FierceBiotech Rating of 2011′s FDA Approvals

As we’ve already discussed, I am a huge sucker for top anything lists and it appears FierceBiotech is too.  In this list, Fierce looks back to 2011 and rates last year’s FDA approvals.

There were some interesting ones last year, especially if you ever find yourself stung by a scorpion, suffering from the very unpleasant Clostridium difficile-associated diarrhea, restlessly dealing with restless leg syndrome, crawling with head lice or if you like to treat your heart and pulmonary system to several cheeseburgers a week.

On a more serious note, number one on their list is a new cancer drug Adcetris, which is produced by Seattle Genetics.  Adcetris is the first therapy of its kind approved since 1977 to treat Hodgkin’s lymphoma and is the first ever to be approved for the treatment of anaplastic large cell lymphoma. Hopefully, this drug will provide hope to those suffering from these types of cancer.

Please read the complete 2011 list here, and I’m excited to see what approvals the FDA has in store for us in 2012.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

Changes Coming – Biogen Idec to Acquire Stromedix, Inc.

Biogen Idec (“Biogen”) recently announced that it has completed a definitive agreement for the acquisition of Stromedix, Inc. The deal includes an upfront cash payment of $75 million and additional payments of up to $487.5 million to be determined based on specified developmental milestones. Biogen’s acquisition strengthens its dug development pipeline with STX-100, Stromedix’s idiopathic pulmonary fibrosis drug currently being tested in clinical trials.

This acquisition is another example of what is certain to continue over the next couple of years as companies scramble to acquire promising new drugs for their diminished pipelines in light of the looming patent cliff so many of them are facing. Read the entire article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

Will the US reach 1 Million STEM Grads in the Next Decade?

The fact that the United States is the leader in the biotechnology and pharmaceutical industries worldwide (with several well known “hotspots” spread throughout the country) would lead you to believe that the number of Americans choosing to study science, technology, engineering and mathematics (STEM) is on the rise.  For the same reason, however, the recent report released by the President’s Council of Advisors on Science and Technology may come as a surprise.  Based on the report, the US will need to produce over 1 million additional graduates with STEM degrees in the next decade in order maintain the upper hand in science and technology.

While 300,000 Americans graduate with bachelor and associate degrees in STEM every year, countries like India and China produce many more. The sad truth is that less than 40% of students who enter college in the STEM fields complete their degree. As a result, the Council has begun to look at new ways to retain students in the STEM disciplines. The US government has sided with the Council and has included $3 Billion for STEM education in the Federal Budget for 2013.

With the impact that the biotechnology and pharmaceuticals industries have on our economy, our health, and the future of innovation, it is nice to see the effort being put into making sure the United States stays on top.

Read the full article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

FDA biosimilars guidance sparks reviews of IP protection

Years after the passage of 2009’s Biologics Price Competition and Innovation Act, as well as 2010’s Patient Protection and Affordable Care Act, the FDA finally issued draft guidance outlining the agency’s current position regarding an abbreviated approval pathway for biosimilars and drugs that are interchangeable with an FDA-licensed biological product under section 351(k).

Konstantin Linnik, a partner at Nutter McClennen & Fish in Boston, as well as former senior corporate counsel at Pfizer, thinks that the current state of the industry has upped the stakes for intellectual property protection at biotech and pharmaceutical companies causing them to assess their patent positions and look at other safety devices such as trade secrets.  He does believe, however, that New England will be a beneficiary of the new biosimilars guidance, as the biotech industry in the region is in an upsurge.  Read the entire Mass High Tech article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

Mass. General researchers find novel way to prevent drug-induced liver injury.

The goal of developing liver-safe pharmaceuticals and providing better treatments for drug-induced liver injury is in the works!

Blocking cell-to-cell communication may prevent liver damage and improve drug safety and with drug-induced liver injury being the most common cause of acute liver failure in the U.S. and the biggest reason for abandoning drugs early in development, or removing them from the market altogether, this could be big news.

Massachusetts General Hospital (MGH) investigators have developed a novel strategy to protect the liver from drug-induced injury and improve associated drug safety. In their report receiving advance online publication in the journal Nature Biotechnology, the team reports that inhibition of a type of cell-to-cell communication can protect against the damage caused by liver-toxic drugs such as acetaminophen.

“Our findings suggest that this therapy could be a clinically viable strategy for treating patients with drug-induced liver injury,” says Suraj Patel, PhD, of the MGH Department of Surgery, the paper’s lead author. “This work also has the potential to change the way drugs are developed and formulated, which could improve drug safety by providing medications with reduced risk of liver toxicity.”

Read the entire article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

Fierce Biotech announces its list of the 25 Most Influential People in today’s BioPharma Industry

I don’t know about you, but I love “top” lists of anything, including but not limited to top 25 movies of all time, top 25 worst foods in America etc. I always stop, read, and debate (usually with myself) the rankings and why they are great or not so great.  Of course when Fierce Biotech came up with another one of their top 25 lists, I had to stop and read.

Some choices are obvious, including Dr. Margaret Hamburg commissioner of the FDA. Realistically the commissioner of the FDA should be on this list every year, however, Dr. Hamburg has brought much needed consistency to the FDA making it easier for drug companies to navigate and react throughout the regulatory process.

Some not so obvious choices include Timothy Anderson, a Senior Analyst at Sanford C. Bernstein who was selected because he broke the story of Pfizer’s intended shake ups and the possibility of the company selling off up to 40% of it’s assets to focus on research.  While this did not come fully to fruition, Anderson’s assessments of the BioPharma industry have become a driving force in the market.

One of these days I will make it onto of these types of lists….top 25 Sequence Listings ever created perhaps? To tide you over until then, read through the full list here and feel free to debate Fierce’s choices in the comment section below.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

NASA – A lot more than just space travel

Although NASA is facing severe budget cuts for the coming year, they are reporting many new and exciting technologies.

•    The Rotary Cell Culture Systems (RCCS) allows for complex and three-dimensional cell structures, produces 10 times more cells than standard systems, and creates more realistic cultures for testing

•    LIDAR cameras – useful for collision avoidance in all types of vehicles

•    Direct-Route – software finds more efficient routes immediately available to aircraft in flight and can save up to 20 million gallons of fuel per year

•    PT Pressure Safe – custom cam and groove fittings to prevent accidental releases of pressurized hoses to help in the prevention of serious injury

•    Firefighting system – utilized the design ideas from advanced rockets and applied the technology to water delivery systems for firefighting – puts out a fire 80 percent faster than a traditional system while using only 6 percent as much water

Even though you probably won’t see NASA involved in the next mission to Mars, it doesn’t mean that they are idly standing by.  As you can see, they are developing some very “state-of-the-art” technology that could potentially affect each of our lives in some way.

Read the full article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

Is the Ideal Workout Written in Your Genes?

While genetic testing has been used to help people learn more about their ancestry and health, people may soon be using it to develop personal workout routines designed specifically for their body type.  Many of us have been in the situation – going to the gym and not losing weight. It gets old and becomes frustrating; however, workouts designed specifically for your body may make working out more enjoyable and provide more noticeable results.

Several companies, including Mygene, have released kits (which start as low as $195) that require only a cheek swab. The tests can tell you everything from what types of activities to participate in to how long to rest in between. While some personal trainers have grasped the idea, and some people have seen wonderful results from designing their training around their genetic makeup, there are still a large number of skeptics who maintain that genetic tests aren’t necessary to define individual workouts.

While the concept of using genetic testing to determine people’s ideal workouts seems neat, I can’t help but think that the novelty will be quick to wear off.

Read the full article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

Lots of Money and No Drugs to Spend It On

As discussed in our January 13th posting, several of the top biotech companies are facing the “patent cliff” and will be losing patent protection on their blockbuster drugs over the next few years. This has left many of them with plenty of money but little reserve in their drug development pipelines. To solve the problem, larger companies will be acquiring and merging with smaller companies that have promising new drugs in phase II or phase III trials. Companies already looking to make big moves in 2012 include Amgen and Celgene, which have made deals to buy Micromet and Avila Therapeutics respectively. Smaller companies named as potential future targets for other acquisition deals and mergers includes Idenix Pharmaceuticals, BioMarin Pharmaceuticals, Pharmacyclics, and Achillion Pharmaceuticals, which all have promising drugs currently in trials.

As more companies vie for opportunities there will be failures and hostilities. Life Technologies recently made a bid for Illumina after Roche tried and was unsuccessful. The next few years should bring many surprises and exciting changes to the biotech industry.

Read the entire article here.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.

FDA Clears Leo’s Picato Gel for 2–3 Day Treatment of Actinic Keratosis

The FDA recently approved Leo Pharma’s Picato® (ingenol mebutgate) gel for the treatment of actinic keratosis (AK) lesions on the face, scalp, trunk, and extremities. Read the entire article here.

For all you fair skinned people out there or anyone dealing with actinic keratosis, this is very good news.  I had to use the Carac cream for two weeks for actinic keratosis (some people have to endure the treatment for up to four weeks) and it wasn’t pretty.  My face was dry, very red, itchy, it burned and was quite unsightly to look at.  So the idea of only having to deal with the side effects and treatment for two to three days is very exciting.

-The Harbor Consulting Team

For more information regarding Harbor Consulting, please visit www.seqidno.com.