The U.S. Food and Drug Administration approved an expanded indication for Merck’s GARDASIL 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
Pfizer and EMD Serono, the biopharmaceutical division of Merck KGaA, jointly announced that their Phase III JAVELIN Head and Neck 100 trial of Bavencio (avelumab) with chemoradiotherapy (CRT) for untreated locally advanced squamous cell carcinoma of the head and neck was unlikely to hit the primary endpoint.
Debiopharm announced that the U.S. Food and Drug Administration granted a Breakthrough Therapy Designation for Debio 1143, the most clinically advanced IAP antagonist, for the treatment of patients with confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in combination with current standard of care (CRT).
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
Merck & Co. Inc.’s blockbuster cancer drug Keytruda won approval from the U.S. FDA to treat a type of head and neck cancer.
The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
Shares of Advaxis plunged more than 28 percent in premarket trading after the company quietly disclosed that Amgen terminated their collaboration on an immuno-oncology program.
AstraZeneca’s immunotherapy treatment Imfinzi did not meet the main goals in a late-stage study for advanced head & neck cancer.
Galera Therapeutics Inc.announced that the clinical-stage biotechnology company secured $150 million in a joint, oversubscribed Series C financing and royalty purchase agreement.
The Food and Drug Administration approved Bristol-Myers Squibb’s Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy.