Filed under: Pharmaceuticals

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BioSante pancreatic cancer drug OKd as orphan

Dow Jones Newswires | BioSante Pharmaceuticals Inc. said its
pancreatic-cancer treatment has received an orphan drug designation from
the U.S. Food and Drug Administration.

Shares rose 8.79 percent premarket to $1.98. The stock was already up 26
percent this year through Friday.

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Study: Abbott mini clip safer than valve surgery

Associated Press | Many Americans with leaky heart valves soon might be able to get them fixed without open-heart surgery. A study showed that a tiny clip implanted through an artery was safer and nearly as effective as surgery, doctors reported Sunday.

The device is already on sale in Europe, and its maker, Abbott Laboratories, hopes to win approval to sell it in the United States next year. Elizabeth Taylor reportedly got one last fall – the 77-year-old actress told fans about it on Twitter.

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FDA puts most severe warning on Plavix

Associated Press | The Food and Drug Administration is adding
its strongest warning to the label for Plavix, cautioning that some
patients do not respond to the blockbuster blood thinner.

The FDA said in a statement Friday that certain patients with a genetic
variation cannot metabolize the drug, putting them at increased risk
for heart attack and stroke.

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Baxter posts results from flu vaccine trial

Associated Press | Baxter International Inc. reported late-stage
clinical trial data for its flu vaccine candidate Preflucel, saying the
drug provided a 71 percent protection rate against all strains of the
flu.

Preflucel is designed to protect against swine flu, influenza B, and
Hong Kong flu. Baxter and its partner DynPort Vaccine Co. said the shot
gave a 78 percent protection rate against flu strains that matched the
ones in the vaccine, and 71 percent from all strains.

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Abbott to take center stage at heart conference

Dow Jones Newswires | A veteran Abbott Laboratories cholesterol drug and a new Abbott
heart-repair tool will take center stage at a major heart conference
this weekend, with data that could disturb the company’s perch in one
market but smooth its path to another.

The American College of Cardiology’s roster of top trials includes
Accord, a large government-funded study that tests adding Abbott’s drug
TriCor to a generic cholesterol drug, which some analysts think will
yield mixed results. Another trial, called Everest II, examines an
Abbott-made tool designed to repair faulty heart valves without major
surgery, which could open up a big market.

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BioSante: Positive leukemia vaccine results

By Michael Oneal | BioSante
Pharmaceuticals Inc. in Lincolnshire today announced that its GVAX
leukemia vaccine had been shown in a human trial to reduce or eliminate
the last remaining cancer cells in some chronic myeloid leukemia
patients taking the drug Gleevec.
 
The study was conducted by researchers at the Johns Hopkins Kimmel
Cancer Center in Baltimore, Md., led by Hyam Levitsky, a professor
of oncology, medicine and urology at the Cancer Center. The research
was funded by the National Institutes of Health, a press release said.

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Abbott gets FDA approval for implantable lens

Associated Press | Abbott Laboratories received Food and Drug Administration approval for a new implantable lens, the drug and medical device maker said Wednesday.

The company received approval for the Tecnis multifocal 1-Piece intraocular lens for cataract patients. The approval covers patients both with and without presbyopia, a condition where the eye loses its ability to focus.

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Moody’s gives negative outlook on Abbott

Associated Press | Moody’s Investors Service affirmed its
ratings and negative outlook for Abbott Laboratories on Wednesday and
warned of a potential downgrade, citing the company’s decision to buy
Facet Biotech Corp. for $450 million.

On Tuesday, drug and medical products company Abbott announced the
$27-per-share deal, which marked a 67 percent premium to Facet’s
closing price of $16.21.

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Walgreens may offer drugs to Delta workers

cbb-a-walgreen-checkout.jpg(JB Reed/Bloomberg)

Associated Press | Media reports on Wednesday indicated
drugstore chain Walgreen Co. is in talks about a plan to offer
prescription drugs directly to employees of Delta Air Lines Inc.

Walgreen and Delta would not confirm any negotiations. The Deerfield,
company is the largest U.S. drugstore chain. It sells prescription
drugs directly to Caterpillar Inc. employees under an arrangement that
appeared to be similar to Wednesday’s reported discussions.

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NeoPharm files orphan application for IPF

By Michael Oneal | NeoPharm Inc. of Lake Bluff said it has filed an
orphan drug application with the U.S. Food and Drug Administration for
a its Idiopathic Pulmonary Fibrosis drug.

Orphan drug designation would prvide a a seven-year term of
market exclusivity for IPF upon final FDA approval. IPF is the most deadly disease of the lungs in humans with very high
morbidity. There is currently no
proven effective treatment for the cure of this lethal disease.

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Pfizer Alzheimer’s disease drug fails in study

Associated Press | A promising experimental Alzheimer’s disease drug worked no better than a placebo in a late-stage study, an unexpected disappointment after the potential blockbuster stopped symptoms from worsening for a year in a prior test. Pfizer Inc. and partner Medivation Inc. are developing the drug, called Dimebon.

Dimebon failed to meet its primary and secondary goals — improving thinking ability and overall daily function over six months in patients with mild to moderate Alzheimer’s disease, Pfizer and Medivation said on Wednesday.

The news sent shares of Medivation and Pfizer down.

Walgreen’s consolidating pharmacy, wellness

Dow Jones Newswires | Walgreen Co. is consolidating all its
pharmacy and wellness services under one division as it announced an
executive in health services was leaving.

The realignment comes as Walgreen completes a major store remodeling
project, dubbed Customer Centric Retailing, which intends to make
stores easier to shop with lower shelf heights and less inventory.

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Baxter to buy bone graft developer for $300 million

By Bruce Japsen | Providing a boost to Baxter International Inc.’s fast-growing
regenerative medicine business, the medical product giant said it would
buy a London developer of next-generation bone graft material for up to
$330 million.
 
The Deerfield-based maker of blood therapies and
medical devices, said privately held ApaTech will bring a new business
that makes “synthetic bone repair materials for orthopedic and dental
applications,” as part of its business researching and developing bone
graft technologies, the companies said in a joint press release.

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Merck to buy Millipore in $7.2B deal

Associated Press | Germany’s Merck KGaA said Sunday that it will
pay $6 billion in cash to buy U.S. biotech equipment maker Millipore
Corp. in a move to expand its presence beyond drugs and chemicals and
into the life science sector. The deal ends more than a week of
speculation over Millipore’s future.

Shares of the Billerica, Mass., company soared last week after reports
said lab instrument maker Thermo Fisher Scientific Inc. had made a $6
billion offer. Millipore, which supplies tests and equipment to the
biotechnology industry, then confirmed that it was evaluating strategic
alternatives — including a possible sale.

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Abbott AIDS drug Norvir may harm heart in combo

By Bruce Japsen |
Abbott Laboratories popular anti-AIDS drug Norvir may harm the heart
when used in combination with another treatment used in the  treatment
of HIV, the U.S. Food and Drug Administration said this morning.

The FDA said preliminary data suggest “Invirase in combination with
Norvir may have potentially important adverse effects on the heart,”
the agency said.

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