For Immediate Release
Chicago, IL –March 18, 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: Pfizer (PFE - Free Report) , Roche (RHHBY - Free Report) , Merck (MRK - Free Report) , Allergan (AGN - Free Report) and J&J (JNJ - Free Report) .
Here are highlights from Friday’s Analyst Blog:
Pharma Stock Roundup: PFE, RHHBY, MRK & More
This week the FDA and European Commission were quite active. Pfizer announced FDA approval for its biosimilar version of Roche’s breast cancer medicine, Herceptin while Merck and Roche gained approval in EU to expand labels of their marketed drugs, Keytruda and Hemlibra, respectively. Meanwhile, the FDA granted a 10-month review period to Allergan’s regulatory application for key pipeline candidate ubrogepant while J&J filed an application with the same authority looking for approval of its multiple myeloma drug , Darzalex in an expanded patient population.
Recap of the Week’s Most Important Headlines
Pfizer’s Biosimilar Herceptin Gets FDA Approval: The FDA approved Pfizer’s Trazimera, a biosimilar version Roche’s breast cancer drug, Herceptin. Trazimera is already approved in the EU. Pfizer’s biosimilar versions of Roche’s other cancer drugs Rituxan and Avastin (Zirabev) are also under review in the United States with FDA decisions on all expected in 2019.
Pfizer and partner Merck KGaA announced that its regulatory filing in the EU looking for approval of Bavencio (avelumab), in combination with Inlyta (axitinib) for advanced renal cell carcinoma (“RCC”), was validated for review by the European Medicines Agency. A similar application is under priority review in the United States with the FDA’s decision expected in June. The regulatory filings in the EU and the United States were based on interim data from the phase III JAVELIN Renal 101 study, which evaluated the Bavencio/Inlyta combination against Pfizer’s older kidney cancer drug, Sutent.
EU Nod to Merck’s Keytruda Combo in Difficult Lung Cancer: Merck announced that the European Commission granted marketing approval to Keytruda, in combination with chemotherapy, as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC – a difficult-to-treat lung cancer patient population. The filing was based on data from the phase III KEYNOTE-407 study. In the United States, a similar label expansion was approved in early October last year.
Roche’s Hemlibra Gets EU Approval in an Expanded Patient Population: The European Commission granted approval to Roche’s regulatory application seeking approval of its drug, Hemlibra for the treatment of hemophilia A patients (adults and children) without factor VIII inhibitors. Hemlibra is presently marketed in the EU for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A patients with factor VIII inhibitors. Hemlibra is now the only haemophilia A treatment approved for patients with and without factor VIII inhibitors that can be administered subcutaneously at multiple dosing options (once weekly, every two weeks, or every four weeks). Hemlibra was approved for a similar indication in the United States in October last year.
FDA Accepts Allergan’s NDA for Ubrogepant: Allergan’s new drug application looking for approval of ubrogepant, its oral anti-CGRP acute migraine treatment, was accepted for review by the FDA. The FDA granted the application a normal review period of 10 months and will give its decision in the fourth quarter of 2019. If approved, ubrogepant would be the first oral CGRP antibody to get approval for migraine and may be used in conjunction with other available migraine treatment.
J&J Files sBLA for Darzalex: J&J filed a supplemental biologics license application (sBLA) seeking approval for its immunotherapy, Darzalex in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone in newly-diagnosed, transplant ineligible multiple myeloma patient population. The filing was based on data from a phase III MAIA study.
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