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Quintiles, Inc. Consolidates EU Business with Headquarters in UK PDF Print E-mail
Friday, 14 October 2011 00:37
Quintiles, the only fully integrated bio pharmaceutical services provider offering clinical, commercial, consulting and capital solutions worldwide, officially opened its new European Headquarters in Reading, United Kingdom, today, bringing together employees from each of its four disciplines.
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Onyx Pharmaceuticals, Inc., Bayer HealthCare (BAY) Restructure Oncology Agreement; Announce Settlement Reached in Litigation; Onyx Gets $160M in Settlement PDF Print E-mail
Friday, 14 October 2011 00:22
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) and Bayer HealthCare restructured their partnership for the global development and marketing of Nexavar® (sorafenib) tablets and entered into a new agreement related to regorafenib, a late-stage oncology compound. 
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Zosano Pharma, Inc. and Asahi Kasei Pharma (AHKSY.PK) Enter Exclusive Licensing Agreement for a Weekly Transdermal Patch Formulation of Teribone(TM) (teriparatide acetate) PDF Print E-mail
Thursday, 13 October 2011 00:23
Zosano Pharma, Inc. (Zosano) and Asahi Kasei Pharma Corporation (AKP) announced today that they have entered into a long-term strategic collaboration for the development, commercialization and supply of a weekly transdermal patch formulation of Teribone™ (teriparatide acetate), AKP's formulation of human parathyroid hormone (human PTH 1-34), for the treatment of osteoporosis patients with a high risk of fracture.
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Pharmasset, Inc. Spikes as Pharma Company Expands Hepatitis C Trial PDF Print E-mail
Wednesday, 12 October 2011 00:18
Pharmasset, Inc. (Nasdaq: VRUS) announced today the addition of two treatment arms to the ELECTRON trial of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV).
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Insmed Incorporated Slumps as FDA Keeps Hold on Lung Treatment Trial PDF Print E-mail
Wednesday, 12 October 2011 00:12
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the Company has been notified by the U.S. Food and Drug Administration (FDA) that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.
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IDEXX Laboratories, Inc. Creating 100 Jobs With Expansion PDF Print E-mail
Tuesday, 11 October 2011 00:46
Greater Memphis Chamber officials will host an expansion ceremony Nov. 16 for Idexx Laboratories, which is adding 35,000 square feet in Memphis and creating 100 jobs.
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Roche’s RoActemra Wins U.K. Backing for More Arthritis Patients PDF Print E-mail
Monday, 10 October 2011 00:43

Roche Holding AG (ROG) won the backing of the U.K. National Institute for Health and Clinical Excellence for the RoActemra rheumatoid arthritis drug after agreeing to provide a discount to the state-run medical system.

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DA Approves Merck & Co., Inc.'s Combination Therapy Juvisync; First Combination Drug to Treat type 2 Diabetes and High Cholesterol in one Tablet PDF Print E-mail
Monday, 10 October 2011 00:34
The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
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Tolerx, Inc. Cuts Staff, Auctioning Assets After Phase 3 Failure PDF Print E-mail
Saturday, 08 October 2011 00:47

Tolerx is winding down operations after more than a decade spent developing drugs for immune-related diseases, three sources familiar with the biotech's plans told FierceBiotech.

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Alchemia's Cancer Treatment Shows Early Promise in Lung Cancer Trial PDF Print E-mail
Saturday, 01 October 2011 00:36
Alchemia’s lead cancer product from its HyACT? technology, HA-Irinotecan, was featured on Channel Seven News at 6pm yesterday in most regions, and was also featured on Sevens Sunrise program this morning (Wednesday 28 September) at 6.45am.
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J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues PDF Print E-mail
Friday, 14 October 2011 00:34

A Johnson & Johnson (JNJ) unit never warned users of the Levaquin antibiotic that it posed a greater risk of tendon damage than rival medications, a lawyer for two men suing the company said today.

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Dynavax Technologies Corporation Reports Positive Immunogenicity Data From an Analysis of Hypo-Responsive Populations in HEPLISAV(TM) Phase 3 Trial PDF Print E-mail
Thursday, 13 October 2011 00:25
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced immunogenicity data for subpopulations known to be hypo-responsive (males, obese, and smokers) to currently licensed hepatitis B vaccines from its Phase 3 trial (HBV-16).
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FDA Approves Boehringer Ingelheim Pharmaceuticals, Inc.'s Combivent(R) Respimat(R) (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease PDF Print E-mail
Thursday, 13 October 2011 00:21
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler (COMBIVENT MDI). COMBIVENT RESPIMAT will be available for patients in mid-2012.
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Biotron Limited Shares Soar on Hepatitis C Phase 2a Positive Results PDF Print E-mail
Wednesday, 12 October 2011 00:16

Australian drug development company Biotron Limited (ASX:BIT) has released headline results from its landmark Phase 2a trial of its lead drug candidate, BIT225 in Hepatitis C virus (HCV) infected patients.

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Clinical Trial Demonstrates Safety and Efficacy of Wound-Healing Treatment PDF Print E-mail
Tuesday, 11 October 2011 00:48
Kerecis, the emerging tissue-regeneration company, has successfully completed the first human clinical trial of its MariGen Lipid Collagen Matrix.
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RegeneRx Receives Notice of Allowance for Key U.S. Heart Patent PDF Print E-mail
Tuesday, 11 October 2011 00:00
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for its application claiming methods for treating, preventing, inhibiting or reducing tissue deterioration due to congestive heart failure disease using Thymosin beta 4 (Tβ4), its isoforms and fragments, and important analogs.
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FDA Approves Eli Lilly and Company's Cialis to Treat Benign Prostatic Hyperplasia PDF Print E-mail
Monday, 10 October 2011 00:37
The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.
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Takeda Pharmaceutical Co. Ltd. Drops Europe Development of Insomnia Drug PDF Print E-mail
Saturday, 08 October 2011 00:56

Takeda Pharmaceutical said on Friday it would discontinue development of insomnia drug ramelteon in Europe, after feedback on development requirements from the region's regulatory body.

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AstraZeneca Will Cut 400 U.S. Jobs Amid Generic Drug Pressure PDF Print E-mail
Saturday, 08 October 2011 00:43

AstraZeneca Plc (AZN), the U.K.’s second- biggest drugmaker, plans to eliminate 400 positions in the U.S. as it prepares for competition from generic medicines.

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New Cephalon probe comes with Teva deal yet unapproved PDF Print E-mail
Saturday, 01 October 2011 00:05

Cephalon Inc. is under investigation again for alleged off-label marketing of a drug.

The Frazer, Pa.-based pharmaceutical company told the Securities and Exchange Commission in a filing Monday that it received a subpoena from the U.S. Attorney's Office for the Southern District of New York, seeking records related to the leukemia drug Treanda.

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