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Top selling diabetes drugs in INDIA

Five anti diabetes drugs are amongst the top ten selling drugs in the country. Control of non-communicable disease has been one of the greatest challenges for the country. This is a major shift from the earlier trend when the organised retail pharma market was dominated by anti infectives and antibiotics. The anti-diabetic therapy segment is estimated to be worth INR 8500 crore and is growing at a strong rate of 12 per cent as per data from AIOCD Awacs. Human Mixtard, ... Read more

China’s Fosun to ink deal for $1.4 billion Gland Pharma buy

Shanghai Fosun Pharmaceutical (Group) Co will sign a definitive agreement on Wednesday to buy a controlling stake in Gland Pharma in a $1.4-billion deal, the Economic Times newspaper reported, citing a source with direct knowledge. In May, Shanghai Fosun had made a non-binding proposal to buy Gland Pharma, which is backed by KKR & Co, to boost its drug manufacturing and research and development capacity. Fosun did not immediately comment, when contacted by Reuters. Gland Pharma made no immediate comment on the report. The ... Read more

Pfizer whacks 150 jobs as it closes out vax production at New York site

More job cuts are coming to Pfizer’s Pearl River, NY, site as the drug giant closes out vaccine manufacturing there by the end of the year. The company recently updated the state that it would be eliminating 151 employees between Aug. 20 and Oct. 28. The cuts include 48 union employees and 103, nonunion employees, according to a so-called WARN notice. Pfizer spokeswoman Susan Rutledge confirmed the cuts today and said that when they are complete about 50 employees ... Read more

Chinese company accused of lying to FDA inspectors

Most drug manufacturers respond immediately to the FDA after having their plant operations criticized in an inspection. Not China’s Xiamen Origin Biotech. It hasn’t responded about the inspection at all. Oh, the Fujian-based operator did contact the FDA about the fact that its API products had been put on an import alert list in May, but about the January inspection that led to its products being banned, and now to a warning letter from the FDA, the agency says it has not ... Read more

CIPLA appointed Kedar Upadhye as its Global chief financial officer (CFO)

Pharma major Cipla has appointed Kedar Upadhye as its Global chief financial officer (CFO) effective from Monday. Until recently, Kedar was Vice President, Global Generics Finance and Head of Investor Relations in Dr Reddy's Laboratories, Cipla said in a statement. Prior to Dr Reddy's, he has worked with Pepsi India and Thermax Group, it added. Cipla MD and Global CEO Subhanu Saxena said: "With his strong financial expertise and deep insights about the global generics industry, he shall be a strong addition to our ... Read more

Rs 73-crore fine on Lupin for anti-competitive practices

The Competition Commission of India (CCI) has imposed a fine of Rs 73 crore on Indian pharma major Lupin for 'co-operating' with the Karnataka Chemists and Druggist Association (KCDA) in its anti-competitive practices. The regulator also imposed a penalty of Rs 8.6 lakh on KCDA. It was alleged that Lupin has refused to supply drugs to the stockist, Maruti and Co for not obtaining No-objection Certificate (NOC) from KCDA. Investigation by CCI found that the druggist association was indulged in the anti-competitive ... Read more

Product RECALL: 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: – Particulate Matter

ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. BACKGROUND: 0.25% Bupivacaine Hydrochloride Injection, USP is indicated for ... Read more

Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy Designation as First-Line Treatment for Advanced Breast Cancer

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor. The Breakthrough Therapy designation is based primarily on positive results of the Phase III MONALEESA-2 trial of LEE011 in combination with letrozole in postmenopausal women who had received no prior therapy ... Read more

FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

The U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999. The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs ... Read more

Dr Reddy’s gets nod to import 15 active ingredients into EU

Hyderabad-based pharmaceutical company Dr Reddy's Laboratories has received approval from the Central Drug Standard Control Organisation (CDSCO) to import drugs for the European Union market. In an order dated August 5, CDSCO gave its nod, which will allow Dr Reddy's to import 15 active pharmaceutical ingredients (APIs) into the European Union. These drugs are used to treat hypertension, pneumonia, bacterial infection, cardiovascular diseases, migraine, among others. The order will enable the company to import these substances for a period of three years, ending ... Read more
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