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FDA Approves Otonomy’s Otiprio
Cardiorentis Gets FDA Fast Track for Heart Failure Drug
Russian Regulators Approve Biocad’s Avastin Biosimilar
NICE Gives Prelim Green Light to Novartis, Astellas Drugs, But Janssen Drug Delayed Read More
The FDA has given its blessing to Wellstat Therapeutics’ Vistogard for the emergency treatment of adults and children who receive an overdose of chemotherapy treatment fluorouracil or capecitabine. Read More
The FDA has granted approval to Genentech’s Alecensa for metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer in patients whose disease has worsened after taking Pfizer’s Xalkori, or who could not tolerate the treatment. Read More
Type 2 diabetes drugs have elevated reporting rates for pancreatitis, hypoglycemia and diabetic ketoacidosis, which adds to suspicions of class-wide side effect issues, especially for DPP-4 drugs, a new analysis from Advera Health Analytics said. Read More
Janssen is petitioning the U.S. Supreme Court to overturn a $124 million verdict that it made false claims about antipsychotic drug Risperdal (risperidone) and hid risk information from physicians. Read More
As Merck looks to expand the indications of its lipid-reducing drug Vytorin to include cardiovascular outcomes, the FDA is asking whether trial findings describe the full picture well enough to substantiate benefit. Read More
Horizon Pharma has acquired Lake Forest, Ill.-based Crealta Holdings for $510 million in cash, in a deal that expands Horizon’s orphan drug business, the Irish firm said Friday. Read More
DoJ Charges Four Compounders in Health Insurance Fraud Scheme
Coherus to Delay BLA Submission for CHS-1701
TapImmune Cancer Vaccine Wins FDA Orphan Drug Designation Read More
Teva Pharmaceuticals is looking to sell various products in anticipation of potential regulatory objections to its planned purchase of Allergan’s generic division. Drug Industry Daily erroneously reported that Teva already is divesting assets and that this was done to avoid complications with the Securities and Exchange Commission. Read More
The FDA issued a warning that active pharmaceutical ingredient baclofen manufactured by Taizhou Xinyou Pharmaceutical & Co. Limited, may be at risk for contamination and should not be used to compound sterile injectable drugs. Read More
Indian analysts attribute ongoing quality control issues with pharmaceutical exports to a dearth of pharmaceutical inspectors and a lack of uniform standards in the country. Read More