On behalf of all of us here at Aspen Brook, Happy Holidays! We will be closed now through Friday, January 3rd as we spend time with family and friends. The Alert will return on Monday, January 6th.

AGC Biologics is significantly expanding its CDMO services with plasmid DNA (pDNA) offerings from its Heidelberg site in Germany. The expansion of the site includes a pDNA manufacturing process improvement project that enables the extensio

Johns Hopkins University will close its graduate programs in Rockville, Maryland by the summer of 2020, dealing a blow to the county's ambitions of expanding higher education opportunities. The university plans to consolidate the Center fo

A U.S. Patent for the "Recombinant Production of Mixtures of Antibodies" was awarded to Merus on December 17th, 2019. The present invention are methods for producing mixtures of antibodies from a sin

Symbiosis Pharmaceutical Services has expanded its sterile biologics manufacturing facility in Scotland, UK by 25%.  The company has invested more than $1.9 million in the expansion of its Stirling site, doubling its current footprint wi

After years of criticism from the FDA, Sun's Halol plant still can't get through an FDA inspection without the agency finding some deficiency. In June, it was just one observation, but a just completed inspection ended with a Form 483 for Halol wi

Charles River Labs (CRL) has announced the acquisition of HemaCare for roughly $380 million in cash. The deal provides CRL with human-derived cellular products for the cell therapy market as well as cell processing services to support the discover

Novartis has made public its decision to abandone development of fevipiprant in asthma after another double phase 3 trial failure. According to published reports, Novartis had been hoping that fevipiprant would prove to be a game-changer in some f

The US FDA has issued a draft guidance explaining its qualification process for drug development tools (DDTs) in line with the 21st Century Cures Act. The 20-page draft guidance comes just ahead of the deadline set in the Cures Act and fulfills so

A late-stage clinical trial has shown therapy combining Roche's immunotherapy Tecentriq with two of its other drugs helped people with a form of advanced melanoma. The study met its primary aim of showing progression-free survival in patients with

Biotech stocks caught fire in late 2019, following a $195 billion biopharma acquisition spree among biopharma giants like Bristol-Myers Squibb and AbbVie during the first nine months of the year. The scorching pace of acquisitions kicked up anothe

A U.S. Patent for a "Mixing and Filtering System" was awarded to Sani-Tech West on December 10th, 2019. The present invention is an apparatus for growing and separating cells or micro carriers from fluid mediu

Researchers at Rice University, Texas A&M University, Biola University and Durham (U.K.) University showed that motorized molecules developed in the Rice lab of chemist James Tour are effective at killing antibiotic-resistant microbes within m

The full US Senate voted this week 72-18 to confirm Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next commissioner of the US FDA. The vote came just over a month since he was nominated, although in t

A U.S. Patent for "Protein Purification" was awarded to Genentech on December 10th, 2019. The present invention is a method for purifying an antibody from a composition comprising the antibody and a contamin

CatSci, a contract research organization (CRO), is furthering its expansion strategy to deliver tailored chemistry services to support the Chemistry, Manufacturing and Controls (CMC) demands of its global biopharma customers. The expansion include

Novartis has shipped CAR-T cell therapies to about 1,800 people with blood cancer, a noteworthy accomplishment for a personalized product made from patients' own immune cells. But some of those people have received treatments that, while safe and

A U.S. Patent for an "Apparatus and Method for Early Diagnosis of Cell Death" was awarded to Lyncee Tec on December 3rd, 2019. The present invention is an apparatus for monitoring cell viability in a sample, s

The US FDA recently warned two US-based drugmakers, Teligent Pharma in Buena, NJ, and OHM Pharma in Mineral Wells, TX, for good manufacturing practice (GMP) violations at their respective facilities. In its warning letter to Teligent Pharma, the F

Large pharma companies oppose legislation being considered by Congress to lower the prices of prescription drugs saying that this will lead to a decline in drug innovation. If that argument is credible, there should be evidence to show that the la