Pharmaceuticals News and Research

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FDA accepts Alexza ADASUVE NDA, assigns PDUFA action date

Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration (FDA) has accepted the ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.

20 Aug 2011

EBD Group, MassBio announce plenary sessions program for BioPharm America 2011

EBD Group and MassBio today announced the plenary sessions program for BioPharm America 2011, being held at the Westin Boston Waterfront Hotel, September 7-9.

20 Aug 2011

Tibet Pharmaceuticals second quarter revenue increases 12% to $8.7 million

Tibet Pharmaceuticals, Inc., an emerging specialty pharmaceutical company engaged in the development, manufacturing and marketing of traditional Tibetan medicine in China, today announced the availability of the transcript for its second quarter 2011 earnings conference call, held on August 16th.

20 Aug 2011

NIH approves BioTime's four GMP human embryonic stem cell lines

BioTime, Inc., a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that four human embryonic stem (hES) cell lines: ESI-035, ESI-049, ESI-051 and ESI-053, developed by a BioTime subsidiary have been approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry.

20 Aug 2011

Cannabis Science enters distribution agreement with PVM for marijuana dispensing machines

Cannabis Science, Inc., a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce that Cannabis Science has entered into an exclusive distribution Agreement with Prescription Vending Machines Inc. ("PVM") and contracted with PVM's principal Vincent Mehdizadeh to provide industry specific consulting and advisory services to Cannabis Science.

19 Aug 2011

Only 15 U.S. pharmaceutical ads adhere to FDA Prescription Drug Advertising Guidelines

A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death.

19 Aug 2011

New Therapy Grants Program supports innovative approach to treat epilepsy

The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) announced today a New Therapy Grant to potentially help those with treatment resistant epilepsy.

19 Aug 2011

Seven research teams across the U.S. to develop new drugs for nervous system disorders

The National Institutes of Health has made awards to investigators across the United States for an ambitious set of projects seeking to develop new drugs for disorders of the nervous system.

19 Aug 2011

Single-molecule imaging reveals how cells prepare to interact with biochemical signals

Researchers at Harvard Medical School have discovered that structural elements in the cell play a crucial role in organizing the motion of cell-surface receptors, proteins that enable cells to receive signals from other parts of the organism.

19 Aug 2011

DiaGenic reports operating revenue of NOK 1,151 thousand for second quarter 2011

DiaGenic: Important milestones achieved. DiaGenic's collaboration with Pfizer is the first collaboration between a diagnostics company and the market leader for Alzheimer's therapeutics that aims to identify blood based diagnostic tools that can detect early Alzheimer's disease, before the disease is clinically overt, or accessible to other either more invasive and costly or less precise diagnostic exploration.

19 Aug 2011

NIH/NINDS awards AMRI to develop pre-clinical drug candidate for spinal muscular atrophy

AMRI today announced it received a federal contract award from the National Institutes of Health (NIH)/National Institute of Neurological Disorders and Stroke (NINDS) to provide chemistry and other drug discovery technologies in support of NINDS' Medicinal Chemistry for Neurotherapeutics Program (MCNP), part of the NIH Blueprint Neurotherapeutics Network.

19 Aug 2011

Temple University, URMC partner to translate novel medical research into new drugs

The University of Rochester Medical Center (URMC) and Temple University School of Pharmacy have announced a partnership that will help translate novel medical research into new drugs for treating diseases.

19 Aug 2011

Uppsala University to lead new advanced cancer study

Several prominent cancer researchers are now joining forces in an advanced new cancer study. The goal is to understand which tumors will be difficult to treat and to find out why certain cancer drugs lose their effect after a period of use.

19 Aug 2011

Furiex enters loan agreement with MidCap Financial, Silicon Valley Bank

Furiex Pharmaceuticals, Inc. announced today it has entered into a loan agreement with MidCap Financial and Silicon Valley Bank to provide up to $15.0 million in capital through a secured term loan. Furiex intends to use the proceeds to support research and development for its clinical stage compounds JNJ-Q2, MuDelta and PPD10558.

19 Aug 2011

Viewpoints: 'Judicial restraint' and health law; mental health parity; perspectives from JAMA and NEJM

A Supreme Court decision to throw out health-care reform on Commerce Clause grounds could open up hundreds of other federal laws to legal challenge -- starting with the Civil Rights Act. It's hard to believe that this court really wants to relitigate the second half of the 20th century, but we'll have an answer soon enough.

19 Aug 2011

NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011

PrEP raises questions regarding 'risk disinhibition' and drug resistance

Nature News reports on "the possibility of unintended public-health consequences" of pre-exposure prophylaxis (PrEP) for HIV and pharmaceutical company Gilead's plan to ask the FDA to evaluate its combination antiretroviral (ARV) drug Truvada for use in healthy people.

18 Aug 2011

Cortex second quarter net loss decreases to $356,000

Cortex Pharmaceuticals, Inc. reported a net loss of approximately $356,000, or $0.00 per share, for the quarter ended June 30, 2011, compared with a net loss of approximately $2,454,000, or $0.04 per share, for the corresponding prior year period, with the difference reflecting revenues in the current year period from the Company's option agreement with Servier, France's largest privately held pharmaceutical company.

18 Aug 2011

ProtoKinetix completes sale of AAGP tool for protecting delicate cells in research

ProtoKinetix, announces today that it has completed the sale of (AAGP) as a vital tool to protect delicate cells in the process of utilizing stem cells, to treat disease and injury. This development will enable the Company to ramp up sales of the unique AAGP family of molecules to the medical research community.

18 Aug 2011

Lucentis receives Health Canada approval for treatment of retinal vein occlusion

Following a priority review, Health Canada has approved Lucentis (ranibizumab) as a treatment for vision loss resulting from retinal vein occlusion (RVO). This makes Lucentis the first approved treatment of its class in Canada for this debilitating condition. Patients will now have access to a treatment that is proven to be effective and has an established safety profile.

18 Aug 2011

Pharmaceuticals News and Research

FDA accepts Alexza ADASUVE NDA, assigns PDUFA action date

EBD Group, MassBio announce plenary sessions program for BioPharm America 2011

Tibet Pharmaceuticals second quarter revenue increases 12% to $8.7 million

NIH approves BioTime's four GMP human embryonic stem cell lines

Cannabis Science enters distribution agreement with PVM for marijuana dispensing machines

Only 15 U.S. pharmaceutical ads adhere to FDA Prescription Drug Advertising Guidelines

New Therapy Grants Program supports innovative approach to treat epilepsy

Seven research teams across the U.S. to develop new drugs for nervous system disorders

Single-molecule imaging reveals how cells prepare to interact with biochemical signals

DiaGenic reports operating revenue of NOK 1,151 thousand for second quarter 2011

NIH/NINDS awards AMRI to develop pre-clinical drug candidate for spinal muscular atrophy

Temple University, URMC partner to translate novel medical research into new drugs

Uppsala University to lead new advanced cancer study

Furiex enters loan agreement with MidCap Financial, Silicon Valley Bank

Viewpoints: 'Judicial restraint' and health law; mental health parity; perspectives from JAMA and NEJM

NPS submits NDA CMC section to FDA for GATTEX

PrEP raises questions regarding 'risk disinhibition' and drug resistance

Cortex second quarter net loss decreases to $356,000

ProtoKinetix completes sale of AAGP tool for protecting delicate cells in research

Lucentis receives Health Canada approval for treatment of retinal vein occlusion

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