Microdosing or Phase 0 trials could become a crucial phase of drug development in years to come, suggests a new study.
The Mumbai-based pharma major Wockhardt Ltd has received the final approval for its anticonvulsant drug Divalproex sodium extended tablets 250 mg from the US Food and Drug Administration (FDA). The company has also bagged a tentative approval for the 500 mg ER tablets of the product.
A host of global pharmaceutical companies including the world's largest drugmaker Pfizer, GlaxoSmithKline (GSK) and Sanofi Aventis are scouting to buy Indian drug firms in a bid to expand into generics market and boost flagging sales. The trend which started in 2008 is now poised to take wings because global innovator companies are looking at alternative revenue streams as their patent pipeline for drugs dries up.
Sanofi-aventis, the world's third largest pharma company with sales of Euro 27.6 billion, has managed to improve its bottom line despite lower sales during the year ended December 2008. The company's net profit improved by 3.2 per cent to Euro 7,186 million from Euro 6,961 million in the previous year. Its net sales declined by 1.7 per cent to Euro 27,568 million from Euro 28,052 million. The earning per share improved to Euro 5.49 from Euro 5.17 in the previous year.
Pharmaceutical and biotechnology major Wockhardt has announced the launch of its new insulin (Glaritus), a recombinant long acting human insulin analogue. Wockhardt is the 1st company in the world after the innovator to launch this new insulin (Glaritus) that works slowly for over 24 hours.
The Union Health Ministry is planning to set up a central procurement agency to bring more transparency and efficiency in its dealing, even as the pharmaceutical department is set to take up the issue with Railways and other agencies on hiking the turnover limit for participating in the purchase bids.
The Drugs Control General of India (DCGI) has taken a decision to discontinue issuance of WHO GMP certificate for both pharma products and plant audits. The decision comes in the wake of objection raised by the World Health Organization on handing over these certificates at random.
The Chennai Patent Office has dismissed the pre-grant opposition filed way back in 2006 by two activist groups against Roche's Indian patent application on antiviral drug Valcyte (valganciclovir hydrochloride).
Dynavax Technologies Corporation announced receipt of communication from the US Food and Drug Administration (FDA) regarding the clinical hold on the two Heplisav Investigational New Drug (IND) Applications, for healthy adults and patients with end-stage renal disease (ESRD).
CLC bio just launched their new enterprise level product line, consisting of CLC Science Server and CLC Genomics Server.
In a move to boost the bilateral trade relationship between Malaysia and India, Malaysian Biotechnology Corporation (BiotechCorp), the lead development agency for the biotechnology industry in Malaysia, kicked off their first business development engagement for 2009 in Hyderabad and Chennai with the Indian media members and industry participants. The latest updates on the Indian-Malaysian investment initiatives were shared to address the current challenging economic climate.
Wipro HealthCare IT Ltd. is now gearing up to market its novel Hospital Information System (HIS) Lite solution. The Pay Per Use Model is targeted at small hospitals and nursing homes which find it difficult to have a huge capital expenditure in hardware and software support. These hospitals do not have in-house information technology (IT) resources to manage the application and infrastructure on an ongoing basis.
Apollo Hospitals Group introduced the most advanced CyberKnife robotic radio surgery system in the Asia Pacific. The world's first and only robotic radiosurgery system is designed to treat tumours anywhere in the body. The CyberKnife was unveiled at the Apollo Specialty Cancer Hospital at Chennai by Dr Prathap C. Reddy, executive chairman, Apollo Hospitals Group.
GlaxoSmithKline and Idenix Pharmaceuticals, Inc. announced the execution of a license agreement granting GSK exclusive worldwide rights to IDX899.
Aloka Trivitron Medical Technologies Pvt. Ltd, a medical equipment manufacturing company formed under the joint venture (JV) between Aloka Japan and Trivitron Healthcare, has commenced the production of portable black and white ultrasound scanner Aloka SSD 500 from its Chennai facility.
AstraZeneca Plc has posted satisfactory performance during the year ended December 2008 on account of significant growth in emerging market. The company's net profit improved by 8.9 per cent to US$ 6130 million from $5,627 million in the previous year. Its revenues increased by 6.9 per cent to $31,601 million from 29,559 million. With better growth in profits, its earning per share improved to $4.20 from $3.74 in the preceding year.
The Union chemicals minister Ram Vilas Paswan is putting all pressure on the Group of Ministers (GoM) to clear the pending pharmaceutical policy, which he has been trying to make it reality over the last four years.
After hurriedly redrafting, the Union health ministry is learnt to have sent the Drugs and Cosmetics (Amendment) Bill, 2007 on the formation of the Central Drug Authority (CDA), to the law ministry for vetting. After the law ministry's vetting, the Bill will be tabled in Parliament in the forthcoming session which is scheduled to begin on February 12.
Ligand Pharmaceuticals Incorporated and Trevena Inc. announced the initiation of a joint research and license alliance to screen targets using Trevena's novel biological platform against Ligand's combinatorial library of compounds, to identify active compounds with potential for development as novel G-protein coupled receptor (GPCR) therapeutics.
Cytori Therapeutics received a Notice of Allowance from the United States Patent and Trademark Office on a patent application which broadens protection of the company's Celution System.