Drugs
A 9/4-9/8/17 FDA inspection at Malladi Drugs & Pharmaceuticals Limited, Chennai, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 3/9 Warning Letter. Specific deviations cited in the letter were: * failing to use appropriate precautions to
Drugs
Researchers from Harvard, Yale, and Johns Hopkins universities say that facilitating patient access to drug manufacturers that had obtained approval from any of seven non-U.S. regulators (the European Union, Canada, Australia, New Zealand, Switzerland, South Africa, and Israel) could help sustain affordable access to essential off-patent drugs.
Drugs
The Massachusetts Supreme Judicial Court says a man who alleged he was injured after taking a generic form of Merck’s Proscar (finasteride) for benign prostatic hyperplasia may amend one portion of his complaint, while the other two elements were dismissed. The court’s opinion says a plaintiff may not
Drugs
FDA has accepted for priority review a Pfizer and Astellas Pharma supplemental NDA for Xtandi (enzalutamide) for an expanded indication to include men with non-metastatic castration-resistant prostate cancer (CRPC). The submission is based on data from the Phase 3 PROSPER trial. The agency has set a user fee
Drugs
As part of the Trump Administration’s opioid crisis plan, the president 3/19 warned pharmaceutical companies marketing opioid and other addictive pain killers that the Department of Justice is “looking very seriously into bringing major litigation against some of these drug companies.” Speaking at an anti-opioid addiction event
Drugs
As House Republicans prepare to advance a right-to-try bill through the Rules Committee process, four former FDA commissioners have issued a brief joint statement opposing the measure. Issued by ex-FDA heads Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, the statement read: “We as former
Drugs
A new FDA drug approval transparency pilot program has released the first Clinical Study Report (CSR) which provides more background on why the agency recently approved Janssen Biotech’s Erleada (apalutamide), the first treatment for non-metastatic, castration-resistant prostate cancer. The drug was approved last month and it was
Drugs
FDA has accepted a pSivida Corp. NDA for Durasert three-year treatment for posterior segment uveitis. The agency has set a user fee review action target date of 11/5. The submission includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months.
Drugs
FDA has approved a Tetra Discovery Partners IND for BPN14770, a novel, selective small molecule inhibitor of the phosphodiesterase type-4D enzyme. The company says its research suggests the drug may be useful in the treating Fragile X Syndrome and possibly other autism spectrum disorders. Tetra plans to initiate a
Drugs
FDA has approved CSL Behring’s Hizentra (immune globulin subcutaneous [human] 20% liquid) as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment. The approval was based on data from the Phase 3 PATH study, which demonstrated that the percentage of patients experiencing
Drugs
Q BioMed has filed with FDA for approval of a new manufacturing facility to make strontium chloride Sr89 injection USP, a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and osteoblastic
Drugs
Bayer has recalled Alka-Seltzer Plus packages that were sold at Walmart, CVS, Walgreens, and certain other stores in the U.S. Affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton. “This may lead consumers to ingest a
Drugs
FDA has issued the first report of generic drug quarterly metrics required under the GDUFA 2 user fee amendments. The report shows that at the end of the FY 2018 first quarter, there were 2,055 ANDAs awaiting FDA action. The mean full approval time was 41.7 months and
Drugs
FDA says it is delaying indefinitely the effective date of amendments to the existing medical product “intended use” regulations to give the agency more time to consider comments on the proposal. A Federal Register notice scheduled to be published 3/16 says the action does not delay the effective date
Drugs
FDA says the Arthritis Advisory Committee will meet 4/23 to discuss Lilly’s NDA for baricitinib tablets. A Federal Register notice says the company is seeking an indication to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Drugs
FDA has granted Breakthrough Therapy designation for Janssen’s erdafitinib in treating urothelial cancer. A company statement says the designation is based on data from a multi-center Phase 2 trial of the drug’s efficacy and safety in treating adult patients with locally advanced or metastatic urothelial cancer whose
Drugs
FDA has placed the Solid Biosciences IGNITE DMD Duchenne Muscular Dystrophy Phase 1/2 clinical trial on a clinical hold following a serious adverse event that occurred in the first patient dosed with SGT-001 in the trial. A company statement says the patient was admitted to the hospital, was
Drugs
FDA says its laboratory analysis shows that United Pharmacy’s glutamine, arginine, and carnitine (GAC) 10/100/200 mg/mL product for injection is degrading before the beyond0use date of six months specified on the product label. An agency notice says it previously reported that the product was labeled as
Drugs
The number and size of federal and state settlements against the pharmaceutical industry remained low in 2016 and 2017, with federal criminal penalties nearly disappearing, according to an analysis published by Public Citizen. The report updates data that the advocacy group previously released in 2016 on criminal and civil settlements
Drugs
Attorneys Anne Walsh and Rachel Hunt (Hyman, Phelps & McNamara) say the Supreme Court is considering a Gilead petition asking it to rule on a question involving “materiality” in False Claims Act (FCA) cases. Writing in their firm’s FDA Law Blog, the attorneys say Gilead’s question arises from
Drugs
FDA says Biogen and AbbVie are withdrawing their multiple sclerosis drug Zinbryta (daclizumab) from the global market due to concerns about the drug’s benefit/risk profile. In an online information sheet, the agency says it is working with the companies to help ensure a well-organized withdrawal from the
Drugs
The House of Representatives has failed to pass HR 5247, the Right to Try Act of 2018, under suspension of the rules. The bill (see earlier story) was crafted to improve access to experimental treatments for patients with terminal diseases or conditions. The vote was 259 to 140 in favor