Thu, Nov. 19, 3:25 PM
- The FDA issues its first approval for a genetically engineered (GE) food, AquaAdvantage Salmon grown by Maynard, MA-based AquaBounty Technologies, a majority-owned subsidiary of Intrexon (XON +4.5%). The company introduces a recombinant DNA construct into the fish which enables them to grow faster and reach market size more quickly.
- Based on its comprehensive review of the scientific evidence, the FDA determined that the GE salmon is nutritious and safe to consume with no biologically relevant differences in the nutritional profile of AquaAdvantage Salmon and other farm-raised Atlantic salmon.
- The approval applies to only two land-based hatcheries, one in Canada and the other in Panama. No AquaAdvantage Salmon are allowed to be bred and raised in the U.S.
- The agency regulates genetically engineered animals under the Federal Food, Drug and Cosmetic Act because the rDNA construct meets the definition of a drug.
- ETFs: KXI, IPS
- ETFs: GRX, IRY, IXJ, BME
Thu, Nov. 12, 11:59 AM
- A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
- Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
- The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in clinicaltrials.gov, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
- Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
- BI is in the process of expanding its rankings to include other years.
- On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
- ETFs: BIB, BIS GRX, IRY, IXJ, BME
Thu, Nov. 12, 10:11 AM
Tue, Oct. 13, 5:26 PM
Wed, Sep. 23, 8:25 AM
- GE Healthcare (NYSE:GE) creates an new business unit, Sustainable Healthcare Solutions (SHS), that will develop high-value, low-cost technologies and healthcare delivery solutions across multiple care settings. It will invest an initial $300M as part of a multi-phase effort to develop a more robust and affordable healthcare portfolio for customers. The business will combine GE Healthcare operations in India, South and Southeast Asia and Africa.
- SHS's aim is to improve access to quality and affordable healthcare around the world by leveraging GE's Fastworks methodology to rapidly develop and commercialize pertinent and affordable technologies. It plans to work with governments, clinicians, private operators and NGOs to deliver value-based solutions that improve outcomes for patients and health systems.
- ETFs: GRX, IRY, IXJ, BME
Fri, Sep. 11, 11:23 PM
Wed, Aug. 12, 11:24 AM
Fri, Jul. 31, 7:52 AM
- According to Reuters, the value of merger and acquisition deals through July 30 was $436.4B, including 14 deals worth over $5B apiece. Although down from June's torrid pace of $546.8B, it still ranks as the seventh busiest month on record. Leading the pack was Teva's $40.5B purchase of Allergan's generic drugs business.
- The top investment bank in terms of the total value of transactions was Goldman Sachs (NYSE:GS), involved in 35 deals worth $148.8B, including half of the top ten. JP Morgan (NYSE:JPM) was second with 30 deals worth $116.1B while Morgan Stanley (NYSE:MS) was third with 33 deals valued at $95.9B.
- Global M&A so far this year is $2.64T, up 41% from last year. The action in the U.S. is up 66%.
- Energy and healthcare are the leading sectors. There have been 1,557 deals in energy worth $407B. Healthcare is close behind with 1,577 deals worth $395B.
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Mon, Jul. 13, 10:10 AM
Wed, Jun. 10, 12:32 PM
Fri, Apr. 10, 2:49 PM
Nov. 12, 2014, 1:23 PM
Under normal market conditions the Fund will invest at least 80% if its total assets in equity securities of companies engaged in the health sciences and related industries and equity derivatives with exposure to the health sciences industry. The Fund will
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