Pharmaceuticals News and Research

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PDR launches new online network to collect, distribute adverse drug events in the U.S.

PDR Network and its partners today announced the launch of a new online network to collect and distribute adverse drug events in the United States.

From Physicians' Desk Reference (PDR) 15 Jun 2011

Akela reports total consolidated revenues of $4.2 million for three months ended March 31, 2011

Akela Pharma, Inc., a drug development company with its lead product, Fentanyl TAIFUN, being developed for the treatment of breakthrough cancer pain and the company's wholly owned subsidiary, PharmaForm, a leading specialty contract service provider in the area of pharmaceutical dosage form development and manufacturing, today announced its financial results for the three months and year ended March 31, 2011.

15 Jun 2011

Sangart commences MP4OX Phase 2b study in acute traumatic injury

Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic tissues through targeted oxygen and other gas delivery, today announced the initiation of a Phase 2b study designed to evaluate the efficacy and safety of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock.

15 Jun 2011

Bayer's submission of IND for BAY 94-9343 triggers $2M milestone payment to ImmunoGen

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced that Bayer HealthCare Pharmaceuticals' submission of an Investigational New Drug (IND) application for the TAP compound, BAY 94-9343, triggers a $2 million milestone payment to ImmunoGen.

15 Jun 2011

FDA approves Abbott's CREON capsules for treatment of EPI due to cystic fibrosis

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of CREON Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.

15 Jun 2011

China Botanic net sales increase 56.1% to $18.9 million for second quarter 2011

China Botanic Pharmaceutical Inc., a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines in China, today announced financial results for the three months ended April 30, 2011.

15 Jun 2011

Actelion awards grants to 2011 ENTELLIGENCE young investigators for research in pulmonary arterial hypertension

Actelion Pharmaceuticals US, Inc. and the ENTELLIGENCE Steering Committee recognized four young researchers and their mentors for their efforts in advancing research in PAH. Each researcher will receive a 12-month mentored grant of up to $100,000 in support, funded through the ENTELLIGENCE program supported by Actelion. The announcement was made at an awards luncheon, during which the recipients of the 2011 awards gave an overview of their proposed work.

14 Jun 2011

Abbott’s CREON receives FDA approval for infant-specific dose

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of CREON® (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The CREON 3,000 units of lipase capsule provides the lowest dosage strength in the class approved by the FDA. This new option will enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines for infant dosing.

14 Jun 2011

CerebralRx launches FitNeS vagus nerve stimulation system for treating epilepsy

CerebralRx, a newly formed spin-off of implantable neuromodulation systems developer BioControl Medical, has announced market entry with the launch of its FitNeS vagus nerve stimulation system.

14 Jun 2011

CorMedix completes enrollment in CRMD001 Phase II trial for treatment of acute kidney injury

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced it successfully completed patient enrollment in its phase II Contrast-Induced Acute Kidney Injury study with its oral drug candidate CRMD001.

14 Jun 2011

Morimatsu acquires Pharmadule

Morimatsu Industry Co., Ltd., the privately owned Japanese pioneer of tank technology, has acquired Pharmadule AB of Sweden, the world leader of modular manufacturing facilities for the pharmaceutical & biopharmaceutical industries.

14 Jun 2011

FDA extends Pacira's EXPAREL PDUFA goal date by three months

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL by three months.

14 Jun 2011

C-Path, IMI sign MoU to accelerate development of safer, more effective medicines for patients

Critical Path Institute (C-Path) and the Innovative Medicines Initiative (IMI) announced today that they have signed a Memorandum of Understanding (MoU) to further the missions of both organizations.

14 Jun 2011

B. Braun receives FDA approval to use 1g and 2g Ceftazidime in DUPLEX Drug Delivery System

The U.S. Food and Drug Administration today approved B. Braun Medical Inc.'s application for 1g and 2g Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX Drug Delivery System.

From B. Braun Melsungen AG 14 Jun 2011

Orexo completes first OX27 pharmacokinetic trial against breakthrough pain in cancer

Orexo AB announces a successful outcome following completion of the first OX27 pharmacokinetic trial.

14 Jun 2011

Dengue vaccine could be available in four years

A vaccine against the mosquito-borne infection dengue, the first to reach the final stage of clinical testing, "has seen 'very promising' results in Thailand, a specialist involved in the tests said on Friday," Reuters reports.

14 Jun 2011

Cypress receives FDA approval for ZUTRIPRO, REZIRA NDA to treat cough and common cold

Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for ZUTRIPRO Oral Solution (CIII) and REZIRA Oral Solution.

14 Jun 2011

Billions committed for children’s vaccines

British Prime Minister David Cameron has pledged £814m to help vaccinate children around the world against preventable diseases like pneumonia. He made the announcement at a summit in London where countries are being asked to give an extra £2.3bn ($3.7bn) by 2015 for child vaccines. He said, “Three children die every minute from pneumonia alone. Waiting is not the right thing to do and I don't think that 0.7 per cent of our gross national income is too high a price to pay for saving lives.”

13 Jun 2011

Frontal cerebral thermal transfer can eliminate insomnia symptoms

People with primary insomnia may be able to find relief by wearing a cap that cools the brain during sleep, suggests a research abstract that will be presented Monday, June 13, in Minneapolis, Minn., at SLEEP 2011, the 25th Anniversary Meeting of the Associated Professional Sleep Societies LLC (APSS).

13 Jun 2011

Positive preliminary results from CytRx bafetinib Phase 2 trial for relapsed B-cell chronic lymphocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that preliminary results from its ENABLE Phase 2 proof-of-concept trial demonstrated that bafetinib, the Company's Bcr-Abl, Lyn and Fyn kinase inhibitor, was clinically active in a group of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments for their cancer.

13 Jun 2011

Pharmaceuticals News and Research

PDR launches new online network to collect, distribute adverse drug events in the U.S.

Akela reports total consolidated revenues of $4.2 million for three months ended March 31, 2011

Sangart commences MP4OX Phase 2b study in acute traumatic injury

Bayer's submission of IND for BAY 94-9343 triggers $2M milestone payment to ImmunoGen

FDA approves Abbott's CREON capsules for treatment of EPI due to cystic fibrosis

China Botanic net sales increase 56.1% to $18.9 million for second quarter 2011

Actelion awards grants to 2011 ENTELLIGENCE young investigators for research in pulmonary arterial hypertension

Abbott’s CREON receives FDA approval for infant-specific dose

CerebralRx launches FitNeS vagus nerve stimulation system for treating epilepsy

CorMedix completes enrollment in CRMD001 Phase II trial for treatment of acute kidney injury

Morimatsu acquires Pharmadule

FDA extends Pacira's EXPAREL PDUFA goal date by three months

C-Path, IMI sign MoU to accelerate development of safer, more effective medicines for patients

B. Braun receives FDA approval to use 1g and 2g Ceftazidime in DUPLEX Drug Delivery System

Orexo completes first OX27 pharmacokinetic trial against breakthrough pain in cancer

Dengue vaccine could be available in four years

Cypress receives FDA approval for ZUTRIPRO, REZIRA NDA to treat cough and common cold

Billions committed for children’s vaccines

Frontal cerebral thermal transfer can eliminate insomnia symptoms

Positive preliminary results from CytRx bafetinib Phase 2 trial for relapsed B-cell chronic lymphocytic leukemia

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