Lupin completes Gavis acquisition
MUMBAI and BALTIMORE — Lupin announced Wednesday that it had completed its acquisition of Gavis, which includes Gavis Pharmaceuticals and Novel Laboratories, for about $880 million.
Lupin said the acquisition will grow the company’s footprint in the U.S. generics market and expands its dermatology, controlled substance product and high value and niche generics pipeline. With the acquisition, Lupin also gains its first manufacturing site in the United States — Gavis’ New Jersey manufacturing facility.
The new combined company will have over 120 products on the market and a pipeline with the fifth-largest number of abbreviated new drug application (ANDA) filings with the Food and Drug Administration.
“We are very pleased to have completed our acquisition of Gavis,” Lupin CEO Vinita Gupta said. “The Gavis portfolio augments our US business and niche generic pipeline. We plan to leverage the formulation expertise of Gavis to enhance both Lupin's generic as well as specialty pipeline.”
Psi Bands line extends nausea-relieving bands with new camouflage look
PACIFIC GROVE, Calif. – Psi Bands recently released a new band design named “Heart Land” – a camouflage-style band punctuated with hearts.
The FDA-cleared medical bands are worn on both wrists at the Nei-kuan acupressure point to help relieve nausea. A package of two generally retails for a suggested $15, the company stated.
Psi Bands are available nationwide at CVS, Target, Babies “R” Us, REI and Amazon, Psi Bands reported. The new Heart Land design just launched on Amazon.
CRN: JAMA Patient Page on herbal supplements misses the mark
CHICAGO – The Journal of the American Medical Association on Wednesday updated its "JAMA Patient Page" regarding herbal medications, stating there are numerous concerns on the use of herbal supplements, starting with the fact that "they are not regulated by the U.S. Food and Drug Administration."
Not true, countered the Council for Responsible Nutrition, which issued a release in response to the JAMA page on herbal supplementation. "The authors may not like the way supplements are regulated, but it is innacurate to state they are not regulated by the U.S. Food and Drug Administration," remarked Steve Mister, president and CEO, CRN. "Supplements are subject to extensive manufacturing and labeling requirements and FDA has enforcement tools to be sure they are followed."
That's not the only exception CRN took to the new JAMA advice on herbal supplementation, which purported that only one herb – cranberry – has any clinical evidence supporting its efficacy. Cranberry supplements are often taken for the prevention of recurring urinary tract infections, JAMA stated.
"The Patient Page is flat-out wrong to suggest that only one herb is supported by scientific evidence — a quick search of PubMed for any particular popular herb will produce dozens of scientific studies linking these products to research on various health conditions," Mister stated. "Granted, this research may not be focused solely on randomized clinical trials as drug research would, but RCTs are necessary for drugs because they are used to treat disease and can have serious side effects. In contrast, herbs … are primarily used today as dietary supplements to maintain health and for mild health conditions," he noted.
"By focusing on alarmist tactics, cherry-picking the science and spreading misinformation, rather than embracing the patient’s desire to focus on a health-based lifestyle that goes beyond prescription medications, physicians could be losing an important opportunity to ensure that their patients are open about what they’re taking," Mister warned.
However, there is a need for JAMA's "Patient Page," Mister added. Doctors and other healthcare practitioners need to know what their patients are taking, he said, especially as some supplements can reduce the effectiveness of prescription drugs. "So the JAMA Patient Page on Herbal Medications is, in theory, a necessary educational tool that raises some important discussion points for doctors and patients. Unfortunately, its close-minded approach creates a missed opportunity for dialogue and patient trust,” Mister said.
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