I give BioMarin a 5% chance of winning approval for drisapersen from the FDA following a negative advisory panel. I might be too generous.
A panel of outside experts convened by the U.S. Food and Drug Administration will spend all day Tuesday reviewing drisapersen, BioMarin's experimental drug for Duchenne muscular dystrophy (DMD).
The last thing the biotech industry needs today is another hit to investor credibility. Clovis isn't helping.
It's almost cruel to see Al Mann being forced back into the CEO role at MannKind, but the company's near-total collapse demands it.
The FDA is highly critical of BioMarin Pharmaceuticals' drisapersen, concluding that efficacy data from three clinical trials do 'not reach the level of substantial evidence' necessary for approval.
BioMarin will almost certainly be halted all day Tuesday, so traders should watch Sarepta Therapeutics and PTC Therapeutics as proxies.
On Nov. 24, a panel of outside experts convened by the U.S. Food and Drug Administration is set to review drisapersen, BioMarin's experimental drug for Duchenne muscular dystrophy.
Clovis Oncology must submit additional clinical data on its targeted lung cancer drug rociletinib to U.S. regulators, delaying the approval review and putting the company further behind rival AstraZeneca.
Biotech columnist Adam Feuerstein answers readers' questions about health care.
MannKind manages to raise a fraction of the money hoped from Israeli investment funds.
I'm often criticized for having nothing positive to say about MannKind, so let the record reflect that I believe the company going to Israel to raise money is smart.
'The chance you would have gotten similar data giving the patients 10 cups of coffee a day instead? Almost 100%,' said Dr. Adam Kline, a researcher who reviewed the data.
Ovarian cancer patients with tumors expressing high levels of a specific protein on their surface respond best to treatment with ImmunoGen's "smart bomb" cancer drug.
New results from a study of Agios' AG-120 in patients with solid tumors were presented at a medical meeting Sunday.
Can Cellectis transform CAR-T from a cool cancer science experiment into a profitable business?
Bluebird Bio is learning differences in the genetic mutation behind beta-thalassemia, a serious, inherited blood disease, is playing a role in how well patients respond to its experimental gene therapy.
Biomarin hasn't started confirmatory trials of DMD drug drisapersen suggested by FDA regulators.
Th purchase of Dyax strengthens Shire's portfolio of drugs treating a rare swelling disorder.
MannKind's signature product contributed only €2 million to Sanofi's diabetes sales in the third quarter.
Lowering its corporate tax burden is a key motivating factor for New York-based Pfizer in any blockbuster deal with Allergan.
Doctors and patients say something must be done to stop Catalyst Pharmaceuticals from emulating the high-priced drug strategies of Valeant and Turing Pharma.
Gilead's hepatitis C drugs are probably the best example of the innovation in medicine we want the biotech industry to strive for when developing new products.
Amgen will market the new drug under the brand name Imlygic. Last Friday, Imlygic also won support from a committee of European drug reviewers.
Merck will conduct an interim analysis before the end of the year of a large, phase III study investigating its cholesterol-lowering pill anacetrapib.