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Archive for July, 2009

Clinical trials market to grow 11% through next decade; India to gain most

Wednesday, July 15, 2009 20:38

Clinical trials market reached $50bn in 2008, despite recession fears, says a new report.

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Premarin offers solution for painful sex, vaginal dryness, says Wyeth study

Wednesday, July 15, 2009 18:32

Premarin, a gel containing a mixture of female sex hormone oestrogens, from Wyeth offers to relieve some of common symptoms of vaginal dryness and painful intercourse in women.

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Glenmark, Aurobindo to market fosinopril-hydrochlorothiazide (Monopril-HCT) generic pills for hypertension in US

Tuesday, July 14, 2009 18:20

India's Glenmark and Aurobindo are set to launch thier generic versions of hypertension drugs fosinopril sodium and hydrochlorothiazide - the therapeutic equivalent of Bristol-Myers Squibb's Monopril-HCT - in the US market.

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Dr Reddy’s faces a deadlock on generic lenalidomide launch in US as Celgene refuses to supply Revlimid samples

Tuesday, July 14, 2009 17:43

Celgene tries to block Dr Reddy's Revlimid generic using REMS as an excuse, say reports.

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Jubilant Organosy’s quarterly profits zoom to Rs 126 cr; sees revenues to grow by 15% for FY 2010

Tuesday, July 14, 2009 17:12

India's leading contract manufacturing and research services (CRAMS) provider Jubilant Organosys has reported a nearly ten-fold jump in its consolidated net profit for the quarter ended June 31, 2009.

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Sun Pharma to license anti-depressant escitalopram (Lexapro) rights to Lundbeck

Tuesday, July 14, 2009 6:41

iIndia’s leading generic maker Sun Pharmaceutical will license certain patent applications related to the anti- depression drug escitalopram (Lexapro) following settlements of lawsuit.

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Pain-free cancer therapy photodynamic technique launched in Chandigarh, India

Monday, July 13, 2009 21:28

Photodynamic therapy is pain-free as it requires no cuts Photodynamic therapy, a pain-free technique for treating cancer, has been launched in Chandigarh, Punjab, India by the Netherlands-based pharmaceutical firm Brema Pharma International, recently.

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Plan B One-Step – One-pill emergency contraceptive approved in US

Monday, July 13, 2009 12:24

Plan B One Step, a new one-pill emergency contraceptive, has been given approval in US. Plan B One Step pill, which contains the synthetic version of estrogen levonorgestrel, can be taken as a single pill in one dose after unprotected sex or in the case of contraceptive failure to avoid unwanted pregnancy, said Teva Pharmaceutical Industries Ltd, the manufacturer of the pill said in a press release. “Emergency contraception is more effective the sooner it’s taken, and with Plan B One-Step women can now act quickly and take it right away when the unexpected happens,” said Amy Niemann, General Manager, Senior Vice President of Teva Women’s Health. Plan B One Step should be taken within 72 hours (3 days) of unprotected sex or contraceptive failure. If taken correctly, about seven out of eight women who would have got pregnant will not become pregnant after taking Plan B One Step, the Israeli-based Teva claimed. Plan B One-Step, however, cannot be used for inducing abortion. Plan B One Step will not work if a woman is already pregnant and it will not terminate an existing pregnancy. Also, Plan B One-Step doesn’t protect against HIV and other sexually transmitted diseases (STDs). Side effects of Plan B One Step include changes in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness. Plan B One Step will be available at licensed U.S. retail pharmacies within the next month. Plan B One-Step will be available over the counter for consumers aged 17 or older, and will be sold to women younger than age 17, as the US FDA is expanding over-the-counter (OTC) access to Plan B One-Step. However, women younger than age 17 will require a prescription but they will need a prescription to purchase the pill. Emergency contraceptive pills are now available over-the-counter after U.S. District Court for the Eastern District of New York  asked in March to FDA to reconsider its decisions on the sale of the Plan B emergency contraceptive and ordered its producer to make the pills available to 17-year-olds without a prescription. The court has also ordered US FDA to reconsider its decisions for Plan B over-the-counter sale. It was currently available only behind the counter then, so those who wanted to use the drug needed to ask a pharmacist for the pills. Plan B was sold by Barr Pharmaceuticals, which was recently acquired by Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. Over 80 percent of Teva's sales are in North America and Europe. Plan B® One-Step is manufactured in partnership with Teva Pharmaceutical Industries Ltd. by Gedeon Richter, Ltd. of Budapest, Hungary. Plan B One Step, a new one-pill emergency contraceptive, has been given approval in US.

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India to make registration of clinical research organizations (CRO) compulsory

Monday, July 13, 2009 10:01

Registration of clinical research organizations which conduct human studies on drugs, cosmetics and medical devices would soon be made mandatory in India.

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Shasun Chemicals forays biogenerics biz by launching streptokinase in India

Sunday, July 12, 2009 15:03

Technology for recombinant streptokinase is developed by IMTech, Chandigarh Indian contract services provider Shasun Chemicals & Drugs Ltd has forayed the fast-emerging biogenerics segment by launching its generic version of the recombinant streptokinase in the Indian market. The Chennai-based Shasun is one of the prominent custom research and manufacturing services (CRAMS) player and a leading supplier of several active pharmaceutical ingredients including ibuprofen etc. Shasun developed the biotherapeutic recombinant streptokinase under public-private-partnership. The technology for streptokinase was developed by the Chandigarh-based Institute of Microbial Technology (IMTech), a constituent laboratory of the Council of Scientific and Industrial Research (CSIR). According to some estimates, the streptokinase market in the country is over $17 million growing in double digits. Apart from Shasun, Shantha Biotechnics (Shankinase),  Bharat Biotech India Ltd (Indikinase), Virchow Biotech (Virkinase) have also either launched or working on their versions streptokinase in India. Streptokinase is a protein produced by beta-haemolytic streptococcus. It belongs to a group of medications known as fibrinolytics, and works by activating plasminogen through cleavage to produce plasmin. Streptokinase is used to break up blood clots in the blood vessels of leg veins, lungs and around the heart. Streptokinase injection can dissolve blood clots that form in the heart, blood vessels, or lungs after a heart attack, or some other disease process. Shasun has biotech facility at Velacherry, Chennai, southern India The facility is involved in the creation of biotechnology capabilities & capacities especially in the area of protein processing solutions to provide services for the biotech & pharmaceutical companies. Shasun Chemicals and Drugs Ltd was founded in 1976 and its headquarters are in Chennai, Tamilnadu, India. Shasun acquired UK-based Rhodia Pharma through its wholly owned subsidiary Shasun Pharma Solutions Ltd . UK. Shasun Chemicals & Drugs Ltd posted revenues of Rs. 127 crore, a growth of 5 per cent compared to Q2 FY08  for the quarter ended September 30, 2008. For Q2 FY09, the company suffered forex losses of Rs. 13.50 crore (against Rs. 10.25 crore gain for Q2 last year) resulting in Net Loss of Rs.10.71 crore as against Net Profit of Rs 6.89 crore for the corresponding quarter of last year. On a consolidated basis, revenues for the quarter stood at Rs 219 crore compared to Rs 206 crore for Q2FY08, registering a growth of 6%. The Net Loss of the period stood at Rs. 19.04 crores as against Net Profit of Rs. 8.2 crore for the corresponding quarter of previous year. Shasun entered into a non-exclusive licensing agreement with Merck & Co., Inc last year on  its proprietary cross-coupling copper technology (also known as Buchwald technology) to manufacture and commercialize active pharmaceutical ingredients. The Buchwald cross-coupling technology is one of the most popular technologies in the pharmaceutical area allowing increasingly complex new drugs to be manufactured in an efficient and economical way. Shasun API facility at Puducherry was established in 1986. The Pondicherry facility is a dedicated plant for the manufacture of Ibuprofen. Shasun is one of the largest manufacturers of ibuprofen in the world. The plant is inspected multiple times by the FDA, MCA and other regulatory bodies in countries across Europe, North America and others. Shasun’s ibuprofen supply chain includes Boots Co, UK - the original innovator of ibuprofen. Shasun offers complete spectrum of ibuprofen derivatives such as S+ Ibuprofen, Ibuprofen Lysinate, and Ibuprofen Sodium. Shasun Pharma Solutions is the vertically integrated chemistry partner for the pharmaceutical industry. Its services include innovative process research and development, small scale manufacture for clinical trial supply and full scale commercial manufacture of advanced intermediates and API’s. Shasun Pharma Solutions is carrying out complex multistage organic syntheses, including chemistry in liquid ammonia, organometallic chemistry, halogenations, Friedel-Crafts reactions and reductions, as well as powerful chiral syntheses such as Jacobsen chiral epoxidation and kinetic resolution.

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