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Alexza reacquires U.S. and Canadian rights for Staccato Loxapine from BLS

Alexza Pharmaceuticals, Inc. announced today that it has reacquired the U.S. and Canadian rights for AZ-004 (Staccato® loxapine) from Biovail Laboratories International SRL, a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

20 Oct 2010

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

20 Oct 2010

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $1.00 in the second quarter of fiscal 2011.

19 Oct 2010

Flamel announces achievement of clinical development milestone with Merck Serono

Flamel Technologies announced today that it has achieved a clinical development milestone under the terms of its license agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, to develop an extended release formulation of interferon beta-1a using the Medusa platform.

19 Oct 2010

Research calls for better environmental risk assessments of pharmaceuticals

The strategies used to assess the environmental risks posed by pharmaceuticals are not enough to protect natural microbial communities, reveals a researcher from the University of Gothenburg (Sweden) who is calling for better environmental risk assessments.

19 Oct 2010

Arcadia Biosciences receives Canadian marketing clearance for SONOVA 400 health product

Arcadia Biosciences, Inc., an agricultural technology company focused on developing technologies and products that benefit the environment and human health, today announced that Health Canada has granted the company clearance to sell SONOVA 400 in Canada. With the December 2009 completion of the New Dietary Ingredient (NDI) regulatory process in the United States, Arcadia is now able to make the health-maintaining oil available throughout the US and Canada.

19 Oct 2010

Johnson & Johnson third quarter sales decrease 0.7% to $15.0 billion

Johnson & Johnson today announced sales of $15.0 billion for the third quarter of 2010, a decrease of 0.7% as compared to the third quarter of 2009. Operational results increased 0.1% and the negative impact of currency was 0.8%. Domestic sales declined 2.5%, while international sales increased 1.1%, reflecting operational growth of 2.6% and a negative currency impact of 1.5%.

19 Oct 2010

Few legitimate opioid users are getting information to keep medications safe

For some people with ongoing or chronic pain, opioids (medications such as oxycodone or hydrocodone) can make the difference between disability and the ability to function at near-normal levels. For those with acute pain, such as pain after surgery or injury, sound pain management with opioids can speed healing and recovery.

19 Oct 2010

Annals of Internal Medicine raises concerns over placebo standard

Much of medicine is based on what is considered the strongest possible evidence: The placebo-controlled trial. A paper published in the October 19 issue of Annals of Internal Medicine - entitled "What's In Placebos: Who Knows" calls into question this foundation upon which much of medicine rests, by showing that there is no standard behind the standard no standard for the placebo.

19 Oct 2010

60 Plus applauds FDA decision to remove unapproved colchicine products

James L. Martin, chairman of the 60 Plus Association, a seniors advocacy group, applauded the Food and Drug Administration's (FDA) decision to remove unapproved colchicine products from the market, and called on drug manufacturers, distributors and pharmacies to help the FDA protect patients from unapproved drugs.

19 Oct 2010

Long-term use of statins reduces colorectal cancer risk

A systematic review of the medical literature supports the hypothesis that statins, cholesterol-lowering drugs used to prevent cardiac problems, are associated with reduced risk of colon and rectal cancers.

19 Oct 2010

Study suggests epoD; microtubule-stabilizing drugs may treat neurodegenerative diseases

Finding a drug that can cross the blood-brain barrier is the bane of drug development for Alzheimer's disease and other neurological disorders of the brain. A new Penn study, published this week in the Journal of Neuroscience, has found and tested in an animal model of Alzheimer's disease a class of drug that is able to enter the brain, where it stabilizes degenerating neurons and improves memory and learning.

19 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

EMA Pediatric Committee adopts positive opinion for CTI's Pixuvri for lymphoid malignancies, solid tumors

Cell Therapeutics, Inc. ("CTI") announced today that the Pediatric Committee (the "PDCO") of the European Medicines Agency ("EMA") has adopted an opinion agreeing to CTI's Pixuvri® (pixantrone dimaleate) Pediatric Investigation Plan ("PIP") for the treatment of lymphoid malignancies and solid tumors in children between ages of 6 months and 18 years.

19 Oct 2010

Purdue Pharma supports NASCSA with $200,000 grant for state prescription drug monitoring programs

The National Association of State Controlled Substances Authorities (NASCSA) announced receipt of a $200,000 grant from Purdue Pharma L.P. today at the organization's 27th annual conference in Charleston, South Carolina. The grant is part of Purdue Pharma's ongoing efforts to support the operation, expansion and awareness of appropriately-designed state prescription drug monitoring programs, which can be an effective tool to address prescription drug abuse and diversion.

19 Oct 2010

NCCN updates Clinical Practice Guidelines for Breast Cancer

The National Comprehensive Cancer Network® (NCCN®) recently updated the NCCN Clinical Practice Guidelines for Oncology (NCCN Guidelines™) for Breast Cancer to affirm the recommendation regarding the use of bevacizumab (Avastin®, Genentech/Roche) in the treatment of metastatic breast cancer.

19 Oct 2010

NeurogesX plans U.S. label expansion for Qutenza in HIV-associated neuropathy

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced plans to pursue a U.S. label expansion for Qutenza® (capsaicin) 8% patch to include patients with painful HIV-associated neuropathy (HIV-AN, also referred to as HIV-distal sensory polyneuropathy (HIV-DSP)).

19 Oct 2010

Elorac acquires world-wide rights to Cidoxepin

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, is pleased to announce that it has acquired world-wide rights to the active agent Cidoxepin from Gideon Pharmaceuticals. Cidoxepin is the cis-isomer of the widely prescribed tricyclic compound doxepin.

19 Oct 2010

Somaxon announces nonreceipt of Paragraph IV certification for generic Silenor ANDA

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the website of the U.S. Food and Drug Administration (FDA) indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Silenor® (doxepin) 3 mg and 6 mg was submitted on September 16, 2010.

19 Oct 2010

Tylenol batch recalled due to strange smell

Johnson and Johnson’s (J&J) commonly used over-the-counter painkiller Tylenol has been recalled again in some batches because of complaints of a musty or moldy odor in the product. The company is facing a U.S. congressional probe of quality control lapses in the past as well. The drugs recalled to date include the painkiller Motrin and allergy treatment Benadryl as well as this batch of 100,000 bottles of Tylenol.

18 Oct 2010

Pharmaceutical News

Alexza reacquires U.S. and Canadian rights for Staccato Loxapine from BLS

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Flamel announces achievement of clinical development milestone with Merck Serono

Research calls for better environmental risk assessments of pharmaceuticals

Arcadia Biosciences receives Canadian marketing clearance for SONOVA 400 health product

Johnson & Johnson third quarter sales decrease 0.7% to $15.0 billion

Few legitimate opioid users are getting information to keep medications safe

Annals of Internal Medicine raises concerns over placebo standard

60 Plus applauds FDA decision to remove unapproved colchicine products

Long-term use of statins reduces colorectal cancer risk

Study suggests epoD; microtubule-stabilizing drugs may treat neurodegenerative diseases

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

EMA Pediatric Committee adopts positive opinion for CTI's Pixuvri for lymphoid malignancies, solid tumors

Purdue Pharma supports NASCSA with $200,000 grant for state prescription drug monitoring programs

NCCN updates Clinical Practice Guidelines for Breast Cancer

NeurogesX plans U.S. label expansion for Qutenza in HIV-associated neuropathy

Elorac acquires world-wide rights to Cidoxepin

Somaxon announces nonreceipt of Paragraph IV certification for generic Silenor ANDA

Tylenol batch recalled due to strange smell

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

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