Last year turned out to be a disappointing one for new drug approvals with the FDA clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015's tally of 45.
Several factors led to the decline: Five new drugs that had been scheduled for approval in 2016 ended up winning an early green light at the end of 2015. There was also a decline in drugs being filed for approval and the FDA rejected or delayed more applications in 2016 than in the previous two years.
ABC News projects the Republicans will retain control of the House of Representatives.
Investors in the healthcare sector have been waiting on the election in order to gauge the likelihood of new legislation or gridlock. Earlier this week, Bloomberg assessed how the sector might react to the different scenarios from today's election.
Total spending on prescription drugs in the U.S. rose 12.2% to nearly $425B in 2015, continuing a steep climb fueled by the introduction of expensive new drugs for cancer and infections, as well as price hikes for older drugs.
The annual report from IMS Health is likely to further fuel the fire of criticism from politicians, healthcare providers, and patients, stating medicines are out of reach and straining budgets.
It's been a "remarkable turn" in relative performance, says Deutsche Bank's David Bianco, noting health care was about 1K basis points ahead of the S&P 500 as recently as mid-August, but both are now about flat and neck-and-neck year-to-date. "We find this reversal unwarranted and think health care could surge into year-end," says Bianco, and if the move doesn't come in 2015, it'll surely happen next year. As for valuation, health care is selling for 14.7x 2016E EPS vs. the S&P 500 at 16x - this even as health care's expected 6% sales growth should easily trump that of nominal GDP and the S&P 500. Biano sees 6-9% EPS growth, also better than the S&P.
Focus on the big picture, says Bianco: "We believe growth in health care products will stay strong owing to an aging population and increasing efforts to treat conditions with drugs and maximize the productivity of scarce healthcare labor with as many tools and conveniences as conceivable." He likes S&P 500 biotech, pharma, devices, equipment, supplies, tech, and tools, but is cautious on managed care and other healthcare services and facilities.
Some health insurers intend to join more state Obamacare exchanges next year, a development that could lead to more moderate price increases, or even prices falls, as competition increases.
In Washington state, for example, four insurers plan to sell coverage for the first time in 2015, while in Indiana, the number of providers could double to eight.
Of the insurers, UnitedHealth Group (UNH) is set to offer new plans in the states mentioned, adding to five exchanges that it already operates on.
The providers could be hoping to benefit from "second-mover" advantage whereby they will look to sign up the increased number of younger and healthier people who are forecast to purchase coverage next year as the penalty for not doing so increases. Those who are in worse health and bought coverage last year are expected to remain with their existing plans.
Meanwhile, the Center for American Progress (CAP) think tank, which is close to the White House, has called for President Obama to appoint a CEO with private-sector experience to oversee Obamacare's federal and state online health insurance exchanges. The idea is that the exchanges would run as e-commerce sites. The CEO would also oversee insurers and market regulations, although not Medicare or Medicaid. (CAP report)
At last night's GeekWire Awards ceremony in Seattle, Leafly won App of the Year. The mobile app, described by some as the "Yelp of cannabis" helps pot consumers stay informed about cannabis strains, products and the best places to purchase them. It also connects patients to doctors who can assist them through the medical authorization process. It contains over 100K user-generated reviews of more than 800 cannabis strains as well as thousands of dispensaries and doctor locations around the world. GeekWire praised its functionality and clean professional appearance.
Leafly founder Cy Scott says, "Our team is truly honored to receive this award. When we released the app, our goal was to offer a simple way for medical and recreational cannabis consumers to get robust information at their fingertips. This award is a win for all who support the cannabis movement."
Imaging equipment, insulin pumps, defibrillators and refrigerators that store blood and drugs are examples of networked gear that have remote access control features.
The devices' software is plagued by common security holes like weak passwords, lack of authentication to access, easy-to-determine default and hard-coded passwords and embedded web servers and administrative interfaces that make it easy to identify and manipulate devices once found on the network.
Hospital are apparently just waking up to the potential risks.
Last spring, the FDA and DHS issued a notice to the health care industry about problems with hard-coded passwords after researchers found issues in ~300 devices.
The Health Care M&A Report tallies Q1 2014 deal volume of 239 transactions valued at $49.6B. The number of deals for Q4 2013 and Q1 2013 were 278 and 212, respectively. The $49.6B total value was up 11% versus Q4 and up 217% versus Q1.
The most deals were consummated in long-term care (60), pharmaceuticals (33), biotech (26) and devices (25).
The FDA proposes an "Expedited Access PMA" (EAP) process for medical devices that treat or diagnose patients with serious conditions whose medical needs are unmet by current technology. The program features earlier and more interactive participation by agency staff to collaboratively develop a plan for the collection of the scientific and clinical data to support approval. The EAP aims to reduce certain devices' development times in addition to the expected shortened premarket review.
Eligible devices must fit the following profile: 1) be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition and 2) represent one of the following: no approved alternative treatment/diagnostic exists or it represents a breakthrough technology that provides a clinically meaningful advantage over existing technology or offers a significant clinically meaningful advantage over currently-available alternatives or the device's availability is in the patient's best interest.
The proposed EAP builds on the Expedited Access Program for pharmaceuticals that the FDA launched in 2011.
Eight million people have enrolled for health insurance under Obamacare, President Obama said yesterday, easily surpassing earlier projections by the Congressional Budget Office for 6-7M signups by the end of March.
The high number of enrollments was achieved despite the technical problems that the online exchanges suffered, particularly when the Affordable Care Act was launched last year.
Around 35% of those who purchased coverage were people under 35, who are thought to be less likely need to treatment and so can help balance the cost of claims for those who need care.
However, Obama didn't provide details about the number of enrollees who already had insurance before Obamacare was introduced.
The recent Ebola outbreak in West Africa that killed 135 people was caused by a new strain of the virus that was not imported from Central Africa. Although it is 97% similar to the Zaire strain scientists believe it has been circulating undetected in the region for an undetermined amount of time.
WHO states that it will take as long as four months to contain the outbreak.
Scientists create patient-specific cell lines from the skin cells of two adult men in a procedure called somatic cell nuclear transfer demonstrating that the technique can work for people of all ages. The embryonic cells are genetically identical to the donor and have profound therapeutic potential.
The cloning procedure is difficult, however. Only one in thirty-nine attempts was successful.
In therapeutic cloning, a jolt of electricity fuses a grown cell (e.g. skin cell) with an ovum whose DNA has been removed. After ~5 days of dividing and multiplying it develops into a hollow sphere-shaped embryo. The interior cells are pluripotent stem cells which can develop into many different kinds of cells. The goal is to coax them to develop into specialized cells for therapeutic purposes.
Complicating the ability to create patient-specific cell lines for millions of people are women's reticence over donating eggs, a sometimes painful process. Widespread donations may not be ultimately necessary since many people have genetically similar immune systems so 100 human embryonic stem cell lines would match over 50% of the U.S. population according to the co-author of the study, Dr. Robert Lanza.