Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
Shares of CStone Pharmaceuticals were up after Pfizer invested $200 million into the company for a nearly 10% stake to support the development of a checkpoint inhibitor aimed at the oncology market in China.
Vaccinex Inc. will pair the company’s lead asset pepinemab with Merck & Co.’s vaunted checkpoint inhibitor Keytruda.
The U.S. Food and Drug Administration approved Bristol Myers Squibb Co.’s combination therapy for previously untreated patients with a form of lung cancer, a much-needed boost as the company battles the dominance of Merck’s Keytruda.
The U.S. Food and Drug Administration approved the anti-PD-1 therapy Keytruda as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) in combination with chemotherapy hit the primary endpoint in the company’s Phase III KEYNOTE-522 in triple-negative breast cancer.
Rare Cancer Treatments and the Power of Checkpoint Inhibitors Among Hot Topics at ASCO
American Society of Clinical Oncology (ASCO), Blockbusters, Cancer, Checkpoint Inhibitors, Clinical Studies, Clinical Trials, Data, Desmoid Tumors, Endocrine Therapy, Gastroenteropancreatic neuroendocrine tumors, Lung Cancer, Nobel Prize, Nobel Prize in Physiology or Medicine, Orphan Diseases, PD-L1 Inhibitor, PD-L1 protein, PIK3CA mutations, R&D, Rare Cancers, Rare Sarcomas, Tenosynovial Giant Cell Tumor (TGCT)With the books closed on another ASCO meeting, it’s clear to see that checkpoint inhibitors keep showing a promise.
EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.
2016 Annual Report: State Of The Bio Industry
Acute Myeloid Leukemia (AML), Analysts, Approvals, Biliary Atresia, Biopharma, Biotech, Biotech/Biopharma, Biotechnology, Checkpoint Inhibitors, Farnesoid X Receptor (FXR) Agonists, Forecasts, Immune System, Immune Systems, Immuno-oncology, Issue Archives, June 2016, Liver Disease, M&A, M&A, Nonalcoholic Steatohepatitis (NASH), PD-1/PD-L1 inhibitors, PD-L1 Inhibitor, Potential Blockbusters, Pricing, Primary Sclerosing Cholangitis (PSC), Special Reports, T-CellsThe outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.
Projected blockbuster bio products with potential launches in 2016
Atopic Dermatitis, Bladder, Bladder Cancer, Clinical Trials, Immunotherapies, Issue Archives, June 2016, Launches, Multiple Sclerosis, PD-1/PD-L1 inhibitors, PD-L1 Inhibitor, Potential Blockbusters, Product Launches, Prostacyclin Receptor Agonists, Pulmonary Arterial Hypertension, R&D, Relapsing Multiple Sclerosis (RMS)Dupilumab, Regeneron/Sanofi Dupilumab is the first systemic therapy to demonstrate positive Phase III results in patients with moderate-to-severe atopic dermatitis. The serious, chronic inflammatory skin disease is marked by widespread […]