A new class of drugs targeting the JAK kinases is set to challenge today’s biggest selling biologics for the treatment of arthritis and other inflammatory diseases. Heading this class is Pfizer’s tofacitinib; this potent, but relatively un-selective JAK inhibitor demonstrated positive results in five pivotal trials earlier this year. Pfizer intends on filing for marketing […]
Antibody Engineering Wars
Therapeutic antibodies have been in use for decades now, becoming a mainstay for the treatment of cancer and inflammatory diseases. The molecules have evolved quickly through scientific advancements from simple mouse antibodies to complex humanized antibody-drug conjugates. Rapid growth in this category has grabbed Big Pharma’s attention, shifting its focus away from traditional small molecule […]
Borrowing Ideas In Drug Development
In the world of small molecule drug development, companies often talk about their large compound screening libraries or special chemistry platforms. You know the story: large numbers of compounds are tested against a target to generate hits, subsequent testing and manipulation narrow down the hits to a small number of leads. Finally, after passing many […]
Celsion- Approval Seems Likely
Celsion is working on a cancer therapy called ThermoDox, a heat sensitive liposomal doxorubicin formulation. The technology was developed as a way to target drug delivery to the tumor. Liposomes were designed to be stable at normal body temperatures but mild hyperthermia (increasing body temperature) in the range of 41 to 42°C would trigger the […]
YMI- Is It Investment Grade?
After taking a post-ASCO fall and sinking below $2.50, YM Biosciences is back near $3.00 with a couple assists from biotech columnist Adam Feuerstein, first naming it a top 10 pick for stocks under $300 million then in a separate article called it the best of the ten. Like many biotechs, YMI’s fortunes are tied […]
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 […]
Cubist Unlikely To Acquire An Antibiotics Company
Now that Cubist has Teva off its back, its stock has risen from the low 20s to the mid 30s. It is often suggested as a takeover candidate, but with a large cash horde and a history of M&A activity, Cubist is just as likely to be the acquiring company. With a market cap of […]
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 […]
Dual-Targeted Kinase Inhibitors: The Next Wave In Cancer Treatments
Cancer drug developers have long waffled between the virtues of potent, highly specific inhibitors versus messier ones like Sutent; but there may be a middle ground. Today, multiple small molecules targeting receptor tyrosine kinases VEGF, EGFR, and HER2 have been approved along with a bunch of non-selective kinase inhibitors. The only successfully targeted non-receptor kinase […]
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 […]
Platform and Specialty Pharmaceutical Companies can bolster Big Pharma
The pharmaceutical industry is in a weak state, with an impending “patent cliff” that is forcing Big Pharma to reorganize and refocus. In 2011, roughly $20 billion in branded US sales dollars are “at risk” to patent expiry and generic competition. The pinnacle will be reached in 2013 and will subside after 2015. Fiscal Year […]
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 […]
