Millennium scores FDA OK on new Velcade administration

Millennium has scored a significant new FDA approval based largely on serendipity.   After a French nurse successfully injected the intravenous drug Velcade under the skin of a patient whose veins were out of reach, the company went on to show in a Phase III study that subcutaneous injections of the multiple myeloma drug were effective and also helped significantly reduce one of the major side effects associated with the treatment. And that is likely to help beef up sales for the...

Experts jab over drug patent reform and the best approach to innovation

One of the most persistent arguments in the biopharma business these days is focused squarely on the length of patent protection a new treatment has when it goes on the market. The industry has always wanted more, basing its argument on the idea that shorter periods of market protection reduce the earnings it can expect and undercut the ability to innovate. Patient advocates typically cry out for less, maintaining greedy pharma companies just want more money and longer patents...

Novo crafts fast-track R&D model for new diabetes drug unit

Novo Nordisk ($NVO) is setting up a new R&D center in Seattle that aims at reengineering the model for early-stage drug work and speeding up development in the diabetes field. Under the direction of noted investigator Matthias von Herrath (see photo at right), this new unit will specialize in the search for new treatments that can be used to treat Type 1 diabetes. The Novo Nordisk Inflammation Research Center in Seattle will host the new research unit, which is slated to open this...

Scientists believe “magic” mushrooms could effectively treat depression

After a brief spurt of interest in the late '60s, scientists in the drug development field abandoned research work on illicit drugs like LSD and "magic" mushrooms. But over the past few years a few bold investigators have been stepping back up to the plate, convinced that some outlawed active ingredients could offer new pathways to treating some common ailments. Enter Professor David Nutt, a prominent and controversial researcher in the U.K. who has just published a new paper asserting that...

Vertex outlines its survival plan for next-gen hep C combo

At the beginning of 2011, Vertex ($VRTX) was basking in the limelight of blockbuster success. Its hepatitis C drug was headed for approval, offering a game-changing approach to the disease, and was the clear favorite in a brewing market showdown with Merck's ($MRK) rival therapy. Vertex went on to win that battle but lost the war for the affection of the industry analysts, who were seduced by the interferon-free promises of the relatively puny Pharmasset ($VRUS), Inhibitex ($INHX) and others....

Insmed shares spike after FDA lifts hold

Shares of Insmed ($INSM) shot up on Friday after the company reported that the FDA has lifted a clinical hold on its trial of Arikace, an inhalable antibiotic for lung disease. Regulators had stepped in after concluding that they didn't have sufficient information to assess the risk involved in the study....

ACT trumpets positive efficacy data from ESC trial sampling

The beleaguered embryonic stem cell field got a boost today from a clinical trial sample in which two legally blind patients demonstrated partially restored vision after getting an injection of new cells prepared by Advanced Cell Technology ($ACTC). The two subjects suffer from two types of macular degeneration, a common condition in which vision blurs as retinal cells die. And after injections of ESC-derived retinal cells, both scored better on vision tests, leaving ACT to claim bragging...

VCs pump more cash into late-stage efforts as startup rounds shrivel

The biotech industry finished 2011 on a high note with a surge in venture investing, but you can still clearly hear the alarm bells ringing in the background. The National Venture Capital Association and PricewaterhouseCoopers concluded that VCs pumped $4.73 billion into biotechs last year, a four-year high and one of the best numbers seen in the past decade. But only 153 of the 785 investment rounds for biotech and medical device companies went to startups, a 15-year low and a worrisome trend...

Columbia shares nosedive after FDA experts reject preterm birth gel

Early last week FDA regulators essentially concluded that Columbia Laboratories had blundered in its clinical trial work for a new gel to prevent preterm births. In the view of regulators, Columbia ($CBRX) had failed to offer data which clearly supported the efficacy of the treatment. And on Friday an FDA panel voted against an approval, triggering a meltdown in its share price. The FDA advisers agreed with the regulators' assessment, concluding that investigators never proved its...

BioMarin perfects the popular rare disease drug model

One of the big trends in drug development over the past three years has been the growing popularity of new treatments for rare diseases. And if you read through Bloomberg's lengthy feature on Novato, CA-based BioMarin's program for achondroplasia--a rare bone growth disorder that causes dwarfism--you'll see why. A drug program targeting a tiny number of patients can be wrapped relatively quickly; developers can achieve special orphan drug marketing status for the program and there's a steady...