FDA rejection AZ’s COPD treatment puts pressure on their competitive edge

FDA has issued a complete response letter for the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate); Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective: “In an attempt to close the gap with chief chronic obstructive pulmonary disease (COPD) rival GlaxoSmithKline (GSK), AstraZeneca pushed to file an

Continue Reading

FDA approve Lilly’s cluster headache treatment

FDA has announced approval of Eli Lilly’s Emgality (galcanezumab-gnlm), the first treatment for episodic cluster headache that reduces the frequency of attacks. Decision was made based on a clinical trial that compared the drug to placebo in 106 patients, and found that during a three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache

Continue Reading

FDA gives green light to ADHD medical device

NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse

Continue Reading

Janssen’s advanced or metastatic bladder cancer treatment approved by FDA

FDA has granted accelerated approval to Janssen’s erdafitinib, a treatment for adult patients with locally advanced or metastatic bladder cancer. Which enables the drug to be used to treat bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. The

Continue Reading

FDA approves Pfizer’s breast cancer biosimilar

US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference

Continue Reading