Biovision

Crowley Decides Against Senate Run

2008-04-06T12:54:00.003-04:00

Asbury Park Press is indicating the John Crowley, CEO of Amicus Therapeutics and an ex BMSer has decided not to run for the Senate seat. There were rumors earlier that John might be getting ready for a Senate race on a Republican ticket. But looks like the political career is a bit far off for John.

Drug industry layoffs

2007-08-06T05:27:00.000-04:00

Since Pfizer's last quarterly investor teleconference, a steady trickle of news-releases from large pharma companies has hinted that the second half of 2008 will be a tough one for a lot of pharmaceutical industry employees. JnJ, BMS, AZ, SP, all have announced plans for workforce reduction.Pfizer, the world's biggest drug company, is eliminating 10,000 jobs, 10 percent of its work force. Merck

Axtinib Phase II Study Shows Promise in Pancreatic Cancer

2007-07-04T19:34:00.000-04:00

Pfizer's multi kinase VEGFR inhibitor axitinib has shown interesting results in Phase II study in Pancreatic cancer. Interim results from a Phase II trial: axitinib + Gemzar median OS 6.9 months vs 5.6 months for single-agent Gemzar - a 26% reduction in the risk of death. In a subset of 94 patients with a good performance status, the combination reduced the risk of death by 33% Word on the

Gardisil has a competitor

2007-07-04T19:19:00.000-04:00

In an article published in journal Lancet, Glaxo Smith-Kline announced that their HPV vaccine Cervarix has completed the pivotal clinical trials, and it is highly effective against HPV, and cervical cancer. The researchers concluded that Cervarix appears highly effective in preventing HPV and ultimately cervical cancer among women aged 15 to 25 years. Only future trials will determine the

RON receptor involved in Pancreatic Cancer

2007-07-02T00:38:00.000-04:00

Recepteur d’Origine Nantais, or RON receptor tyrosine kinase and its ligand, macrophage-stimulating protein, have been long implicated in progression and metastasis of tumors including breast cancer. Now comes a study from the scientists Andrew Lowy, MD, and Susan Waltz, PhD, at University of Cincinnati that implicates involvement of RON in aggressive pancreatic tumors. From their press

Sunitinib to be tested in first line mCRC

2007-07-01T23:23:00.001-04:00

Pfizer is moving into metastatic Colorectal cancer with the announcement of a multinational Phase III study with sunitinib malate, Sutent. The study will enrol 700 patients in South America, Canada, Europe and Asia. Conducting a first line study would be a herculean task in the United States as the first line is pretty much the domain of Avastin based therapy.Penetration in first-line use is

Temsirolimus bring new hope to renal cancer patients

2007-06-01T09:36:00.000-04:00

Temsirolimus is a new drug from Wyeth which brings new hope for patients with the most agressive form of Renal cell cancer. Temsirolimus was originally slated for approval in march/april 2007, but FDA requested additional information to ascertain whether the drug indeed had an impact on tumor growth. From yesterday's action it appears that FDA is satisfied that the drug will help patients.

Chinese Cancer Market Opportunity

2006-12-13T18:39:00.000-05:00

China is often touted as a great market for consumer goods. However there exists a great market in China for pharmaceutical and bio-technology products as well. A study recently released by the Ministry of Health provides an indication of the scope of opportunity.As an example, compared to the 5 year survival rate of 60-70% in western Europe and United states, in China, the 5 year survival

New tools for help with Cancer treatment choice

2006-12-12T23:26:00.000-05:00

Chicago Tribune has a nice article on new tools that have been developed by doctors to help the patients make choices about the drugs they should be choosing.Click here for the articleThat we should have the problem of helping patients choose the drugs shows just how far we have come in the last few years in terms of treatments for cancer.The two tools being discussed are "Adjuvant! Online",

Merck's Januvia Approved For Type II Diabetes

2006-10-19T20:49:00.000-04:00

Diabetes is an insidious disease that affects over 20 million in the US and 200 million world wide. The epidemic of diabetes seems to be growing rapidly around the world and doesn't seem to be abating at all. Primary contributors of increase in diabetes around the world is the influence of western food habits and sedentary lifestyle. With globalization of the economy, this cultural change is

Sutent, Active in GIST

2006-10-14T16:31:00.000-04:00

Sutent seems to be active against GIST. Results of a Phase III study published in Lancet this week seemed to indicate that in Gleevec failed patients, treatment with sunitinib increased meadian time to progression from 6 weeks to 27 weeks. This is of course a good news for the GIST patients who are failing Gleevec because there is nothing available for them right now. Gleevec itself works in

Genentech Doldrums

2006-10-13T13:40:00.000-04:00

One would think that with Avastin recieving NSCLC indication, Genentech stock would be on an uptick. The FDA has approved the use of Avastin for lung cancer combination treatment with carboplatin and paclitaxel chemotherapy for first line treatment. Avastin is now approved for the most common lung cancer - locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC)

Changes Changes Changes at Imclone

2006-10-11T10:37:00.000-04:00

So, Imclone announced the resignation of its Chairman Kies and board member William W. A company regulatory filing said their decisions weren't the result of any disagreements with ImClone over operations, policies or practices.Yeah right! The market thinks otherwise, and its betting that Imclone will be sold for a price far higher than the $35 or 36 that Kies agreed to sell out for. Well, when

Glaxo Files Tykerb in Europe

2006-10-09T22:34:00.000-04:00

Just a month after filing the NDA for Tykerb in US, Glaxo has filed for its approval in Europe. Tykerb or lapatinib, a small molecule HER2 inhibitor, has been studied in breast cancer in patients who failed Herceptin treatment. In patients who failed Herceptin treatment, Tykerb, incombination with Xeloda was found to double to Time to Progression. This from the Glaxo press release.......Phase

Merck Gets Zolinza Approved. Proof of Principle for HDACs

2006-10-09T22:08:00.000-04:00

Well, what do you say about this...the big bad pharma industry is backswinging. Merck, the venerable big Pharma that got itself into hotwaters over Vioxx, is back in the game. This time the drug is Zolinzaor vorinostat, which was approved by the FDA today for treatment ofCutaneous T cell Lymphoma. Zolinza is a HDAC inhibitor which islikely to find use in a broad array of tumors.While this is a

Mello and Fire Discovery Fires Up Nobel Committe

2006-10-02T14:37:00.000-04:00

Drs. Craig Mello and Andrew Fire of U Mass, and Stanford respectively, have won the 2006 Nobel Prize for medicine. The duo wins the Nobel for their discovery of RNAi, which is implicated in turning genes on and off. RNAi or interference due to bits of RNA is a relatively new discovery. Mello and Fire, working with C. elegans model, discovered that unlike the conventional belief (that RNA

Abgenix Deal Paysoff For Amgen

2006-09-28T21:53:00.000-04:00

At the turn of the year, Amgen agreed to pay $2.2B for Abgenix and already the first signs are that the deal will be fruitful to Amgen. Yesterday the FDA granted approval for Vectibix (panitumumab) for treatment of Colorectal cancer. The other drug on which Amgen and Abgenix were collaborating is densomumab, a drug for treatment of bone mets - a very painful spread of cancer to the bones.

Avastin related risk of RPLS and nasal septum perforation

2006-09-26T12:54:00.000-04:00

Genentech & Avastin can't seem to catch a break! First the FDA asked Genentech to generate more data on MBC, and now this.

Genentech and FDA notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to inform healthcare professionals of 1] cases of a rare brain-capillary leak syndrome [reversible posterior

British Colorectal Cancer Patients May be Denied Access To Avastin and Erbitux

2006-08-28T11:03:00.000-04:00

The UK health authorities need to make up their mind. Either they will let the UK patients have technologically cutting edge medicine or they will not.Just this week, there were two news reports that sent mixed signals. In one news report NICE, the watchdog agency that decides whether Brits can have access to cutting edge, but expensive medicine or not, has decided in favor or paying for

Strange Bedfellows OSI & Genentech

2006-08-11T17:46:00.000-04:00

Biotech makes for strange bed fellows! Take for instance OSI pharmaceuticals and Genentech. On one hand Colin Goddard worked hard to cultivate the relationship with Genentech CEO Arthur Levinson so that the Big Biotech would invest in OSI drug Tarceva (and therefore give it the much needed cache), and on the other hand Genentech has caused the company to take a hefty $310M charge.Of course Mr.

Amazing, this drug Lucentis - A VEGF inhibitor

2006-08-08T07:46:00.000-04:00

A while back I used to work in the area of Macular degeneration. Macular degeneration is an insidious disorder in which people start loosing their sight from the center to the periphery. Until recently there wasn't much available in terms of treatments, and the treatments available would basically stem the growth of the disease and nothing more. But today there is hope for people suffering

Nexavar Approved For Kidney Cancer

2005-12-21T17:56:00.000-05:00

Nexavar : Sorafenib tosylateApproval on: December 20, 2005Manufacturer: Bayer & Onyx PharmaceuticalsIndication: Advanced renal cell carcinoma (Cancer of the kidneys)Benefit: Progression free survival of six months vs 3 mths on BSC. (patients live for 6 months without the disease progressing any further compared to 3 months on placebo).39% improvement in survival (39% people lived longer

Merck: Don't Write An Obituary Yet

2005-08-21T21:20:00.000-04:00

Within minutes of the jury announcing a crushing $253 million verdict against Merck, the wallstreet reacted with a precipitous 8% decline in Merck's stock price. Today the stock price declined another 2% and is now hovering around $28. Its an emotional reaction as any can be. Sure this was the first trial and the world was watching to see if Merck would win or loose. But loose one trial does

Is Bristol Out of The Woods??

2005-05-09T21:42:00.000-04:00

Good question. The fact that Bristol-Myers Squibb took a major hit in the last quarters earnings, to increase its reserve for legal costs by $110 million, would suggest that the execs are getting prepared for something or the other. Of course I am not the only one to think this way, others do to. There are several analysts quoted in Business Week who seem to believe that Bristol might be

Requip Approved For Restless Leg Syndrome

2005-05-07T11:41:00.000-04:00

Glaxo SmithKline announced that its drug Requip (r) ropinirole HCL, has received FDA approval for Restless Drug Syndrome (RLS). Requip (r) is the first and only drug approved for moderate to severe RLS. Requip (r) is a dopamine agonist that stimulates the dopamine receptors in the brain. It is theorized that RLS is caused when the dopamine, which carries the signals between the nerves in the

New CEO for Merck

2005-05-06T16:29:00.000-04:00

Merck has a new CEO, and no, its not the Hollywood/TV celebrity Dick Clark, but another Dick Clark who rose through the ranks, and comes from the Manufacturing ranks. Challenges abound for the new CEO, not the least of which is, what is Merck's strategy to get out of this mess created by Vioxx, and the pipeline funk that looks like won't be delivering anything for the forseeable future. Forbes

Byetta Approved But Amylin Swoons

2005-04-29T16:55:00.000-04:00

Amylin received approval for its new diabetes drug yesterday, and the company was exstatic about it. But the market didn't respond with the same level ofexhuberence. Amylin shares were down today 6.6% due to the talk that the drug may have toxicities that might limit its use in broader population. That may or may not be true. Byetta has demonstrated activity in patients who are not controlled

2005-03-30T21:41:00.000-05:00

A Think Week For Me!Just yesterday I read an article about the Bill Gates "think week" in the "Wall Street Journal". If you don't know what I am talking about, here is the story. Apparently, Bill Gates, each year, twice a year, sets aside one week to do nothing but read up on interesting ideas, papers, concepts put together by Microsoft employees from around the world and think about them. Any

2005-03-20T19:52:00.000-05:00

Bristol Myers Does The Right Thing! Bristol-Myers Squibb company had a good week, with its Hepatitis B drug, Baraclude being given a thumbs up by the FDA advisory committee in United States. Granted, Hepatitis B is not a huge market in United States, and the monetary rewards for the company are rather limited, but this drug could be very important for the Asian countires. In fact, Baraclude is

2003-07-02T13:18:00.000-04:00

Medicare Reform Bill – Why is it such a big deal? The new Medicare Reform Bill in the conference committee will be a big help – to both the patients and to the pharmaceutical industry. To see how beneficial it will be to the industry, lets take a look at the Insurance coverage of Rxs in United States. Medicare is a federally funded health insurance program that covers folks over the age of 65,

2003-06-20T12:31:00.000-04:00

An article in Wall Street Journal put the price tag on rep-based pharmaceutical promotion at $12 billion. $12 BILLION! Why do the companies spend this kind of money? Well, the answer is, competition. Companies, inorder to maintain the sales growth trajectory plotted for wall street, need to make sure that their message gets through to the physicians. So, in early 90s, when the wave of

2003-06-10T09:05:00.000-04:00

According to a report out by PHARMA, Diabetes is the next big health challenge to confront the nation. [Diabetes Report] There are an estimated 17 million diabetics already, and 1 million new diagnosed each year. By 2050, the diabetes population will have grown 165%! Clearly, the challenge is huge, but so also is the opportunity to do something about it. Already, the spending on diabetes

2003-06-10T00:29:00.000-04:00

Amyln announced that Ginger Graham, who was on its board of directors for seven years, will become the new CEO of the company. Amylin has a strong connection with Lilly; most of its upper management has been with Lilly at some point or the other for a long time. Ginger Graham is no exception. Ginger started with her career Lilly, and rose through the ranks in variety of functions to become the

2003-06-09T09:22:00.000-04:00

This is a new thing for me. I have opinions about a lot of things about the pharmaceuticals, biotechnology industry, but haven't really shared them with any one yet. So, in future, this will become my sounding board for ideas and I hope you will join me in contributing to this blog.