Latest Headlines

Latest Headlines

Novartis' duo of COPD drugs clears Phase III on the path to an FDA decision

Novartis, working to get a pair of Europe-approved COPD treatments onto the U.S. market, reported some positive Phase III data while awaiting final word from the FDA.

Amgen's PCSK9 contender lines up for first place in the blockbuster EU race

Amgen is likely to come in second in the race to launch new cholesterol treatments in the U.S., but the Big Biotech is leading the charge in Europe, securing a crucial regulatory recommendation that clears the way for approval.

Lpath eyes job cuts after a crushing AMD failure

Lpath's in-development treatment for wet age-related macular degeneration flunked in Phase II, wrecking the company's value and setting a stage for a round of layoffs.

Bluebird offers a promising peek at a potential cure for sickle cell

Bluebird bio, at work on a gene therapy for a rare blood disorder, unveiled some early but promising data on the one-time treatment's secondary indication of curing sickle cell disease, sending the biotech's value further skyward.

Regeneron's arthritis drug aces Phase III with the FDA in sight

Regeneron posted another round of clinical successes from its sweeping Phase III rheumatoid arthritis program, plotting to submit its Sanofi-partnered antibody for regulatory scrutiny this year.

J&J touts a blockbuster-rich pipeline with 10 filings on the horizon

Johnson & Johnson says it's on track to submit more than 10 new drugs for FDA approval over the next four years, and the company believes each of those contenders has the potential to bring in $1 billion in peak revenue.

Regeneron speeds toward the FDA with its would-be asthma blockbuster

Regeneron has advanced dupilumab, regarded by many as the company's next big innovation, into a Phase III asthma study, rolling toward an FDA submission behind its lead eczema program.

Third Rock's Eleven Bio flunks a Phase III dry eye study

Eleven Biotherapeutics' top pipeline prospect bombed a late-stage study in dry eye disease, failing to beat out placebo and forcing the Third Rock Ventures-founded biotech to pivot its focus.

Galapagos pulls off a $275M IPO as biotech hopefuls eye $195M more

Belgian biotech Galapagos came through with a $275 million IPO on the strength of its pipeline of immunology treatments, stirring hopes among a new crop of companies that the industry's Wall Street window will remain open through the year.

One of Takeda's big cancer bets flops in a Phase III lymphoma trial

Alisertib, a jewel of Takeda's $8.8 billion acquisition of Millennium Pharmaceuticals back in 2008, failed to make the grade in a Phase III lymphoma trial, forcing the Japanese drugmaker to pull the plug and pivot to other indications.