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AstraZeneca to Expand Frederick, MA Biologics Manufacturing Center

November 24, 2014 8:46 am | News | Comments

AstraZeneca has announced plans to expand its biologics manufacturing center in Frederick, Md. The more than $200M project will increase production capacity at the facility to support AstraZeneca’s maturing pipeline, and will help position the company to keep pace with a growing demand for the development and use of biologics, which currently represent nearly 50% of AstraZeneca’s overall pipeline.

AstraZeneca and Isis Pharmaceuticals to Co-Develop Targeted Oligonucleotide Delivery Methods

November 13, 2014 8:23 am | News | Comments

Isis Pharmaceuticals and AstraZeneca today announced a strategic alliance to discover and...

AstraZeneca Initiates Development Program for BRILINTA Reversal Agent

November 13, 2014 8:06 am | News | Comments

AstraZeneca has begun a pre-clinical development program to evaluate the ability of...

Amgen and AstraZeneca Announce Brodalumab Phase III Results

November 12, 2014 9:01 am | News | Comments

AstraZeneca and Amgen today announced that AMAGINE-3TM, a pivotal, multi-arm Phase III trial...

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AstraZeneca to Divest Myalept to Aegerion

November 6, 2014 10:44 am | News | Comments

AstraZeneca has entered into a definitive agreement with Aegerion Pharmaceuticals, Inc. to divest Myalept™ (metreleptin for injection), an orphan product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy.

Isis Pharmaceuticals Earns $7.5M Milestone Payment from AstraZeneca

November 6, 2014 8:52 am | News | Comments

Isis Pharmaceuticals has earned a $7.5 million milestone payment, the first of two milestone payments totaling $15 million, from AstraZeneca for the advancement of ISIS-STAT3Rx, also referred to as AZD9150, in patients with advanced cancers.  

AstraZeneca And Pharmacyclics Enter Clinical Trial Collaboration to Evaluate IMBRUVICA In Hematologic Cancers

November 4, 2014 6:09 pm | News | Comments

AstraZeneca and Pharmacyclics announced that they have entered into a clinical trial collaboration to evaluate novel combination therapies targeting a number of hematologic cancers.            

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FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

October 30, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.               

Off-Label Prescribing of Antipsychotic Drug Highlights Lack of Oversight

October 22, 2014 8:38 am | by Adam Miller, The Canadian Press | News | Comments

An increase in the number of prescriptions of a powerful antipsychotic drug for conditions not approved by Health Canada is raising concern about what medical experts call lack of professional and government oversight of doctors' prescribing practices.

MedImmune Receives FDA Fast Track Designation for Development of MEDI3902 for Prevention of Nosocomial Pneumonia

September 23, 2014 8:22 am | News | Comments

AstraZeneca announced today that its global biologics research and development arm, MedImmune, has received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen.

AstraZeneca and Lilly to Develop and Commercialize Alzheimer’s Disease Treatment

September 16, 2014 8:39 am | News | Comments

AstraZeneca and Eli Lilly announced an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.  

AstraZeneca and Redx Pharma to Collaborate on Targeting Genetic Drivers of Tumor Growth

September 3, 2014 8:54 am | News | Comments

AstraZeneca has entered into a research collaboration with Redx Pharma Limited to discover and develop new molecules targeting a genetic driver of tumor growth and survival. The research will complement AstraZeneca’s strategic approach focused on genetic drivers of cancer and mechanisms of resistance to established and novel cancer therapies.

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UK High Court Gives Positive Judgment in Teva's Patent Case Against AstraZeneca

September 3, 2014 8:33 am | News | Comments

Teva Pharmaceutical announced that a positive judgment has been given by the UK High Court in support of Teva's case against AstraZeneca relating to the validity of EP 1,085,877 covering the SMART ( S ingle inhaler M aintenance A nd R eliever T herapy) indication for AstraZeneca's fixed dose formoterol/budesonide combination product, Symbicort®.

DOJ Closes Probe Into AstraZeneca Trial

August 19, 2014 4:37 pm | by Associated Press | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.                

AstraZeneca Advances Tralokinumab for Severe Asthma to Phase III

August 14, 2014 8:32 am | News | Comments

AstraZeneca announced the start of the Phase III program for tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by MedImmune, the company’s global biologics research and development arm.  

AstraZeneca Announces Results of Phase III Gout Treatment Trial

August 13, 2014 8:46 am | News | Comments

AstraZeneca today announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout.

AstraZeneca and Kyowa Hakko Kirin Partner on Immuno-Oncology Clinical Study

July 30, 2014 10:02 am | News | Comments

AstraZeneca today announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.

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AstraZeneca to Acquire Almirall's Respiratory Disease Business

July 30, 2014 8:11 am | News | Comments

AstraZeneca today announced that it has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones.

AstraZeneca and QIAGEN to Develop Diagnostic Test for Lung Cancer Patients Suitable for Treatment with IRESSA

July 28, 2014 8:49 am | News | Comments

AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®.  

AstraZeneca and Roche to Develop Companion Diagnostic Test for AZD9291

July 28, 2014 7:57 am | News | Comments

AstraZeneca today announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC).

Obama Wants Limits on US Company Mergers Abroad

July 25, 2014 8:32 am | News | Comments

Staking out a populist stand ahead of the midterm elections, President Barack Obama on Thursday demanded "economic patriotism" from U.S. corporations that use legal means to avoid U.S. taxes through overseas mergers.      

MedImmune and Advaxis Partner on Immuno-Oncology Combination Clinical Trial

July 22, 2014 8:20 am | News | Comments

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies.    

AstraZeneca Reveals Designs For New R&D Center & Corporate HQ In Cambridge, UK

July 18, 2014 9:08 am | by AstraZeneca | News | Comments

AstraZeneca today revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters in Cambridge in the UK. The plans for the new facility, which will be located on the Cambridge Biomedical Campus (CBC), include designs for the Global Centre, an R&D Enabling Building and an Energy Centre.

AstraZeneca and Max Planck Institute to Create Satellite Chemistry Unit for Cardiovascular and Metabolic Diseases

July 8, 2014 8:47 am | News | Comments

AstraZeneca today announced an agreement with the Max Planck Institute of Molecular Physiology (MPI), Germany, to establish a ‘satellite unit’ in cardiovascular and metabolic disease (CVMD), linked to AstraZeneca’s CVMD Innovative Medicines unit (iMed) in Mölndal, Sweden, to study new modalities chemistry.

Panel: Flu Spray Better Than Shots for Young Kids

June 26, 2014 8:30 am | by MIKE STOBBE, AP Medical Writer | News | Comments

When it comes to flu vaccines, a federal panel says a squirt in the nose is better than a shot in the arm for young children. The advisory panel voted Wednesday to advise doctors that FluMist nasal spray is a bit better at preventing flu in healthy young kids.

AstraZeneca Licenses Synairgen's Asthma Therapy for $225M

June 13, 2014 8:43 am | News | Comments

Under the terms of the exclusive license agreement, AstraZeneca will pay Synairgen a $7.25 million up-front fee and potential development, regulatory and commercial milestones of up to $225 million. In addition, AstraZeneca will pay tiered royalties ranging from single-digit up to mid-teens on commercial sales. AstraZeneca will be responsible for future development costs.

Isis Pharmaceuticals Earns $15M from AstraZeneca for Initiation of Phase 1 Study of ISIS-AR Rx

June 10, 2014 8:21 am | News | Comments

Isis Pharmaceuticals announced today that AstraZeneca has initiated a Phase 1 clinical study of ISIS-ARRx in patients with cancer.  Isis earned a $15 million milestone payment associated with the clinical advancement of ISIS-ARRx. ISIS-ARRx is an antisense drug designed to treat patients with prostate cancer by inhibiting the production of the androgen receptor (AR).

AstraZeneca’s Novel Antibiotic Candidate AZD0914 Given Fast Track Status by FDA

June 3, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has designated its novel investigational drug AZD0914 as a Qualified Infectious Disease Product (QIDP) and awarded its development program Fast Track status for the treatment of uncomplicated gonorrhea, which is increasingly resistant to existing antibiotics and poses a serious global public health threat.

Actavis Confirms Generic Onglyza Patent Challenge

May 28, 2014 9:05 am | News | Comments

Actavis has filed an Abbreviated New Drug Application with the FDA seeking approval to market Saxagliptin Hydrochloride Tablets, 2.5 mg and 5 mg. Actavis' ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb's Onglyza. 

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