A U.S. Patent Application for "Recombinant Yeast Strains for Pentose Fermentation" was published by Novozymes on November 21st, 2019. The present invention arerecombinant yeast cells expressing a xylulose kina

AstraZeneca has announced that the U.S. FDA has given its go ahead for the company's Calquence drug to treat chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. The drug was approved roughly two months after bei

The U.S. FDA will give Roche's experimental therapy for spinal muscular atrophy an expedited review and will decide on approval within six months, If approved, Roche's risdiplam would be the third SMA therapy to reach market in the U.S., following

Novartis will buy cholesterol drug developer The Medicines Company for $9.7 billion, the latest and largest in a string of deals under CEO Vas Narasimhan aimed at reshaping the Swiss pharmaceutical company around newer technologies and higher-marg

AstraZeneca has announced that the U.S. FDA has given its go ahead for the company's Calquence drug to treat chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. The drug was approved roughly two months after bei

A U.S. Patent for "Methods of Making T Cell Compositions" was awarded to Bluebird Bio on November 19th, 2019. The present invention is a method for manufacturing T cells comprising: a) activating a populati

With a shortage of new tuberculosis drugs in the pipeline, a software tool from the University of Michigan can predict how current drugs -- including unlikely candidates -- can be combined in new ways to create more effective treatments. "This cou

The US FDA this week released product-specific guidance documents for 81 active pharmaceutical ingredients to aid generic drug development, including 28 new draft guidances and 53 revised draft guidances. The guidances, when finalized, are intende

Sanofi is holding discussions over options for its consumer-health business that could be worth $30 billion as new Chief Executive Officer Paul Hudson seeks to rejuvenate the French drugmaker, people familiar with the matter said. While the biopha

Eli Lilly and Co. will invest $400 million in its manufacturing facility in Indianapolis, an upgrade that will lead to an additional 100 highly skilled jobs at the Indianapolis-based drug manufacturer. The money will go to enhancing the existing f

Arkuda Therapeutics, a biotechnology company developing therapies to change the trajectory of neurodegenerative disease, has signed a 10,819 square foot lease at Arsenal Yards' new state-of-the-art life science lab space. The biotech becomes the l

The World Health Organization (WHO) recently drafted a new guideline on data integrity that explains the important elements to ensure the reliability of data and information in the production and control of biopharmaceuticals. The WHO echoed simil

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

Tuesday, November 26th, 2019

The complexity of biotherapeutic products and their man

Medicines Co., the developer of a promising cholesterol drug, has attracted takeover interest from suitors including Novartis AG, people familiar with the matter said. Novartis has been holding talks about a potential acquisition of Medicines Co.,

Novo Ventures has committed up to $25 million over a five-year period to fund seed-stage drug discovery projects at the Broad Institute of MIT and Harvard in a deal which it says will propel it into the Massachusetts biotech community. The new bio

A reactor blast in the upper floors of Jeevika Life Sciences in Hyderabad, India has killed two and injured two others. According to published reports, about 20 persons were working near the reactor when it exploded. The blast blew the roof of the

A U.S. Patent Application for "Methods for Evaluating Monoclonality" was awarded to Lonza on November 14th, 2019. The present invention is a method of evaluating a value for probability of monoclonality, comp