Micromet Leads In Bispecific Antibodies, Watch For DARTs

Bispecific antibodies are another front in the race to modify therapeutic antibodies for increased efficacy. Unlike normal antibodies, bispecifics are able to recognize and bind two or even three different antigens. The modified antibodies have new attributes allowing them to perform functions inconceivable for standard antibodies. The pursuit of bispecific antibodies began at least two […]

GSK: What To Do With ViiV

Great story came out May 6 from Reuters, reporting that Morgan Stanley analysts recently told investors a ViiV IPO or spinoff could be beneficial for GSK and the Pfizer/GSK joint venture. ViiV was formed in 2009 to wrap together GSK and Pfizer’s HIV drug assets under the premise that a separate entity would allow for […]

Vertex is Overvalued

Don’t get me wrong here, I think Vertex’s telaprevir is an incredible development that will usher in a new era in HCV treatment. Current estimates of the HCV market are about $2.5 billion, with the number increasing 4-fold as new therapies enter the market- that’s potentially $10 billion, getting close to the $15 billion expected […]

Pharmasset Stock Triples- Have We Seen This Before?

Pharmasset stock has risen from $33 to $100 in the last six months on the back of impressive data for its lineup of HCV antiviral drug candidates. The company specializes in a class of compounds known as nucleoside polymerase inhibitors. Its most advanced compound, RG7128 is partnered with Roche. PSI-7977 and PSI-938 are its two […]

Incyte Or YM Biosciences, Which JAK To Choose?

Advances in treatment for myelofibrosis (MF) have come by leaps and bounds in the last few years since the discovery of the activating mutation JAK2V617F in myeloproliferative disorders including MF, polycythemia vera, and essential thrombocytopenia. Incyte’s JAK inhibitor, ruxolitinib (INCB018424), looks to be the first drug to reach approval for the disorder, but a slew […]

Lack Of New Antibiotics: How Severe Is The Problem?

An analysis from the British Medical Journal (BMJ) titled Stoking the antibiotics pipeline noted only 1.6 % of drugs in development by the world’s 15 largest pharmaceutical companies were antibiotics. The author blames this lack of investment on several things including current practice dictating that older generics are used as first line treatments while new […]

Sunesis Signs Deal, Improves Pipeline Prospects

South San Francisco based Sunesis announced a license agreement on April 5 with Millennium Pharmaceuticals to develop its pan-Raf kinase inhibitor. Under the terms of this deal, Sunesis received $4 million upfront and potentially $60 million in milestones as well as royalties. Millennium will pay for all costs of the Phase I trial, after which […]

Personalized Medicine Is Rapidly Progressing

An article cited by popular blogger Derek Lowe from Nature News, noted the genetic diversity of tumor cells. The scientists compared the genome sequences of tumors from 50 estrogen receptor positive patients from two clinical trials of aromatase inhibitors. Of these, 26 were estrogen-sensitive tumors while 24 were resistant. The data was crunched with supercomputers […]

Xenoport Drug Horizant approved

Today, the FDA approved Xenoport’s (NASDAQ:XNPT) and GlaxoSmithKline’s (NYSE:GSK) Horizant (gabapentin enacarbil) for the treatment of Restless Leg Syndrome (‘RLS’). EfficacyThe efficacy of Horizant in the treatment of patients with moderate-to-severe primary RLS was demonstrated in two 12-week clinical trials in adults. Recommended DoseThe recommended dosage of Horizant  is 600 mg once daily taken with food at about […]

Cubist and Optimer Holding Hands

After yesterday’s 13-0 FDA advisory committee vote of confidence in Optimer’s Clostridium difficile infection (CDI) drug, now known as Dificid (fidaxomicin), the company has moved quickly to secure a co-promotion agreement with antibiotics maker, Cubist. The agreement calls for joint sales of Dificid to physicians in hospitals, long-term care facilities and other healthcare institutions in […]

Be You Own VC

Venture capital investing has always belonged in the realm of an elite group of investors such as high net-worth individuals and large pension funds. VC is most commonly used to fund the development of early stage companies with novel technologies and require long holding periods. While the chance of failure for each individual project is […]

Optimer Receives Nod From FDA Panel

Today, the FDA’s independent expert panel voted unanimously 13-0 that Optimer’s drug, fidaxomicin, is safe and effective for the treatment of Clostridium difficile infection (CDI). The panel was split six for, six opposed, and one abstaining on the question of whether the drug was effective in lower the risk of recurrence. Given the strong backing […]

Cubist Settles Patent Lawsuit- Reader Questions

First off, Cubist has just settled with Teva over their patent litigation that will prevent Teva from entering the market until 2018. More details on that later. I got a some very good questions from a reader regarding Cubist and Cubicin so I thought I’d share them. There were quite a few, so I’m cherry […]

POZEN Gets Going With Licensing Deals, Positive Clinical Data

POZEN recently announced it had struck a licensing deal with Cilag GmbH, a division of Johnson & Johnson to develop and commercialize its migraine treatment, MT-400 in Brazil, Colombia, Ecuador and Peru. The company also reported positive data in a Phase I study titled Co-Rx of its combination aspirin/ immediate-release omeprazole tablet, PA32540 in conjunction […]

Cubist Has A Date With Teva

The date is fast approaching for Cubist’s face-off with Teva in its court battle over Teva’s Paragraph IV filing against Cubicin patents. A judge is set to hear their case in less than a month on April 25 unless the two parties settle beforehand. I’ve opined on multiple occasions that I do not believe Teva […]

Strategies and Outlook for Xenoport’s Upcoming FDA PDUFA Date

Within a week, Xenoport (NASDAQ:XNPT) and partner GlaxoSmithKline (NYSE:GSK) should receive feedback from the FDA regarding the NDA for Horizant, a gabapentin pro-drug for the treatment of Restless Leg Syndrome (‘RLS’). With several recent clinical trial failures, approval is paramount for Xenoport. Earlier this month, Xenoport announced that its ‘GERD’ product candidate, arbaclofen placarbil, was […]

Gilead Is On A Roll

It appears the tide is finally turning for Gilead Pharmaceuticals. After hitting a 52-week low of $31.76 in late August 2010, it has since rallied 30% to reach $41.30 on news of successful Phase III trials of its integrase inhibitor, though that is still well below the stock’s $48.44 high from March last year. Gilead […]