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Developing Analytical Techniques for Biotherapeutics

News-Medical talks to Dr. Lewis about the development of analytical equipment for a new era of drug development that goes beyond small molecule synthesis.

From Malvern Panalytical 11 Sep 2013

Improved lung function in patients with moderate asthma severity observed with investigational Tiotropium

Boehringer Ingelheim will present a pooled analysis of new data from the Phase 3 UniTinA-asthma® program at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona. The data from the individual MezzoTinA-asthma® Phase 3 studies (NCT01340209 and NCT00565266), from which the pooled data are derived, show the addition of tiotropium delivered via the Respimat® inhaler to medium-dose maintenance inhaled corticosteroid (ICS) therapy (defined as 400-800 µg budesonide/day or equivalent) improved lung function and provided sustained bronchodilation over 24 hours in patients with moderate asthma and airflow limitation. Tiotropium is being investigated to determine the medicine’s efficacy in treating asthma patients and is not currently approved for this indication.

11 Sep 2013

Astrazeneca, Hadasit Launch Drug Discovery Alliance

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10 Sep 2013

Bayer, Broad On Five-Year Mission To Search For Novel Cancer Therapeutics

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10 Sep 2013

Roche Signs Up To $422.5M Collaboration With Inovio

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10 Sep 2013

Paragon Bioservices awarded 2013 CMO Leadership Award for Quality and Reliability

Paragon Bioservices, a contract manufacturing organization whose expertise is the process development and manufacturing of biopharmaceuticals, announced today that it has been awarded the 2013 CMO Leadership Award for Quality and Reliability.

10 Sep 2013

Boehringer Ingelheim completes patient enrolment for interferon-free hepatitis C treatment

Boehringer Ingelheim today announced the completion of patient enrolment for a Phase IIa clinical trial investigating a new interferon-free, all-oral, direct-acting antiviral combination treatment for patients with genotype-1a chronic hepatitis C virus infection.

10 Sep 2013

Hospira announces EC approval of Inflectra, Europe's first biosimilar mAb therapy

Hospira, the world's leading provider of injectable drugs and infusion technologies, today announced the European Commission (EC) approval of Inflectra™ (infliximab), Europe's first biosimilar monoclonal antibody (mAb) therapy. Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

10 Sep 2013

Patients with COPD show improvements in lung function with olodaterol

Data from the olodaterol Phase 3 clinical program, presented for the first time at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona, showed the addition of olodaterol 5 and 10 µg delivered once daily via the Respimat® inhaler provided improvements in lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

10 Sep 2013

Roche, Inovio Pharmaceuticals to develop DNA-based vaccines for prostate cancer and hepatitis B

Roche and Inovio Pharmaceuticals, Inc. announced today that they have entered into an exclusive worldwide license agreement to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B.

10 Sep 2013

Researchers develop TSUNAMI method to create animal model of adult-onset version of SMA

A research team at Cold Spring Harbor Laboratory has used a recently developed technology they call TSUNAMI to create the first animal model of the adult-onset version of spinal muscular atrophy, a devastating motor-neuron illness.

10 Sep 2013

Biogen Idec And Isis Ink Fourth Deal In Two Years

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9 Sep 2013

Once-daily COPD portfolio data from Novartis presented at European Respiratory Society (ERS) Annual Congress

Novartis announced new analyses of data for once-daily Ultibro® Breezhaler® (investigational QVA149 - indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), which showed significant improvements in lung function, shortness of breath and health-related quality of life for chronic obstructive pulmonary disease (COPD) patients versus all comparators1,2. These data were part of 39 respiratory abstracts presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain.

9 Sep 2013

Study: More MSLs build, maintain relationships with KOLs on reimbursement committees

Medical science liaisons are increasingly forming relationships with key opinion leaders who serve on reimbursement committees, according to a study by Cutting Edge Information.

7 Sep 2013

TCSPP to offer online M.P.H program from 2014

With more than 17 programs in psychology and behavioral and health sciences already established, The Chicago School of Professional Psychology (TCSPP)—one of the leading nonprofit institutions of its kind-- is offering for the first time in its history a Master of Public Health (M.P.H.) Program beginning spring 2014 online and fall 2014 in Los Angeles.

7 Sep 2013

Avanir Pharmaceuticals, Wockhardt settle patent litigation related to NUEDEXTA capsules

Avanir Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Wockhardt USA, LLC and Wockhardt Ltd. (collectively, "Wockhardt") to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.

7 Sep 2013

Altaire Pharmaceuticals recalls 9 lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution

Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so far.

7 Sep 2013

Adheris files suit against HHS for attempting to restrain speech that serves public health interest

Adheris, Inc., an inVentiv Health company, filed suit today against the U.S. Department of Health and Human Services, asking a federal court to enjoin the government from implementing a new regulation that imposes unconstitutional restrictions on the speech of a company whose business is encouraging patients to properly take their medicine.

7 Sep 2013

D&A PHARMA to present 3 clinical studies for ALCOVER in 14th Congress of ESBRA at Warsaw

D&A PHARMA, a leading company in the Addiction therapeutic area, announces today its strong participation in the 14th Congress of European Company of Biomedical Search on the Alcoholism (ESBRA), which will be held in Warsaw from September 8th to 11th.

7 Sep 2013

Abraxane drug gets FDA approval for patients with advanced pancreatic cancer

The U.S. Food and Drug Administration today approved Abraxane for patients with advanced pancreatic cancer, following 7 years of rigorous clinical trials overseen by Scottsdale Healthcare and the Translational Genomics Research Institute.

7 Sep 2013

Pharmaceuticals News and Research

Developing Analytical Techniques for Biotherapeutics

Improved lung function in patients with moderate asthma severity observed with investigational Tiotropium

Astrazeneca, Hadasit Launch Drug Discovery Alliance

Bayer, Broad On Five-Year Mission To Search For Novel Cancer Therapeutics

Roche Signs Up To $422.5M Collaboration With Inovio

Paragon Bioservices awarded 2013 CMO Leadership Award for Quality and Reliability

Boehringer Ingelheim completes patient enrolment for interferon-free hepatitis C treatment

Hospira announces EC approval of Inflectra, Europe's first biosimilar mAb therapy

Patients with COPD show improvements in lung function with olodaterol

Roche, Inovio Pharmaceuticals to develop DNA-based vaccines for prostate cancer and hepatitis B

Researchers develop TSUNAMI method to create animal model of adult-onset version of SMA

Biogen Idec And Isis Ink Fourth Deal In Two Years

Once-daily COPD portfolio data from Novartis presented at European Respiratory Society (ERS) Annual Congress

Study: More MSLs build, maintain relationships with KOLs on reimbursement committees

TCSPP to offer online M.P.H program from 2014

Avanir Pharmaceuticals, Wockhardt settle patent litigation related to NUEDEXTA capsules

Altaire Pharmaceuticals recalls 9 lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution

Adheris files suit against HHS for attempting to restrain speech that serves public health interest

D&A PHARMA to present 3 clinical studies for ALCOVER in 14th Congress of ESBRA at Warsaw

Abraxane drug gets FDA approval for patients with advanced pancreatic cancer

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