Amgen wins FDA approval for cholesterol-lowering drug Repatha.» Read More
U.S. health regulators charged Boston Scientific with inadequate record-keeping and reporting following the deaths of five patients implanted with an experimental device to treat a dangerous ballooning of the body's main artery.
An update from the NewsMakers in Biotech conference in NYC on an item of intense interest. Amylin Pharmaceuticals just held a well-attended PowerPoint presentation followed by a very cramped breakout session. And pretty much the only thing investors and analysts wanted to talk about is Byetta LAR (long-acting release).
Merck said Thursday the New Jersey Supreme Court has reversed a lower court ruling that had granted nationwide class-action status to insurers seeking reimbursement for past spending on Vioxx, the drugmaker's withdrawn arthritis treatment.
Benefits of an experimental AIDS drug developed by Merck & Co appear to outweigh risks, according to U.S. Food and Drug Administration staff documents released Friday ahead of an advisory panel meeting.
Schering-Plough and Merck Tuesday said U.S. regulators had accepted the marketing application for their experimental allergy drug, which combines two widely used existing treatments into a single tablet.
In case you hadn't heard September is Prostate Cancer Awareness Month. It's the #2 cancer killer of American men behind lung cancer. The American Cancer Society estimates nearly 220,000 men will be diagnosed with the disease this year. And as the emails coming into our inboxes indicate, it's going to be a busy month for those who are trying to get more money, research and drugs to help fight it.
A state judge in Michigan has sided with Wal-Mart Stores and dismissed a lawsuit by former marketing executive Julie Roehm over her firing, saying the case should be filed in Arkansas.
In an editorial today, USA Today calls on the Food and Drug Administration to let dying patients get quicker, easier access to promising, potentially lifesaving or life-extending, developmental drugs. The paper argues that thousands of people in "dire circumstances" deserve "the chance to take a last-ditch gamble".
Shares of Dendreon rose Monday after the company said its breast cancer drug was effective in an early stage clinical trial.
On Amgen's conference call the other day regarding the biotech company's cutbacks, officials repeatedly stated that they think the federal government's new, restrictive guidelines for use and payment of Amgen's bread-and-butter anemia drugs will hurt patients and specifically, result in the need for more risky, old-fashioned blood transfusions to treat the condition.
Biotechnology firm Amgen said after U.S. markets closed Wednesday that it will slash its employee base by between 12 and 14% in hopes of reducing its 2008 cost forecasts by $1 billion to $1.3 billion on a pre-tax basis.
For the second time in two weeks, an op-ed item appears in The Wall Street Journal today calling out the FDA for its record on timely approval of cancer drugs.
In very early trading MRK shares are rallying this morning on the wings of an upgrade at Cowen & Co. by analyst Steve Scala from Neutral to Outperform. He's been at a Neutral since a year and one month ago when the stock was sitting in the 30s. Today it's in the low 50s.
U.S. regulators have delayed approval of an experimental two-in-one migraine drug from GlaxoSmithKline and Pozen yet again, sending Pozen stock down 45 percent on Thursday.
This morning we learned that the FDA has issued another "approvable" letter to Pozen and GlaxoSmithKline for their migraine drug Trexima over safety concerns. POZN shares are down big. The company has scheduled a conference call for 11 a.m. ET. This is the third regulatory stumbling block for this drug and puts it on a timeline now where it could end up competing...
An independent advisory panel told the U.S. Food and Drug Administration that GlaxoSmithKline's widely used diabetes pill Avandia increased heart risk but the drug should remain on the market.
As a big FDA Advisory Committee meeting is taking place here in Gaithersburg, Maryland on the safety of GlaxoSmithKline's Avandia, the head of the agency has been named in a separate lawsuit. A non-profit group calling itself "CareToLive" is suing FDA Commissioner Dr. Andrew von Eschenbach over the recent delay in the potential approval of Dendreon's Provenge.
I think I just killed a tree. This morning I printed out the GlaxoSmithKline and FDA documents that were posted on the agency's Web site ahead of the advisory committee meeting on Avandia safety next Monday. About 700 pages! Nearly as many pages as the new "Harry Potter" book, but not nearly as entertaining.
A new study of health insurance records of more than 400,000 U.S. diabetics found no higher risk of heart attacks with GlaxoSmithKline Plc's pill Avandia when compared with other oral diabetes drugs, the drugmaker said in documents made public Thursday.
U.S. regulators should wait for final survival data before deciding whether to approveGPC Biotech proposed prostate cancer pill Orplatna, an advisory panel said on Tuesday in a 12-0 vote.