The Big Red Biotech Blog

Merck Shutters RNAi Center in San Francisco

Merck announced the closing of the RNAi research center it obtained in its acquisition of Sirna Therapeutics five years ago.  The company still plans to utilize the RNAi technology throughout its global R&D operation according to a company spokesman.

Merck’s acquisition of Sirna raised eyebrows across the industry from the beginning, because of the high price tag ($1.1 billion), and the early-stage nature of RNAi technology. This technology has intrigued scientists for several years, because it offers the potential of hitting biological targets of disease that are currently inaccessible by conventional small-molecules or larger biotech drugs.

Merck hasn’t pointed to any RNAi-based drugs that have emerged in its pipeline, and it has publicly emphasized the challenge it has faced finding ways to effectively deliver these drugs in the body.  There are no such RNAi-based drugs approved yet by the FDA for sale in the U.S. (or elsewhere).  Roche earlier this year also pulled the plug on its RNAi program.  See Xconomy.

Posted by Bruce Lehr July 29th 2011.

 

Wall Street Says Hep Hep Hooray for Vertex's Incivek

Vertex exceeded all Wall Street projections for sales of its new anti-hepatitis C agent Incivek when it reported revenues of $74.5 million.  This was more than double the consensus estimates of $31 million and were achieved in a period of only 6 weeks post-market approval. WOW!

Incivek has shown in clinical trials that when it is added to a couple standard treatments, it can double the cure rate to about 80 percent of patients, while cutting the course of treatment in half, to about six months.  Many patients are lining up to get treatment for the first time for this chronic liver damaging disease, since the cure rate is so much higher, and the Vertex drug enables patients to shorten the time they must endure the flu-like side effects of the standard drugs.  See Xconomy.

See what can happen if you deliver a novel therapeutic for an unmet need that really delivers the goods in the clinic?  Patients like it.  Payers like it.  Wall Street and investors like it. 

 

 

 Posted by Bruce Lehr July 29th 2011.

Pharma R&D Spending May Be Down But Amgen's Is Up 26%!

Many of my posts today have been about pharma and biotech firms cutting back on their R&D expenditures as a way of changing the way they do business and managing profitability in the wake of flagging pipelines. What if your pipeline is in healthier condition?  What then?

Well Amgen's answer is increase spending by 26%.  Why?  It now has 10 programs in phase III development and the big biotech is pushing to get them to market. Key targets include the cancer drug ganitumab and AMG 386, according to their website. 

Of course, strong top line sales growth didn't hurt at all -- with Prolia and Xgeva (both denosumab) growng strong, joined by increased sales of Neulasta, Neupogen and Enbrel -- overall sales were up 4.1% to 3.96 billion for the quarter. See LA Times and Fierce Biotech. 

 

Posted by Bruce Lehr July 29th 2011.

Court Rules on AMP vs USPTO (i.e. Myriad) Case

The Federal Court has spoken on AMP vs USPTO.

In an extensive and thorough opinion by Judge Lourie, the Court affirmed the District Court's decision on standing, reversed the decision regarding isolated DNA claims (i.e. allows patenting of isolated DNA sequences), and affirmed the decision of unpatentability for method claims reciting merely "comparison" steps, on the grounds that these claims failed the machine or transformation test from Bilski.

Judge Moore wrote a separate concurring opinion, explaining her decision to join Judge Lourie (with regard to the isolated genomic DNA claims) on the grounds that, at this late date it is up to Congress, not the courts, to extend the "laws of nature" exception to isolated DNA.

From my reading of the various legal opinions on this case, this is the result that has been expected since the very moment Judge Sweet made his original ruling in the case. See the Patent Docs blog.

Posed by Bruce Lehr July 29th 2011.

Comments on "improved" NDA Approvals in 2011

The Life Sci VC blog takes a closer look at the improved rate of 2011 approvals of NDAs by the FDA.  A couple weeks ago, many commentators -- and including FDA's Janet Woodcock -- ballyhooed the improvement in NDA approval rates and wondered aloud if this signalled big pharma R&D turning the corner toward more success in development of new drugs -- especially given some changes in R&D models over the past years.

Bruce Booth took a bit more somber (and realistic) approach to the data.  He noted two facts that should be considered before one declares unconditional victory in revamping the big pharma R&D machine.  Firstly, Booth notes that the majority of new NDAs were not sponsored by the originating organization and only 7 of 18 came from big pharma.  Thus, most did not originate the sponsors R&D group but rather in its BD group.  The jury must remain out on the value of any new R&D structures or models that have been implemented in the past five years as this data really doesn't speak to those changes.

Secondly, Booth noted that most of the newly improved drugs have been in development a long long long time -- since the 1990's -- and again appear to be from legacy R&D efforts rather than from any new fangled permutation that has arisen since then.  So again, any new changes in R&D will have to await their day in court to assess whether they are more effective than "the old ways". 

Finally, Booth concludes, it is great to celebrate the increased rate of NDA approvals but it is too early to attribute it to changes in R&D models.  One can also conclude that business development activity is very important in the mix of bringing new drugs to market.  And, one cannot forget that the time to market is a very long and complex journey making it damn difficult to assess the effectiveness of   changes to the R&D model in the short-term.

Posted by Bruce Lehr July 29th 2011.  

Stem Cell Suit Over -- For Now

The U.S. District Court for the District of Columbia Chief Judge Royce Lamberth agreed with the with the appeals court’s finding that NIH can interpret Dickey-Wicker to allow funding for research on human embryonic stem cells but not on their derivation because the definition of “research” in the law is ambiguous.

So for now, the suit contesting NIH funding of embryonic stem cell research is out.

PharmTech Talk » Stem Cell Suit Tossed.

Stem cell researchers, their supporters in and out of the science community, and patient advocacy groups are all letting out a sigh of relief. Stephanie Sutter, Assistant to the President and Deputy Senior Advisor, posted yesterday in her blog “For too long, patients and families have suffered from debilitating, incurable diseases and we know that stem cell research offers hope to millions of Americans across the country. President Obama is committed to supporting responsible stem cell research and today’s ruling was another step in the right direction.”

This does not prevent another appeal by plaintiffs.  Ain't the legal system grand?  We may not have heard the end of this for awhile.  Of course, if we do not pass a Federal budget, the NIH may not be funding anything.

Posted by Bruce Lehr July 29th 2011.

Andrew Says Shakeout Coming for Pharma Industry

GSK CEO Andrew Witty, never at a loss for words, says that the R&D cutbacks and fall in R&D spending signal a fallout in the industry over the next several years. He says it's his belief that 5 to 7 years from today, you'll see a significant number of companies retreat from the pharmaceutical space, one way or another and only a few hardy ones will survive.

"There is tremendous opportunity for the few companies who solve the R&D equation," Witty told reporters. "It's the companies who deliver multiple new products, not one or two, that address material clinical needs of patients and address the economic needs of the payers--so they are fairly priced, if I can put it that way." 

Witty is determined that GSK will be one of the winners.  He's banking on a clinical pipeline that GSK expects by the end of 2012 will deliver more than 30 Phase III read-outs on 14 of its 15 late-stage assets -- and that the majority will be successful. As that happens, Witty is predicting that the shakeout will begin taking root. See Fierce Biotech.

I have no doubt there will continue to be consolidation among the players, and as penned here before that big pharma, biotech, small and large molecule, generic and innovator, biosimiar and biobetters will begin to blend within the same companies.  The business will continue to become more global and international.  But I don't think it will coalesce to the point where the number of players will be that dramatically reduced only 5 to 7 years from now.

Posted by Bruce Lehr July 29th 2011.

Biotech's Join R&D Cutback Parade -- Increase Cash On-hand

BDO conducted a new analysis of R&D spending in the biotech industry -- reported in Fierce Biotech and Pharmalot. The results (based on 10K filings of 86 public companies) showed that biotech R&D spending was down 7% in 2010.  A drop in spending mirrored the 3% drop seen with 12 big pharma companies in 2010.

Overall, 70 percent of revenues were spent on R&D expenses in 2010, down from 84 percent in 2009 and 117 percent in 2008. Average R&D expense as a percentage of revenue was 108 percent for smaller companies (< $50 M), compared to 206 percent last year and 353 percent in 2008. For larger biotechs (>$50 M), the average R&D expense as a percentage of revenue was 54 percent; in 2009, this was 55 percent.

The biotech companies "are cutting programs," says Aftab Jamil, a partner and national director of the technology and life sciences practice at BDO, "focusing on what they believe are the best drug candidates with a higher level of probability for commercialization."

Meanwhile, 51 percent of smaller biotechs last year were able to raise an average of $64 million in equity financing, which BDO describes as “a promising rebound” to levels last seen before the recent economic crisis. In 2007, for instance, 61 percent of smaller biotechs raised financing and the average value was also $64 million.

The average biotech had $142 million in cash and short-term investments in 2010, a 3 percent decrease from 2009, although larger companies reported a 10 percent decline. Smaller biotechs reported a 6 percent increase, thanks to R&D cutbacks.  Overall, BDO found cash reserves were equivalent to approximately 2.64 years of R&D spending in 2010, up a little from 2.54 years in 2009.

As a group the 86 public biotechs in BDO's basket spent only a fraction of the multibillion-dollar R&D budgets you'd find at a Big Pharma company. But Jamil notes that the companies that can fill a particular gap in any pharma company's pipeline are well positioned to profit from the partnering trend now in full swing. And that bodes well for the future of the business.

It looks like discipline is coming to the biotech world too.  Companies are being forced to be more judicious with which programs they back -- particularly with regard to allocation of R&D expenses.  If they can successfully develop their products, they should be able to profit with all the Big Pharma companies swarming to increase their pipelines through acquisition, licensing or partnering. 

Posted by Bruce Lehr July 29th 2011.

Bydureon Goes to the Heart of the Matter

If at first Bydureon don't succeed, then try try again.  Well, the last time Amylin, Alkermes and Lilly submitted their package to the FDA to gain approval for Bydureon -- as a oonce-weekly version of Byetta -- it was not accepted.  The FDA wanted more studies to determine whether the drug caused heart problems.

The companies announced recently that a new study failed to find an issue with heart rhythms.  Now they plan to resubmit their application (for the third time!) to gain the agency's approval.  Here's betting that a third time will be a charm. See Fierce Biotech.

Posted by Bruce Lehr July 29th 2011.

BMS Strings Some More Pearls

BMS added to its holdings this week when it announced the purchase of Amira Pharmaceuticals for $325 M upfront with milestones that could total another $150 M.  The key to the deal was BMS acquisition of new drugs (namely AM152 an LPA1 antagonist) for pulmonay fibrosis. A new thearpeutic area with no approved FDA treatments.

"As part of the continued execution of our focused biopharma strategy, BMS has identified fibrotic diseases as an area of high unmet medical need that complements our research efforts in several of our therapeutic areas," said Elliott Sigal, the company's president of R&D.

Thus, BMS remains true to its "string of pearls" acquisition strategy for enhancing its portfolio and patients should benefit by the pursuit of a treatment in a novel therapeutic area -- which is good to see.  See Fierce Biotech.

Posted by Bruce Lehr July 28th 2011.

Pipelines Emptying, Costs Rising, What's Big Pharma To Do?

From the Pharmalot blog yesterday, Big Pharma is facing the dual problem of emptying pipelines and rising costs for developing new drugs - largely from increasing costs of doing trials. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey of 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations.

Those surveyed pointed to higher costs for enrolling patients, higher vendor fees and expenses for recruiting trial sites, and technology costs.   Staffing for drug development is also rising.  Phase IV staffing increased by 85 percent from 2008 to 2011, while Phase IIIa doubled. Phase IIIb staffing rose 57 percent, Phase II staffing jumped 106 percent and Phase I staffing spiked 108 percent. 

Average per-patient trial costs across all therapeutic areas, in Phase I, costs rose from $15,023 in 2008 to $21,883 in 2011. In Phase II, the cost rose from $21,009 to $36,070. In Phase IIIa, the cost increased from $25,280 to $47,523 and in Phase IIIb, cost jumped from $25,707 to $47,095. Finally, Phase IV expenses rose from $13,011 to $17.042.

“Everybody is working hard to control those costs. The biggest thing on the horizon is trying to get a handle on earlier go-no-go decisions,” Cutting Edge chief operating officer Adam Bianchi tells us. “The competition for quality sites is creating a lot of headaches. You have a greater number of sites worldwide than ever before, but not all are yielding quality data that companies want.

So we not only can't find enough new drugs, but we are also having trouble finding quality sites to cost-effectively test them.  More cheery news from the drug development front.

Posted by Bruce Lehr July 28th 2011.

 

Convergence of Biosimilar and Big Pharma Competitors is Natural Order

The WSJ Health blog published this commentary noting that increasingly Big Pharma and Biosimilars (formerly generics only) are competing more head to head.  Big Pharma is crossing more into biosimilar territory as they lose drugs to the patent cliff and try to claim some of the resulting biosimilar or generic revenue as their own.  Generic/biosimilar competitors are increasing partnering with or buying companies that produce novel therapeutics as a means of expanding their offering and protecting themself from generic competition. 

I'm not sure what the surprise is here.  As the world competition becomes more global and the industry consolidates through mergers -- I think it is natural that these companies with start converging in a similar space.  As I've posted here many times, I think a significant number of competitors will be selling innovative drugs, generics and biosimilars -- alone and in partnerships and there will soon be little distinction among the majority of the biggest players. 

This seems to me to be merely the result of a natural evolution of a competitive market.  Let the best men and women win. Soon you won't be able to tell the players without a score card.

Posted by Bruce Lehr July 26th 2011.

Pfizer on a Mission to Grow Pipeline

Pfizer continues to search for ways to bolster its pipeline outside its own investment in internal R&D resources.  In this case, the company has decided to invest $100 M over 5 years in a research collaboration with the University of California at San Francisco's Mission Bay campus.

The deal is part of Pfizer's strategy to invest in existing biotech R&D clusters and is similar to a deal Pfizer did previously at the Center for Therapeutic Innovation in Boston. Investing in clusters has become a trendy device amongst several members of big pharma (Sanofi, Lilly, Bayer, etc).  Given Pfizer's recent history in R&D investment over the past several years -- Pfizer investors probably hope that this isn't just another cluster.  See Fierce Biotech.

 

 

Posted by Bruce Lehr July 26th 2011.

Will biosimilars really have an impact on capacity?

Here's an interesting point of view from The Bioprocess Blog where they weigh in on the question of whether or not biosimilars will have any impact on the worldwide need for biological manufacturing capacity.  Short version: they conclude they will not have a significant impact.

Will biosimilars really have an impact on capacity?.

I don't really agree with their reasoning. I think when yo ufocus on the current pipeline and use it as a surrogate for what will happen you aren't properly viewing success rates.  In the current pipeline you end up with lots of failures from the novel drug candidates.  But with biosimilars, you should see much higher success rates in development as the targets are proven. 

Secondly, the authors focus on the impact of biosimilars that have hit Europe to date -- mainly molecules like EPO and hgh.  I think this neglects all the mAbs that we should be seeing soon and I think those will have a higher impact on manufacturing needs. 

Thirdly, the discussion seems to be centered on what is happening (or not) in Europe and the US.  The post was ostensibly about "worldwide biological manufacturing" capacity.  If so, there should be much more attention paid to what will happen as biosimilars start coming on line in China, India, Korea, etc.  I don't think the EU model will be a very good surrogate for what will happen in those local markets when local producers start bringing their drugs to market. 

So I respectfully disagree with the authors conclusions. I think the new players in the new economies will have a much bigger impact and represent a much larger opportunity.

Posted by Bruce Lehr July 26th 2011.

 

Merck's Frazier Says He Will Spend on R&D

Merck's CEO Ken Frazier said that he will continue to spend on R&D to create new drugs regardless of the various investor and analyst calls for him to cut back. He says "science and innovation" are in his company's DNA. 

"I'm trying to run the company in a way that I can satisfy the short- and intermediate-term needs of investors without sacrificing really what we're about,"  said Frazier.

I'm glad to see it.  I think it is the right call and is courageous to do.  The pharma industry does depend on innovation and discovery.  While it may be fine to redeploy some R&D spending into various new models (e.g. hubs, partnerships, biotech acquisitions, academic collaborations) rather than sticking to only in-house groups, it is a mistake to make drastic cuts for the short-term pleasure of shareholders at the expense of long-term company health. 

 

Posted by Bruce Lehr July 19th 2011.

We Want More Biotech Execs on Pharma Boards!

I thought this was a great post by Bruce Booth of the Life Sci VC blog (or maybe I just like his first name). In it, he analyzes the make-up of the Board of Directors (BOD) of the top 12 Big Pharma Companies.  To his (and surely my) surprise, he finds that only 3 BOD members out of 182 are from the biotech industry.  While he freely acknowledges that not all BOD members should be from biotech -- don't you think more you'd find more than 3?  Especially when the industry is chanting as one that they want to become more biotech-like, especially in regard to how they approach R&D?  

Bruce recommends that shareholders and activist investors in these companies really should be pushing their BOD to alter their make-up to give more seats to former biotech execs who can help formulate the strategy of becoming more "biotech-like" with the obvious benefit of having been in the game before.  Strong members with positive and negative experiences can't but help to improve decision making for these companies. It seems like a no-brainer and one that is quite past due.

 

Posted by Bruce Lehr July 19th 2011.

Roche Readies Approval Request for Combo Breast Cancer Therapy

Roche reported hitting its primary endpoint in the latest test of its antibody, pertuzumab, used in combination with Herceptin and docetaxel for the treatment of Her2-positive breast cancer patients. The combination therapy reportedly worked better than Herceptin and docetaxel alone as measured by progression-free survival (PFS). 

Roche says it plans to file for approval with the FDA before the end of 2011.  Some industry analysts, however, questioned whether PFS improvements alone would be enough to sway the FDA to approve without more data on overall patient survival.

With pertuzumab, Roche has at least found a new way to target Her2 (found in about 25% of breast cancers).  It is the same receptor that Roche's other drug Herceptin targets but hits a different region of the receptor for a multi-pronged attack of the cancer.  Combination therapies of mutliple antibodies and/or chemotherapeutic agents are becoming a more predominant means of attacking cancers. See Fierce Biotech.

 

 

Posted by Bruce Lehr July 15th 2011.

Vical and Astellas Agree on CMV Vaccine Deal

Astellas will pay Vical $130 M for rights to its cytomegalovirus (CMV) vaccine to prevent the virus' reactivation in immunosuppressed transplant patients.  A phase III trial of TransVax in hematopoietic stem cell transplant patients and a phase II study in solid organ transplant recipients will begin in 2012.

Astellas will develop and commercialize the vaccine in the US and for the rest of the world.  It will also take on all development and commercialization costs.  Vical will retain rights to co-promote in the US and provide manufacturing support. The deal extends Astellas offering in the transplant market -- a key focus area. See Fierce Biotech.

 

 

 

Posted by Bruce Lehr July 15th 2011.

 

What have you done for me lately Seattle Genetics?

Yesterday, FDA advisory panels recommended that Seattle Genetics new "empowered antibody" drug called Adcentris (brentuximab vedotin) receive accelerated approval from the agency in late August for the treatment of Hodgkin's patients (non-responsive to chemo) and patients with anaplastic large cell lymphoma (ALCL) who've relapsed.  Pretty good stuff, huh?

Today, investors thus far have rewarded the company by driving down its stock price 5.7% from $20.33 to $19.17 in premarket trading.  Wow. What have you done for me lately? See Forbes.

 

Posted by Bruce Lehr July 15th 2011.

Valeant to Buy Janssen’s Ortho Dermatologics business

Valeant is at it again with another aquisition.  This time it will buy Janssen's Ortho dermatologics business for $345 million in cash. The business had sales of $150 million in 2010. It includes the brands Retin-A-Micro, Ertaczo, and Renova.

GEN | News Highlights:Valeant to Buy Janssen’s Ortho Dermatologics business for $345M.

Valeant has now added two dermatology groups within a week with its previous acquisition of Sanofi's Dermik unit for $425 million. "With the combination of this transaction and other recently announced transactions, Valeant is well on its way to being one of the leading companies in dermatology," states J. Michael Pearson, Valeant's CEO and chairman.

 

Posted by Bruce Lehr July 15th 2011.

Why Isn't Pharma R&D More Successful with All Its Money?

If you read the Pharma Reform blog, you'll know that its author, Mike Wokasch, often writes that for drug companies to be successful in developing new products in the future, they will need to work cross functionally to generate a comprehensive understanding of disease (e.g., pathophysiology, biochemistry, and molecular biology).

In this post, he poses a couple of questions around why pharma isn't way more successful than academics or biotechs at discovering new drugs despite a big advantage in R&D spending.  One mitigating effect, is that even though Big Pharma says it spent $68 M last year on R&D, only about 30% went to new discovery and preclinical activities -- so the absolute spend is misleading in that context.

Secondly, he postulates -- effectively -- that Big Pharma has a lot more distractions for its scientists. They are bothered much more by organizational expectations, bureaucracy,  and time pressures to deliver compounds rather than understanding the science.  And -- to top it off -- when they are successful, top scientists tend to get promoted to other projects, administrative duties, or increased management responsibilities that removes (mitigates) their expertise to focus on the day to day work of discovery research.

Do you think that is true?  Do academics get to apply their expertise, time, and a passionate focus for a comprehensive understanding of the science behind their work to a higher degree than those scientists at Big Pharma?

 

Posted by Bruce Lehr July 14th 2011.

And Then There Were Two - Adcetris Gets OK for ALCL

Seattle Genetics' Adcetris (brentuximab vedotin) recieved its second thumbs up from a second FDA advisory panel today -- this time for the treatment of anaplastic large cell lymphoma (ALCL).  Once again, the panel voted 10-0 to recommend the drug's approval. 

About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months. The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions.

The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new drug will be Seattle Genetics’ first marketed product after 14 years in business, and it would the first commercially successful version of an “empowered antibody” -- a completely new type of molecule in the fight against cancer. See Xconomy.

 

Posted by Bruce Lehr July 14th 2011.

 

 

BMS' Yervoy Gains EU Approval

BMS' Yervoy (ipilimumab) is now approved in Europe to be used in the treatment of advanced melanoma. The drug was approved in March for use in the US and is the first treatment to extend lives of patients with melanoma.  BMS gained the drug when it acquired its partner Medarex and its pipeline. 

Since, Yervoy's approval in March, BMS has worked a collaboration deal with Roche to test Yervoy as a combination therapy.  BMS says it will look to do more of these type of deals in the future as combination therapies are expected to gain in popularity as a treatment strategy. See Fierce Biotech.

 

Posted by Bruce Lehr July 14th 2011.  

 

Seattle Genetics' Adcetris Gains FDA Panel Endorsement

Seattle Genetics, as expected, got the endorsement of an FDA advisory panel to approve Adcetris (brentuximab vedotin) for the treatment of Hodgkin's lymphoma.  If the drug is now approved by the FDA for sale (decision Aug 30th), it will be the first approved antibody drug conjugate (ADC) on the market.  Another FDA expert panel will be discussing this afternoon whether or not Adcetris should also be recommended for the treatment of anaplastic large cell lymphoma (ALCL). 

"Brentuximab works and it works well. People with Hodgkin's lymphoma will have another option for treating a terrible disease," said Michael Sekeres, an oncologist at the Cleveland Clinic. See Xconomy. 

Seattle Genetics will not only be gaining its first approved drug but as an ADC the first one of that class.  This is the second drug this year from the Seattle biotech pool, besides Dendreon's Provenge, that represents a novel treatment type for a cancer.  Fierce Biotech notes in an article today that Dendreon and Seattle Genetics would both appear to be high on Big Pharma's short list of acquisitions.  Cancer therapies are expected to grow twice as fast as the rest of the pharmaceutical market (according to IMS Health) and many novel oncology drugs have been approved so far in 2011 (see next post on Yervoy).  Indeed, look for more acquisitions in the oncology space to happen.

 

Posted by Bruce Lehr July 14th 2011.

 

 

FDA Gives Guidelines on Companion Dx

Companion diagnostics are being developed to try to identify patient groups (or subgroups) that will respond best to a given therapy.  It is hoped that this will give better results in the clinic for responder populations and will spare non-responders from exposure to potential side effects of drugs that will not work for them.

The FDA recommends that there be early engagment between the agency and developers of such tests. It says it now plans to review the diagnostics and therapies in tandem -- where both exist.  The FDA says it will still approve therapies with no diagnostic for very serious illnesses with no other available treatments.  In such an instance, the companion test might receive later approval.

"These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability," said CDRH director Jeffrey Shuren.  See Fierce Biotech.

Posted by Bruce Lehr July 14th 2011.