For Immediate Release
Chicago, IL – March 11, 2019 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: J&J (JNJ - Free Report) , Lilly (LLY - Free Report) , Pfizer (PFE - Free Report) , AstraZeneca (AZN - Free Report) and Merck’s (MRK - Free Report) .
Here are highlights from Friday’s Analyst Blog:
Pharma Stock Roundup: JNJ, LLY, PFE & More
This week, J&J gained FDA approval for its antidepressant, Spravato (esketamine). It was the first approval for a depression drug in decades. Lilly said that it will soon launch a cheaper version of its popular insulin, Humalog amid increasing pressure to lower drug costs. The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA) meanwhile recommended marketing approval for several drugs.
Recap of the Week’s Most Important Headlines
J&J’s Spravato Gets FDA Approval with a Boxed Warning: J&J gets FDA nod for its new nasal spray, Spravato (esketamine) for treatment-resistant depression, a difficult-to-treat mental disease. With the approval, Spravato, which works differently from all other currently available antidepressants, became the first new medicine in 30 years to treat depression.
While most antidepressants take a couple of weeks or months to show effects, Spravato works in hours. To avoid misuse and abuse of the drug, Spravato has been approved with a boxed warning on its label regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behavior in pediatric patients and young adults.
CHMP Gives Positive Opinion to Several Drugs: Pfizer gained positive CHMP opinion, which recommended conditional marketing approval of lorlatinib for ALK-positive previously treated non-small cell lung cancer (“NSCLC). Lorlatinib will be marketed by the trade name of Lorviqua in the EU. In the United States, it gained FDA approval in the name of Lorbrena in November 2018.
The CHMP also gave a nod to AstraZeneca and Merck’s application looking for approval of cancer drug Lynparza in a new patient population — germline BRCA-mutated HER2-negative advanced breast cancer previously treated with chemotherapy. Lynparza is already approved in the United States for this indication. Merck also gained CHMP nod for a six-week dosing schedule of Keytruda across all current monotherapy indications.
Lilly to Launch Cheaper Insulin: Lilly announced plans to launch a cheaper version of its popular insulin, Humalog. The list price of the authorized generic version, to be called Insulin Lispro and containing an identical molecule as Humalog, will be 50% lower than the current list price of Humalog. Insulin Lispro will be available in vial and pen (KwikPen) options. Lilly is working to make the insulin available as quickly as possible.
The FDA granted priority review to Lilly’s filing looking for approval of label expansion of its CGRP antibody, Emgality (galcanezumab) for preventive treatment of episodic cluster headache. Lilly gained FDA approval for Emgality for the preventive treatment of migraine in adults in late September last year.
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