medical administrative assistant training
> March 10th, 2010
WALTHAM, Mass. — ImmunoGen,
Inc. (Nasdaq: IMGN), a
biotechnology company that develops targeted anticancer products using
its antibody expertise and Targeted Antibody Payload (TAP) technology,
today announced that the US Food and Drug Administration (FDA) has
granted orphan drug designation to its IMGN901 compound when used for
the treatment of Merkel cell carcinoma (MCC). Through a separate
process, the European Union (EU) Committee for Orphan Medicinal Products
(COMP) concurrently also granted IMGN901 orphan medicinal product
designation for the treatment of MCC.
“IMGN901 has shown promising activity among the small number of MCC
patients treated to date, suggesting this is a potential registration
path for the compound,” commented Daniel Junius, President and CEO.
“Metastatic MCC is a rare and highly aggressive cancer with no approved
treatments today. We are preparing to be ready to initiate pivotal
testing of IMGN901 in MCC in 2011 and will make the final decision based
on expanded clinical experience and regulatory input. Gaining orphan
drug designation for IMGN901 in the US and Europe is an important step
in this process.”
Six patients with metastatic MCC had received IMGN901 at the time of the
AACR-NCI-EORTC meeting in November 2009.1 Among these, two
patients had an objective response – including a patient who has had a
sustained complete remission – and a third patient had clinically
meaningful stable disease.
In the US, the Orphan Drug Act is intended to encourage companies to
develop therapies for the treatment of diseases that affect fewer than
200,000 people in this country. Orphan drug designation provides
ImmunoGen with seven years of market exclusivity that begins once
IMGN901 receives FDA marketing approval for the treatment of MCC. It
also provides certain financial incentives that can help support the
development of IMGN901 for MCC.
Similarly, in the EU, orphan medicinal product designation is intended
to encourage companies to develop therapies for life-threatening or
chronically debilitating conditions that affect no more than five in
10,000 people in the EU. Orphan medicinal product designation provides
ImmunoGen with ten years of market exclusivity that begins once IMGN901
receives European approval for MCC. It also enables access to certain
financial incentives as well as to protocol assistance.
* DELAYED-ONSET MUSCLE SORENESS (DOMS) is a double-edged sword. On one hand, muscle damage and soreness promote intracellular repair processes that make your muscles bigger and stronger. On the other hand, when DOMS is extreme, it can limit your range of motion and affect how often you train. Enter BounceBack, a blend of proteolytic enzymes, cur-cumin and phytosterols from avocado and soybean oils, resveratrol and vitamin C. Researchers from the UCLA School of Medicine (Los Angeles) recently reported that in a small study of 10 men and women, 30 days of BounceBack supplementation significantly reduced pain and tenderness induced by Smith machine squats. A small improvement in range of motion (knee flexion) was also noted, along with trends for decreases in serum markers of muscle damage. * CREATINE CONTINUES TO IMPRESS. In addition to improving muscle strength and size, bone health and even cognition in vegetarians, it now appears to help lifters recover their strength faster after a hard workout. Researchers from Australia, Baylor University (Waco, Texas) and Tasmania teamed up to study the effects of creatine monohydrate administered five days before and 14 days after a standardized lower-body resistance-training session (four sets of 10 reps of the eccentric-only leg press, leg extension and leg curl). Five days before exercise, subjects took about 20 grams of creatine and 84 grams of glucose or a placebo. Fourteen days later, they took about 7 grams of creatine and 28 grams of glucose or a placebo. The effects of creatine were dramatic: a 21% greater recovery of strength and 84% less muscle damage compared to the placebo group. This study underscores the importance of daily creatine supplementation, especially on “off” days, to accelerate recovery from intense weight training.
WALTHAM, Mass. — BG Medicine, Inc. today announced that it has entered into an agreement
with Abbott Laboratories (NYSE: ABT) to extend its current development
and commercialization collaboration to include the development of a
galectin-3 test for Abbott Point of Care’s i-STAT® System.
Galectin-3 is a novel biomarker that may play a role in detecting the
development and progression of heart failure.
Under the agreement, Abbott will be responsible for the development of
the test in accordance with certain plans and milestones, and BG
Medicine and Abbott will collaborate in support of regulatory filings
and studies to support the clinical utility of galectin-3 in the
management of patients with acute decompensated heart failure.
“Heart failure is one of the most costly medical conditions. Despite
important advances in diagnosis, there remain significant unmet needs in
assessing patients with heart failure and selecting a course of action
both in emergency room and non-acute care settings,” said Pieter
Muntendam, M.D., President and CEO of BG Medicine. “This collaboration
is an important step toward determining the exact role this test can
play in assisting physicians in their efforts to improve outcomes and
reduce cost of care.”
The i-STAT System from Abbott Point of Care is at the forefront of
patient-side point-of-care testing with the industry’s most
comprehensive menu of tests in a single platform. The i-STAT System is
an advanced, handheld, diagnostic tool that provides real-time
lab-quality results within minutes to accelerate the patient care
decision-making process. Lightweight, portable, and easy-to-use, the
i-STAT System features single-use disposable test cartridges that can be
used throughout the hospital to perform a broad menu of critical care
tests, including cardiac markers, blood gases, chemistries and
electrolytes, lactate, coagulation, and hematology. The i-STAT System is
currently in use in one out of every three U.S. hospitals and more than
500 emergency departments. With more than 50,000 placements in
high-acuity settings worldwide and 35 million test cartridges produced
annually, the i-STAT System has a global impact on point-of-care testing
at the bedside.