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In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the popularity of these drugs also continues to expand. Read More
Aldeyra Therapeutics on Monday announced receipt of an FDA complete response letter (CRL) for the NDA of reproxalap, for the treatment of dry eye disease, asking the company to conduct an additional trial to show the efficacy of the drug. Read More
Continued efforts to obtain approval for a drug to treat a rare neuromuscular disorder appear in this month’s Research Roundup along with an oral anticoagulant, and treatments for peanut allergy in children and migraine. Read More
Nearly half of rare oncology drug approvals include postmarketing requirements (PMR) for drug-drug interactions (DDI), a particular concern for cancer patients who are frequently being treated for co-morbidities and palliative care. Read More
In this edition of Quick Notes, we review recent FDA drug approvals of combination drug Truqap/Faslodex for breast cancer, DefenCath for hemodialysis patients, non-small cell lung cancer treatment Augtyro, a 38th approval for Keytruda, and an approval for Xtandi for prostate cancer. Read More
Merck appears destined for another disappointment with its investigative cough suppressant gefapixant, after an FDA advisory committee almost universally panned the drug’s phase 3 data, citing an almost complete overlap of patient-reported outcomes, a 57 percent placebo response rate, and a 28 percent dropout rate related to taste disturbance, the drug’s biggest side effect. Read More
Two oncology drugs that hold the records for the longest-marketed accelerated approval cancer drugs without confirmed clinical benefit and safety profiles need shorter, more focused study in a subgroup, members of the Oncologic Drugs Advisory Committee agreed in a meeting on Thursday, expressing concerns about the sponsor’s proposal for a large phase 3 trial. Read More
A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for patients aged 12 and over. Read More