Tag Archive | "development"

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Roche halts development of diabetes drug

ZURICH–Roche Holding AG (RHBBY) said Wednesday it is halting development of a diabetes drug partly because of serious side effects, raising questions about a category of medicines that has already seen other pharmaceutical giants cancel similar projects.

Basel-based Roche said an independent safety committee had recommended the company discontinue a late-stage clinical trial of aleglitazar, which caused kidney and heart failure in some patients. Roche also said the drug, which is designed to lower both blood sugar and so-called bad cholesterol, hadn’t proved as effective as initially hoped.

“We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with Type 2, or late-stage, diabetes who are at risk of cardiovascular disease,” Hal Barron, Head of Roche’s Global Product Development said in a statement.

Roche’s decision to cancel the trial, which involved more than 7,000 patients suffering from heart problems and Type 2 diabetes, is the latest setback for a class of drugs with similar mechanisms. Once considered promising, so-called dual PPAR agonists have failed in earlier trials, causing companies, including AstraZeneca and Bristol-Myers Squibb, to scrap their programs and pull back from the drug class.

The setback is also likely to weigh on a regulators’ decision on Avandia, a similar diabetes medicine made by British rival GlaxoSmithKline PLC and a one-time big seller. Use of the drug in the U.S. was restricted by the Food and Drug Administration, while European regulators banned it in 2010 over concerns it could lead to heart risks.

A U.S. government panel last month called for easing restrictions on the drug, which Glaxo maintains is safe.

Drug companies have been trying to develop better treatments for diabetes, a group of chronic metabolic diseases which can lead to a wide range of complications. Diabetes affects about 47 million people worldwide, according to the World Health Organization and is expected to be the seventh leading cause of death in 2030.

The failure marks a stumbling block for Roche as it tries to move beyond its key cancer-drug business and follows the 2010 discontinuation of taspoglutide, which treated similar indications.

Roche didn’t quantify the impact of its decision to halt the development of aleglitazar or say how much it had invested in the compound.

Before the halt, analysts estimated aleglitazar sales might have peaked at between 2 billion and 4 billion Swiss francs ($2.1 billion to $4.1 billion) if the compound was approved. They also said Roche may now have to re-evaluate its diabetes portfolio, where the company still has two compounds.

Alexander Klauser, Roche’s chief spokesman, said the company “will assess its portfolio and R&D efforts in the metabolic diseases area” and added the company remains committed to expanding into areas beyond oncology.

Zurich-based analyst David Kaegi with J. Safra Sarasin said in a note to investors that aleglitazar was regarded as one of Roche’s more attractive pipeline products. Mr. Kaegi has a buy rating on Roche stock.

At 1100 GMT, Roche shares were little affected, gaining 0.1% at CHF244.

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SOURCE: http://www.marketwatch.com/story/roche-halts-development-of-diabetes-drug-2013-07-10-11485928

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Biogen inks drug-development deal with Isis

Biogen Idec (BIIB) inked a deal with Isis Pharmaceuticals Inc. ISIS +4.84% to discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders that could see Isis receive over $230 million.

The deal is the third collaboration between the drug companies.

Shares of Isis rose 5.4% to $9.47 in recent premarket trading, while those of Biogen were inactive. Isis shares have risen 26% in the past year, while Biogen’s have climbed 34%.

“Our latest collaboration with Isis to discover and develop novel targets for the treatment of neurological disorders is a perfect fit within our early-stage research strategy,” said Richard Brudnick, vice president and co-head of business development at Biogen. “By combining Isis’ knowledge with Biogen Idec’s expertise as a leader in neurology, we believe this latest discovery collaboration holds great potential for finding novel approaches to treating neurologic diseases.”

Under the terms of the latest agreement, Isis will receive an upfront payment of $30 million and is responsible for the discovery of a lead antisense drug for each of the three undisclosed targets

Biogen and Isis are also developing antisense drugs to treat spinal muscular atrophy and myotonic dystrophy type 1 under previously established collaborations.

Isis is also eligible to receive substantial development milestone payments prior to the exercise by Biogen of its option to license each program. Biogen has the option to license a drug from each of the three programs through the completion of Phase 2 trials. If Biogen exercises its option, it will assume global development, regulatory and commercialization responsibilities.

Isis will receive double-digit royalties on sales of drugs, and could receive up to another $200 million in a license fee and regulatory milestone payments per program. In addition Isis will be responsible for development of the drugs through the completion of the initial Phase 2 clinical trial, with Biogen providing advice and assistance.

In June, Biogen and Isis said they had entered into an agreement to develop and commercialize an antisense drug to treat Steinert disease, a deal that could see Isis receive more than $271 million. And prior to that, in January, Isis entered into a collaboration agreement with Biogen with a potential value of $299 million to develop and commercialize the drug developer’s investigational treatment for spinal muscular atrophy.

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SOURCE: http://www.marketwatch.com/story/biogen-inks-drug-development-deal-with-isis-2012-12-10-14485552

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Geron to discontinue brain-cancer drug development

Geron Corp. GERN +4.96% said it has stopped developing its treatment for brain cancers, and will cut its work force and replace its chief financial officer.

The pharmaceutical company said it plans to reduce its work force by 40% to 64 full-time positions. It expects to lower its annual cash operating expenses from about $65 million in 2012 to about $33 million in 2013–which includes nonrecurring costs of about $3 million associated with the restructuring and about $3 million for the discontinuation of clinical trials.

As part of the restructuring, CFO Graham Cooper will be leaving to pursue other opportunities, the company said. He will be replaced by Olivia Bloom, currently vice president of finance, chief accounting officer and treasurer, effective Friday.

As it discontinues the development of brain-cancer treatment GRN1005, Geron will focus on developing imetelstat, its telomerase inhibitor, in hematologic myeloid malignancies and in patients with solid tumors that have short telomeres.

The decision to discontinue development of GRN1005 was made after the company completed a planned interim analysis for GRABM-B, the company’s Phase 2 study in patients with brain metastases arising from breast cancer. This analysis showed that there were no confirmed intra-cranial responses among the first 30 evaluable patients in the trial.

In October, Geron reported that its third-quarter net loss narrowed on significantly higher licence fees and royalties.

Shares, which were halted after hours Monday, closed at $1.48. The stock was down 46% over the past three months.

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SOURCE: http://www.marketwatch.com/story/geron-to-discontinue-brain-cancer-drug-development-2012-12-03

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GreenWorld Development, Inc. (OTC:FRXP) Stacks Up Promotions

GreenWorld Development, Inc. (OTC:FRXP) stock advertising campaign was joined by a second promoter today. The company had their own news to make a further impact as well.

GreenWorld announced intentions to acquire majority shareholding in a UK waste recycling company FE4 Ltd. The process is still in negotiation phase and might not lead to real deal in the end.

Along with the announcement, a $30 thousand dollar promotion run by Raven Consulting Corp. guarantees a one day increase in trading volume. The payment was made by a third party, Wall Street Grand. Two days ago the stock got promoted in another $30 thousand campaign, paid for by Stock Mister LLC, and carried out through newsletter of hototc.com and stockegg.com.[BANNER]

FRXP is one of the wealthier penny stock companies, but still has no business revenue and a questionable balance sheet. For a development stage company, the most troublesome part is the lack of cash or any other liquid assets. The main value lies in property leases, held by GreenWorld. Debt is considerably low, but continues to increase.

greenworld_logo.jpgThe share price advance is limited by the overall value of the company. The market cap is currently near $20 million, thought the net tangible assets of the business are only slightly above $1.3 million. Furthermore, the stock related management’s decisions cause trouble for investors. In addition to continuous stock dilution, shareholders were also presented a 3 for 1 forward split this year.

The share price has been bashing against resistance at 50 cents, and didn’t manage to break that even under very strong volume this month.

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Vaenza Feels Profitable Winds of Change With New Technology Development

Vaenza a Wholly Owned Subsidiary of SBRH Enters Into Wind Power Generation Sector With Pending Sales in Place

 SEOUL, SOUTH KOREA, Jul 20, 2010 (MARKETWIRE via COMTEX) — Vaenza, Inc., a wholly owned subsidiary of (PINKSHEETS: SBRH), Mr. Sang Gil Oh, announces this morning that the company is entering into the wind power generation sector alongside its photovoltaic energy developments. “This comes at a time when clean energy is finally seen as a long-term, cost-effective moral imperative,” states Oh. “We are making tremendous headway on application development for our solar and photovoltaic energy compounds and have recently found an opportunity that will allow us to seamlessly enter into the Wind Energy segment without interruption to our progress there.”

The opportunity is one called for by current prospective clients in discussion for long-term contracts utilizing Vaenza’s photovoltaic industrial product solutions. “It includes a current commercial customer base for Vaenza that will allow for cross-marketing in its solar initiatives and sales are currently pending for the products and solutions we will develop in this sector,” states Oh. “We have the team in place with skills to make this happen and can do so in a manner we feel will be altogether beneficial for the company and its long-term shareholders.”

Mr. Oh quotes Steve Sawyer, secretary general at the Global Wind Energy Council, who said he is most astonished by a year-on-year market growth of 41% for Wind Energy worldwide. “Total investment in the sector was $63 billion globally,” Sawyer said. “For the last 12 to 14 years, the wind industry has doubled its global install capacity approximately every 30 months and we would expect that to continue.”

The company is confident it will move forward with impressive developments in clean, alternative energy, with a focus in photovoltaic and wind energy solutions, placing it “well ahead of the competition in that we can be seen by governments and industrial clients as more of a ‘one-stop-shop’, if you will, over our competitors. We can do so effectively and efficiently and will proceed accordingly toward company growth, service expansion and overall shareholder value,” concludes Oh.

Safe Harbor Act: This release includes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involves risks and uncertainties including, but not limited to, the impact of competitive products, the ability to meet customer demand, the ability to manage growth, acquisitions of technology, equipment, or human resources, the effect of economic business conditions, and the ability to attract and retain skilled personnel. The Company is not obligated to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.

SOURCE: http://www.marketwatch.com/story/vaenza-feels-profitable-winds-of-change-with-new-technology-development-2010-07-20?reflink=MW_news_stmp

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The Need for A Radical New Approach in Africa: Part II

Yesterday I outlined the problem , today I address the solution: Why charities should place Africa ahead of other areas or issues also in need of assistance?  After Africa, south Asia/India has the greatest preponderance of child poverty in the world, followed by China.  Both India and China have emerging economies that, arguably, have a far greater capacity to provide assistance to their most needy citizens.  India and China already have or will have the wherewithal to address their indigenous poverty.  Whether they choose to do so is another matter.  At least they have the option.  However, Africa stands alone and has no other options.  There is no large emerging African-based economy or any regional benefactor that can realistically address its extreme poverty or alleviate the human deprivation.  Africa has no one else to turn to.  Charities have an opportunity to make a real impact and serve as a major catalyst in finally reversing a century of misguided policies and squandered aid. What specific actions can Charities take to help address African poverty?  I believe a radically different approach is in order.  I agree with Dambisa Moyo, the Zambian economist and former World Bank/Goldman Sachs employee who argues that over reliance on aid has trapped developing nations in a vicious circle of aid dependency.  She contends that charitable aid to African nations is not just ineffective – it is worse than no aid.  In her opinion, aid keeps Africa and Africans in a sub-servant’s role at a critical time when its governments need to step up and become more self-sufficient.  She strongly recommends shutting off all foreign aid to African nations within 10 years.  Charity from Western nations cripples African governments by fostering dependency and corruption without requiring positive change.  Efforts to increase giving by foreign celebrities like U2 singer Bono are out of touch with the real needs of African countries. I fully endorse Moyo’s approach which proposes stopping the tide of money that, however well intentioned, only promotes corruption in government and dependence in citizens.  Aid is often diverted to the coffers of cruel dictators and occasionally conflicts with the interests of citizens – free mosquito nets, for instance, killing the market for the native who sells them.

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The Need for A Radical New Approach in Africa: Part II

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Stocks to watch On Friday May 5 , 2010 , After 1,000 Dow Jones Plung Down – side ….

Other Stocks to Watch – 05/08/2010 LEAP-Leap Wireless International Inc. PARL-Parlux Fragrances Inc

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Stocks to watch On Friday May 5 , 2010 , After 1,000 Dow Jones Plung Down – side ….

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Top April Penny Stocks To Buy ( Coin ) , ( SIR ) Converted Organics Inc. (Public, NASDAQ:COIN) & Serengeti Resources Inc. (Public, CVE:SIR)

Converted Organics Inc.

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Top Penny Stocks For 2010 ( SIRI,FNM,ABR,C,BEHL,BZCN )

SIRIUS ST5TK1 Satellite Radio Receiver 1. Sirius XM .62 a share target price .95 SIRIUS ST5TK1 Satellite Radio Receiver Sirius XM Radio Inc. has two principal wholly owned subsidiaries, XM Satellite Radio Holdings Inc

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Top Penny Stocks For 2010 ( SIRI,FNM,ABR,C,BEHL,BZCN )

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Top 50 stocks to buy in 2009 & 2010 & 2011

Gentex (GNTX, news, msgs) and other auto parts suppliers are transforming the rearview mirror from a low-tech assemblage of plastic and glass to a sophisticated electronic module that automakers use to introduce safety and communications features to their vehicles. Diversify your portfolio Gentex’s specialty is a rearview mirror that uses electricity to automatically dim the headlight glare from trailing vehicles. It also has mirror devices that display the temperature, hold microphones that permit hands-free cell phone conversations, open your garage door and turn on your home’s lights

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Top 50 stocks to buy in 2009 & 2010 & 2011

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