Exelixis- Why The Holdup?

Why so long to file an SPA (Special Protocol Assessment), investors wonder. An SPA in itself is not necessary, but sets up agreed upon protocols and endpoints of a pivotal trial that will be used to file for a new drug application (NDA). Having one in place may give the trial sponsor more confidence while […]

On Eli Lilly And Innovation

Eli Lilly CEO John Lechleiter is calling for U.S. immigration officials to issue more green cards, saying a shortage of highly skilled immigrants is stifling innovation in the pharmaceutical industry. (Bloomberg) Really? Last I heard the industry has been on a firing binge, cutting back on R&D while outsourcing a multitude of functions to CROs. […]

AstraZeneca- How Much Longer Can It Go On?

A great article in the Wall Street Journal by Hester Plumridge AstraZeneca’s Too-Concentrated Solution talks about the company’s sale today of its medical devices unit AstraTech to Dentsply International. With the sale, AstraZeneca is focusing its resources the core prescription drugs business. This doesn’t sound like a good plan considering AstraZeneca doesn’t exactly have the […]

Opioid Pain Drug by Pfizer and Acura approved by FDA

The FDA has granted approval for an abuse-resistant opioid formulation made by Acura Pharmaceuticals (NASDAQ:ACUR) and Pfizer (NYSE:PFE).  The drug is a reformulation of immediate release oxycodone.  The trade name of the drug will be OXECTA, it was previously known as ACUROX.  Pfizer’s media relations said that they can provide more information once the press […]

Exelixis May Have Competition For Its Prostate Cancer Drug

Bone metastases is a painful condition that occurs in about 90% of advanced prostate cancer patients and is associated with shorter overall survival. In the last few years, many advances have been made in the treatment of prostate cancer, with several new drugs approved and more on the horizon. Approved drugs include Provenge, Jevtana, Zytiga, […]

YM Biosciences Continues Post-ASCO Fall

YM Biosciences has taken it on the chin after its ASCO presentation failed to impress investors. Its stock is now down about 21% from a high of $3.78. The company has several projects but practically all its value is placed on lead JAK inhibitor CYT387, in development for the treatment of the blood cancer Myelofibrosis. […]

Pharmasset’s Backdoor Entrance Into The HCV Market

Another day, another upgrade. Today, it’s Citi increasing its target from $71 to $200. It would seem all the analyst must rely on the same numbers. The thesis here is Pharmasset’s lead wholly owned compound, PSI-7977, could get on the market as early as 2014 and the company could become profitable by 2016. Those are […]

Pharmasset Price Targets at $200 and $175

Last Tuesday, JPMorgan raised the target price for Pharmasset stock from $100 to a whopping $200. Brean Murray followed that up today by initiating with a $175 target. That is quite an increase from today’s closing price of $100.87 and 52-week high of $110.58. The company already sports a market cap of some $3.75 billion. […]

Good News For Pfizer Oral RA Drug

Pfizer announced results from two clinical trials of its JAK inhibitor, tofacitinib for rheumatoid arthritis at the European League Against Rheumatism (EULAR) in London on Wednesday. One study, a Phase III trial called ORAL Sync compared tofacitinib plus methotrexate to methotrexate alone in 792 patients with moderate to sever active RA who had an inadequate […]

Oncogenex Jumps In Anticipation To ASCO

Oncogenex stock has been range-bound for over half a year but finally found some life today, jumping 18%. The company will be preventing three posters together with Teva June 4-6 at ASCO around its lead anti-cancer drug Custirsen. Custirsen has shown in Phase II trials the ability to extend survival and reduce pain in prostate […]

Rumors, Rumors

It would appear Cubist has its choice of partners. Ever since it settled its patent dispute over its antibiotic, Cubicin, with Teva early last month, the company seems to have been put in play. Under terms of the settlement, Teva will not launch a generic until at least 2017, and even then, will buy the […]

Sanofi Ditches New R&D Model For Newer Model

When Eias Zerhouni, head of Sanofi’s R&D arrived at the company, he set about changing the company’s large pharma research model to a more “biotech” like one in an attempt to be more creative and nimble. However, Eias has just realized that discovering drugs is more difficult than he had originally thought. No worries- there […]

Most Innovative Pharmaceutical Companies

From 2006 through 2010, 112 new drugs were approved by the FDA at an average rate of 22.4 approvals per year; there wasn’t much variance- 23 in 2006, 19 in 2007, 23 in 2008, 26 in 2009, and 21 in 2010. (In fact, an average of 23 new molecular entities (NMEs) per year were approved […]

Neurogesx and Depomed seek to persuade pain specialists

I attended a recent medical conference where pain specialists outlined the history and direction of the pain industry, covering both nociceptive and neuropathic pain.   After the conference, I had a chance to talk one-on-one with several pain specialists.  I asked for their input on the industry and several products that I found particularly promising. […]

Pfizer moves forward with Pristiq for Hot Flashes

Last week, Pfizer (NYSE:PFE) announced that they had presented results from sub-study of Pristiq (desvenlafaxine) at the 59th annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG). The results were from a large, phase 3 trial, that sought to elaborate the safety and efficacy of Pristiq for the use in hot flashes […]

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 […]