scrutiny 4/27 during a House hearing for its role in advising Purdue Pharm during the opioid epidemic while also being under contract to advise FDA. “We have learned that at the same time McKinsey was providing secret advice to Purdue to
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the current methods used by the Federal Trade Commission (FTC) and Department of Justice (DoJ) to evaluate proposed drug company mergers are working well as demonstrated by FDA statistics. In its comment letter, PhRMA says the level of innovation output of drug
Drugs
FDA says Pfizer has recalled five lots of Accupril (quinapril HCl) due to the presence of N-nitroso-quinapril observed in recent testing above the acceptable daily limit level. An agency announcement says that to date the company is not aware of reports of adverse events that have been assessed
Drugs
FDA is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorization package that is moving through Congress, to help overturn a 2021 appeals court decision that has disrupted FDA’s orphan drug program. Asked to comment
Drugs
Janssen has filed suit in New York federal court to stop several drug wholesalers and their executives/founders from distributing counterfeit forms of Janssen’s Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide), a multi-drug HIV medication in one tablet. The Janssen complaint names Safe Chain Solutions, Propharma Distribution, Scripts Wholesale,
Drugs
FDA has published a guidance, Providing Submissions in Electronic Format—Postmarketing Safety, providing general information on the electronic submission of specified postmarketing safety reports to CBER and CDER. The document does not apply to vaccines, whole blood or blood components, combination products with a drug or biological product constituent part
Drugs
A 4/6-4/27/21 FDA inspection at the Clinical Resolution Laboratory drug manufacturing facility in Brea, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in its production of finished drugs. A just-released 3/1 Warning Letter says specific CGMP violations were:
Drugs
Attorney Bryan Feldhaus (DuVal & Associates) says his firm does not think the new FDA “intended use” rule published on 9/1/21 represents a material change for drug and device manufacturers in 2022. In this way, his analysis differs from some observers who have projected an increased exposure for
Drugs
A 9/13-9/22/21 FDA inspection at the Vitae Enim Vitae Scientific drug manufacturing facility in San Diego, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/17 Warning Letter says specific violations were: * failing to establish and follow
Drugs
Six Wilson Sonsini attorneys say FDA enforcement actions were featured in the Justice Department Civil Division’s Consumer Protection Branch’s (CPB) first-ever “recent highlights” report. In an online post, the attorneys say (includes link to report) the report “gives some insight into the enforcement trends companies can expect
Drugs
Members of Universities Allied for Essential Medicines (UAEM), a global alliance of university students urging their universities to register and report clinical trials, are asking to meet with FDA commissioner Robert Califf to discuss ways in which UAEM and FDA could work together to improve clinical trial transparency. In a
FDA Policy/General
Former FDA principal deputy commissioner Joshua Sharfstein, now a professor at the Johns Hopkins University Bloomberg School of Public Health, says Congress needs to be looking at the impact of the global consulting firm McKinsey working for FDA and Purdue Pharma simultaneously and whether the consultants abused FDA’s trust.
Drugs
Philips Respironics and certain Philips subsidiaries in the U.S. recently received a subpoena from the Department of Justice for information on the events that led to the recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, according to a first
Drugs
FDA has issued a four-item Form FDA-483 to Wedgewood Connect after an inspection of its San Jose, CA drug manufacturing facility cited significant GMP violations. For example, the agency says the firm’s responsibilities and procedures applicable to the quality control unit are not in writing and fully
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is seeking comments on a research proposal to understand the “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.” The research is intended to examine the “relative importance of prescription drug product information such as prescription
Drugs
Axsome Therapeutics says it expects to receive a complete response letter on its NDA for AXS-07 (meloxicam-rizatriptan), indicated for the acute treatment of migraine, after the agency recently told the company that chemistry, manufacturing, and controls issues identified during the NDA’s review remain unresolved. The user fee
Drugs
FDA has expanded the approval of Gilead Sciences’ Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age and older weighing at least 3 kilograms. FDA says the therapy in this population is for those hospitalized, or not hospitalized but at high risk for progression to severe
Drugs
CDER’s Office of New Drugs say it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx of a complete response letter (CRL) it received 7/2021 on its NDA for tenapanor to control serum phosphorus in chronic kidney disease patients on dialysis. The
Drugs
Biogen has withdrawn a European marketing authorization application for its troubled Alzheimer’s drug aducanumab. This is the latest chapter for the therapy, which gained FDA accelerated approval 6/7/21 that ignited a firestorm of criticism and the resignation of several advisory committee members. In the aftermath, then-acting
Drugs
FDA has accepted for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, in response to a 10/2021 Complete Response Letter. The agency has set a 9/8 user fee review action date. The company says the submission adheres to