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Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA).

4 Jan 2012

Accelrys announces acquisition of VelQuest

Accelrys, Inc., a leading scientific enterprise research and development software and services company, today announced that it has acquired privately-held VelQuest Corporation for $35 million in an all-cash transaction.

3 Jan 2012

Regeneron, Genentech enter non-exclusive license and partial settlement agreement for EYLEA

Regeneron Pharmaceuticals, Inc. today announced that the Company has entered into a non-exclusive license and partial settlement agreement with Genentech, Inc., a member of the Roche Group relating to U.S. ophthalmic sales of EYLEA (aflibercept) Injection.

3 Jan 2012

Ampio completes enrollment phase of Australian Ampion In Knee trials

Ampio Pharmaceuticals, Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities, today announced that it is has completed the expanded patient enrollment phase of its Ampion In Knee (AIK) trials in Australia.

3 Jan 2012

Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

AVEO Pharmaceuticals, Inc. and Astellas Pharma Inc. today announced that tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma.

3 Jan 2012

Combination of biomarkers indicates high risk of Alzheimer's in the future

Physician Oskar Hansson and his research group are studying biomarkers - substances present in spinal fluid and linked to Alzheimer's disease. The group has studied close to 140 people with mild memory impairment, showing that a certain combination of markers (low levels of the substance beta-amyloid and high levels of the substance tau) indicate a high risk of developing Alzheimer's disease in the future.

3 Jan 2012

FDA notes shortage of ADHD medicines

According to the U.S. Food and Drug Administration (FDA) drugs to treat attention deficit hyperactivity disorder (ADHD) are in such short supply that hundreds of patients complain daily to the agency that they are unable to find a pharmacy with enough pills to fill their prescriptions.

2 Jan 2012

FDA approves Prevnar 13 pneumococcal conjugate vaccine for adults 50 and older

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

31 Dec 2011

ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program

ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program.

31 Dec 2011

ARCA biopharma extends pharmacogenetic intellectual property protection around bucindolol

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for treating patients with bucindolol based on genetic targeting and focused on a specific genotype - homozygous wildtype for Deletion 322-325 in the alpha-2C adrenergic receptor.

31 Dec 2011

RBCC: 2012 could turn out to be better for the global biotechnology sector

With strong growth predicted for the biotech and pharmaceuticals industry in 2012, emerging biotech firm Rainbow Coral Corp. anticipates a prosperous new year ahead.

31 Dec 2011

Chengdu Tianyin receives approval for renewed High Tech Enterprise status

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and active pharmaceutical ingredients today announced the approval of the Company's operating subsidiary, Chengdu Tianyin Pharmaceutical Co., Ltd's application for the renewal of its High Tech Enterprise Status in Chengdu, Sichuan Province of China.

30 Dec 2011

Meditation, yoga and physical awareness benefit breast cancer survivors

Women recently diagnosed with breast cancer have higher survival rates than those diagnosed in previous decades, according to the American Cancer Society. However, survivors continue to face health challenges after their treatments end. Previous research reports as many as 50 percent of breast cancer survivors are depressed.

30 Dec 2011

Avastin fails to live up to expectations for extending survival in ovarian cancer

Cancer drug Avastin has been found to add about four months to the time it takes for the cancer to worsen for women with advanced cases of ovarian cancer says a new report. However it may not extend survival significantly.

29 Dec 2011

ASBMB names Yale scientist as winner of inaugural Alice and C.C. Wang award

The American Society for Biochemistry and Molecular Biology has named Elisabetta Ullu, professor of internal medicine and cell biology at the Yale University School of Medicine, the winner of the society's inaugural Alice and C.C. Wang award.

29 Dec 2011

Alexion to acquire 100% of capital stock of Enobia

Alexion Pharmaceuticals, Inc. and Enobia Pharma Corp. today announced that the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia.

29 Dec 2011

Powerful painkiller on its way to the market: Experts worry about addiction woes

Drug makers are on their way to a pure, more powerful version of the nation’s second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse. The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin.

28 Dec 2011

Mylan receives final FDA approval for Levetiracetam ER Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg.

28 Dec 2011

Mylan receives final FDA approval for Eprosartan Mesylate ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).

28 Dec 2011

CEL-SCI to expand Multikine Phase III trial in head and neck cancer

CEL-SCI Corporation is in the process of expanding its Phase III clinical trial of the investigational therapy Multikine (Leukocyte Interleukin, Injection) to 4 additional European countries - Spain, Czech Republic, Slovakia and Croatia.

27 Dec 2011