American Conference Institute will be holding another "FDA Boot Camp" in Boston, September 22-23. The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies. The conference features FDA regulatory and patent law experts [...]
The pharmaceutical industry and the FDA have entered the realm of digital media very slowly and cautiously. Three companies that I know of now have YouTube channels - Abbott, GlaxoSmithKline and Johnson & Johnson. Of the three, Johnson & Johnson has been the most active in posting videos while the [...]
Here is a new addition to the Eye on FDA YouTube channel going under the Investment Vids playlist from Morningstar on Biotech stocks to watch. Morningstar associate director of equity research Debbie Wang offers her take on possible takeout targets: Here is a new addition to the Eye on FDA [...]
On Tuesday, NexMed announced that it would shelve its previously filed NDA for an onychomycosis treatment (NM100060) following disappointing Phase III clinical results. Onychomycosis, or toenail fungus, affects six to eight percent of the adult U.S. population. Because the infection is embedded within the nail and is difficult to reach, [...]
Pursuant to my posting earlier today, by coincidence, Johnson & Johnson announced the receipt of a Complete Response Letter. It is worth noting that they provided no details about the contents of the letter, except to say that there were "questions" and that no further clinical studies were needed. This [...]
On August 11, the Center for Drug Evaluation and Research (CDER) put into force a new final rule on the way it respond to New Drug Applications (NDAs) that effectively did away with Approvable Letters and Not Approvable Letters in favor of Complete Response Letters (CRLs). While maintaining that this [...]
Image via Wikipedia One of the talks I wanted to attend at OSCON, but missed in the blur of booth duty and conflicting sessions was Aaron Thul's talk on Electronic Medical Office Logistics (EMOL). The talk was a talk on PostgreSQL talk, but wrapped around what it takes to develop [...]
Revenues at Kensey Nash grew to a record $22 million in the company's latest quarter, a 29% increase over the same period last year. Net sales grew to $15.0 million, a 42% increase from the $10.5 million reported in Q4 2007. Orthopedic sales increased 39% to $8.4 million, primarily due [...]
It is poetic that following the close of the Olympics in Beijing - an event that went very well in spite of all the worries leading up to it - that Boehringer Ingelheim announces a cooperation deal with a Chinese company calleed Hisoar. If you google the company, there is [...]
CFO as Enterprise Risk Management Leader: How financial executives add value to this critical process Enterprise risk management (ERM) has the ability to help medical device companies align people, processes and ideas which support corporate objectives, improve cash flow and earnings, capture opportunities, allocate capital and manage growth. For this [...]
Device giant Medtronic Sofamor Danek has filed a complaint against NuVasive, alleging patent infringement by certain NuVasive products. Nuvasive is in the process of reviewing the complaint and assessing its defenses. Based on an initial review, Alex Lukianov, the company's Chairman and CEO, does not expect operations to be “significantly [...]
The Washington Post reports today that the California Supreme Court ruled day before yesterday that physicians do not have the right to withhold care from a patient on the basis of the patient's sexual orientation. Meanwhile, this summer, religious conservatives in Washington state headed to court this year to appeal [...]
CNET reports that Khosla Ventures has led an investment round of $3 million in ZocDoc, a health 2.0 company a little off the beaten path. ZocDoc, which currently operates only in Brooklyn and Manhattan, allows you to find an appointment with a doctor or dentist. Now that's a service I [...]
GlaxoSmithKline opened a YouTube channel earlier this year that apparently was a beta for what they were eventually going to accomplish. GSKCIC opened up, had little added to it, and didn't allow you to embed the vids, which was defeating the purpose of a YouTube channel. As I've mentioned in [...]
Matt Asay ask's an interesting question in a recent column. "Should you sell out your next big open source idea?". As is the tendency in these parts, that got me thinking about life science startups. What kind of exits can disruptive life science startups expect. In recent years, Solexa got [...]
It’s been tough going for Ophthalmic Imaging Systems (OIS). The digital imaging company reported second quarter net revenues of $3.2 million, compared with net revenues of $3.6 million for the same period last year. The company lost $249,000 in the second quarter of 2008. In its second quarter last year, [...]
Seth Berkley, head of the IAVI or International AIDS Vaccine Initiative (a not-for-profit developing preventive HIV vaccines) believes the majority of HIV vaccines now under development need to be abandoned. These vaccines tweak cell-based immunity, a strategy first explored by Merck. Berkley wants to focus IAVI’s substantial energies on vaccines [...]
Just a few weeks ago I posted about Mendeley and offered some invite codes. The demand was overwhelming and I delivered about 20 invites, that were offered to me by the kind folks at Mendeley, in just under a day. Since then, Mendeley has moved into public beta, therefore anyone [...]
In May, I reported stagnation at Retractable Technologies, a Texas-based safety needle manufacturer. Pointing to a robust balance sheet, I recommended the company makes some moves. I’d like to think my call to action were responsible for this quarter’s promising results: Retractable reported revenue of $6.5 million in the three [...]
Here is a newsbreaker I think. Stem cells hold a great deal of promise in research and clinical trials are underway around the world to make that promise a reality. However, many entrepreneurial efforts have been underway to use stem cells immediately, usually be extracting one's own stem cells and [...]
Healthcare reform is high on the political agenda this year. The upcoming Presidential and Congressional elections promise to focus public and business leaders’ attention on proposals to heal our ailing healthcare system. This requires more than force of will or mere innovation. Everyone would agree that the current system is [...]
Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" - but it looks like one flew off the shelf just in the nick of time - at least per the headline on the press release from Cardiome. Cardiome Pharma [...]
In July, Biogen-Idec and Elan, who co-market the multiple sclerosis drug Tysabri, announced two new cases of PML a potentially deadly side effect. The stocks sold-off almost entirely. Biogen-Idec[...]
Arbios Systems has suspended operations and laid-off employees while it focuses on raising additional funds. If the company fails to secure financing by the end of August, Arbios will consider liquidating its assets. Last May, Arbios began a pivotal trial for its SEPET liver assist device. The company received an [...]
ACI's "Biotech Patents" conference will be held at the Royal Sonesta Hotel in Boston, September 15-16. According to ACI, this is the "ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today." The agenda includes several talks that look interesting: [...]
