Pharma News

(6th August, 2014); Roche announced on last Monday that it has agreed to acquire Santaris Pharma, a privately held biopharmaceutical company based near Copenhagen, Denmark. Santaris Pharma has pioneered its proprietary Locked Nucleic Acid (LNA) platform that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the potential to address difficult to treat diseases in a range of therapeutic areas.

(6th August, 2014); Central Drugs Standard Control Organization (CDSCO) ensuring uniform procedures in regulatory inspection for issuance of Certificates of Pharmaceutical Products (COPP) and other Good Manufacturing Practices (GMP) inspections. These procedures were discussed in 47^th Drugs consultative committee (DCC) meeting.

(6th August, 2014); Indian Council of Medical Research (ICMR) have initiated a multi-disciplinary cohort study in Delhi and national capital region to find out adverse effects of Radio Frequency Radiation (RFR), if any, emitted from cell phone on adult Indian population.

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(5th August, 2014); It is known that data related to antibiotics consumption is not maintained in India. And truly it is hard to obtain such data when everything is mess up around. But it is of utmost importance to capitalize such data to fight with microbial resistance. The concern is growing for antimicrobial resistance in pathogens on account of increased availability and use of antibiotics across the country meant for human, animal and industrial consumption.

(5th August, 2014; Business Wire India); Studies since 2012 have estimated that over 74% of urban Indians are overweight (i.e. BMI over 23 kg/m²). A recent survey conducted by Fitho, a leading wellness services organization that works with partners like Lal Pathlabs, showed that along with increasing weight, there is also increasing awareness and 5 out of 10 urban Indians are trying to lose weight. While 40% of the overweight people have intent to lose weight but are not taking action to control their weight, the remaining 60% are making an effort to lose weight. The survey revealed that looking good, keeping fit and staying confident are the major reasons for the women and men under 35 to lose weight, while people aged over 35 and the heavily overweight (BMI>25 kg/m²) are doing it primarily for a better health.

(1st August, 2014); There are total 968 pharmacy degree institutions (as per section 12) in India as per government updated list of May 2014 with 65,415 seats. And government is working to improve the quality of pharmacy education in India.

(31st July, 2014); Indian Patent Act does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy which is major concern for US pharma companies. This indigenous rules agitated US multinational companies for doing fruitful business in India.

(31st July, 2014); U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

(29th July, 2014); It's starting a new era for diagnosis of cancer with a single blood test which bypassing physicians to detect certain symptoms, saving time and preventing costly and unnecessary invasive procedures such as colonoscopies and biopsies. In contrast to present methodologies, it could be a useful aid for investigating patients who are suspected of having a cancer that is currently hard to diagnose.

(29th July, 2014); Looking at the current regulatory environment of clinical trial in India, it is important that all information related to 4 major domains i.e, Sponsor/ CRO, Investigator, Ethics Committee, Patient of clinical trials are captured through online in an organized manner. Hence, for ensuring transparency and faster dissemination of information about clinical trials, health ministry may start information technology (IT) enabled platform. The recommendation of such platform is provided by Prof. Ranjit Roy Chaudhary Committee.