Drugs
Responding to an FDA discussion paper on distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that “globally harmonized approaches towards innovative manufacturing regulation will help ensure these advances provide their intended benefits.” The PhRMA comment letter encourages
Drugs
FDA has approved a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVie’s Humira (adalimumab), indicated for a range of autoimmune disorders. The tumor necrosis factor (TNF) blocker is a monoclonal antibody that binds TNFα and blocks its general cytokine effects, the company says. The biosimilar
Drugs
Sharon Carter, the former director of operations at the now-defunct New England Compounding Center (NECC), has been sentenced in a Massachusetts federal court to five months in prison, one year of supervised release, and a fine of $4,000 for conspiring to defraud FDA. Carter was the last of
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee has voted 8 to 3 against recommending approval of Cytokinetics’ omecamtiv mecarbil for treating heart failure (HF) with reduced ejection fraction. The NDA included data from the phase 3 GALACTIC-HF trial which evaluated 8,256 adults who were either hospitalized for
Drugs
FDA has accepted for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises tropicamide and phenylephrinem, which is delivered using its Optejet drug delivery technology, for in-office pupil dilation. The agency has assigned it a standard review and a 5/8/2023
Drugs
CDER and CBER are announcing a funding opportunity of up to $2.25 million per award for a project to support the use of real-world data (RWD) to generate real-world evidence (RWE) in regulatory decision-making. The funding notice says its purpose is to address topics related to
Drugs
An FDA inspection at the Centrient Pharmaceuticals India Private Limited drug manufacturing facility in Punjab, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 12/7 Warning Letter says specific deviations were: * failure of the quality unit to exercise its responsibility to
Drugs
Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) have introduced HR 9487, Advancing Safe Medications for Moms and Babies Act of 2022. The legislation would build upon prior legislation to help better understand the effect of medications on pregnant and lactating women and their
Drugs
A USC-Brookings Schaeffer Institute for Health Policy study says FDA delays in approving therapeutic equivalence (TE) codes for some injectable drugs are hurting consumers by slowing competition between branded and generic products. In a blog post, Brookings says that FDA requires injectable drugs to contain, with some exceptions, the
Drugs
Harvard Medical School researchers say policymakers should consider new incentives for developing new antibiotics since many new antibiotics developed in the last five years lacked efficacy evidence on clinical endpoints. Writing in an open-source BMJ article, the researchers say most antibiotics introduced in the U.S. between 2016 and
Biologics
Moderna and Merck say their mRNA-4157/V940 investigational personalized mRNA cancer vaccine in combination with Keytruda (pembrolizumab) met its primary endpoint in the Phase 2b KEYNOTE-942 trial. A joint announcement says the vaccination demonstrated a significant and clinically meaningful reduction in the risk of disease recurrence or death
Drugs
The Department of Justice has announced an indictment charging Marina Sievert (Dunedin, FL) with introducing into interstate commerce an unapproved new drug, mail fraud and monetary transactions in criminally derived property. According to the government, from 7/2019 through 4/2022 Sievert owned and operated Beauty Forever Florida (BFF), a
Drugs
FDA has announced a Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee joint meeting 3/28-29/2023 to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for acne drug isotretinoin. An agency notice says the panel will discuss
Drugs
FDA has released two Form FDA-483s after inspecting QuVa Pharma outsourcing facilities in New Jersey and Texas. The 10/14-dated 483 for the firm’s Bloomsburg, NJ facility cited it for failing to thoroughly review any unexplained discrepancy, deficient monitoring of aseptic processing areas, not establishing adequate written
Drugs
FDA has granted accelerated approval to Mirati Therapeutics on its NDA for Krazati (adagrasib), a RAS GTPase family inhibitor for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. This is determined by simultaneously approved companion diagnostics — Qiagen’s therascreen KRAS RGQ PCR
Drugs
FDA has notified Iceland’s Alvotech that the new BsUFA goal decision date for the company’s BLA for AVT02, a Humira biosimilar, is 4/13. Alvotech says the notification indicated that the agency has completed its review of the BLA and confirmed that the data provided are sufficient to
Drugs
Celltrion USA says it has submitted to FDA a BLA for its CT-P13, a novel subcutaneous formulation of infliximab to be used as maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s disease. A company statement says CT-P13 is the only infliximab to
Drugs
FDA has accepted for review a Pfizer NDA for etrasimod for individuals living with moderately to severely active ulcerative colitis. A company statement says an FDA decision is expected in the second half of 2023. Etrasimod is described as an oral, once daily, selective sphingosine-1-phosphate (S1P) receptor modulator
Drugs
FDA says samples of the SnoreStop NasoSpray, a homeopathic product it obtained from Green Pharmaceuticals, Camarillo, CA, were adulterated because they consisted in whole or in part of a filthy, putrid, or decomposed substance. A 12/16/22 Warning Letter says the firm is registered with FDA as an over-
Drugs
Madrigal Pharmaceuticals says its resmetirom, a liver-directed selective thyroid hormone receptor agonist, met both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. A company statement reported results from the pivotal Phase
Drugs
Rep. Abigail Spanberger (D-VA) has called on FDA and the Drug Enforcement Agency (DEA) to initiate a comprehensive federal response to alleviate the nationwide shortage of prescription Adderall (amphetamine mixed salts) and ensure access to the medication. In a statement (includes letter to agencies), Spanberger says Congress relaxed restrictions
Drugs
Two 12/8 JAMA viewpoint articles examine potential tweaks to FDA’s accelerated approval program to make it easier for the agency to pull an approval if a confirmatory study does not demonstrate clinical benefit. One article, authored by Harvard Law School’s Daniel G. Aaron and I. Glenn Cohen,