The FDA usually, but not always, follows the advice of its advisory panels. But the FDA has previously determined it may be appropriate to license biosimilars for additional conditions for which a branded product is approved, even if the biosimilar has not been tested for them. Steven Solga, head of gastroenterology at St. Luke's University Hospital in Bethlehem,...» Read More
The drugmaker Novartis said Monday that the European Commission had approved its Exelon skin patch to treat Alzheimer's disease.
It's relatively lightly traded and it's a very small market cap (under $500 million), but shares of Sirtris Pharmaceuticals are sitting at a new high in the early going today. The stock has had a very nice move since the end of June when it was trading for less than 10 bucks. Today, it's over $15.
BioCryst Pharmaceuticals drew the short straw, er, needle. The biotech company says a majority of patients in a mid-stage clinical trial of its experimental seasonal and pandemic flu antiviral Peramivir got the drug using too short of an injection needle.
Australian drug maker and distributor Sigma Pharmaceuticals cut full-year forecasts for the second time in three months on Thursday as regulatory changes hit profits, sending its shares plunging as much as 15%.
I'm fully aware that this story actually broke yesterday, and was picked up by a couple of competitors, but after receiving today's morning research note from Miller Tabak healthcare analyst Les Funtleyder, I couldn't resist writing this post.
U.S. health officials said Wednesday they approved the Flumist nasal spray influenza vaccine for children between ages 2 and 5. Flumist is made by MedImmune Inc, which was recently acquired by AstraZeneca.
Because it's so extraordinarily rare--if not unheard of--for one analyst to publish research specifically to refute another analyst I thought this is blogworthy. Last Friday, FBR biotech analyst Jim Reddoch told clients in a research note that he was downgrading ImClone Systems to Market Perform in the wake of the robust data released last week on Erbitux...
In a study that could change the way hip fractures are treated, doctors have discovered that giving the Novartis osteoporosis drug Reclast can prevent later fractures and helps patients live longer.
Could a new pharmaceutical partnership be the best way to trade the rise in diabetes? In Thursday’s Web.Extra the traders reveal how to play the latest news. Also get their trades on hard drive behemoths Western Digital and Seagate.
Bayer's heart surgery drug, Trasylol, linked in some studies with an increased risk of death, should remain on the market, advisors to the U.S. Food and Drug Administration said onWednesday.
Recently I blogged about the hiring of a new CEO at ImClone Systems and the unique clause in his contract requiring him to buy half-a-million dollars worth of stock in the company. My suspicion was that ImClone Chairman and billionaire shareholder Carl Icahn had a hand in that.
There’s a ton of Big Pharma and Biotech news coming out. And most of it reinforces the call from the Fast Money traders to buy these stocks heading into the end of this year.
Yesterday, I blogged that messages to each of David Maris' lawyers seeking comment on Biovail "dropping" or "settling" its case against the former Bank of America Securities analyst had gone without a response. Well, this morning I got this email from one of his attorneys tossing the ball back in Biovail's court:
The cancer drug Erbitux unexpectedly extended survival in a trial of patients with advanced lung cancer, sending shares of its maker, ImClone Systems, soaring as much as 24 percent.
Is the Senate coming to the rescue of patients, investors or both? That's the question being raised after the passage of a non-binding resolution telling Medicare to "immediately reconsider" its new policy to cut anemia drug use and reimbursement. Analysts are stunned by the move.
A follow-up to my post yesterday about the New York Post story regarding Biovail "dropping" its lawsuits alleging collusion to beat down its stock. This email showed up in the blog inbox this morning..."Your report on Biovail is not accurate..."
So, I thought I'd be spending today monitoring the webcast of the FDA Advisory Committees that are meeting to decide whether doctors should use less of the anemia drugs from Amgen and Johnson & Johnson to treat kidney dialysis patients.
Wall Street is counting down to next week's Fed meeting and not much else is influencing trading. Stocks are readying for a higher opening as investors wait for a speech from Fed Chairman Ben Bernanke later this morning and watch the action at OPEC.
Swiss drugmaker Roche Holding is taking legal action against Israel's Teva Pharmaceutical Industries in the United States to prevent Teva from selling a generic version of Roche osteoporisis drug Boniva, Roche said on Tuesday.
The New York Post broke the news today that Biovail Corporation, Canada's biggest biotech, is dropping its lawsuit against a hedge fund, a research outlet, Bank of America Securities and its former specialty pharmaceuticals analyst David Maris. "60 Minutes" did a piece on the lawsuits last year. Shortly after being sued, Maris left B of A. He and the company never disclosed..