Drug approval pilot plan formally launched in China
06 November 2015
Following on from a presentation to the State Council earlier this week, China announced Thursday it will launch a three-year pilot plan to speed up approvals for new drugs. China's Food and Drug Administration (CFDA) said in a statement on its website that the pilot plan will take place in 10 regions and will allow research organizations and researchers themselves to seek approval for new drugs rather than forcing them to transfer their findings to drug manufacturers who then would be allowed to produce the drugs and reap most of the benefits.
Biotech sector roars back with strong October performance
06 November 2015
After suffering a 20 percent drop in value during August and September, the BioWorld Blue Chip Biotech Index, comprising 20 of the leading companies ranked by market cap, recovered over half of its losses with an 11.5 percent jump in October. Biotech benefited from a calmer, more positive period in the capital markets with the Nasdaq Composite index and the Dow Jones Industrial Average also recording strong growth of 10 percent and 9 percent, respectively.
Pharma dealmaking and collaboration shine brightly through the fog
06 November 2015
The value of up-front payments in global biopharma licensing agreements is still climbing, and global M&A spending on R&D-stage companies so far in 2015 is the best in more than a decade. Despite the gathering clouds on both the funding and reimbursement fronts – and despite the strictly nonmetaphorical fog that delayed the arrival of many delegates – those who made it to the introductory session of the 21st BIO-Europe Fall meeting Monday heard some upbeat messages from David Thomas, director of industry research and analysis, at the Washington-based Biotechnology Industry Organization (BIO).
Here's a welcome new-drug side effect: Physician access is on the rise, CMI/Compas' survey shows
05 November 2015
The doctor is ready to see you, pharma. CMI/Compas' annual Media Vitals study out today forecasts increased access to physicians for pharma companies this year. Across the board, physicians are more willing to talk to pharma companies, with only 19% saying they won't see reps in person, down from 25% in 2014. Susan Dorfman, CMI/Compas' chief commercial officer, said in the three previous years of the study, doctors noted tighter access to reps and decreased engagement with pharma brands.
JAMA: 'Groundbreaking,' 'miracle' drugs not all they're cracked up to be in news stories
05 November 2015
Back in September, researchers cautioned against overhyped language in FDA press releases about new meds, saying that using the terms "breakthrough" and "promising" in statements could sway individuals' expectations about a drug. Now scientists are adding more words to the wise, showing that news stories often use rosy descriptors that aren't necessarily warranted.
Genomics boom puts strain on data storage, electricity grid
05 November 2015
A widely seen and much-celebrated chart maintained by the National Institutes of Health shows how the fall in the cost of sequencing has outstripped the steady decline of Moore's law in recent years. The chart is a visual representation of the race toward the $1,000 genome, but now the industry is feeling the flip side of the graph: It can no longer rely on Moore's law to meet its storage needs.
03 November 2015
NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced that Timothy Cooke, Ph.D., NovaDigm’s Chief Executive Officer, has been appointed to a four-year term on the National Vaccine Advisory Committee (NVAC) by Karen B. DeSalvo, M.D., MPH, MSc, Acting Assistant Secretary for Health at the U.S. Department of Health and Human Services.
Researchers develop topical device that measures skin health, blood flow
03 November 2015
Researchers have developed an epidermal electronic device that can monitor skin health and blood flow that is easier and less expensive to use than other noninvasive sensors relying on optical or ultrasound technology.
Haves and Have Nots in Biotech Venture Capital
03 November 2015
Recent data from the BIO Industry Analysis team tells a story of “haves and have-nots” in US biopharma venture capital. Three key findings were discussed Wednesday at the 14th Annual BIO Investor Forum.
With targets aplenty, precision medicine seeks precise path forward
03 November 2015
With trailblazer 23andme Inc. re-emerging in the personal genomics space with a $115 million series E to reinvigorate its direct-to-consumer efforts and the price point for whole genome analysis falling below the important $1,000-per-person barrier, precision medicine (PM) has made its way into the everyday vernacular.
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