SAN FRANCISCO – In a presentation during the opening day of the BIO International Convention, industry veteran Dave Thomas, senior director of industry research for the Biotechnology Innovation Organization (BIO), took a deeper dive into findings from two recent industry reports that he co-authored. Read More
LONDON – Less than one year after arriving on the scene with a $119 million series A, Mereo Biopharma Ltd. has raised a further $21.3 million and is joining the Alternative Investment Market (AIM) in London. Read More
CHICAGO – "In cancer pharmacology," Memorial Sloan-Kettering Cancer Center's Charles Rudin told the audience at the annual meeting of the American Society of Clinical Oncology, "it's all about the therapeutic window" – the dose range at which a drug will kill tumor cells without poisoning the patient taking them. Read More
CHICAGO – In what could change the standard of care for advanced multiple myeloma (MM) patients, providing more hope for an otherwise dire diagnosis, anti-CD38 monoclonal antibody daratumumab reduced the risk of cancer progression by 61 percent and doubled partial and complete response rates just by being added to Velcade (bortezomib, Takeda Oncology Co.) and dexamethasone in a pivotal phase III trial. Read More
CHICAGO – Detailed data from the IMvigor 210 study that led to the accelerated approval of Tecentriq (atezolizumab, Genentech Inc./ Roche AG), presented over the weekend, showed impressive benefits of the drug. The case for the complementary diagnostic approved along with it, however, was decidedly more mixed. Read More
CHICAGO – Early data of a phase II trial, called MyPathway, suggest validity for a new approach of treating patients according to genetic alterations – as opposed to tumor types – outside of approved indications. Read More
HONG KONG – Swiss pharmaceutical giant Novartis AG has officially launched its third global R&D hub, this one in China, where spirited debate over whether the country has true innovation or not is a daily occurrence. Read More
State angst over the murky realm of ever-increasing U.S. drug prices has moved from rhetoric to action, with Vermont leading the charge on requiring more transparency from biopharma. Read More
CHICAGO – A study to assess the accuracy of using liquid biopsies to determine cancer mutations or biomarkers, and thereby assist in treatment decisions, helped to identify approved therapies for 49 percent of the more than 15,000 patients who participated. Read More
The Medicines Co., of Parsippany, N.J., said it proposes to offer $350 million aggregate principal amount of convertible senior notes due 2023. The company also expects to grant to the initial purchasers an option to purchase up to an additional $52.5 million of the notes. The company expects to use a portion of the net proceeds to repurchase about $220 million of its 1.375 percent convertible notes due 2017 in privately negotiated transactions effected through one of the initial purchasers. The remainder will be used for general corporate purposes. Read More
Adamis Pharmaceuticals Corp., of San Diego, said it received a complete response letter from the FDA regarding its new drug application (NDA) for Epinephrine Injection USP 1:1000 0.3 mg pre-filled single-dose syringe for emergency use in acute anaphylaxis. The NDA was filed May 28, 2014. The FDA raised questions about the volume of dosage that the syringe delivers, including what is claimed in the label and what is required by the FDA. Adamis said it will request a meeting. Adamis' stock (NASDAQ:ADMP) lost 53.8 percent, to close at $4.09 on Monday. Read More
Beigene Ltd., of Beijing, presented initial data from an ongoing phase I dose-escalation trial of BGB-A317 in patients with advanced solid tumors. BGB-A317 is a humanized monoclonal antibody against the immune checkpoint inhibitor PD-1. The preliminary data show that BGB-A317 is well-tolerated and demonstrates antitumor activity in a range of advanced solid tumors. Read More
Stealth Biotherapeutics Inc., of Boston, said its MMPOWER phase II trial evaluating the systemic delivery of elamipretide for the treatment of primary mitochondrial myopathy, or muscle weakness, in patients with a genetically confirmed mitochondrial disease yielded positive data. Read More