weekly biotechnology news wrap up

January 20, 2017

January 20, 2017

This week’s headlines include: The Stem-Cell Revolution Is Coming — Slowly, FDA Issues Long-Awaited Biosimilar Interchangeability Guidance, MilliporeSigma Opens Meglumine Production Facility in Spain, Biogen to pay Forward Pharma $1.25 billion to protect MS drug, ‘Biobead’-based TB vaccine shows potential in mice, Donors and Drug Makers Offer $500 Million to Control Global Epidemics, and A Superbug That Resisted 26 Antibiotics.


“The Stem-Cell Revolution Is Coming — Slowly,” The New York Times

“In 2001, President George W. Bush issued an executive order banning federal funding for new sources of stem cells developed from preimplantation human embryos. The action stalled research and discouraged scientists. Five years later, a Kyoto University scientist, Shinya Yamanaka, and his graduate student, Kazutoshi Takahashi, re-energized the field by devising a technique to “reprogram” any adult cell, such as a skin cell, and coax it back to its earliest “pluripotent” stage. From there it can become any type of cell, from a heart muscle cell to a neuron.”

“FDA Issues Long-Awaited Biosimilar Interchangeability Guidance,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability.”

“MilliporeSigma Opens Meglumine Production Facility in Spain,” Genetic Engineering News”

“MilliporeSigma opened a facility in Mollet des Vallès, Spain, dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media. The facility, validated by the FDA, is the only location in Europe that manufactures meglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient, said Andrew Bulpin, head of process solutions strategic marketing and innovation at MilliporeSigma. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as active pharmaceutical ingredients (APIs), he added.”

“Biogen to pay Forward Pharma $1.25 billion to protect MS drug,” Reuters

“Biogen Inc said on Tuesday it would pay Forward Pharma A/S $1.25 billion to license the Danish company’s patents covering multiple sclerosis drugs, providing Biogen an insurance policy on future sales of Tecfidera, its blockbuster oral treatment for the disease. Biogen and Forward Pharma have been locked in a dispute over the patents for dimethyl fumarate, the key active ingredient in Tecfidera, which had sales of about $4 billion in 2016. While the deal gives Biogen a share of Forward’s intellectual property, the legal cases are ongoing.”

“‘Biobead’-based TB vaccine shows potential in mice,” Fierce Biotech

“While Bacillus Calmette-Guérin is the only approved tuberculosis vaccine, its variable efficacy, along with the rise of drug-resistant TB, means there is always room for an updated shot. A new candidate, based on “biobeads,” elicited an immune response in mice and could lay the path for a new approach to preventing the disease.”

“Donors and Drug Makers Offer $500 Million to Control Global Epidemics,” The New York Times

Stung by the lack of vaccines to fight the West African Ebola epidemic, a group of prominent donors announced Wednesday that they had raised almost $500 million for a new partnership to stop epidemics before they spiral out of control.

“A Superbug That Resisted 26 Antibiotics,” NPR

“People keep asking me, how close are we to going off the cliff,” says Dr. James Johnson, professor of infectious diseases medicine at the University of Minnesota. The cliffside free fall he is talking about is the day that drug-resistant bacteria will be able to outfox the world’s entire arsenal of antibiotics. Common infections would then become untreatable.