Archive for January, 2008

Barr wins patent for Seasonique

Seasonique PillsBarr Pharmaceuticals Inc. has been granted patent protection by the FDA for its extended cycle oral contraceptive, Seasonique. The patent would run through January 30, 2024. Seasonique, which was approved by the FDA in May 2006, is a birth control pill that limits menstrual cycles to four in a year. The regimen comprises of taking active contraceptive pills daily for 84 days, followed by 7 days of a low dose of estrogen.

FDA found lagging in device and food safety inspections

The Food and Drug Administration (FDA) is on the erring side when it comes to ensuring that medium- and high-risk medical devices and food supplies are safe for Americans, according to the Government Accountability Office (GAO). Government investigators found that U.S. manufacturing sites of high-risk medical devices are inspected only once every three years, instead of every two years as stipulated by the law, while overseas sites are inspected every six years.

According to the GAO report:

“Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace.”

Medtronic receives FDA approval for CGMS iPro Recorder

Medtronic logoMedtronic Inc. has received FDA approval for its CGMS iPro Recorder, a new physician use continuous glucose monitoring system. The CGMS iPro Recorder records the glucose pattern in a patient, who is advised to wear it for three days. The data is then reviewed by physicians to uncover glucose patterns in the patient and optimize therapy. The device is reimbursable by Medicare.

Bypass better than stents in multiple blockages

Mortality rates for patients with multiple blocked arteries are lower if they undergo coronary artery bypass surgery, rather than opting for multiple stents, according to a large-scale study published in this week’s New England Journal of Medicine. The study showed that for patients with two clogged arteries, the death rate over the next 18 months among those who had coronary bypass surgery was close to 30% lower than among those opting for the insertion of drug-eluting stents.

Over the last few years, angioplasty has become significantly more popular than bypass.

Taro gets FDA nod for Flo-Pred

Taro Pharmaceutical Industries Ltd. has received FTaro logoDA approval for its NDA (New Drug Application) for Flo-Pred (prednisolone acetate oral suspension) in its NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent used in the treatment of asthma, certain allergic and dermatologic conditions as well as various other indications. Taro expects to launch the product later this year. Adverse reactions common to corticosteroids include fluid retention, high blood pressure, high blood sugar, mood swings and weight gain.

Roche acquires Ventana Medical Systems at $89.50 per share

Roche logoGlobal healthcare provider Roche acquired Ventana Medical Systems in a merger on January 22. Both companies’ boards approved the merger agreement, which included a premium of 4.9% to Ventana’s shareholders. Ventana employees will also be able to continue working for the company at the existing location in Arizona.

Roche expects to gain growth in companion diagnostics as well as advanced and primary staining from its acquisition. It is currently the world’s biggest biotech company, and global leader of in-vitro diagnostics, cancer pharmaceuticals and transplantation, and virology.

Sedentary lifestyle quickens aging

A sedentary lifestyle may accelerate biological aging, according to The King’s College London study published in the Archives of Internal Medicine. The researchers studied twins with different activity levels and the study, based on DNA samples, found that people with less physically active lifestyles had shorter leukocyte telomeres than those who were more active. The length of leukocyte telomeres is considered as “markers” of a person’s biological age.

Aurobindo Pharma gets FDA nod for generic Omnicef

Aurobindo Pharma Ltd., headquartAurobindo logoered in India, has received FDA approval to market the 300mg strength of its Cefdinir capsules in the US. Cefdinir is a generic version of Abbott Laboratories’ Omnicef, which is used to treat or prevent bacterial infections. According to IMS Health, Omnicef sales totaled about $787 million in 2006. Aurobindo Pharma already has FDA approval to market the 125mg and 250mg strengths of Cefdinir capsules.

Demand for implantable devices estimated to rise 9.3% annually

Despite the past few years’ product recalls and safety controversies, The Freedonia Group, Inc. estimates the demand for implantable devices will increase 9.3% annually in the US. Sales will reach $43.6 billion in 2011.

Driving the increased demand are shortcomings in existing drug therapies. In their place is a resurgence of cardiac and orthopedic implants; estimated to grow in demand at 9% and 8.8%, respectively. Cardiac implants represent the top seller of implantable medical devices, due to the prevalence of heart disease in the United States, and the extremely life-threatening nature of the disease itself.

Birth control pills reduce ovarian cancer risk

The use of oral contraceptives reduces the risk of ovarian cancer, according to a new study published in the Lancet medical journal. The longer women use the pill, which contains progestin or a combination of the estrogen and progestin hormones, the lower is their risk of developing ovarian cancer at a later stage. While the pill is linked to breast and cervical cancer, the risk associated with these is lower than the protection offered by oral contraceptives against ovarian cancer, said study co-author Dr. Valerie Beral of Oxford University’s Cancer Research UK Epidemiology Unit.

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