Secondary trading environment critical for small businesses
16 March 2015
Emerging companies are considered to be the drivers of U.S. economic activity, innovation and job creation. Their ability to survive and prosper depends on ready access to capital, particularly in the private markets
Watchdog groups decry FDA's move to let reps hand out journal articles
13 March 2015
Little did the FDA know that allowing drugmakers to hand out medical-journal articles to doctors would be so controversial. After talking about the idea for years--since 2007, at least--the agency rolled out some guidelines last June that would govern the practice. And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.
Don’t edit the human germ line
13 March 2015
It is thought that studies involving the use of genome-editing tools to modify the DNA of human embryos will be published shortly.
Return to pre-antibiotic era? AMR hits developing countries hardest
13 March 2015
New antibiotic agents are urgently needed to overcome the burgeoning problem of antimicrobial resistance (AMR) in infectious bacteria, but novel agents alone may not be sufficient to prevent a return to the dark days of the pre-antimicrobial era, an infectious disease specialist has warned.
Building a viable U.S. market is the next big quest for biosimilars
13 March 2015
While the FDA may have opened the biosimilar pipeline with its approval of Sandoz Inc.'s Zarxio Friday, a lot of heavy lifting has to be done before biosimilars are a viable market in the U.S.
Marinus Pharmaceuticals Provides Business Update and Reports Year End 2014 Financial Results
12 March 2015
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative epilepsy and other neuropsychiatric therapeutics, today provided a business update and announced its financial results for the year ended December 31, 2014.
Mitigating Risk for Single-Use Assemblies in Sterile Filling
12 March 2015
Single-use technologies can offer significant benefits compared with traditional stainless-steel systems. The key driver is overall time savings. There are risks associated with single-use technologies, however, that can include product loss and questions around sterility assurance and product safety.
Behind the Scenes with Buffers
12 March 2015
The therapeutic efficacy of protein-based drugs depends in large part on their structure. Unfortunately, many proteins are highly sensitive to pH and other environmental factors and therefore are unstable unless maintained under certain conditions. To maintain a viable environment, different buffer solutions are required for nearly all downstream biopharmaceutical processing steps, including filtration, capture, and chromatography operations.
The Fierce survey: Is this a biotech bubble or a sustainable bull market?
12 March 2015
When Juno Therapeutics first approached investors with plans for an IPO, the year-old biotech was thinking of selling shares at $16 to $18 a share. The biotech wound up going public at $38 and this morning the share price is $51.
Sergey Beloborodov: Produce locally, think globally
12 March 2015
“The production strategies based only on import substitutule won’t last for long,” noted Sergey Beloborodov, the Ecexutive Director of NovaMedica at the round-table discussion “Attracting investments to pharmaceutical industry” held during the InvestRus International Conference in Moscow March 11, 2015.
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