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Bayer Selects Cardinal Health as U.S. Based Contract Manufacturer for Xofigo Injection

December 18, 2014 1:20 pm | News | Comments

Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of Xofigo.  As part of the agreement, Cardinal Health will build a state-of-the art, 64,000 square foot facility in Indianapolis, which will be dedicated exclusively to the manufacturing of Xofigo.

GSK Reports Positive Outcome of Phase III Study of Shingles Vaccine Containing Agenus Adjuvant

December 18, 2014 10:58 am | News | Comments

Agenus and its partner GlaxoSmithKline have reported that the ZOE-50 Phase III study met its...

Pfizer Reports Top-Line Results from a Phase III Pain Study

December 18, 2014 10:08 am | News | Comments

Pfizer has announced top-line results from a double-blind Phase III study evaluating pregabalin...

European Commission Approves Lynparza™ for Advanced BRCA-Mutated Ovarian cancer

December 18, 2014 9:04 am | News | Comments

AstraZeneca today announced that the European Commission has granted Marketing Authorization for...

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Merck Acquires OncoEthix for $110M

December 18, 2014 8:05 am | News | Comments

Merck has acquired, through a subsidiary, OncoEthix, a Swiss-based privately held biotechnology company specializing in oncology drug development. Through the acquisition, Merck has gained an investigational, novel oral BET inhibitor, OTX015, which is currently in Phase 1b studies for the treatment of hematological malignancies and advanced solid tumors.

Alcon's Xtoro Approved to Treat Swimmer’s Ear

December 17, 2014 4:17 pm | News | Comments

The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal.

FDA Accepts Apotex’ Filing of its Biosimilar Application for Pegfilgrastim

December 17, 2014 11:24 am | News | Comments

Apotex has announced that the FDA has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta. The product has been jointly developed with Intas Pharmaceuticals.  The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).

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Pfizer Starts Phase II Study of PF-06252616 in Duchenne Muscular Dystrophy

December 17, 2014 8:14 am | News | Comments

Pfizer has announced enrollment of the first patient in a multicenter Phase II clinical trial of the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness.

Bayer Submits BLA Hemophilia Treatment

December 17, 2014 8:11 am | News | Comments

Bayer HealthCare has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.

Eli Lilly Bumps Dividend for First Time Since 2009

December 16, 2014 10:54 am | News | Comments

Lilly has been dealing with a drop in both earnings and revenue due to the loss of patents protecting key drugs from cheaper generic competition. Company executives have said they remained committed to the dividend, despite the financial blows the company was absorbing, but some analysts have questioned whether that commitment might waver.

FDA Approves Novartis’ Signifor for Acromegaly

December 16, 2014 8:12 am | News | Comments

Acromegaly is a rare, debilitating endocrine disorder caused by the excess production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). In the majority of cases, the disease is caused by a non-cancerous tumor on the pituitary gland.

Baxter Recalls Two Lots of Sodium Chloride Injection

December 15, 2014 3:10 pm | News | Comments

Baxter announced it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.

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Gilead Names Senior Vice President, Hematology and Oncology Therapeutics

December 15, 2014 9:17 am | News | Comments

Gilead Sciences has announced that Philippe C. Bishop, MD, will join the company as Senior Vice President, Hematology and Oncology Therapeutics. In this position, Dr. Bishop will report to John McHutchison, MD, Executive Vice President, Clinical Research.

New York Judge Halts Alzheimer's Drug Swap

December 15, 2014 8:35 am | News | Comments

New York's attorney general says a drug manufacturer has been ordered to halt plans to discontinue its widely used Alzheimer's medication, allegedly in an effort to drive patients to a newer patented drug.        

Lilly's Cyramza Gets New Marketing Approval

December 15, 2014 8:12 am | News | Comments

The Food and Drug Administration is allowing Lilly to market the drug as a treatment for cases that have spread. Earlier this year the FDA approved the drug as a treatment for gastric cancer.          

Pfizer Pays OPKO $295M to Collaborate on OPKO’s Long-Acting Human Growth Hormone

December 15, 2014 8:07 am | News | Comments

Under the terms of the agreement, OPKO will receive an upfront payment of $295M and is eligible to receive up to an additional $275M upon the achievement of certain regulatory milestones. Pfizer will receive the exclusive license to commercialize hGH-CTP worldwide.

Gilead Faces Lawsuit Over Hepatitis C Drug Pricing

December 11, 2014 1:59 pm | by The Associated Press | News | Comments

Philadelphia's Transportation Authority has filed a lawsuit against Gilead Sciences over the pricing of its hepatitis C drug. Gilead has been selling a 12-week treatment of Sovaldi in the United States for approximately $84,000, or $1,000 per pill.

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J&J Named Happiest Company to Work For

December 11, 2014 8:15 am | News | Comments

CareerBliss has announced the 5th annual CareerBliss 50 Happiest Companies in America awards list. The list honors the top companies dedicated to creating happier work environments - as voted for by their own employees.     

FDA OKs Gardasil 9 to Prevent Cancers Caused by Five Additional Types of HPV

December 10, 2014 3:27 pm | News | Comments

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil, Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Merck Advances Breast Cancer Drug

December 10, 2014 1:44 pm | by The Associated Press | News | Comments

Merck will advance a new cancer drug into bigger patient tests, after promising findings in an early study against a very aggressive, common type of breast cancer.               

GlobalData: Patent Cliff Means Pharmaceutical Companies Will Lose $65B by 2019

December 10, 2014 9:24 am | News | Comments

Pharmaceutical companies will suffer an estimated $65B drop in sales by 2019 due to the patent expiries of several leading drugs, according to research and consulting firm GlobalData. The company’s report states that the drug makers hit hardest will include Otsuka, Eli Lilly, and AstraZeneca, with a significant proportion of losses coming in the Central Nervous System treatment sector.

Cubist Patent Losses Won't Deter Merck

December 9, 2014 10:03 am | by The Associated Press | News | Comments

Merck remains committed to its $8.4 billion acquisition of Cubist Pharmaceuticals even though a federal court invalidated most of the company's patents protecting its top-selling antibiotic just hours after the deal was announced this week.  

FDA Approves Amgen's XGEVA

December 8, 2014 10:40 am | News | Comments

Amgen announced that the FDA has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA.  

Sigma-Aldrich Stockholders Approve Acquisition by Merck KGaA

December 8, 2014 8:50 am | News | Comments

Sigma-Aldrich Corporation stockholders voted to adopt the previously announced merger agreement providing for the acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany at a special meeting of stockholders.       

Paralegal Says Sanofi Fired Her for Whistleblowing

December 8, 2014 8:41 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

A paralegal recently fired by French drugmaker Sanofi has filed a whistleblower lawsuit, claiming she was discharged after protesting an alleged kickback scheme to increase U.S. sales of its insulin medicines.       

Takeda Forms Takeda Oncology to Commercialize Cancer Medicines

December 8, 2014 8:37 am | News | Comments

Takeda Pharmaceutical Company Limited announced its global oncology business unit, headquartered in Cambridge, MA, will be called Takeda Oncology. The creation of Takeda Oncology will improve the company’s ability to meet the unique and urgent needs of cancer patients.

Charges Dropped Against Two Former Lilly Scientists

December 8, 2014 8:34 am | News | Comments

Two former Eli Lilly and Co. employees who were accused of sending trade secrets worth more than $55 million to a competing Chinese drug company will no longer face charges, the U.S. attorney's office announced Friday.      

FDA Approves Labeling Update of Abilify Maintena®

December 8, 2014 8:30 am | News | Comments

Otsuka Pharmaceutical and H. Lundbeck A/S announced that FDA approved the labeling update of Abilify Maintena® for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia.

Dynavax and AstraZeneca to Move Asthma Treatment Into Phase 2a Clinical Study

December 8, 2014 8:18 am | News | Comments

Dynavax Technologies and AstraZeneca signed an amendment to the existing Research Collaboration and License Agreement under which AstraZeneca will fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma.

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