October 2016: A Biotech Recap

October was a busy month for biotechnology! Here are some of the highlights:

“Merck Drug Gets FDA Approval as a First-Line Lung Cancer Treatment,” The Wall Street Journal

“Merck & Co.’s immunotherapy cancer drug Keytruda received U.S. Food and Drug Administration approval as a first-line treatment for certain lung cancer patients.”

“EMA Transparency: New Clinical Reports Go Live,” Regulatory Focus

“The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a new online database.”

“Glaxo Seeks FDA Approval for Experimental Shingles Vaccine,” Bloomberg

“GlaxoSmithKline Plc said it sought regulatory approval in the U.S. for its experimental shingles vaccine which, if successful, could generate more than $700 million in annual sales for the British drugmaker and compete with Merck & Co.’s Zostavax”

“Unicef Cuts Cost of Vaccine That Protects Against 5 Diseases,” The New York Times

“The United Nations Children’s Fund has made a deal with six vaccine manufacturers that will cut in half the price of a shot that protects children against five diseases, the fund announced last week.”

“GSK links with Fimbrion to develop UTI drug,” PharmaTimes

“GlaxoSmithKline has formed a partnership with US biotech Fimbrion Therapeutics to develop a first-in-class small molecule drug for the treatment and prevention of urinary tract infections (UTIs).”

“Heat, UMiami seek to create fetal Zika vaccine,” BioCentury

“Heat Biologics Inc. (NASDAQ:HTBX) and the University of Miami said they are collaborating to develop vaccines targeting the Zika virus and other infectious diseases based on Heat’s heat shock 90 kDa protein beta 1 (Hsp90B1; GP96; GRP94) vaccine platform. Heat CEO Jeff Wolf told BioCentury that using GP96 to induce an immune response in the placenta could allow the partners to develop the first vaccine to provide fetal protection against Zika.”

“Selexis to Provide ImmuNext with Cell Lines for Research into Treatment for MS, Autoimmune Diseases,” Multiple Sclerosis News Today

“Selexis has entered into a commercial arrangement with ImmuNext, providing that company with access to research cell banks from its SURE technology Platform (a best-in-class cell line development technology). ImmuNext will use the cell banks in further developing its anti-CD40 ligand antibody, a potential therapeutic agent for chronic autoimmune disorders such as multiple sclerosis (MS).”

References are hyperlinked for the interested.

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Sartorius Launches Crossflow Filter Device

Crossflow filters are primarily used in biopharmaceutical processes to filter materials across a membrane. Sartorius, a pharmaceutical supplier, has recently developed a new crossflow filter device that is designed specifically for use in membrane screening and small-volume process development.
Called the Sartocon Slice 50, the module has a filter area of 50 cm2 and a wide variety of molecular weight cutoffs. The self-contained unit eliminates the need for a compression holder and is available in a choice of two polymers. The first is the Hydrosart membrane, which is a stable polymer suitable for a broad pH range and can be depyrogenated using NaOH at elevated temperatures. It is extremely hydrophilic, making it non-protein-binding and virtually non-fouling. The second is a polyethersulfone membrane (PESU), which is well established in the biotechnological and pharmaceutical industries, which is a stable polymer that is ideal for a broad pH and temperature range.
 Reference

Ohusmi Wins 2016 Nobel Prize in Medicine for Work in Autophagy

The 2016 Nobel Prize in Medicine or Physiology was granted to Yoshinori Ohsumi, a Japanese biologist who studies the process of waste digestion/recycling in cells, known as “autophagy.”

Autophagy is derived from Greek, and translates to “self eating.” It describes the process by which cells break down non-essential components within themselves and reuse it to release energy, perform metabolic functions, or give way to new functional parts. The disruption of autophagy is also thought to have a key role in cancer, immunological/neurological diseases, and aging.

In his research, Ohsumi experimented with yeast cells to identify 15 genes responsible for coding the elaborate mechanism of autophagy. Ohsumi’s work has led to a plethora of research in the field of autophagy, as more and more scientists are starting to recognize the value and potential that innovations in this field can have. Understanding the intricate mechanisms that guide cellular processes can shed light on possible cures for diseases such as cancer or Parkinson’s disease.

References: http://www.nytimes.com/2016/10/04/science/yoshinori-ohsumi-nobel-prize-medicine.html