The FDA recently approved availability of Plan B contraceptive to women aged 15 and older without a prescription, apart from a federal judge’s ruling that it should be available to sexually active women of all ages without a prescription. Katie DeLong’s story “FDA Approves Marketing Plan B to Women 15 or Older” appeared on Milwaukee’s [...]
Reaching Out for Marketing Help Boosts Vivus Stock Price
Vivus, a biotech company whose obesity drug Qsymia is its only source of revenue, got a boost in its stock price recently when it announced that it was seeking a marketing partner to increase sales of the drug. Amy Reeves posted the story “Vivus, Obesity Drug Stocks Finally Get Some Good News” on the Investors [...]
Cancer Specialists Band Together to Protest Drug Prices
Specialists who treat chronic myeloid leukemia, a blood cancer, joined together to write and publish a commentary online that called the prices of the drugs used to treat chronic myeloid leukemia “astronomical, unsustainable and perhaps even immoral.” They suggested that charging high prices for a medicine needed to keep someone alive is profiteering, akin to jacking [...]
New Hepatitis C Drug Granted Accelerated Review
A recent report from PharmaTimes confirms that the U.S. Food and Drug Administration (FDA) has agreed to review Janssen’s Hepatitis C drug, Simeprevir, under an accelerated review. This type of priority review process is designated only for drugs that have potential to offer medical breakthroughs where no other treatments exist. According to Selina McKee in her article “Janssen Gets Speedy [...]
New COPD Drug Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved a new drug from GlaxoSmithKline and Theravance Inc. for use in treating chronic obstructive pulmonary disease. The drug is an inhaled corticosteroid called Breo, and it contains fluticasone furoate for inflammation reduction and vilanteral to open the airways. In “FDA Approves Glaxo/Theravance Drug for COPD Lung Disease,” Toni Clarke notes that Breo [...]
Senate Bill Takes Aim at Biosimilar Drugs
On Monday, the Senate Appropriations Committee was presented with SB 596, which proposed regulation of injectable drugs similar to current biomedical drugs produced by Amgen Inc. and Genentech Inc. Drug manufacturers who typically do not produce biomedical medicines want to cross into the biotech industry, creating their own versions of Amgen and Genentech’s drugs known as “biosimilar” [...]
FDA Approves Ilartis for Childhood Arthritis Treatment
The U.S. Food and Drug Administration (FDA) has approved Ilartis for treating a rare form of childhood arthritis known as systematic juvenile idiopathic arthritis (SJIA). Ilartis is produced by Novartis, In his article “Second FDA Thumbs-Up for Novartis Ilaris,” Kevin Grogan of PharmaTimes explains that the drug is approved for patients two years and older. He continues: “SJIA [...]
New Oral Contraceptive to Launch After Receiving FDA Approval
Warner Chilcott recently received approval from the U.S. Food and Drug Administration (FDA) for their new oral contraceptive, which has not yet been named. In her article “US Green Light for Warner Chilcott’s New Contraceptive”, Selina McKee says that the new contraceptive is a chewable pill regimen, consisting of 24 white pills and four placebo tablets. McKee continues: [...]
Keeping an Eye on Biosimilar Drugs
As patents expire on best-selling biologic compounds, determining the status of “biosimilar” drugs in development differs greatly between the FDA and the EMA (European Medicines Agency). The standards for what constitutes “biosimilar” will determine which drugs eventually can be marketed in the US. The story “Biosimilars: 10 Drugs to Watch” recently appeared in Genetic Engineering [...]
New Anticoagulant Reversal Drug Gives Doctors Options
The Food and Drug Administration has recently approved a drug from CSL Behring called Kcentra, which reverses the effects on anticoagulant drugs in patients with acute major bleeding. In his article “FDA Approves Anticoagulant-Reversal Product”, Alaric Dearment explains that Kcentra is approved for the urgent reversal of vitamin K antagonist (VKA) drugs like Warfarin. Noting that the only treatment previously available for [...]
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