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Archive for the 'Regulatory agencies' Category

Sanctions follow stock trade complaint

April
1

The Financial Industry Regulatory Authority has barred Thomas Joseph Downs from any association with any FINRA member business. Downs, who had addresses in Pleasantville and Peekskill, settled a FINRA complaint without admitting or denying guilt, the agency said in its March disciplinary report. Downs was accused of making two unauthorized trades in two separate accounts, and later ignoring FINRA requests for information on the case. Downs does not have a local telephone listing and could not be reached for comment.

Posted by Jerry Gleeson on Wednesday, April 1st, 2009 at 12:50 pm |
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MBIA shareholders may qualify for payments

October
7

Some shareholders of MBIA Inc. may be eligible for compensation as a result of the company’s settlement of a long-standing investigation by the Securities and Exchange Commission in January 2007.

The shareholders who bought MBIA stock from Sept. 11, 1998 through Nov. 22, 2004, may qualify for payments from a $60 million fund established as part of the settlement, according to a notice posted on MBIA’s Web site.

Depending on when shareholders bought and sold the stock, they could receive compensation of $1.11 per share or $1.80 per share.

The SEC investigation focused on MBIA’s relationship with Allegheny Health, Education and Research Foundation, a Pennsylvania hospital chain that defaulted in July 1998 on $256 million of bonds that MBIA had guaranteed. MBIA, an Armonk-based bond insurer, expected that the Allegheny default would lead to a potential loss of $95 million to $100 million, exceeding the company’s unallocated loss reserve of $75 million, regulators said.

“Rather than take a loss that would dwarf any previous loss it had suffered, MBIA entered into a fraudulent scheme to avoid booking the loss,” read a 2007 statement from regulators.

Posted by Jay Loomis on Tuesday, October 7th, 2008 at 1:34 pm |
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Regeneron drug shown to aid gout patients

September
3

Regeneron Pharmaceuticals Inc. said today clinical studies have shown its Arcalyst drug to be effective in reducing incidents of sudden pain in patients with gout, a form of arthritis.

In tests of 83 patients, Arcalyst reduced the number of gout flares 81 percent in patients prescribed allopurinol, a drug used to reduced the amount of excess uric acid in the blood that is known to trigger acute spasms of joint pain and inflammation, the Eastview-based biopharmaceutical company said.

None of the patients experienced any side effects from Arcalyst, an injected drug. The successful completion of the Phase 2 clinical trial opens the door for Phase 3 studies, which Regeneron expects to begin early next year, it said.

Arcalyst, Regeneron’s only marketable drug, was approved earlier this year for treatment of a rare auto-inflammatory condition known as CAPS. Shares of Regeneron rose nearly 6 percent in trading today to end at $21.80 a share, up $1.22.

Posted by David Schepp on Wednesday, September 3rd, 2008 at 4:43 pm |
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State OKs $4.5B takeover of Energy East

September
3

State regulators today approved the $4.5 billion sale of Energy East Corp. to Iberdrola SA., with a requirement that the Spain-based energy conglomerate credit New York customers $275 million.

The sale includes two New York state subsidiaries: Rochester Gas & Electric Corp. and New York State Electric & Gas Corp., which has nearly 90,000 customers in Westchester, Putnam and Dutchess counties.

New York was the last of four Northeastern states to weigh in on the deal. Connecticut, New Hampshire and Maine previously approved the buyout.

The Public Service Commission 4-0 vote follows a non-binding determination by an administrative law judge in June that state regulators should deny Iberdrola’s takeover of Portland, Maine-based Energy East, saying the sale wasn’t in the interest of New York state residents.

Further, the judge advised that should PSC officials approve the sale, regulators should place conditions on the deal, including requiring Iberdrola to sell wind-turbine generators to prevent any possibility of electricity price manipulation.

Last month, Sen. Charles Schumer, D-N.Y., urged the commission to drop its insistence that Iberdrola sell all its wind power assets, saying that requirement wasn’t in keeping with the goal of moving the state toward renewable sources of energy.

In announcing its approval yesterday, commission Chairman Garry Brown said in permitting the sale, PSC required that Iberdrola credit ratepayers $275 million as a condition in allowing the company to operate both generation and transmission facilities in the state, which the state generally views as unacceptable.

Iberdrola will also be permitted to own and operate Energy East hydroelectric plants but will be required to sell those that operate on fossil fuels, ordering the company to file a divestiture plan of such assets within 90 days of the buyout’s completion.

Iberdrola must file a written statement of acceptance of the commission’s order before the deal can close, PSC said.

Posted by David Schepp on Wednesday, September 3rd, 2008 at 4:36 pm |
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Address change satisfied banking regulators

August
25

Hudson Valley Bank has been identified as the largest locally-based bank in Westchester County, although in a narrow legal sense the claim is a little cloudier.
The commercial bank, with assets of more than $2 billion, officially moved its principal banking office late last year from 21 Scarsdale Road in Yonkers to 1055 Somer St. in Stamford, Conn. Top management continues to run the show from the bank’s familiar headquarters on Scarsdale Road; the parent company, Hudson Valley Holding Corp., is still in Yonkers as well.
Hudson Valley Bank’s offices are listed on the quarterly reports that the bank must file with the Federal Deposit Insurance Corporation as being in Stamford.
Why the distinction? The bank has targeted Fairfield County for growth. Chief Executive Officer James J. Landy said Hudson Valley Bank faced the prospect of serving two regulators, the state of Connecticut as well as the U.S. Office of the Comptroller of the Currency, as it adds branches in Fairfield.
The bank holds a national charter. New York state has reciprocal regulatory agreements with New Jersey and Pennsylvania, but not with Connecticut. Such an agreement is in the works.
Landy said the bank’s attorneys learned that they could avoid that situation if they moved the principal banking office to the new market. It’s not a loophole in the strict sense of the word; the headquarters must be near the principal banking office, even if a state boundary intersects the line between the two, Landy said.

Posted by Jerry Gleeson on Monday, August 25th, 2008 at 3:22 pm |
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Barr confirms patent challenge

July
29

Barr Pharmaceuticals Inc. confirmed today that its Pomona-based subsidiary, Barr Laboratories Inc., has challenged four patents held by Amgen Inc. for its Sensipar drug, used by dialysis patients to treat side-effects of the treatment.

Barr said it filed an Abbreviated New Drug Application with the Food and Drug Administration on March 10, the first date the agency could accept such an application for the kidney drug.

On Monday, Amgen, along with patent partners Brigham and Women’s Hospital Inc. and NPS Pharmaceuticals Inc., filed suit against Barr and Israeli drug-maker Teva Pharmaceutical Industries Ltd. for planning to sell generic Sensipar before the expiration of patent protection.

Sensipar recorded $377 million in U.S. sales during the 12 months ending May, Barr said.

Teva, the world’s largest generic-drug maker, is buying Montvale, N.J.-based Barr for $9 billion, the companies said jointly earlier this month.

Shares of Barr were down fractionally in noontime trading to $65.81 a share.

Posted by David Schepp on Tuesday, July 29th, 2008 at 11:11 am |
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Emisphere reports upbeat results in drug tests

July
28

Emisphere Technologies Inc. said today new study results show an oral form of vitamin B12 that the company is developing reduced the amount of time it took for the body to absorb the nutrient, while increasing the amount of the nutrient that was absorbed.

Developing an effective oral form of the nutrient may save millions of Americans from painful injections, needed to ensure they get adequate levels of vitamin B12.

The study, which involved 20 men divided into four groups, showed vitamin B12 absorption was 10 times higher in those given a supplement using Emisphere’s eligen technology, according to the Cedar Knolls, N.J.-based company, which employs 60 workers in research and development at the Landmark at Eastview office complex.

Eligen, which the company has been developing in some form for years, essentially chaperons the nutrient through the digestive system, where it would otherwise be destroyed, into the bloodstream.

Data from the study hold “real promise for improving the way we approach vitamin B12 supplementation,” said Donald W. Jacobsen, professor of molecular medicine at Case Western Reserve University in Cleveland.

At least 5 million people a year in the United States receive some 40 million B-12 injections to treat a range of debilitating diseases.

Shares of the company at midday were up by nearly 7 percent to $3.29 a share.

Posted by David Schepp on Monday, July 28th, 2008 at 11:09 am |
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Energy East deal in limbo, Schumer seeks meeting

June
19

New York’s senior senator, Charles Schumer, lashed out at the state’s Public Service Commission today, calling its demands “irrational and illogical,” following a non-binding ruling by an administrative law judge Monday to reject Iberdrola SA’s $4.5 billion buyout of Energy East Corp., parent to New York State Electric & Gas Corp.

NYSEG has nearly 90,000 customers in Westchester, Putnam and Dutchess counties.

The commission is seeking “to place severe restrictions on the world’s leading wind power producer,” Schumer said in a written statement.

In his ruling, the judge urged the commission, should it decide to go ahead with the buyout, to require Iberdrola to sell of all of its wind-energy assets in the state, among other conditions.

But Schumer said that stipulation would risk jobs and a $2 billion investment in the state’s economy. The Democrat said he is seeking to meet with PSC Chairman Garry A. Brown about Iberdrola’s bid, which likely will be withdrawn if PSC rejects the plan.

“I am requesting this meeting to discuss the importance of brokering a deal that will keep customer rates low, provide system reliability and bring much-needed wind power to New York,” Schumer said.

The PSC is expected it issue its ruling on the buyout next month.

New York is the last of four Northeastern states to weigh in on the deal. Connecticut, New Hampshire and Maine have approved the buyout.

Posted by David Schepp on Thursday, June 19th, 2008 at 4:00 pm |
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Business group back greater insurance rate scrutiny

June
6

The head of the Westchester County Association called for greater regulation of the insurance industry in the wake of a recent settlement requiring Oxford Health Insurance to refund $50 million in overcharges to about 37,000 small businesses.
President William M. Mooney Jr. said he supports a proposal that would require the state Insurance Department to approve rate increases. The agency currently reviews increases after the fact; a review of Oxford led to the refund settlement.
“Our own Blue Ribbon Task Force on the Healthcare Crisis has been advocating this measure be passed for the past three years,” Mooney said in a statement. “We are pleased that the governor also recognizes the need for lawmakers to restore the tools to better monitor and manage the marketplace for health insurance rates.”

Posted by Jerry Gleeson on Friday, June 6th, 2008 at 4:56 pm |
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Oxford Health to refund $50 million to small businesses

May
29

Oxford Health Insurance Inc. will refund $50 million to about 37,000 small businesses in the New York metro area, including nearly 7,000 in the Lower Hudson Valley, who were overcharged on their policies, the state Insurance Department said today.
The department reviewed Oxford after the insurer reported that its loss ratio for small group policies in 2006 was below the 75 percent minimum. The company said the benefits it paid amounted to 70.6 percent of its overall premiums that year.
The affected products are Oxford’s small group Freedom Plan Direct, Freedom Plan Metro and Freedom Plan EPO. The settlement does not affect Oxford’s small group and direct pay HMO and “point of service” policyholders.
The small business policyholders have about 300,000 employees and family members. The refunds average $1,360 per business, about 5.5 percent of the total average annual premium in 2006, but the refund will vary depending on the number of covered individuals.
The state said that Oxford will be contacting its clients about the settlement. It estimated that 15 percent of the affected businesses were in Westchester, 2.9 percent were in Rockland, and just under 1 percent were in Putnam.

Posted by Jerry Gleeson on Thursday, May 29th, 2008 at 4:13 pm |
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EpiCept shares inch up following news of delisting notice

May
12

Shares of EpiCept Corp. were higher by a penny a share in afternoon trading today, at 48 cents a share, after reaching a 52-week low of 44 cents a share Friday, following news that the company’s shares face renewed scrutiny by Nasdaq officials.

The Eastview-based biotechnology company said Friday it was notified two days prior that it hadn’t yet regained compliance with a regulation that requires the company’s shares to maintain a market value of $35 million for 10 consecutive trading days.

Last month, Nasdaq officials gave EpiCept until May 5 to regain compliance with the listing requirement.
With last week’s news, EpiCept said it plans to seek a hearing with Nasdaq officials.

EpiCept shares also face delisting for failing to maintain a minimum $1 a share bid price, Nasdaq officials warned the company last month. The company. which is developing treatments for pain and cancer, has until Oct. 13 to regain compliance with minimum-bid price rules.

In the event the company’s shares are delisted, EpiCept said, they may be eligible to trade on the over-the-counter market, an informal method for trading stocks.

Posted by David Schepp on Monday, May 12th, 2008 at 1:18 pm |
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White Plains firm critical of FDA’s review of drug

April
18

Two consumer-advocacy organizations are criticizing a U.S. Food and Drug Administration investigation into a generic version of a popular, once-daily dose antidepressant, calling the regulatory agency’s review “inadequate.”

White Plains-based ConsumerLab.com and The People’s Pharmacy, of Durham, N.C., faulted a affirmative determination by the FDA that a generic version of Wellbutrin XL 300, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals,  because the findings were based on information from a lower dose of the drug.

In reporting its findings this week, the FDA said the generic version, marketed as Budeprion XL 300 milligrams, was “safe and effective.” The agency also said the generic version was equivalent, and therefore interchangeable with, Wellbutrin XL 300.

Calling the FDA’s findings disappointing, ConsumerLab.com and The People’s Lab said there was no evidence that the FDA evaluated the generic drug fully.

“For the FDA to say that it has reviewed the safety and efficacy of this product is not correct,” said Dr. Tod Cooperman, president of ConsumerLab.com.

“The FDA is misleading the public by publishing a positive review which actually provides no data for the 300 milligram product – the strength about which people are complaining,” said Joe Graedon of The People’s Pharmacy (www.peoplespharmacy.com).

The agency undertook its investigation after receiving complaints that patients taking the branded product experienced a loss of effectiveness when switched to the generic pill. Further, patients reported new onset or worsening of side effects.

Posted by David Schepp on Friday, April 18th, 2008 at 4:43 pm |
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Business in the Burbs is our online news blog about businesses based or operating in the Lower Hudson Valley. Visitors here will also find items of interest to consumers in the region. Most contributions are from business reporters and editors covering Westchester, Rockland and Putnam counties.

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