Astellas, CoMentis in $760M Deal for Alzheimer's Treatment Japanese drugmaker Astellas Pharma Inc. is partnering with CoMentis Inc. to develop a compound for Alzheimer's disease under a deal potentially worth $760 million for the latter.

 Asia gets its first Bio Safety Level-4 facility BANGALORE: Biovet, an integrated biotechnology firm, on Wednesday launched Asia's first Bio Safety Level-4 (BSL-4) manufacturing facility, specifically designed to enable product development and manufacturing of vaccines like Foot and Mouth Disease vaccine (FMD), in Malur, 30 km from here.

 Biovail Receives FDA Approval for Aplenzin (BVF-033) TORONTO--(BUSINESS WIRE) Biovail Corporation (NYSE: BVF) (TSX: BVF) announced today that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzin(TM)...

 Ranbaxy gets US Patent Office booster dose in Lipitor case NEW DELHI: India's Ranbaxy Laboratories has received a boost in its patent litigation with Pfizer over cholesterol lowering drug Lipitor (atorvastatin), with the US Patent and Trademark Office rejecting the world's biggest pharma firm's request for reissue of patent.

 Chemotherapy May Not Affect Memory In Breast ...  ScienceDaily,  Women receiving chemotherapy for breast cancer frequently report problems with memory and concentration, but two new studies suggest that chemotherapy is not the cause of these problems, and the stress of the diagnosis may be. "This is an important issue, particularly as survival rates for breast cancer improve," said study author David G. Darby, MD, chief medical officer of CogState Ltd., an Australian company that developed the cognitive tests used in the studies. "People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain.' Hopefully this information will help people make informed decisions."

 

If Tylenol Happened Today  FDA News – In the blog, the author writes about the changes in communication strategies Johnson & Johnson (J&J) has made since the 1982 Tylenol tampering scare when the company was lauded for its fast, open response.

“Since then, J&J has had problematic product withdrawals of Confide in 1997 (a home HIV test) and another Tylenol problem in 2005. And, by the way, there were the withdrawals of Propulsid and Duragesic. In each instance, the company was criticized for not acting decisively enough. J&J calls it Slow Cooking — or taking their time. Slow Cooking is fine when you are making soup. When your products are a matter of life and death, you don’t have the luxury of taking your time. Communications can’t be a ‘by the way’ afterthought; they need to be fully integrated into your overall strategy,” the author writes. The author believes if the Tylenol scare happened today, the company would take weeks or months to respond.

 

Pharma companies demerging NCE, NDDS operations  Economic Times, That's what top Indian pharma companies are realising as they step out to leverage the expertise gained in reverse engineering of patented molecules, ...

  

Devgen starts pharma split-off  BRUSSELS, (Reuters) - Belgian biotech group Devgen reported a 7 percent fall in nine-month revenues on Friday and said that it had taken the first steps to separate its agro and pharmaceutical businesses.  

Current Chief Financial Officer Hilde Windels had been appointed chief executive officer designate of the new pharma company. Devgen said it would complete the focusing of its agro activities in the first two quarters of 2008.

 

NEW YORK, Nov 16 (Reuters) - Pharmaceutical companies see U.S. regulators applying a tougher standard to some new medicines by looking for evidence they are better than drugs already on the market, officials told Reuters this week.

The Food and Drug Administration is demanding more safety data amid a heightened spotlight on risks, after the recall of Merck & Co's pain drug Vioxx in 2004, executives said.

 

   _______________________________________________________________________

 Previous NEWS Editions:

  PharmEng Announces Opening of Pharmaceutical Manufacturing

Earthtimes, UK - Contract manufacturing includes pharmaceutical support, formulation development, laboratory testing, and finished solid dosage and liquid products. PharmEng International Inc., a full-service consulting and contract manufacturing company, today announced the official grand opening of its state-of-the-art pharmaceutical manufacturing facility in Nova Scotia. ...

 Drug Research
Chemical & Engineering News - According to Bast, major pharmaceutical companies traditionally discover and develop drug candidates, obtain clinical trial approvals from FDA, and only then take the drugs to academic centers for patient testing. "Very often, there can be months of delay between the time that FDA signs off on a drug and the time that the first patients get on trial," he says.

Working in partnership, he explains, will reduce this time by giving clinicians access to drugs earlier in development so they can begin identifying relevant biomarkers, developing diagnostic imaging tools, and designing trials.

 Elusive Hormone May Yield New Drugs Against Hypertension
AHN - Ithaca, NY (AHN) - Researchers at Cornell and the Boyce Thompson Institute for Plant Research (BTI)have found a hormone from human urine that safely rids sodium out of the body. It could be harnessed to develop more effective and safer treatments for high blood pressure, or hypertension.

The discovery opens the door to developing new medications to control sodium levels and treat hypertension.

Currently, drugs that lower sodium levels all have serious side effects because they also reduce potassium levels.

Time runs out on talks on drugs for poor countries
Guardian Unlimited, UK 
The pharmaceutical industry has condemned the WHO draft plan and richer countries home to much of the global drug industry remain cool to the plan. The goal of the talks is to produce guidelines that would encourage research and development of affordable drugs to treat diseases prevalent in poor countries while respecting intellectual property rights of big pharmaceutical firms.

 

The industry argues it needs strong revenues from drug sales to finance research and development into new treatments, including for diseases prevalent in developing countries.

 

Pakistanian Investors to Open Pharmaceutical Industry in

AllAfrica.com, Washington – A delegation of international dealers in pharmaceutical products from Pakistan is in the country to assess the viability of the local market. The three-man-delegation visited the Private Sector Federation (PSF). Rwanda

They promised to venture in distribution of a wide-range of their medicinal products and equipment in the country, and latter go in for a fully fledged pharmaceutical industry, but hastened to add: "but only if it makes economic sense," said Dr. Abdullah Qureshi.

Qureshi, who is part of a three-man delegation, is the chief executive of Technovision Pharmaceuticals.