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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: FDA

Pharma / Biotech R&D Budgets – A Proposal For Measuring Performance

During the BioFinance 2011 conference held in Toronto last week, one presenter showed a slide that outlined the number of new chemical entities (NCEs) approved by the FDA over a number of years. Since this slide was used in the context of the increase in global industry R&D budgets, it was meant to show that the huge increase in R&D budgets had not produced an appropriate increase in NCEs approved at the FDA. Is this the correct way in which R&D performance should be measured?

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Biotech Trends in 2011: Biosimilars

In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been issued and the the U.S. BCPI Act working its way through the FDA’s rule-making process.

The biosimilars market has also evolved in a couple of unexpected ways: 

  1. Teva decided not to wait for a distinct U.S. biosimilars pathway, and instead submitted a full BLA for Neupoval (which was accepted). Although Neupoval’s approval is now delayed, with the 12-year exclusivity period in the BCPI Act far exceeding similar periods in the EU and Canada, more companies may follow Teva’s approach instead of navigating the U.S. biosimilar regime.
  2. At the JP Morgan conference last week, the CEO’s of Amgen and Biogen Idec, two companies that have been built on innovator biologics, both openly discussed their own plans to produce biosimilars. Although Amgen’s Sharer said the company “should participate in an intelligent way without disturbing the core business,” and was looking to Asian and Latin American markets, Biogen Idec’s Scangos said flatly that “[t]he next decade will be about access and cost as much as it is about innovation,” and that biosimilars are “a low risk way to generate substantial revenue.”

As the regulatory and business environments continue to evolve, we’ll continue to keep an eye on the latest developments.

This post is the fourth in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Biotech Trends in 2011: Social Media in Biotech and Healthcare

Use of social media by pharmaceutical companies, biotechs, and industry observers will continue to grow in scale, value and importance this year. The emergence of Twitter as a public health surveillance tool and the pending (still pending…) release of the FDA’s social media guidelines will contribute to this growth in the short term, and we’ll continue to keep an eye on novel developments.

This post is the first in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars

Reuters reports that the European Medicines Agency (EMA), which has already approved 13 biosimilars, is expecting to publish guidelines in November on biosimilar antibody therapeutics. EMA Executive Director Thomas Lonngren said that clinical trials will be required for antibody biosimilars (as they are for the products EMA has approved to date), but that requirements were likely to be less onerous than in the United States.

Reuters says that the small number of requests (six) received by EMA so far “reflects the difficulties of making such copycat medicines [antibodies]” but with the earliest therapeutic antibodies coming off patent (in Europe) in 2014, I expect these initial inquiries are just the tip of the iceberg. Of couse, biosimilars are hard (as we’ve noted); but a lucrative opportunity of that scale will not go untapped.

Meanwhile, as expected based on the draft notice leaked in September, the FDA is holding public meetings on the implementation of the Biologics Price Competition and Innovation Act (i.e., the biosimilars legislation). The full Federal Register notice (pdf) is up, and Mark Sernak at has extracted the questions posted for comment.

In addition to a long list of scientific and technical questions, there are a couple of inquiries that I’d highlight from a corporate law perspective:

  1. Which types of related entities may be ineligible for a period of 12-year exclusivity for a subsequent BLA, given the “potential transfer of BLAs from one corporate entity to another and the complexities of corporate and business relationships”; and
  2. Whether the existing fee structure under the Prescription Drug User Fee Act (PDUFA) should be considered as a model in establishing a user fee structure for biosimilar applications.

Interested in attending or in submitting a comment? The FDA’s meeting information page is here, and it includes webcast access for November 2 and November 3.

Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

Adam Feuerstein at reported this morning on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation.

The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure of a biological product” — pretty broad, so we’ll have to stay tuned for the actual meeting notice. However, the legislation provides some hint in permitting “product class-specific guidance” specifying criteria that will be used to determine whether a biological product is highly similar to a reference product in such product class.

If the FDA decides to move ahead with product class guidance, it would likely specify the criteria that will be used to determine whether a biological product meets the standards for “interchangeability”.

In other cases, the FDA may determine that “the science and experience [to date] … with respect to a product or product class … does not allow approval of a [biosimilar] for such product or product class.”

Bottom line: following the FDA’s November meetings, biosimilars will be one step closer in the U.S.

P.S. Adam Feuerstein cites Alec Vachon (@HEALTH_NOTES) on Twitter for breaking the story Friday. Not sure why I haven’t found him before, but Alec is now added to my Biopharma-IT-Health Twitter list.

Biotech Trends Update: ChemGenex and the Importance of Companion Diagnostic Development

Australian cancer drug developer ChemGenex was scolded by the FDA’s oncology panel for “fairly sloppy drug development.” The company’s mistake? It presented its leukemia drug, designed for patients with a particular genetic mutation, without a validated diagnostic test for the mutation.

ChemGenex says it’s a matter of months, not years, before it gets a test validated for Omapro; but the company’s stock took a beating on news of the FDA’s decision, losing 37% of its value on record volume.

Many companies, unwilling to risk such delays, have already shifted to a joint Dx/Rx co-development model.  Until it was bought by Qiagen, DxS was making an entire business out of developing companion diagnostics in partnership with pharmaceutical companies.  Similarly, Dako Denmark is developing companion diagnostics for AstraZeneca’s oncology pipeline.

The FDA’s message here is pretty clear: the quality of companion diagnostics matters.  One day, when everyone’s genome is fully sequenced, many personalized products won’t even need diagnostics.  Until that day, when you’re developing a personalized product, don’t give the diagnostic short shrift.

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Should FDA Special Protocol Assessments be Public?

A provocative post by Matthew Herper at Forbes’ The Science Business Blog this week argues that special protocol assessments (SPAs) should be public.  SPAs are the FDA’s way of pre-approving a clinical trial design, so that a company can conduct its trials secure in the knowledge that the FDA won’t later withhold approval based on a design flaw.

SPAs are currently “confidential communications” not subject to public disclosure, but Herper argues for congressional action to put them into the public record:

“It might take an act of Congress to allow the FDA to make SPAs public, but that should happen. This would increase their value to biotechnology firms who are trying to raise money and prevent run-of-the-mill stock buyers from getting fleeced.”

The event that triggered Herper’s call for new legislation is yesterday’s revelation that Seattle-based Cell Therapeutics deviated from an agreed protocol in 2008.  Herper characterizes this mainly as the FDA’s failure for leaving SPA disclosures “entirely up to the company” and says the confidentiality protection “represents one way in which the regulator fails to  make sure investors have information they need.”

However, as much as I’m a fan of government transparency, the responsibility to investors lies with the company not with the FDA.  To the extent details of an SPA are material, they should be disclosed.  Ongoing developments with respect to clinical trials should likewise be assessed as part of a company’s disclosure controls and procedures and disclosed as necessary.

Did Cell Therapeutics fail in this duty?  Unclear.  As an article by Adam Feuerstein pointed out on Feb. 1, Cell Therapeutics did disclose that they halted enrollment in the trial early.  However, the company did continue to reference the SPA in subsequent press releases.

Would FDA publication of the SPA have helped?  Also unclear.  The FDA’s guidance on SPAs (pdf) says, clearly:

“Failure of a sponsor to follow a protocol that was agreed upon with the Agency will be interpreted as the sponsor’s understanding that the protocol assessment is no longer binding on the review division.”

So I’m not sure what would have been added by having the SPA available.

My bottom line: Companies that fail to disclose material developments or that misrepresent material facts will subject themselves to liability to their shareholders.  Herper’s hope is that disclosure by the FDA would “prevent run-of-the-mill stock buyers from getting fleeced,” but absent evidence that securities laws are failing to provide adequate incentives or remedies, I’m not convinced that forcing these confidential FDA communications open to public scrutiny would help investors or patients.

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Biotech Trends Update: Teva’s BLA for Neupoval is Accepted at the FDA

Teva’s decision last year to submit a full biologic license application (BLA) for Neupoval looks positively prescient today.  Teva’s product is already sold in the EU as a biosimilar to Amgen’s Neupogen, but a U.S. biosimilars pathway is stalled along with the rest of health reform and today, the FDA accepted Teva’s BLA, clearing the way for a review of Teva’s clinical data and potentially for approval of the product.

FDA approval isn’t Teva’s only hurdle, though.  Amgen’s U.S. patents on Neupogen don’t expire until 2013, and the two companies are currently litigating the issue of whether Teva’s product infringes those patents.  Furthermore, the Dow Jones article quotes Credit Suisse analyst Michael Aberman who points out that in the EU Teva’s product only has 5% market share, competing against both the original Neupogen and Amgen’s longer-acting Neulasta.

Investors’ reaction? Teva shares were up 1.4 percent, Amgen shares were off minutely.

My bottom line: If you want to read tea-leaves to predict the approach other biosimilar products will take (and I do), watch the Neupoval BLA closely.  The calculus undertaken by other potential market entrants will weigh Teva’s success and costs with this approach against the costs of any Congressional requirement for data exclusivity period and any FDA requirement for clinical trials in an eventual biosimilars regime.

Follow our coverage of North American biosimilars news on this Biotech Trends in 2010 page.

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Analyzing the FDA’s 2009 Approval Statistics

Two interesting Tweets appeared this morning:

Biotech drug approvals spiked in 2009.

followed shortly by

#FDA Drug Approvals Mostly Flat in 2009

The actual numbers, which are based on analysis by investment research group Washington Analysis, are that 2009 saw 26 total approvals compared to 25 in 2008 and of those, seven were for biotech drugs compared to four in 2008. 

Is that a spike for biotech? Ira Loss (from Washington Analytics) tells FierceBiotech maybe, but wants to see if the increase holds in subsequent years.  Fisher’s exact test gives a p-value of 0.499, indicating that seven out of 26 is not a statistically significant increase over four out of 25; but as the Pharmaceutical Processing article says, “[t]he FDA can’t approve drugs that aren’t submitted.” 

So, we can’t really reach an answer without a real denominator — I’d suggest using the number of drugs with a PDUFA deadline during the calendar year; but even then it would be very hard to control for NDA quality or other possibly confounding factors.

Bottom line? Seven is better than four; and as FierceBiotech points out, fears that the Obama FDA would ratchet back approvals have not been substantiated.

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FDA Meeting on the Internet, Social Media and Online Drug Marketing

Following some perplexing moves by the FDA, including cracking down on Google search ads, the agency convened a two-day hearing on the use of the internet and social media for online drug marketing last week.  The goal of the hearings was to seek comments from

“all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry … [in order to] help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.”

If you are interested in the topic, you can:

  1. Watch the whole thing via an archived webcast (until they take it down, but then you can read the transcript);
  2. Search #FDASM on Twitter and read the real-time reactions; or
  3. Read yesterday’s genius FiercePharma post by Tracy Staton that boils the whole thing down to a delicious executive-summary-type bite-size blurb. [See what I did there, FiercePharma headline writers?]

I highly recommend #3.

The FDA is collecting comments until February 28th (2010), after which it will digest the whole lot of them and formulate some guidance (likely) or regs (less likely) that will shape online behaviour.

P.S. Thanks LogoTwitter!

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A Third REMS Advantage? Allergan Says REMS for Botox Requires Off-Label Communication

Allergan sued the FDA earlier this month, claiming that the FDA’s prohibition of off-label promotion violates Allergan’s First Amendment rights by preventing Allergan from communicating about BOTOX’s REMS restrictions to physicians who need the information to properly treat off-label.  As the Allergan press release says:

“To serve the objectives of the FDA-mandated REMS program for BOTOX(R) and to assist physicians in evaluating the benefits and risks of the product, Allergan seeks a judgment that would permit it to provide currently available and truthful information to doctors for common off-label uses of BOTOX(R)”

I.e., the REMS forces Allergan to discuss the off-label uses.  Hrm.  The In Vivo Blog picks this one up and runs with it:

“the simple truth is that FDA now has the authority to do exactly what Allergan wants—allow, or indeed, require greater communication about off label uses. The suit focuses on the fact that FDA is not allowing as complete communication as Allergan wants—but the fact is that FDA could allow that under the existing law and in some sense “approve” an off-label promotion campaign.”

We’ll keep an eye out for the decision, but we don’t expect the District Court’s word to be final.  Meanwhile, having a product subjected to REMS “restrictions” is looking better and better.

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Revised FDA Warning Letters Webpage To Feature Close-Out Letters

fda_logo_onlyImprovements to the FDA’s warning letters webpage were announced last night.  The most recent warning letters will be easier to find, and most notably, the warning letters table will now include

“the Close Out Date … and detailed information about the Warning Letters Close Out Program.”

Or at least it will for warning letters issued after September 1, 2009 (the date the Warning Letter Close-Out Letter Program kicked in).

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FDA Has It In for Double Vowels: Cheerios, Google Ads Targeted

Cheerios picThe FDA, you may have heard, has told General Mills that the statement “clinically proven to help reduce cholesterol” on Cheerios boxes “cause[s] it to be a drug” and, therefore, that Cheerios “may not be legally marketed with the above claims in the United States without an approved new drug application.”  Ouch.

This follows a crackdown by the FDA on Google search advertisements bought by pharma companies, which do not contain the mandated risk information.  Since the risk info would never fit within the 95-character limit of the ads, the ads link to the product websites, which do provide the required risk disclosures. “Immediately cease,” says the FDA.

Chris Morrison at the In Vivo Blog has an interesting theory explaining why this is good news for the industries regulated by the FDA:

[T]he more the public views the head of the agency as a tough, anti-industry regulator, the more ambitious the agency can be in taking on initiatives that benefit the regulated industries.

Chris draws a parallel to the actions of former FDA commissioner David Kessler, appointed in 1990, who seized a huge quantity of Citrus Hill orange juice from Procter & Gamble, claiming that the “fresh” appellation could not be applied to juice from concentrate, which Chris says,

set the tenure for Kessler’s term and gave him a platform and reputation of [a] decisive regulator from which to undertake a range of initiatives at FDA – including getting user fees for drug approvals and speeding approvals of AIDS drugs.

I agree that “[t]he publicity [from the Cheerios letter] can re-establish FDA in the public’s eye as a force that is willing to take on big commercial products,” but I’m not sure it’s a tactical move.  It may just be the more aggressive regulatory instincts of the Democratic appointees.

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H1N1 Human Swine Flu Wednesday Update: Ontario, Genetics and Sanofi News

antigenicshift_hirescrop1Ontario confirms 13 new cases as of Wednesday afternoon, bringing the total to 49 in the province, all considered mild.  A lot of the public health messaging over the last 48 hours has been advising people not to relax too much.

Today also saw an interesting Canadian development on the scientific front.  Although commentary around the different numbers of flu deaths in Mexico versus other areas has included the possibility that there are genetic variations in the virus, genetic differences do not appear to be  responsible. Researchers at the National Microbiology Lab in Winnipeg sequenced Mexican and Canadian isolates and found no significant differences. According to Dr. Frank Plummer, the chief science adviser of the national lab:

“Essentially, what it appears to suggest, is that there is nothing at the genetic level that differentiates this virus that we got from Mexico and those from Nova Scotia and Ontario, that explains apparent differences in disease severity between Mexico and Canada and the United States.”

Also, speaking of not relaxing too much, the FDA just announced that they have approved a new Sanofi Pasteur vaccine manufacturing facility in Swiftwater, PA.

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Trends Update — Personalized Medicine: No Medicare Funding for Warfarin Testing, For Now

dna_sequenceThe WSJ Health Blog reports that Centers for Medicare and Medicaid Services (CMS) has decided there is not enough scientific evidence for Medicare to pay for genetic testing to customize Warfarin dosing.

CMS proposes paying for more research, and the New York Times story questions the cost effectiveness of a prospective study; but as we reported in February, NIGMS is already working on a prospective study that Frank Torti boosted at the time.

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BioFinance Lunch Keynote: U.S. Health Reform

Just finished listening to Scott Gottlieb at the BioFinance lunch keynote. Scott was Deputy Commissioner at the FDA in the Bush administration, and is now a Fellow at the American Enterpirse Institute.

Here’s what he had to say. Stay tuned for questions from the audience, including Dani and I, at the end…

Healthcare in the U.S.

First, good flu vaccine news: current surge capacity for vaccine production is up to half a billion (500,000,000) doses, much better than even a few years ago.

Update: the MaRS Blog has a video of this part of Scott’s talk.

Health care reform:

FOB: Waxman can’t get his bill out of committee. Likely booted to next year.

Comparative Effectiveness: will be a committee in the fall that sponsors research and promulgates guidelines.

1) Medicare has tried to implement some CE: functional equivalence (legislated away), least costly alternative (e.g., wheelchairs) tried to apply to Sepracor, got sued, lost on appeal; tried to take accelerated approval drugs out of reimbursement, didn’t fly. Legislation likely to pass giving CMS back authority to do least costly alternative reimbursement.

Large private plans have hundreds of physicians and thousands of clinicans, CMS has at best 25 physicians. E.g., have made 160 decisions on cancer product reimbursement without a single oncologist on staff.

2) Price controls: private market will be increasingly able to pay off medicade pricing schedules. Drug benefit for dual-eligible patients will be moved to medicade best price schedule.

Similar changes: medicare advantage plans will want to be able to price off medicare if their reimbursement rates are cut.


“Regulatory creep” at the FDA: balance shifts on approval metrics debates because of increased public desire for and tolerance of regulatory caution.

Medical devices: changing regulatory paradigm for diagnostics. Laboratory-developed tests will likely be regulated as devices. Kennedy has a bill pending.

I asked about the regulatory environment for personalized medicine, and Scott pointed interestingly to different regulatory approaches taken in the U.S. vs EU to screening HER-2 as a precursor to Erbitux treatment for colon cancer. EU uses it based on retrospective data, U.S. has wanted to do dedicated prospective controlled trials.

Dani asked about drug reimportation: Scott thinks it will happen, but regulatory structure and currency changes will increase cost, and increased drug reimbursement in the U.S. will decrease demand.

Brian Bloom, a banker at Bloom Burton, asked about how the Obama administration’s vocal support for innovation meshes with the health care reforms and comparative effectiveness initiatives. Scott diplomatically focussed on the administration’s support for basic reseach, then segued less diplomatically to predict the end of cancer drug development that he says could follow if the NICE model in the UK is globalized.

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Wednesday Brain Dump: March 11, 2009

Regulatory Brain Dump…

Regulating Nanotech:  The FDA is collaborating with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to expand knowledge of how nanoparticles behave and affect biologic systems.  Results will be placed in the public domain.

Regulating Natural Health Products: Health Canada launched the first phase of Online Solution, a secure online system for regulating natural health products in Canada.

Not Waiting for Regulation: Like Teva’s decision in February, Momenta Pharmaceuticals doesn’t think it needs to wait for a follow-on biologics pathway.  It’s proceeding with its application (presumably still a BLA) for a generic version of Lovenox, and unlike Teva, Momenta doesn’t think the FDA will require human trials for its product.

Commissioning Regulation:  A number of reports, including the In Vivo Blog and the WSJ Health Blog have been pointing to the nomination of Margaret Hamburg as FDA Commissioner, with Joshua Sharfstein as deputy.


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Wednesday Brain Dump: March 4, 2009

Monkey Business: glycerol monolaurate (GML), a well-known microbicide, may protect macaques against SIV; but future experiments may need to use a modified HIV strain instead; meanwhile, who will protect them from the University of Louisiana? 

Smoky Business: the tobacco industry is facing new litigation in Ontario, and FDA regulation in the U.S.

Actual, Honest-to-Goodness* Profitable Business:  The Burrill report marks this year as the first one to show an overall profit from the biotech industry.

*well, sort of.

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Wednesday Brain Dump: February 25, 2009

The question this week: a shot in the arm or a kick in the teeth?

A shot in the arm for:

  • Fewer shots in the arm! (har) 
    • British Columbia is the first jurisdiction in North America to offer a children’s vaccine called Infanrix-hexa™, which contains six immunizations in one, resulting in three fewer needles in the overall B.C. infant vaccine schedule, and
    • With the discovery of a constant region of flu virus protein hemagglutinin, a universal flu vaccine may be possible (no more yearly shots);
  • The Naval Surface Warfare Center in White Oak, a suburb of Washington, where the FDA is spending $1.15 billion to consolidate its offices and labs and to anchor a new biotech hub;
  • Pine Island, near Rochester, Minnesota, which could soon be the home to a new biotech research, development and manufacturing park with the help of up to $900 million in funding reportedly pledged by Steve Burrill.  Funding announcements also from Maryland and Pittsburgh;
  • Sustainable agriculture, when the White House announced its nominee for second-in-command at USDA: Kathleen Merrigan of Tufts University, who had been a top choice of the Cornucopia Institute to run USDA’s National Organic Program;
  • The National Science Foundation, from the stimulus (a $3 billion boost) and the budget (a 6.7% increase, to $6.49 billion);
  • Multiple Sclerosis, with Merck, Novartis, Teva, Biogen Idec and Sanofi Aventis all planning to release new oral therapeutics between now and 2012;
  • Conflict of interest disclosure, with a new editorial in PLoS Medicine;
  • Deterrence, with the arrest of four animal-rights extremists;
  • Organ failure biomarkers,
    • with the discovery of liver toxicity-associated MicroRNAs, and
    • with the injection by Pfizer Canada of $1 million to the PROOF Centre to fund research into vital organ failure biomarkers; and
  • Aliens.

A kick in the teeth for:

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Warfarin and Personalized Medicine

dna_sequenceThe optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1.  In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations.  However, population-wide assessments of outcomes based on genetic testing were not definitive.

A paper in the current issue of the New England Journal of Medicine uses retrospective data to build a new dosing algorithm and predicts significant benefit from the use of the algorithm for the 46% of patients who require lower- or higher-than-normal doses.  The algorithm and data used to derive it will be made available via PharmGKB, a database managed by researchers at Stanford, and the research has prompted a full-scale prospective study of the personalized approach.

Frank M. Torti, M.D., acting commissioner of Food and Drugs said that the prospective study

is precisely what is needed to advance the promise of personalized medicine, ensuring that patients receive the safest and most effective drug dose.

Read our other posts on personalized medicine.

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Trends in 2009: Facing the Challenges of Introducing Biosimilars or Follow-on Biologics in the North American Market

The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology-based drugs will come off patent and enable the development of new biologics. The race by pharmaceutical companies to get into biologics, or further support their existing biologics capacities in order to start developing biosimilars or follow-on biologics (FOBs), is illustrated by the rapid pace of recent deals in this sector. The latest of these deals is the acquisition of Insmed by Merck, which was announced last Thursday; however I believe this deal was more about expanding state-of-the-art manufacturing facilities rather than acquiring extremely valuable FOBs.

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Personalized Medicine: First SAEC Data

The FDA (as part of the Critical Path Initiative) and the International Serious Adverse Event Consortium (SAECannounced the release of their first data on the genetic basis of adverse drug reactions today.
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News: FDA Launches Secure Supply Chain Pilot Program

The FDA announced a new pilot program, which will select 100 applicants who will get expedited import clearance for up to 5 of their drugs that have a demonstrably secure supply chain.  Think of it as NEXUS for (FDA-approved!) drugs.  The idea is to decrease overall risk associated with imported drugs by allowing the FDA to focus resources on imports that are not part of the program.

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