Continuous Manufacturing: Novartis’ experiment in the future of drug production

Continuous manufacturing has long been touted as the future of drug production. Pharmafile approached Novartis for more details about its successes in the area, and the challenges, of developed the new process.
Why did Novartis decide to take the step to experiment in continuous manufacturing processes? 
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Filed under: Company

Oral anticoagulants still underutilized in AFib: study

Drugmakers have turned new generation anticoagulants into blockbusters as treatments for strokes and heart attacks, but one area of care where they have made little progress is for treating atrial fibrillation. Cardiology professionals in a new study says that is unfortunate for patients.

Filed under: Cardiovascular

China FDA changes will speed up approval process, says CRO

Proposed changes to drug, medical device and clinical testing regulations provide stimulus for conducting trials in China, says CRO George Clinical.

Filed under: Emerging Markets

AbbVie’s rheumatoid arthritis drug succeeds in late-stage trial

(Reuters) – U.S. drugmaker AbbVie Inc said on Wednesday its drug to treat moderate-to-severe rheumatoid arthritis met the main goal in a late-stage study.

Filed under: Arthritis

Chiesi backs up COPD triple therapy with real world study

Italian firm takes on mighty GSK
The post Chiesi backs up COPD triple therapy with real world study appeared first on Pharmaphorum.

Filed under: COPD

Approval for biomarker-based Keytruda a US FDA first

US FDA has approved a cancer treatment based on a common biomarker, as opposed to the location in the body where the tumour developed.

Filed under: Cancer, Immunotherapy

New EMA guidelines on biosimilar medicines

Filed under: Biosimilar

AstraZeneca taps outcomes deals to boost CV, diabetes meds

Two agreements with Harvard Pilgrim for Brilinta and Bydureon will link drug cost to certain patient outcomes — the most recent examples of value-based deals.

Filed under: Diabetes

Updated NSCLC Guidelines Incorporate PD-L1 Testing and Molecular Assays

Filed under: Cancer, Immunotherapy

Industry Pulse: R&D spending in charts

Biopharmas are always on the hunt for ever-elusive innovations, but some are better at allocating investment than others. Here are five charts showing how the industry spends on R&D.

Filed under: R&D

Merck licenses Teijin Pharma’s Alzheimer’s candidate

Merck has signed a worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau.

Filed under: Alzheimer’s

Sanofi and Regeneron score FDA approval for arthritis

The FDA has awarded Sanofi and Regeneron’s Kevzara (sarilumab) approval for the treatment of moderate to severely active rheumatoid arthritis (RA) in patients who have not responded to prior therapy.   
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Filed under: Arthritis

FDA clears Merck’s Keytruda for cancer patients with certain biomarkers

(Reuters) – The U.S. Food and Drug Administration on Tuesday approved Merck & Co’s immuno-oncology treatment, Keytruda, for cancer patients who carry a specific genetic feature.

Filed under: Cancer, Immunotherapy

AstraZeneca offloads more non-core assets

The British drugmaker has worked to trim its portfolio, selling off older drugs to help offset revenue declines from key products.

Filed under: Company

Nokia, Kantar collaborate for diabetes database project

Deal looks to measure impact of ‘Lifestyle Therapy’ on diabetes treatment.
The post Nokia, Kantar collaborate for diabetes database project appeared first on Pharmaphorum.

Filed under: Diabetes

Celgene’s Data Could Lead To New Option For Multiple Sclerosis Patients

Celgene reported Monday that an experimental pill for the main type of multiple sclerosis met its main goals in a two-year study. By the end of the year, the Summit, NJ, drugmaker will ask the FDA to consider the drug, ozanimod, for approval. The Celgene (NASDAQ: CELG) drug is being tested in patients with relapsing […]

Filed under: MS

GOLD guidelines for the management of COPD – 2017 update

Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States1 and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”2 with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains […]

Filed under: COPD

Sanofi Receives CHMP Recommendation for Approval of Insulin Lispro Biosimilar

Sanofi Receives CHMP Recommendation for Approval of Insulin Lispro Biosimilar – Positive opinion based on a clinical development program involving over 1,000 people with type 1 or type 2 diabetes – ..

Filed under: Biosimilar

Roche builds case for T-cell bispecific-anti-PD-L1 combo

Roche has published early clinical data on its bispecific antibody in heavily pretreated patients with metastatic colorectal cancer. The readout hints that the T cell-activating antibody may improve outcomes in this hard-to-treat population when given as a monotherapy and in combination with anti-PD-L1 drug Tecentriq.

Filed under: Cancer, Immunotherapy

What marketers need to know about tax reform, off-label promotion, pricing

The ad-tax deduction is likely once again on the table.

Filed under: Marketing