Peptidream Inc. scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment of multiple disease targets.
U.S. FDA Approves Kaléo’s AUVI-Q 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Privately held pharmaceutical company kaléo announced that the U.S. Food and Drug Administration approved its supplemental New Drug Application for AUVI-Q (epinephrine injection, USP) 0.1 mg.
Acorda Therapeutics Inc. said the company would stop developing its Parkinson’s disease drug tozadenant less than a week after reporting deaths in key studies testing the treatment.
Tesaro Inc.’s PARP inhibitor Zejula was approved by the European Commission for recurrent ovarian cancer.
Developing new antiretroviral (ARV) drugs and using technology for early diagnosis are among steps needed to sustain momentum in fighting HIV/AIDS and ending the disease as a public health threat by 2030, UNAIDS said in a report.
Roche shares were lifted by two clinical trial wins for its new cancer and hemophilia drugs, potential blockbusters that the Swiss drugmaker is counting on to offset shrinking revenue from older medicines.
Samsung Bioepis Co. Ltd. announced the European Commission’s marketing authorization of Ontruzant – a biosimilar referencing Herceptin (trastuzumab) – for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
A filing with the U.S. Securities and Exchange Commission (SEC) indicates that the UK’s GlaxoSmithKline has a 13 percent stake in Spero Therapeutics, with 1,854,006 shares in the Massachusetts biotech company.
The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.
The Trump administration proposed changes to Medicare drug plans including limits on opioid prescriptions and rules aimed at reducing drug costs for seniors, such as requiring health insurers to pass on discounts to consumers.
The U.S. FDA approved the use of Pfizer Inc.’s cancer drug Sutent to help prevent kidney cancer from returning following surgical removal of a kidney.
A California jury ruled in favor of Johnson & Johnson in a lawsuit by a woman who said she developed the cancer mesothelioma after being exposed to asbestos in the company’s talc-based products including J&J’s Baby Powder.
A federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.
Shares of Merit Medical Systems jumped more than 9 percent after the company announced it plunked down $100 million for two product lines belonging to Becton, Dickinson and Company (BD).
Ionis Pharmaceuticals and Janssen strengthened their alliance with a second deal for gastrointestinal drugs. Janssen put up $5 million to secure the licensing of Ionis’ antisense drug, IONIS-JBI2-2.5RX.
Immunotherapy company Cue Biopharma Inc. announced a strategic research collaboration and license agreement with Merck & Co. Inc.
Battle lines are being drawn as the first gene therapy for an inherited condition nears the U.S. market, offering hope for people with a rare form of blindness and creating a cost dilemma for healthcare providers.
The U.S. Food and Drug Administration approved Roche’s first-in-class therapy Hemlibra for hemophilia suffers.
The U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.
The billionaire founder of Insys Therapeutics Inc. appeared in federal court in Boston to plead not guilty to charges that he participated in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug.