Merck KGaA and Pfizer have bagged FDA breakthrough therapy designation for avelumab, the pair's anti-PD-L1 monoclonal antibody. And while the immunotherapy is lagging behind rivals' PD-1 and PD-L1 drugs in some indications, Merck KGaA and Pfizer think the breakthrough status could help them steal a lead in metastatic Merkel cell carcinoma.
GlaxoSmithKline has struck a deal to trial its anti-OX40 monoclonal antibody in combination with Merck's Keytruda. The Phase I study is part of a slate of programs that GSK is hoping will support filings for up to 20 new drug approvals in the coming years, the success rate of which will go a long way to deciding whether the company can bounce back from its recent travails.
ThromboGenics is trying to give the TB-403 cancer drug Roche walked away from in 2012 a new lease of life. The arrangement sees ThromboGenics teaming up with life science research institute VIB to create a new biotech focused on shepherding the drug through clinical development.
Phase II data from Genmab have ratcheted up expectations for a fast-track approval of its Johnson & Johnson-partnered treatment for double refractory multiple myeloma. Analysts see the data as strong enough to bring the CD38 monoclonal antibody to market in the first half of 2016.
Biotech Inovio revealed that all the mice that received its monoclonal antibody targeting chikungunya virus were protected from the disease, raising hopes that the first drug for the condition could be on the horizon.
Swiss biotech Novimmune has closed a $66 million B round to bankroll its broad pipeline of monoclonal antibodies, and one of the company's lead investors told a local newspaper that it's considering going public to further finance its projects.
Theraclone Sciences was hoping for a federal cash infusion to keep its anti-influenza antibody program rolling, but a denial from the government will force the biotech to handle Phase II on its own.
Less than a year after striking a $1.1 billion antibody development deal with French drugmaker Servier, the Rockville, MD-based biotech has snagged a $10 million milestone for dosing the first patient in an early-stage study of their tumor-targeting drug MGA271.
Back in 2007 when Japan's Eisai agreed to pay $325 million in cash for the U.S.-based Morphotek, the pharma company had high hopes for the biotech's pipeline-leading drug focused on ovarian cancer. But those hopes could not live up to a pivotal test as farletuzumab, also known as MORAb-003, failed to hit a statistically significant goalpost for progression-free survival.
In the hunt to develop targeted drugs against plaque psoriasis, Amgen and Eli Lilly reported positive study results.