FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Eli Lilly and Company (NYSE: LLY)   announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company's Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.

According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

New drug may prevent malaria in pregnant women

Researchers at LSTM, working with colleagues of the Centres for Disease Control and Prevention (CDC) in Kenya and USA, and from the Kenya Medical Research Institution have found that a new drug may be more effective at preventing malaria in pregnant woman, especially where there is resistance to the current treatments.

LSTM's Professor Feiko ter Kuile, who heads the Malaria in Pregnancy (MiP) Consortium, was senior author on the study which has been published today in the journal The Lancet. The study evaluated the efficacy and safety of two alternative strategies in comparison to the standard treatment recommended for the prevention of malaria in 1546 HIV-negative pregnant women in western Kenya.

Malaria infection during pregnancy is a significant health problem to both the mother and the unborn child. It has been associated with chronic anaemia in the mother, and with loss of the pregnancy due to miscarriages or stillbirths and with low birth weight in pregnancies that result in livebirths, which in turn results in an increased risk of infant death. The World Health Organization (WHO) currently recommends that women in areas of stable malaria transmission receive intermittent preventative treatment in pregnancy (IPTp) with the antimalarial drug sulfadoxine-pyrimethamine (SP). Sulfadoxine-pyrimethamine is currently the only antimalarial drug that is recommended by WHO for this IPTp strategy, however high levels of resistance from the malaria parasite to this drug threatens its efficacy.

New drug may prevent malaria in pregnant women

Two studies identify promising new anti-retroviral strategy to combat HIV-1

A pair of studies by researchers at the University of Massachusetts Medical School, the University of Trento in Italy, and the University of Geneva in Switzerland, point to a promising new anti-retroviral strategy for combating HIV-1. The two studies, published online in Nature, show that the host cell membrane proteins SERINC5 and SERINC3 greatly reduce the virulence of HIV-1 by blocking the ability of the virus to infect new cells. HIV-1 encodes a protein called Nef that counteracts the SERINCs. New drugs that target the HIV-1 protein Nef would permit the SERINC proteins to inactivate the virus. The papers will appear in the October 8 issue of Nature.

"It's amazing, the magnitude of the effect that these proteins have on infectivity," said Jeremy Luban, MD, the David J. Freelander Professor in AIDS Research and professor of molecular medicine at UMass Medical School. "The SERINC proteins reduce the infectivity of HIV-1 virions by more than 100-fold."

Heinrich Gottlinger, professor of molecular, cell and cancer biology at UMass Medical School said, "The ability of HIV to inhibit these SERINC proteins has a profound impact on its capacity to infect other cells. Disrupting this mechanism could be a very powerful strategy for treating HIV and similar viruses that express the Nef protein."

The two studies, each done independently, used completely different, yet complementary, methodologies to unravel the complex interaction between the HIV-1 protein Nef and the cell surface membrane proteins SERINC5 and SERINC3, both of which are expressed in the immune system's T cells. Dr. Luban, working with former members of his lab, Massimo Pizzato, PhD, now of the University of Trento in Italy, and Federico Santoni of the University of Geneva in Switzerland, performed massively parallel sequencing on 31 human cell lines that differed in terms of the magnitude of dependence on Nef for HIV-1 replication. Independently, Dr. Gottlinger approached the problem biochemically. Conducting proteomic analysis of purified virions, he was able to identify host cell proteins that Nef regulated.

Two studies identify promising new anti-retroviral strategy to combat HIV-1

Two studies identify promising new anti-retroviral strategy to combat HIV-1

Experimental drug shows promise in mice with multiple sclerosis

An experimental drug originally identified in a National Cancer Institute library of chemical compounds as a potential therapy for brain and basal cell cancers improves the symptoms of mice with a form of the debilitating neurological disorder multiple sclerosis (MS), according to new research from NYU Langone Medical Center.

The experimental drug employed by the NYU Langone team of neuroscientists is called GANT61. It blocks the action of a key protein, Gli1, which is involved in so-called sonic hedgehog signaling, a biological pathway closely tied to neural stem cell development and the growth of some cancers, and whose signaling is raised in tissue samples taken from brain lesions in patients with MS.

A report describing the findings is being published in the journal Nature online Sept. 30.

In the study, mice with chemically damaged brain myelin were given daily doses of GANT61 for one month. Results showed that mice that received the drug had 50 percent more myelin at the end of treatment than did untreated mice. Myelin is the nerve-protecting sheath whose degradation is a principal cause of MS.

Experimental drug shows promise in mice with multiple sclerosis

Tris Pharma announces launch of generic TUSSIONEX

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced the launch of Tris-labeled generic TUSSIONEX®, an extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex.

Tussionex®, originally approved in the early 1980's, had no generic competition until 2010 when Tris Pharma's generic product entered the market under an exclusive distribution agreement with Par Pharmaceuticals. Under the terms of the distribution agreement, Par had the exclusive right to market Tris Pharma's hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension for a five year period ending September 30, 2015. With the conclusion of the five year term, the rights have reverted back to Tris and as of October 1, 2015, hydrocodone polistirex and chlorpheniramine polistirex ER Suspension in 115ml and 473 ml bottles (compare to Tussionex®) will be marketed and distributed by Tris Pharma's generic business.

Tris Pharma announces launch of generic TUSSIONEX

Beta-catenin shows treatment target potential for TKI-resistant CML

Nuclear β-catenin could be a treatment target for patients whose chronic myeloid leukaemia (CML) is resistant to tyrosine kinase inhibitors (TKIs) independent of additional BCR–BL1 mutations, US researchers suggest.

“Collectively, our data implicate nuclear β-catenin in intrinsic BCR-ABL1 kinase-independent TKI resistance, but argue against a direct role for β-catenin in BM [bone marrow]-mediated (extrinsic) TKI resistance”, write Michael Deininger, from the University of Utah in Salt Lake City, and co-investigators.

However, writing in Leukemia, they add “the caveat that even primary CML cells cultured ex vivo on primary MSCs [mesenchymal stromal cells] may not fully recapitulate persistent leukemia cells in patients on long-term imatinib therapy, including heterogeneity across patients.”

The team demonstrated that imatinib therapy reduced β-catenin levels in TKI-sensitive cell lines but had no impact on β-catenin in cells lines with either intrinsic or extrinsic BCR-ABL1 kinase-independent TKI resistance, indicating that “imatinib-resistant cells have uncoupled β-catenin expression from BCR-ABL1 activity.”

Beta-catenin shows treatment target potential for TKI-resistant CML

AbbVie reports positive results from ABT-494 Phase 2 clinical trials in patients with rheumatoid arthritis

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced results from two Phase 2 clinical trials evaluating its investigational selective JAK1 inhibitor, ABT-494, in patients with inadequate response to either methotrexate or TNF inhibitors. The clinical trials, BALANCE-I and BALANCE-II, achieved ACR20 at week 12 across all dose levels, except the lowest dose in BALANCE-II. BALANCE-I and BALANCE-II evaluated patients with moderate to severe rheumatoid arthritis with inadequate responses to prior anti-TNF (TNF-IR) or methotrexate (MTX-IR) treatment, respectively.

"We believe ABT-494 has the potential to become a best-in-class therapy, particularly in the most challenging patient population of TNF-inadequate responders," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are encouraged by the results of our Phase 2 studies and we will advance ABT-494 to Phase 3 studies with a once-daily formulation."

AbbVie reports positive results from ABT-494 Phase 2 clinical trials in patients with rheumatoid arthritis

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for Tresiba® (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba® is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba® provides a long duration of action beyond 42 hours. While patients are encouraged to take their insulin at the same time each day, Tresiba® allows patients to dose at any time of the day.

"Since 1923, Novo Nordisk has been committed to advancing insulin therapy for patients with diabetes, and we are proud to bring forward the first new basal insulin molecule to be approved by the FDA in 10 years," said Jesper Høiland, president of Novo Nordisk in the U.S. and executive vice president of Novo Nordisk A/S. "Novo Nordisk is excited to launch Tresiba® in the United States in the first quarter of 2016."

Ref : http://www.diapedia.org/management/insulin-degludec 

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Allergan releases generic INVEGA (paliperidone extended-release tablets) in the U.S.

In continuation oof my update on paliperidone

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that it has launched a generic version of Janssen's INVEGA® (paliperidone extended-release tablets) in the U.S. Allergan is the first company to receive FDA approval for and launch a generic version of INVEGA®, demonstrating the deep expertise of the Company's global generics R&D, regulatory and supply chain teams.

"This launch reinforces Allergan's commitment to developing, manufacturing and bringing to market high-quality, affordable versions of challenging products like INVEGA®, benefiting patients and reducing healthcare costs," said Robert Stewart, Allergan's Executive Vice President & President, Generics and Global Operations.

INVEGA® extended-release tablets are indicated for the treatment of schizophrenia in adults and adolescents (12-17 years of age).

For the 12 months ended July 31, 2015, INVEGA® had total U.S. brand sales of approximately $612 million, according to IMS Health data.

Allergan releases generic INVEGA (paliperidone extended-release tablets) in the U.S.

TUM scientists develop molecules that could pave way for new treatments to fight Alzheimer's, diabetes

When proteins change their structure and clump together, formation of amyloid fibrils and plaques may occur. Such 'misfolding' and 'protein aggregation' processes damage cells and cause diseases such as Alzheimer's and type 2 diabetes. A team of scientists from the Technical University of Munich (TUM) headed by Professor Aphrodite Kapurniotu have now developed molecules that suppress protein aggregation and could pave the way for new treatments to combat Alzheimer's, type 2 diabetes and other cell-degenerative diseases.

The scientists designed and studied 16 different peptide molecules in order to find out which of them are able to impede the 'clumping' of the proteins amyloid beta (Aß) and islet amyloid polypeptide (IAPP), which are associated with Alzheimer's and type 2 diabetes.

The molecules were designed on the basis of scientific work that shows that the Aß and IAPP proteins interact with each other, and that this 'cross-amyloid interaction' suppresses their clumping. The researchers selected short sequences of the IAPP protein that correspond to the key regions involved in the interaction with the Alzheimer's protein. These "hot segments" were then chemically linked to each other by using specific peptide segments as 'linkers' in order to mimic and optimize the IAPP cross-amyloid interaction surface.

Ref : http://www.tum.de/en/about-tum/news/press-releases/short/article/32611/

TUM scientists develop molecules that could pave way for new treatments to fight Alzheimer's, diabetes