19 Perfectly Timed Pictures That Will Make You Cringe or Laugh...
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Tuesday, July 2, 2013
Mylan introduces eight new women's care products in India
Mylan introduces eight new women's care products in India
Generic and specialty pharmaceutical company Mylan Pharmaceuticals has introduced a portfolio of women's healthcare products in India, expanding its product base in the country.
Consisting of eight products initially, the portfolio is focused on hormones, pre- and post-natal nutrition and management of premenstrual syndrome (PMS).
Mylan CEO Heather Bresch said women's care being a high-growth therapeutic category in India provides the company with an opportunity to help satisfy unmet medical needs.
"More than 85% of women of childbearing age in India suffer from PMS, approximately one in five pregnancies in Indian women end in miscarriage, and it is estimated that the number of infertile couples in India is around 12 million.
"In addition to launching our innovative, high quality product portfolio, Mylan will help to strengthen the capabilities of health care providers in this area through training programs and workshops, working together with the medical community to address areas of concern in women's health and improve timely access to appropriate high quality treatment."
The company has launched a complete portfolio of antiretroviral products in India earlier and expects to continue to expand into new therapeutic categories along with field force expansion.
Friday, June 28, 2013
FDA’s move to cancel Johnson & Johnson licence upheld by Maharashtra Government
After finding residues of carcinogenic substances in 15 batches of Johnson & Johnson baby powder, Maharashtra Food and Drug Administration (FDA), the apex body for food and drug products in the State, had, in March, cancelled the licence of Johnson & Johnson, the multinational healthcare and consumer products major, to manufacture cosmetic products at their Mulund plant. On Monday, The Maharashtra Government also upheld the Food & Drug Administration (FDA) Commissioner’s decision to cancel the same.
The FDA had cancelled the company’s licence after finding that the carcinogenic residue was found because the batches were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant.
“The State Government has given no relief and upheld the FDA move to cancel the Johnson & Johnson India”s licence to manufacture cosmetics,” FDA Commissioner Mahesh Zagade said.
J&J’s appeal was heard by the Maharashtra Minister of Food and Drugs Administration, Manohar Naik, on June 20.
The State Government in its order ruled that “J&J has violated section 18 of the Drugs & Cosmetic Act, 1940 and rule 142 (c) of 1945 rules. The appeal stands rejected. FDA directives issued in this regard on March 30 are upheld. The licence stands cancelled from June 24.”
The State FDA alleged that Johnson & Johnson did not register the process with the local FDA and failed to conduct tests to check for traces of ethylene oxide in the batches of talcum powder.
In its appeal, Johnson & Johnson explained the circumstances under which it had to use ethylene oxide to sterilise the 15 batches – which comes to about 1,50,000 bottles of baby powder.
A J&J India spokesman was quoted in Business Standard saying that, “We appreciate that the Maharashtra State FDA has given us a hearing on the matter of our Mulund plant. However, we are deeply disappointed with the outcome. Nothing is more important to us than the safety of our products and the health of the consumers who use them.”
He further added, “We would like to reaffirm that we have been manufacturing Johnson’s Baby Powder at the Mulund plant for more than four decades with a strong record of safety, quality and regulatory compliance, and that product safety was not compromised at any point.”
He further added, “We would like to reaffirm that we have been manufacturing Johnson’s Baby Powder at the Mulund plant for more than four decades with a strong record of safety, quality and regulatory compliance, and that product safety was not compromised at any point.”
What all consumers should learn from this is that blindly following a brand is not wise. The contents of the products should be carefully checked by them to prevent themselves from such things.
Monday, February 25, 2013
FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer
FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer
Roche announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Roche to receive FDA approval for people with advanced cancers within the past two years.
An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them. Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease.
"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, M.D., Roche's Chief Medical Officer and Head, Global Product Development. "We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future."
Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Roche ADC approved by the FDA. Roche has studied ADC science for more than a decade and has eight ADCs in Phase I or Phase II studies for different types of cancer.
Roche has also submitted a Marketing Authorisation Application to other Regulatory Authorities around the world, including the European Medicines Agency (EMA), for Kadcyla for the treatment of people with HER2-positive mBC. This application is currently under review by the EMA.
About Kadcyla
Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC to result from Roche and Genentech’s 30 years of HER2 pathway research and the third medicine Roche has developed for the treatment of HER2-positive breast cancer.
Like Herceptin, Kadcyla binds to HER2-positive cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once Kadcyla is taken up by those cells, it is designed to destroy them by releasing the DM1 inside the cells.
Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
About breast cancer
Breast cancer is the most common cancer among women worldwide.2 Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually.In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as "HER2 positivity" and affects approximately 15-20 percent of women with breast cancer HER2-positive cancer is a particularly aggressive form of breast cancer.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.2 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.
Friday, February 22, 2013
Saturday, February 16, 2013
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