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Conn. addresses insurance rates, Mass. physician groups evaluate controversial payment plan

"House and Senate leaders are eyeing passage of a second midyear spending bill before the start of the next legislative session to address more caseload-driven accounts that are running short on funds five months after Gov. Deval Patrick signed the fiscal 2011 budget. The deficiencies, which follow inaccurate enrollment estimates for MassHealth and other social service programs, threaten to eat into some the revenue surpluses the state has amassed over the first half of fiscal 2011, when tax receipts have exceeded projections" (Murphy, 12/7).

8 Dec 2010

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

8 Dec 2010

QLT's oral synthetic retinoid granted orphan drug designation for treatment of Leber Congenital Amaurosis

QLT Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for QLT091001, its oral synthetic retinoid, for the treatment of Leber Congenital Amaurosis (LCA). LCA is an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth. QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle.

8 Dec 2010

FDA grants QLT's QLT091001 orphan drug designation for treatment of Retinitis Pigmentosa

QLT Inc. today announced that QLT091001, the Company's oral synthetic retinoid, has been granted orphan drug designation for the treatment of Retinitis Pigmentosa (RP) from the U.S. Food and Drug Administration (FDA). This follows the FDA grant of orphan drug designation for QLT091001 for the treatment of Leber Congenital Amaurosis (LCA) also on December 7, 2010.

8 Dec 2010

NIH awards Scripps Research $2.35M to study new treatment for obesity

The Scripps Research Institute has been awarded a $2.35 million grant from the National Institutes of Health to study a new way of treating obesity as part of a national consortium with the Dana-Farber Cancer Institute.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

$Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL$

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive data from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of ALCL. The data were presented today during an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

7 Dec 2010

John Theurer Cancer Center presents research findings at ASH meeting

The John Theurer Cancer Center at Hackensack University Medical Center announced today important research findings presented at the annual meeting of the American Society of Hematology taking place December 4-7, 2010 in Orlando, Florida. The ASH meeting is the world's leading scientific gathering of hematologists and hematology researchers.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

First Edition: December 7, 2010

In today's headlines, Senate leaders appear to be nearing a one-year deal on Medicare's physician pay problem.

7 Dec 2010

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

While the medical community continues to debate the benefits of CYP2D6 genetic testing for women on the breast cancer treatment tamoxifen, patients using the medication are anxious to have the tests. According to a new survey of more than 700 women with breast cancer currently taking tamoxifen, almost 80 percent of respondents would choose to have a genetic test that determines CYP2D6 genotype, yet only 14 percent of these women have been tested. CYP2D6 is an enzyme that influences how well the body processes tamoxifen into its more active form.

7 Dec 2010

Studies highlight need for new antiviral treatment options and strategies

Two new studies raise public health concerns about increasing antiviral resistance among certain influenza viruses, their ability to spread, and a lack of alternative antiviral treatment options.

7 Dec 2010

Apexigen enters collaboration with Centocor R&D for antibody discovery

Apexigen, Inc. announced today that it has entered into a collaboration and worldwide license agreement with Centocor Research & Development, Inc. and its affiliates to utilize Apexigen's proprietary therapeutic antibody technologies to discover and develop monoclonal antibody drugs. Apexigen will generate and screen antibodies to several targets specified by Centocor R&D, which will be responsible for development and commercialization of all products resulting from the collaboration.

7 Dec 2010

New ways to identify patients most likely to respond to cancer vaccine treatment

A personalized vaccine is a powerful therapy to prevent recurrence among certain follicular lymphoma patients, according to the latest results of ongoing research led by the University of Pennsylvania School of Medicine. The new findings show that when these patients - whose tumors are marked by a specific protein that may be present in up to half of people with this type of cancer -- receive a vaccine made from their own tumor cells, disease-free survival is improved by nearly two years, compared with patients who receive a placebo.

7 Dec 2010

Interleukin-1 plays major role in wound healing

Anesthesiologists are playing a leading role in research into the molecular factors affecting inflammation, pain, and healing of surgical incisions, as illustrated by papers published in the December issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

7 Dec 2010

IMO-4200 dual agonist increases antitumor activity in lymphoma models: Study

Idera Pharmaceuticals, Inc. today presented data showing that IMO-4200, a dual agonist of Toll-like receptor (TLR) 7 and TLR8, in combination with approved cancer treatments, rituximab or bortezomib, significantly increased antitumor activity in several preclinical lymphoma models. The presentation, entitled "Antitumor Activity of an RNA-Based Agonist of TLR7 and 8 in Preclinical Models of Hematological Malignancies," was made at the 52nd Annual Meeting of the American Society for Hematology in Orlando, Florida by Idera scientists.

7 Dec 2010

Global phase III study to provide novel extended release of topiramate

Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers.

7 Dec 2010

No overall cancer risk in people who donate stem cells

American Society of Hematology reveals that there is no increase in overall cancer risk in people who donate stem cells and that the utilization of a double cord blood stem cell transplant is associated with better overall outcomes when used early in the treatment of acute leukemias.

7 Dec 2010

Mayo Clinic scientists say JAK inhibitors may help treat patients with myelofibrosis

Two janus kinase (JAK) inhibitors are substantially improving treatment of myelofibrosis in patients, say Mayo Clinic researchers who are presenting results of several clinical trials at the 52nd annual meeting of the American Society of Hematology (ASH) Dec. 4 in Orlando.

7 Dec 2010

New drug appears to help patients with chronic myeloid leukemia

A new drug appears to help chronic myeloid leukemia patients who are out of treatment options after first- and second-line drugs have failed them or because their cancer cells have a mutation that makes them resistant from the start, researchers reported at the 52nd Annual Meeting of the American Society of Hematology.

7 Dec 2010