Demonstrating Biosimilarity
Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

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Advancing Peptide Synthesis Through Stapled Peptides
Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.

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New Gene Patent Rules
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders. Includes bonus online coverage.

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MHRA Warns of Dangerous Traditional Chinese Medicines
The MHRA has issued a warning to the public not to use unlicensed traditional Chinese medicines after discovering that some of them contain dangerously high levels of lead, mercury, and arsenic.

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Amgen to Acquire Onyx Pharmaceuticals in $10.4 Billion Deal
Amgen acquires Onyx Pharmaceuticals for $125 per share in cash.

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Dr. Reddy’s Voluntarily Recalls Five Lots of Ranitidine
Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Akorn To Acquire Hi-Tech Pharmacal
Akorn will acquire Hi-Tech Pharmacal for $640 million to expand specialty pharma business.

AstraZeneca's MedImmune To Acquire Amplimmune
AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.

FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance
FDA’s draft guidance provides answers to questions received on FDA’s abbreviated new drug application stability guidance.

Sanofi Pasteur's High-Dose Flu Vaccine Shows Superior Clinical Benefit in Older Adults
A Sanofi Pasteur flu-vaccine trial in adults 65 years of age and older meets a primary endpoint for superior efficacy.