TNF blockers get child cancer warning; DOR drug gets orphan status;

> FDA is tacking new, stronger warnings on TNF-alpha blockers. The new label language highlights an increased risk of cancer in children and adolescents who take the blockbuster meds. Report

> Wisconsin's Department of Workforce Development has pledged $100,000 to help teach leaders of the state's biotech companies how to scale up their businesses. Report

> DOR BioPharma announced that the FDA has granted orphan drug designation to its drug, OrBec, which is designed to treat gastrointestinal symptoms associated with chronic GVHD in patients who have undergone a certain type of cell transplantation. Report

> Debiopharm and Mercury Therapeutics have inked a license agreement for the development and commercialiation of Debio 0930, a small molecule activator of AMPK (adenosine monophosphate activated protein kinase) for the treatment of diabetes and metabolic diseases. Release

> Canadian medical device maker Adaltis has filed for bankruptcy. Report

> Novavax said it could manufacture its vaccine candidate for the new strain of H1N1 influenza virus within 11 weeks of receiving the gene sequence CDC, sending its shares up more than 20 percent in trading before the bell. Report

Pharma News

> Drugmakers may thing Washington's push for transparency has gone a bit too far. That's because the latest healthcare reform legislation includes a requirement for employee prescription drug plans to disclose its discount agreements with pharma. Report

> In another round of ethical questions for drugmakers and medical journals, newly unveiled court documents show that Wyeth paid ghostwriters to author some 26 articles supporting hormone replacement therapy, which were published in journals under the bylines of doctors who often contributed little but their names to the text. Report

> Is another wave of sales-rep cuts in the offing? Well, at least one Big Pharma is once again revamping its marketing ops: Eli Lilly is offering buyouts to 4,000 U.S. reps, in hopes of shedding "several hundred" jobs, or less than 10 percent of its sales force. Report

Manufacturing News

> A Massachusetts man has been sentenced to more than three years in prison for smuggling and distributing anabolic steroids, human growth hormone, insulin-like growth factor, and clenbuterol originating from unregulated sites in China, Turkey, Poland, and Romania. Report

> Contract packager Compass Pharma Services of Clifton, NJ, joins Swiss pharmaceutical group Helsinn as among the latest to jump into the potent compounds game. Report

> DSM Pharmaceuticals has earned the SafeBridge Potent Compound Safety Certification for the handling of potent active pharmaceutical ingredients and drug products. Report

> Having momentarily finished with Caraco in Michigan, FDA inspectors made their way south to Teva Animal Health in St. Joseph, MO, and then north to Apotex in Toronto. Report

And Finally... GlaxoSmithKline announced that in the past two weeks it has received orders from 9 more governments, for a total of 96 million additional vaccine units. The drugmaker is now committed to meet 25 requests for 291 million H1N1 vaccines--and is still in talks with other governments. Analysts estimate GSK's contracts are worth $1.5 billion, and preorders could reach $3 billion if contracts continue to roll in as they have. The drugmaker has said it will begin shipping vaccine in September, but the company tells the Press Association it is unsure how quickly its vaccine can be produced to fulfill its orders. Swine flu report

Suggested Articles

Inovio CEO J. Joseph Kim is undeterred by short sellers and other detractors who doubt his company can shuttle a COVID-19 DNA vaccine to market.

Adding entinostat to hormone therapy did not help patients with HR-positive, HER2-negative breast cancer live longer.

The data add to the evidence in support of the IL-6 drug ahead of a FDA decision to approve it in a rare disease served by Alexion’s Soliris.