Showing posts with label Vivus. Show all posts
Showing posts with label Vivus. Show all posts

Tuesday, July 17, 2012

FDA approves Vivus weight-loss drug Qsymia


The Mountain View-based company's (NASDAQ: VVUS) drug, a combination of the generic weight loss drug phentermine and the anti-seizure drug topiramate, can be used by obese or overweight adults who have high-blood pressure, diabetes or high cholesterol.
The company's website late Tuesday afternoon featured a screen promoting Qsymia with a sash that said, "Now approved."

Oops! Vivus awaits weight-loss drug approval, even as story breaks

USA Today ran a story online Tuesday about Mountain View-based Vivus Inc. (NASDAQ: VVUS) winning approval of its weight-loss drug, Qnexa. The story had new details about the drug -- like a new name (Qsymia) and when the drug would be available to consumers (later this year) -- as well as quotes attributed to President Peter Tam and a photo of Qsymia pills and bottles.
Great news, right? After all, the FDA was expected to rule on the drug Tuesday. Except the FDA has not -- at least, not yet -- approved Vivus' drug.

Tuesday, March 6, 2012

Biotech's battle: Rebuild industry for next wave of drugs

Maybe it’s overdramatizing to say it feels like we’re passing through history, but as a number of Bay Area biopharma companies approach the cusp of drug approvals, it feels like we may not pass this way again.
It’s something to consider as the state’s biomedical industry players meet this week for the CalBio 2012 conference in San Francisco.
Maybe it’s my limited experience, but the sheer volume of drugs from Bay Area companies that are in front of the FDA in early 2012 seems unprecedented. After watching capital dry up for four years, just getting to this point seems a victory for some companies.
But for today's small life sciences companies to deliver big-time drugs in the coming years will take a new model for funding.

Thursday, February 23, 2012

Vivus shares soar after FDA panel vote on obesity drug

Shares of Vivus Inc. soared more than 80 percent into late-afternoon trading Thursday, after a Food and Drug Administration panel recommended Thursday that the Mountain View-based company’s obesity drug be approved.
The panel voted 20-2 late Wednesday to recommend that the FDA approve Qnexa by April 17.
The FDA, which rejected the once-a-day oral drug from the Mountain View-based company (NASDAQ: VVUS) in October 2010, isn’t required to follow the panel’s recommendation but often does.

Friday, February 17, 2012

The skinny on Vivus obesity drug: safety issues, FDA says

Ahead of a Feb. 22 advisory panel meeting for Vivus Inc. weight-loss drug Qnexa, a report from Food and Drug Administration staff cited safety concerns about the treatment.
The stock of Mountain View-based Vivus (NASDAQ: VVUS) was up 3 percent to $11.53 per share by late afternoon Friday.
If approved, Qnexa would be the first new prescription drug approved for weight loss in more than a decade.

Friday, January 13, 2012

Scenes, thoughts from the J.P. Morgan Healthcare Conference

If the Occupy Wall Street folks wanted to shut down biotech’s biggest wheeling-and-dealing session, the 30th annual J.P. Morgan Healthcare Conference, couldn’t they just contact the San Francisco fire marshal?
The Occupy movement supposedly was the reason J.P. Morgan asked the Westin St. Francis for additional security for the conference this week. Badge-checkers were at their usual stations inside the hotel but also were moved outside of the hotel, creating more logjams than usual on the sidewalk along Union Street.
Folks staying at the hotel had to show their room keys, so the security crush significantly cut down “clock tower” meetings in the hotel’s lobby. Coupled with the unusually good January weather, Union Square became the preferred chat-up locale, to the point that the park was overrun by posses of (mostly) men in black suits.
All in all, the mood seemed less dreamy, more serious. Even last year, life sciences companies still in shock from the financial crisis seemed like zombies: “Must focus portfolio … arrrrrgh … Be virtual … ugh.” They walked the talk, but they didn’t really seem to mean it. This year, the companies indeed were focused, their milestones tangible.

Friday, December 23, 2011

Vivus takes heavy hit on obesity drug danger study

Vivus Inc. saw its shares plunge 15 percent Thursday after bad news about an ingredient in its Qnexa obesity drug, now under review by U.S. regulators.
Mountain View-based Vivus (NASDAQ: VVUS) tested topiramate, an ingredient in Qnexa, and found that babies born from moms taking the drug had a higher rate of cleft lip and cleft palate.

Friday, September 2, 2011

FDA to decide on Vivus erectile dysfunction drug by end of April

Federal regulators accepted Vivus Inc.’s potential treatment for erectile dysfunction, the Mountain View company said Thursday, moving the drug one step closer to approval by the end of April.

Tuesday, August 23, 2011

Vivus to raise $45M in stock sale

Drug developer Vivus made a deal with institutional investors, who agreed to buy 6.889 million shares at $6.65 per share. The company will net a little more than $45 million after expenses of about $562,000.

Monday, April 4, 2011

Vivus shares climb on obesity drug data

Vivus Inc., seeking to reverse the Food and Drug Administration’s October rejection of its obesity-fighting drug Qnexa, said a long-term study shows that patients who took the drug used blood pressure pills 18.9 percent less.
After two years, patients in the study also saw a 26 percent drop in their levels of triglycerides, high levels of which are associated with obesity and heart disease, the Mountain View-based company (NASDAQ: VVUS) said.
The study is important for Vivus because the company must show that weight loss is tied to improvement of other obesity-related health markers.

Tuesday, November 9, 2010

Vivus wraps up $22M sales of Muse unit

Mountain View-based Vivus Inc. finished selling Muse, its erectile dysfunction drug, for $22 million in cash.
Vivus (NASDAQ: VVUS) could get $1.5 million more from the buyer, Sweden’s Meda A.B., depending on how well Muse does on the market.