The Food and Drug Administration looks like it’s bowing to the inevitable this week and drawing the blueprint for the first-ever human experiments with human embryonic stem cells.
FDA advisors meet Thursday and Friday to begin to design how these embryonic stem cell tests will be conducted. It’s an important regulatory step that could lead to human testing as early as this year. So far, biotechs have tested their spinal-cord drugs in animals, not people.
"[The FDA meeting] is the first step towards clinical trials," said Laurie Zoloth, professor of medical humanities and bioethics at Northwestern University. "It’s an important moment. And it’s only the very beginning."
Human embryos are prized by medical researchers because of their fast and malleable regenerative properties. In theory, they could be used to heal severed spines, as well as damaged or diseased brains, hearts and other organs.
But their use is one of the most controversial issues in medical research, a controversy that centers on whether embryonic cell groupings, called blastocysts, are considered human life.
Dave Prentice, senior fellow for life sciences at the Christian organization Family Research Council, opposes the use of human embryos in research. "You shouldn’t be destroying human embryos at the earlier stage of human life to harvest cells," said Prentice, who has a PhD. in biochemistry from the University of Kansas.
Other stem cell options are available, he said, such as harvesting them from umbilical cord blood or adult tissue, or "reprogramming" adult cells to behave like stem cells, as demonstrated in recently-released but early-stage studies.
Zoloth said she supports stem cell research because "the human embryo does not have the moral status of a dying child." Like other supporters, she pointed to the vast potential - though still unproven - of this science in healing traumatic injuries and degenerative diseases.
"I strongly support learning as much as we possibly can about human embryonic stem cells, as well as learning about other types of regenerative medicines," she said. "The fact that science could develop ways of healing very tragic human fates is an extraordinary capacity that we have been given by God. For people who aren’t religious, you might say that we stand in a remarkable moment in human history."
The FDA seems to be more concerned with the stem cells’ possible side effect of producing tumors. Because of the "potential risks" of human embryonic stem cell products, data showing a drug’s effectiveness "may need to be particularly strong," the document said.
An administration spokesman would not comment further than the released document.
"The FDA needs to feel comfortable that the cells we use for our cell products will not cause teratomas," said Alan Lewis, chief executive of privately-held biotech Novocell, which hopes to begin human stem cell testing within three years for a possible diabetes treatment.
Lewis described the teratomas as non-malignant but unwanted pieces of muscle, hair or other matter that form as an offshoot of embryonic stem cells, which replicate quickly and can morph into different types of tissues, such as the liver or pancreas.
Geron (GERN) could be the first company to conduct experiments in humans with drugs made from human embryonic stem cells payday loans. The biotech is developing a treatment to repair spinal cord injuries. Geron has already filed an application to the FDA to begin human testing, according to analysts. But the biotech refused to confirm this and would not discuss the upcoming meeting.
So far, Geron’s animal experiments have been tumor-free, said UBS analyst Graig Suvannavejh, who doesn’t expect the company to run into problems with the FDA.
"For Geron, the best possible outcome overall is for [the] FDA to be peachy with everything they’ve done so far," said Suvannavejh in an email to CNNMoney.com. He believes Geron could begin human testing by mid-2008.
Steve Brozak, analyst for WBB Securities, emphasized that tumor-safety is imperative, and there is little room for failure in the current environment.
"It is one of the things that can be a problem if the science is not understood completely," he said. Geron needs "to make sure that the critics of the field don’t have room to assail them with."
Advanced Cell Technology is using embryonic stem cells to develop a treatment for vision loss. Chief scientific officer Robert Lanza said his company plans to file an application for human testing to the FDA within months. He said the company has found a way to "differentiate" stem cells to reduce the possibility of tumor formation.
Neuralstem (CUR) works with stem cells derived from a donated human fetus, rather than embryonic stem cells. CEO Richard Garr said his company is developing a treatment for Lou Gehrig’s disease, which degrades spinal cord nerve cells. He intends to file an application for human testing to the FDA in September or October.
Garr said that his company’s pig tests have been tumor-free, and he hopes the FDA panelists focus on the science of stem cells, not the controversy, in designing requirements for clinical trials.
"What we hope to come out of this meeting is rationality," said Garr. "[We] hope that this isn’t just something that a stem cell-unfriendly administration is trying put in place before they leave."
Washington Mutual told employees Monday that it will exit the wholesale lending business and close home-loan centers nationwide.
Washington Mutual, the nation’s largest savings-and-loan association, is taking those steps to focus on delivering home-lending products to customers through banking stores and online, a WaMu spokesperson said.
Sara Gaugl, WaMu spokesperson, told CNN that the bank will no longer work with third party brokers. She said WaMu also will close its remaining stand-alone Home Loan Centers.
Gaugl said the company has not posted specific information about how many stores and employees will be affected.
The bank is close to a deal with private-equity firm TPG and other investors to receive a $5 billion investment, according to The Wall Street Journal.
The infusion would help WaMu meet its pressing capital requirements as the bank faces steep losses stemming from the housing crisis payday loan.
WaMu (WM, Fortune 500) shares rose nearly 30% in active trade in Monday’s session.
You may think your job is safe. But you still may not be spared the pain resulting from the weak labor market.
The loss of nearly a quarter-million jobs so far this year and a jump in the unemployment rate means the debate over whether there is a recession is pretty much over.
"There is a recession. The question now is how deep and how long," said Lakshman Achuthan, the managing director of the Economic Cycle Research Institute. And he thinks the economy could get worse.
Here’s a look at how a deteriorating job market could lead to a worse recession than many are predicting.
Less money in workers’ pockets
First of all, a weak labor market could lead to smaller wage increases for workers in all types of industries, as employers get more conservative.
A recent survey by human resources consulting firm Mercer found that 6% of U.S. employers are already trimming their compensation budgets and another 10% are considering cuts.
But the real problem for workers is that slim salary increases may not keep up with inflation, especially with food and energy prices soaring.
From November through February, average hourly wages have fallen compared to a year earlier, when adjusted for inflation, and the modest gain in wages reported for March will likely be wiped out by price gains when the Consumer Price Index is reported later this month.
Inflation pressures could intensify further if the Federal Reserve continues to slash rates in an effort to spur the economy. That’s because the Fed’s rate cuts have been one factor behind the weak dollar.
A weaker dollar means higher prices for imported goods, especially commodities like oil. The record high for gasoline and the record lows for the dollar are not a coincidence.
Ashraf Laidi, chief foreign exchange strategist for CMC Markets US, said the dollar could lose another 5 percent this year versus both the dollar and the yen as the economy continues to slow. He thinks it will be "difficult for the dollar to make any recovery" if the Fed keeps cutting rates.
Deeper problem for troubled sectors
It now appears the recession started late last year. But the labor market was the one bright spot for much of 2007. Now, a rising unemployment rate has the potential to further dent consumer confidence and put a crimp in spending.
"As long as the unemployment rate was low, people had the sense they could continue to spend and count on improving income," said Bernard Baumohl, executive director of The Economic Outlook Group, a Princeton, N.J. economic research firm. "That has all dramatically changed since the summer of 2007."
An even bigger fear is that the most troubled spots in the economy — housing, Wall Street and the auto sector — will suffer even more.
More home price declines
The housing market has already taken a major hit. And the plunge in home values, the worst since the Great Depression, happened even with the labor market being relatively healthy last year.
Normally, home sales and prices don’t plunge unless there is weakness in the job market. Well, now there is. So that’s another big concern for the already battered real estate market.
Some homeowners who lose their jobs may not be able to afford their mortgage payments because of a loss of income. That could force more people to sell at distressed prices, or have their homes go into foreclosure if they can’t find a buyer.
And this could hurt you even if you have a safe job and home that’s fully paid off since it may mean that your house will now be worth less than previously.
More shocks to Wall Street
The housing problems triggered a meltdown on Wall Street last year, the aftershocks of which are still being felt http://paydayloans-on.com. When mortgage defaults and delinquencies on subprime mortgages started to rise, it caused big problems for securities backed by those riskier home loans.
But if more people who had conventional home loans find themselves out of work and have difficulty paying their mortgages, this could affect safer loans backed by government-sponsored mortgage finance firms Fannie Mae (FNM) and Freddie Mac (FRE, Fortune 500).
A rise in defaults in mortgages made to people with good credit, Fannie’s and Freddie’s bread and butter, would put more strain on their already stretched capital reserves.
In the worst case scenario, they might need their own government-sponsored rescue, said Dean Baker, co-director of the Center for Economic and Policy Research.
"Subprime loans went bad first but a lot of the prime loans will go bad as well," he said. "I would be surprised [Fannie and Freddie] don’t need some help before this over."
What’s more, Wall Street is awash in securities backed by other types of consumer debt, including car loans and credit card balances. If rising unemployment causes higher delinquencies with those types of loans, then there is a strong possibility of more unpleasant surprises ahead in the credit markets.
"I’ll be surprised if we don’t see another investment bank get itself into trouble," Baker said.
Auto woes: Not just Detroit any more
The auto industry was battered by high gas prices last year. Sales fell 2.5% in the U.S last year. This year started out even worse, with first quarter sales down 8% compared to a year ago.
And the weak economy is starting to hurt overseas automakers like Toyota Motor (TM), which also saw U.S. sales fall in the first quarter.
Automotive market research firm CNW reports that buyer traffic is sharply lower across the industry. According to the most recent report from CNW, floor traffic at dealerships plunged nearly 30% in the second half of March, the largest drop since the early 1990s.
If more people find themselves out of work, this trend is likely to continue. That could spell trouble for employees of leading Asian automakers, which now make about half the cars and trucks they sell in the U.S. at North American plants.
So far, many of these manufacturers have avoided the temporary shutdowns and closings common at GM (GM, Fortune 500), Ford (F, Fortune 500) and Chrysler. But weak demand could lead to job cuts and reduced hours by the likes of Toyota, Honda and others.
And if that happens, this could be bad news for many companies that depend upon the auto industry, from parts makers to dealerships and even to media companies that depend on advertising from car companies.
Simply put, fewer auto sales could lead to a deeper recession.
Novartis AG (NOVN.VX: Quote, Profile, Research) has agreed to buy Nestle AG’s (NESN.VX: Quote, Profile, Research) 77 percent stake in U.S. company Alcon (ACL.N: Quote, Profile, Research) in a deal worth up to $39 billion to boost its eye care business, the Swiss drugmaker said on Monday.
Novartis will acquire a first, 25 percent stake in Alcon for $11 billion and is set to buy Nestle’s remaining 52 percent for a fixed price of $28 billion between January 2010 and July 2011.
“The margins are higher than our pharma business and are obviously very attractive,” Novartis Chief Executive Daniel Vasella told reporters.
Novartis is keen to broaden its business from prescription drugs, which face increasing competition from generic medicines and a tougher path to markets, to non-traditional areas like vaccines, eye care and generics cheap payday loans.
The price of the first stake is at a 4 percent discount to Alcon’s closing price on Friday.
Novartis, Europe’s second-largest pharmaceuticals company by market capitalization, would pay a 22 percent premium to Alcon’s closing price if it went ahead with the purchase of the second tranche.
Nestle can force through the purchase of the second tranche, but Novartis can opt out if there is a material change in the business, Novartis said.
The acquisition of the first stake values Alcon at 22.8 times expected 2008 earnings and the possible second step at a 2010 multiple of 22.5, according to Novartis.
Nidus Center for Scientific Enterprise, a Creve Coeur-based biotech business incubator, announced Friday that Victoria Gonzalez will take over April 15 as president and chief executive.
In a news release, Nidus said Gonzalez has more than 20 years’ experience with early stage startup companies and Fortune 500 corporations.
Most recently, she was interim chief executive at Graphic Surgery LLC, located at Nidus us fast cash. Graphic Surgery develops software to help insurers and patients manage surgical decisions and expenses.
Gonzalez will replace Bob Calcaterra, who ran the center since it was created in 1999 and is leaving to form a venture capital fund.
Employers cut payrolls in March for a third straight month and the jobless rate jumped to a 2-1/2-year high, further evidence that a housing downturn and credit crisis may have pushed the economy into recession.
The Labor Department on Friday said nonfarm employment fell by 80,000 jobs in March, more than expected and the biggest drop in five years. Financial markets saw this as reinforcing the need for further Federal Reserve interest rate cuts.
It was the first time the U.S. economy had shed jobs for three consecutive months since a five-month string in 2003, when the economy was mired in a recovery from the 2001 recession which created few jobs.
“The odds that it will turn out that a recession started in the early part of this year have certainly been rising,” said Harvard professor Jeffrey Frankel, a member of the private-sector panel that dates U.S payday loans. recessions.
While members of the National Bureau of Economic Research’s Business Cycle Dating Committee have been in communication, the panel has yet to call a recession.
“No sign that a recession has begun yet,” said Northwestern University professor Robert Gordon, a member of that panel.
Adding to the bleak picture, the Labor Department said a total of 152,000 jobs were lost in January and February, sharply above the prior estimate of 85,000, and the jobless rate jumped to 5.1 percent from 4.8, the highest since September 2005.
Most economists, having seen a third monthly decline, were now convinced that the economy is in recession.
The U.S. office market showed the first indication of a slowdown in the first quarter as tenants occupied less space for the first time in more than four years, according to real estate research firm Reis.
“While rent growth remains healthy overall, the office market is showing signs of weakness amid uncertainty about the economy and short- and medium-term hiring plans,” Reis’ chief economist Sam Chandan said.
In the three months ended March 31, occupied office space fell by 1.73 million square feet — the first drop since the third quarter 2003.
The national vacancy rate inched up 0.20 percentage points to 12.8 percent, marking the second consecutive quarter the rate has increased.
Tenants hesitated to sign leases for fear they won’t need the space in the near future or held out for cheaper rents, Chandan said.
“There definitely are some folks out there, particularly in financial services, where their need for space may not be what they had anticipated,” he said.
Asking rent rose 1.7 percent during the first quarter but has been slowing since the second quarter last year paydayloans. Landlords typically do not give up on rents until well after vacancy rates rise.
Effective rent — the amount landlords receive after concessions — rose 1.5 percent, slowing to less than half the peak rate of 3.2 percent seen in the second quarter 2007.
Philip Morris International shares rose on their first day of trading as analysts started covering the cigarette maker with "Buy" ratings.
Philips Morris International was spun off from Altria Group Inc. (MO, Fortune 500) and began regular trading on Monday. Analysts from Lehman Brothers and Stifel Nicolaus initiated coverage with "Buy"-equivalent ratings.
Lehman analyst Michael Branca placed PMI shares on his Favorites list in the beverage and tobacco sector and set a price target of $59 per share cashadvance.com. He said the stock will benefit from being separated from Altria’s slowing U.S. sales and the threat of lawsuits.
Branca believes Philip Morris International Inc. can surpass its own profit targets in the next two years and said the company’s stock buybacks and rising dividends should lead to solid growth.
The stock rose $2.82, or 5.6%, to $53.50 in morning trading.
Powered by WordPress -- XHTML 1.0