A U.S. Patent Application for and"Airlift Perfusion Bioreactor for the Culture of Cells" was published by the Keck Graduate Institute on September 26th, 2019. The present invention is a bioreactor apparatus, com

Women with a type of advanced breast cancer unsuited to drugs like Roche's Herceptin lived significantly longer when given targeted therapies made by Novartis and Eli Lilly, new study results showed. The data unveiled Sunday at the European Societ

A U.S. Patent for "Method and System for Leak Testing" was awarded to Pall on September 24th, 2019. The present invention is a method of leak testing a flexible expandable bag having at least one port and at l

Within six months of the U.S. FDA's move to restrict the label of two immunotherapies, usage of those therapies among oncologists dropped by about 50 percent, according to a new study from researchers in the Abramson Cancer Center at the Universit

The US FDA said this week that the planned reorganization of its Office of New Drugs (OND) will move forward thanks to Congressional approval, including changes to its Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality

In September 2012, when neurologist Chris Austin at the National Institutes of Health (NIH) in Bethesda, Maryland, took charge of a new translational science center, he faced a host of skeptics. In launching the new center, NIH Director Francis Co

Novartis' Sandoz unit this week said it is recalling its prescription ranitidine capsules in the U.S. after confirming contamination with the carcinogen NMDA. The move builds on the Swiss drugmaker's decision last week to stop distribution of the

Biocon has announced the acquisition of Pfizer's R&D site at the TICEL Bio Park in Chennai, India. The 60,000 sq. ft. bench to pilot scale biologics research facility is expected to employ roughly 250 scientists. Plans for the site include an

Evotec and Takeda have made public a strategic, multi-year drug discovery collaboration designed to establish at least five drug discovery programs to pursue into clinical development. Under the terms of the collaboration, Takeda will pay Evotec a

The US FDA this week released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on March 23rd, 2020. The shift is caused by the Biologics Price Competition and Innovation Act of

The U.S. FDA is again expanding its recall of widely prescribed blood pressure drugs due to contamination with a cancer-linked chemical. The announcement targets an additional five lots of the generic drug losartan made by Torrent Pharmaceuticals.

A former biopharma CEO has been sentenced to 33 months in prison by an Indiana federal court for distributing "adulterated" drugs, including sedatives and opioids which were administered to infants. Judge James Sweeney of the US District Court for

The biopharma industry in the U.S. is under the regulatory gun to bolster its ability to accurately track and trace the drugs it manufactures and ships to store shelves and healthcare facilities. Currently, the industry uses a patchwork of central

WuXi Diagnostics, a one-year-old joint venture between New WuXi Life Science Investment Limited and Mayo Clinic, has confirmed that it plans to open a "research and diagnostic testing development facility" in downtown Rochester, Minnesota ... "to

Bioinorganic chemist Osami Shoji of Nagoya University and collaborators have found a way to hijack this 'haem acquisition system' for drug delivery. They developed a powder formed of HasA and the pigment gallium phthalocyanine (GaPc), which, when

Facing more than $4 billion in claims from 8,000-plus filings, Insys Therapeutics does not expect to come close to fulfilling all outstanding demands but has proposed a path forward in bankruptcy court anyway. On September 17th, Insys filed a prop

The complexity of molecular structures in the cell is amazing. Having achieved great success in elucidating these structures in recent years, biologists are now taking on the next challenge: to find out more about how they are constructed. A new r

Researchers at the US FDA have developed a new computational tool to predict whether the body will mount an immune response that blocks the activity of biological drugs. Specifically, the tool, dubbed TCPro, simulates how the body's CD4+ T cells w

Ginkgo Bioworks has raised another $290 million to expand the breadth of a technology that tinkers with a cell's genetic code and reprograms it-like programming a computer. Boston-based Ginkgo uses a combination of software and robotic systems to

WuXi Diagnostics, a one-year-old joint venture between New WuXi Life Science Investment Limited and Mayo Clinic, has confirmed that it plans to open a "research and diagnostic testing development facility" in downtown Rochester, Minnesota ... "to

As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US FDA has unveiled its Technology Modernization Action Plan (TMAP). Near-term modernizat