Filed under: Pharmaceuticals

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Pfizer’s Sutent falls short in lung-cancer trial

Pfizer Inc.  said its cancer treatment Sutent failed to meet its endpoint of improving overall survival for late-stage lung cancer in a late-stage trial, though it did improve progression-free survival.

Sutent, also known as sunitinib, has been one of Pfizer’s more successful drugs to launch in recent years. Approved for kidney cancer and certain gastrointestinal tumors, Sutent had $964 million in sales last year, but studies of the drug for other indications haven’t been home runs. Get the full story »

Hospira drug receives additional approval in Japan

Drug and medical device maker Hospira Inc. said Japanese regulators have approved the use of its sedative Precedex in patients for more than 24 hours. The drug was originally approved there in 2004 to sedate intubated and mechanically ventilated patients in intensive care for up to 24 hours.

A Hospira spokesman said the Lake Forest, Ill., company has done trials of the sedative in the United States, where it also is seeking approval for the longer-term use.

Hospira CEO Christopher Begley to retire

Hospira CEO Chris Begley. (Hospira)

Hospira Inc. on Friday  said Chief Executive  Christopher Begley will retire after more than six years in the top job but remain active in the management and operation of the Lake Forest-based maker of generic drugs and hospital products.

Begley, 58, is the only CEO Hospira has had since it spun off from Abbott Laboratories in 2004 into its own publicly traded company. He will remain CEO until a successor is named and then take on the position of “executive chairman,” which Begley described in a conference call with analysts as a chairman who stays on as an employee “and plays a greater role in the company than a non-executive chair.” Get the full story »

FDA panel OKs Cymbalta use for back pain

A majority of federal health advisers say a best-selling antidepressant from Eli Lilly & Co. appears effective in treating back pain, but not arthritis.

The Food and Drug Administration is considering whether to broaden approval of Cymbalta to treat chronic pain, which would expand sales of a drug already used by 15 million U.S. patients. Get the full story »

Lilly stops work on late-stage Alzheimer’s drug

Eli Lilly and Co. halted development of an Alzheimer’s drug after it worsened patients’ symptoms in late-stage studies, dealing a fresh blow to the U.S. drugmaker and to research to fight the disease.

The Alzheimer’s setback comes as U.S. regulators raised concerns about using Lilly’s antidepressant Cymbalta to treat chronic pain and follows patent case losses on two other key products in the last month. Get the full story »

French morning-after pill wins U.S. approval

A French drugmaker says it has won U.S. approval for a new type of morning-after contraceptive that works longer than the leading drug on the market.

The pill Ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, is effective only if women take it within three days of sex. Get the full story »

SEC, Justice probe Merck’s activities abroad

U.S. drugmaker Merck & Co.  said Friday  that it has received letters from the federal government seeking information about its activities in foreign countries, in connection with a U.S. anti-foreign bribery law.

Merck disclosed in a regulatory filing it has received letters from the Justice Department and Securities and Exchange Commission. The company said it is cooperating with the requests. Get the full story »

FDA orders halt to some Provenge marketing

The Food and Drug Administration has asked Dendreon Corp.  to stop using some promotional materials for Provenge, saying they are “false or misleading” because they omit or minimize the prostate-cancer drug’s risks and overstate its effectiveness.

Provenge, which was approved by the agency in late April, is seen as the first in a new class of cancer-fighting drugs that use a patient’s cells to stimulate the body’s immune system to fight cancer. Get the full story »

Horizon Pharma files to sell up to $86.3M in IPO

Biopharmaceutical company Horizon Pharma Inc. plans to sell up to an estimated $86.3 million in an initial public offering. The shares are expected to trade on the Nasdaq Global Market under the symbol HZNP. Get the full story »

Walgreens introduces live pharmacy chat

Walgreens unveiled a new service Thursday that makes it possible for pharmacy customers to chat with a pharmacist online 24 hours a day.

Available at Walgreens’ Web site, customers register online to give a pharmacist access to their prescription information, just as they would in a pharmacy, and a registered pharmacist pops up in a chat window to answer confidential prescription-related questions. Get the full story »

Sanofi-Aventis makes $18B bid for Genzyme

Shares in Sanofi-Aventis SA are trading near a low for the year amid new reports that the French pharmaceutical giant is close to launching an $18 billion takeover offer for U.S. biotechnology firm Genzyme Corp.

Flu vaccines on the way earlier than usual

Two flu vaccine makers said Friday that they had started shipping supplies for the U.S. market, one of the earliest starts to distributing seasonal influenza vaccine.

And U.S. officials said they were changing the labeling on a vaccine made by Australia’s CSL Ltd. because it appears to have caused a higher than usual rate of seizures in children. Get the full story »

Merck earnings take 52% hit in 2Q

Merck & Co.’s second-quarter earnings dropped 52 percnet on acquisition and other charges as sales of its key drugs weren’t as strong as in recent quarters.

The drug giant also narrowed its 2010 earnings forecast while trimming the top end of its sales view for the year. Get the full story »

Regulatory issues overshadow Hospira 2Q profits

Though Hospira Inc.’s second-quarter profits more than tripled from a year earlier, the company’s stock lost more than 7 percent Wednesday as the medical product maker continued to be dogged by regulatory issues.

The Lake Forest-based maker of medication delivery devices and injectable generic drugs had net income of $83.5 million, or 49 cents a share, in the period ended June 30. That compares to $25.5 million, or 16 cents a share in the second quarter of 2009, when it had reported charges related to its cost-cutting initiative, “Project Fuel,” that is saving the company more than $100 million annual and has cut several hundred jobs. Get the full story »

Aetna deal offsets 2Q weakness at CVS Caremark

CVS Caremark Corp. Wednesday reported weaker quarterly earnings and lowered its profit forecast, but shares rose as investors approved of a large pharmacy benefit management services contract struck with Aetna.

CVS Caremark will administer Aetna’s retail pharmacy store network and manage customer service. It will also handle prescription drug purchasing, manage inventories and fill prescriptions for Aetna’s mail-order and specialty pharmacy operations. The contract will ramp up over several years and bring in revenue of $8.2 billion next year. CEO Tom Ryan said the 12-year contract is the largest and longest contract in the industry. Get the full story »