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By Bruce Japsen | Medical product giant Baxter International Inc. and a San Diego biotech
company issued a voluntary recall of Hylenex vials after discovering
small “flake-like glass particles in a limited number of vials.”
The recall comes less than a year after Baxter launched the product as
a new way to administer intravenous fluids to rehydrate children and
infants more quickly and efficiently. Hylenex can be administered
without the tricky search for a tiny vein.
Associated Press | Lincolnshire-based BioSante Pharmaceuticals said Friday its first-quarter loss widened
on higher development costs for its drug candidate LibiGel. The company lost $10.5 million, or 19 cents per share, compared
with a loss of $4.1 million, or 15 cents per share, during the same
period a year prior. The company did not report revenue.
BioSante said the potential drug LibiGel is in three late-stage
clinical trials. It is intended to treat sexual dysfunction in women.
LibiGel is a testosterone gel applied to the skin.
By Bruce Japsen and Sandra M. Jones | The U.S. Food and Drug Administration has given San Diego-based Pathway Genomics 15 days to respond to the agency’s request for information regarding its controversial genetic home test kit.
In a letter released this evening, FDA Deputy Director for Patient Safety and Product Quality James Woods said the agency has been “unable to identify any Food and Drug Administration clearance or approval number” for the product.
By Bruce Japsen | The looming decline in sales from the blockbuster diabetes drug Actos
figured into Takeda Pharmaceutical Co.’s decision Wednesday to slash
nearly 1,600 U.S. jobs — including hundreds in Chicago’s northern
suburbs.
Japan’s largest drug maker operates from its U.S. base in Deerfield
under the name Takeda Pharmaceuticals North America Inc. It faces
competition in the next two years from upcoming generic versions of its
flagship product, the diabetes prescription Actos.
By Sandra M. Jones and
Bruce Japsen | Genetic testing is making its way to the corner drug store, and federal
regulators aren’t too happy about it.
Walgreens will begin
selling personal genetic testing kits on Friday, the first major retail
chain in the U.S. to offer the home tests. CVS plans to have the same test kits in its stores
by August.
Both drug store chains are buying the kits from
Pathway Genomics, a San Diego-based startup that offers genetic health
and ancestry reports.
The over-the-counter tests, which have been available through a few
Internet retailers, haven’t reached a mass audience until now. And their
pending arrival has scientists and bio-ethicists concerned that
consumers will misuse or misunderstand the results.
By Bruce Japsen | Abbott
Laboratories said it has signed a deal with India-based Zydus Cadila of
India to sell a portfolio of the India company’s drugs, including
generic medicines, in 15 emerging markets.
Former Vice President Al Gore gives the keynote address to the Bio International Convention this week in McCormick Place. (Phil Velsaquez/Tribune)
By Bruce Japsen | The economic crisis could be preventing the next life-saving drug or medical treatment from reaching consumers, say biotech companies and their leaders.
According to data provided to the Tribune at the Biotechnology Industry Organization’s annual meeting in Chicago this week, the banking crisis that has tightened lending and investors skittish about risky propositions including biotechnology have led to a 25 percent decline in public biotech companies.
Dow Jones Newswires | Walgreen Co. said its same-store sales
declined 0.2 percent in April, breaking a two-month streak of
increases. Overall, sales increased 5.9 percent to $5.68 billion,
helped 2.2
percentage points by its recent Duane Reade acquisition. Duane Reade
stores aren’t included in same-store results.
By Bruce Japsen | The U.S. Food and Drug Administration ordered Baxter International Inc.
to recall 200,000 of the company’s Colleague brand pumps, escalating its
scrutiny of infusion pumps used primarily in hospitals.
The FDA said the Deerfield-based drug and device maker must “recall and
destroy” all of its Colleague pumps, saying the action is based on “a
longstanding failure” of the company to correct serious problems with
the pumps. Baxter will incur a special pretax special charge of $400
million to $600 million in the first quarter to cover the cost of the
recall.
By Bruce Japsen
| Though a much-touted Chicago appearance today of former Presidents
George W. Bush and Bill Clinton will not be open to the public or the
press at the Biotechnology Industry Organization’s annual meeting, the group
has offered up former Vice President Al Gore for five minutes tomorrow.
BIO said the first “five minutes of the Vice President’s keynote address
will be open” to registered media. Gore’s keynote address is sponsored
by California-based biotech giant Amgen Inc. The fees being paid to Gore for his
appearance are not being disclosed, BIO said.
Dow Jones Newswires | The U.S. Food and Drug Administration is conducting a safety review of
hormone-therapy drugs that are used to treat prostate cancer to see if
the treatments increase the risk of heart attacks, strokes and diabetes.
The drugs, which fall into a class of products known as
gonadotropin-releasing hormone agonists, are sold under brand names that
include Abbott Laboratories’ Lupron, AstraZeneca PLC’s Zoladex and
Sanofi Aventis SA’s Eligard. The products are designed to lower levels
of male hormones, which can shrink prostate tumors and slow the growth
of prostate cancer.
By Bruce Japsen | Good news on the biotech front: The biotechnology industry grew, despite soaring unemployment and thousands of jobs shed by pharmaceutical companies during the recession, according to a report presented in Chicago this morning from the Biotechnology Industry Organization.
The U.S. bioscience sector grew 1.4 percent to 1.42 million jobs in 2008, the latest year statistics were available, said the report by research firm Battelle. Meanwhile, the larger unemployment picture was dismal, with nearly one in 10 Americans without jobs.
Dow Jones Newswires | Abbott Laboratories’ rheumatoid arthritis
treatment Humira will replace Pfizer Inc.’s cholesterol-fighting
Lipitor as the world’s biggest-selling drug in 2016, but Pfizer will
still be the biggest seller of medicines after the pharma industry
experiences its looming drug patent expiry “cliff”, according to a
report published Monday by EvaluatePharma.
Dow Jones Newswires | Mead Johnson Nutrition Co.’s first-quarter profit rose 21 percent,
beating expectations, on strong sales from emerging markets as business
in developed markets remained stable.
“China business continues to be the largest contributor to our revenue
growth,” said Chief Executive Stephen Golsby. “It was just one of 10
major markets in Asia and Latin America to report double-digit gains,
demonstrating the broad-based success of our growth strategy.”
By Bruce Japsen |
The top-selling brand-name diabetes drug, Actos, will be available in
generic form in two years under a settlement reached by Deerfield-based
Takeda Pharmaceuticals North America Inc. and several makers of generic
drugs trying to bring a cheaper version to U.S. consumers.
