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Biotechnology

Gene tests raise legal and ethical questions

State stepping in to halt practices

Do your personal genetics make it more likely that you could develop cancer or Alzheimer's disease? Or do you need a personalized nutrition plan because your genetic profile shows you are unable to absorb certain vitamins properly?

A growing number of companies around the globe are offering to provide the answers to these questions and more by selling direct-to-consumer genetic tests.

More Biotechnology News

U.S. urges genetic test before using Glaxo AIDS drug: AIDS patients should have a genetic test before treatment with GlaxoSmithKline Plc's drug Ziagen to see whether they face a higher risk of a potentially fatal reaction, U.S. regulators said Thursday.

Officials: Search for HIV vaccine needs overhaul: Scientists will have to take “enormous intellectual leaps” to develop an AIDS vaccine in the coming years, say researchers clearly frustrated by the failure of a once-promising shot.

Bristol-Myers Squibb posts 8 percent profit jump: Drugmaker Bristol-Myers Squibb Co. on Thursday reported an 8 percent increase in second-quarter profit, beating Wall Street expectations, as the weak dollar boosted foreign sales and several key drugs saw big jumps in U.S. sales. Shares were up nearly 2 percent.

Gene tied to muscle weakness from cholesterol drugs: British researchers have located a gene responsible for muscle pain or weakness experienced by some people taking statin drugs to fight “bad” cholesterol, they reported Wednesday.

Biogen Idec's 2Q profit rises 11 percent: A surge in multiple-sclerosis drug sales drove an 11 percent boost in Biogen Idec Inc.'s second-quarter profit, prompting the biotechnology company to boost its full-year outlook and aim for record revenue of $4 billion.

Illumina's bountiful day - and then some:It was an up kind of day yesterday for San Diego genetics analysis company Illumina. Its shares rose more than 4 percent in after-hours trading after the company's report of a 66 percent jump in revenue and a $6.1 million increase in quarterly profits.

Top Roche, Genentech officials meeting: Top officials of Swiss pharmaceutical giant Roche Holding and Genentech Inc. are meeting Tuesday to discuss Roche's proposed $43.7 billion takeover bid for the U.S. biotechnology pioneer.

Diabetes drug maker Amylin posts wider second-quarter loss: The expense of developing a once-weekly version of its diabetes drug, Byetta, led to a wider second-quarter loss, Amylin Pharmaceuticals reported yesterday.

Merck and Schering delay 2Q reports to afternoon: Drugmakers Schering-Plough Corp. and Merck & Co. took the highly unusual step of delaying their second-quarter results until after the closing bell Monday so European researchers can present data from a study of the companies' cholesterol drug Vytorin.

Traveler's diarrhea drug said to work: A San Diego company developing an antibiotic for traveler's diarrhea said results from a late-stage clinical trial show that its product is faster and works on a broader range of gut-wrenching bacteria than those already on the market.

Stem cell patent ruling contested:Two consumer groups yesterday filed an appeal of a U.S. Patent and Trade Office ruling that said the University of Wisconsin's Alumni Research Foundation could maintain its patents on all embryonic stem cells used in the United States.

Abbott tops forecast: Abbott Laboratories Inc Wednesday said second-quarter earnings jumped 34 percent, beating its expectations, fueled by sizzling sales of its medical devices, Humira arthritis treatment and other drugs.

St. Jude Medical earnings rise: St. Jude Medical Inc on Wednesday said quarterly earnings rose 55 percent, beating Wall Street estimates, as sales of its implantable cardioverter defibrillators, or ICDs, rebounded from a year earlier.

Neurogen stops adipiplon trial due to side effects: Biotechnology company Neurogen Corp. said Sunday it stopped a clinical trial of its insomnia candidate adipiplon because of negative side effects.

Gen-Probe bows to higher bid by rival for Belgian biotech: San Diego medical diagnostics giant Gen-Probe declined yesterday to increase its June 3 offer for a Belgian biotechnology company after a European rival topped its $297 million bid with a higher offer.

Scientists: 'Gene wiki' could decode genome faster: Unraveling the mysteries of the human genome, the chain of chemicals that determine everything from a person's hair color to predisposition toward cancer, is a mammoth undertaking.

New U.S. drug marketing code draws line at gift pens: Come next year, doctors may start to see a problem they've yet to experience – a pen shortage.

U.S. FDA changing notices on drug decisions: U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved, the Food and Drug Administration said Wednesday.

U.S., Europe, Australia to expand drug inspections: Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in China and India that make raw materials for medications.

Invitrogen wins approval for cancer-gene drug test: A test made by Invitrogen that can determine whether women with breast cancer could be helped by taking the powerful drug Herceptin was approved yesterday by the Food and Drug Administration.

Lilly to buy biotech SGX in $64 million cash deal: Eli Lilly and Co. said yesterday that it will acquire SGX Pharmaceuticals in a $64 million cash deal that will pay shareholders in the San Diego biotech a substantial premium.

FDA OK's Invitrogen genetic test for breast cancer: The U.S. Food and Drug Administration said Tuesday it approved Carlsbad-based Invitrogen Corp's genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin.

Pa. company will acquire S.D.'s Inovio in reverse merger: Inovio Biomedical Corp., a San Diego company that developed technology for electrically charging cells to make them more porous for drugs to enter, said yesterday that it will be acquired in a reverse merger with VGX Pharmaceuticals, a privately held company developing DNA vaccines.

FDA to urge black box warning for epilepsy drugs: Food and Drug Administration officials will seek a strong “black box” warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters Monday.

Stem cell grant review upsets some applicants: The state's stem cell institute, which so far has approved $554 million in taxpayer-funded research grants, is basing its funding decisions on recommendations from panels of scientists who sometimes make significant factual errors in their reviews of grant requests, some applicants say.

S.D. stem cell efforts awarded $5 million total: San Diego scientists were awarded $5 million in grants yesterday from a pool of $24 million approved by the California Institute for Regenerative Medicine.

Repairing damage to brain may be nearer: SAN DIEGO – A team of San Diego scientists has moved embryonic stem cell research a step closer to helping repair the brains of stroke victims and people with diseases such as Parkinson's and Alzheimer's.

Report defends drug companies: Answering critics who accuse drug companies of reaping obscene financial reward for little that is innovative, a conservative think tank investigated how the companies turned publicly funded science into therapies for cancer, hypertension and arthritis.

Biotechs now welcoming patient-advocacy funds: With all the panel discussions at the Biotechnology Industry Organization's annual convention about ways to get funding for drug discovery, it is hard to believe that Robert Beall, chief executive of the Cystic Fibrosis Foundation, once had a hard time giving money away.

Governor lauds bio's 'brain power': Gov. Arnold Schwarzenegger yesterday lauded the world's biotechnology industry for tackling a pile of complicated issues – therapies for disease, diagnostics to improve health care and alternative fuels that may one day create “a carbon-free world.”

Biotechs fight bulge: Good news for the overweight: Three San Diego biotechnology companies say the battle with the bulge is about chemicals in your body, not just a lack of will to exercise and cut calories. Amylin Pharmaceuticals, Arena Pharmaceuticals and Orexigen Therapeutics are among about 20 companies that are developing drugs to treat obesity.

Big Pharma generous with big swag: Santa Monica's Ye Ye has lofty ambitions. One of these days, the microbiologist would like to defeat the SARS virus. Yesterday at the BIO International Convention downtown, though, her goal was more down-to-earth: a pair of Crocs. Size 6. Free.

Biotech bandwagon: Across the country, states are investing billions of dollars to fuel scientific research and create biotechnology hubs like those in California, which has the world's largest concentration of biotechnology companies and investment. On Monday, Massachusetts signed into law a $1 billion incentive package to ignite biotechnology development under a proposal Gov. Deval Patrick revealed a year ago.

Turning personalized medicine into reality: It's been a hot couple of years for genomics, the study of the long chain of chemicals that determines all the hereditary information in a person's DNA, from hair and eye color to propensity for disease.

Pfizer, Ranbaxy deal would delay generic Lipitor: Pfizer Inc said Wednesday that Ranbaxy Laboratories Ltd can begin selling a U.S. generic form of its Lipitor cholesterol fighter by late 2011 under a settlement deal, some five months later than Wall Street expectations.

Biology reborn: The word “biotechnology” conjures some intimidating images of people in white lab coats working with test tubes, and maybe expensive robotic equipment, that somehow magically results in the creation of new drugs.

Plowing ahead on biofuel research: Ethanol from corn is yesterday's news, though you might not know it from the headlines and congressional hearings blaming the alternative fuel for rising food prices and disappearing rain forests.

China boosts biotech: PacificGMP, a tiny local manufacturer of biotechnology drugs, will announce today that it is expanding to 25 times its size with the help of the Chinese government. The company, which has an 8,000-square-foot facility in Sorrento Mesa for manufacturing biological agents used in cutting-edge therapies for disease, will join a collaboration that is building a 200,000-square-foot plant in Taizhou, China.

Schizophrenia drug by Acadia will be scrapped: Acadia Pharmaceuticals shares plummeted more than 40 percent yesterday after the San Diego company announced that its experimental schizophrenia drug failed in a midstage clinical trial.

Building a brain bank: Leave your baking-soda volcanoes and rubber-band balls at home. Collaborators for the San Diego Science Festival say they'd like to ignite the scientific impulse within school-age children and eventually refurbish a dwindling supply of U.S. scientists. The event, planned for next spring, will be no cafeteria-style science fair but rather a jumbo, weekend-long expo preceded by a monthlong series of kid-friendly events involving perhaps 1,000 scientific organizations, companies, universities and Nobel laureates.

It all adds up : After working in the hotel and mortgage industries, Jami Martinsen moved into biotech in June 2005 when she joined the finance team at the San Diego company Gen-Probe.

A beam of hope: Tony Grover is working to make sure a new treatment for stroke victims qualifies as “reasonable and necessary” under government standards. Grover, who works at the Carlsbad company PhotoThera, says the current treatment for stroke works best if patients get treatment within three hours.

A validating experience: An interest in science is what got Greg Budahazi started in the biotech industry. After graduating from UCSD with a bachelor's degree in biochemistry, he began his biotech career in San Diego in the mid '80s, working in research and development.

After impact : Mary Bauman joined the team at Amylin Pharmaceuticals six months ago and moved to San Diego from the Bay Area, where she had worked for Bayer for 17 years.

Giving biotech a spin: Leigh Amini had no intention of getting into the biotech industry. In fact, she was going to college to become a teacher when a job in administration led her down a different path.

UCSD study: DHEA not beneficial: Healthy seniors who take DHEA tablets to protect memory or pep up their sex lives are wasting money, according to a yearlong UCSD study that found no gains from the over-the-counter hormone supplement.

Culture clash: San Diego attained its position as home to the world's third-largest concentration of biotechnology companies through its volume of small firms.

BIO chief talks about industry's concerns: The biotechnology industry considers funding for the Food and Drug Administration and the National Institutes of Health, as well as rules for making generic drugs, as its top political issues this year, said James Greenwood, who heads the national Biotechnology Industry Organization.

Biotech breakthroughs: Dave Christensen got the bad news five years ago: The lump in his neck was non-Hodgkin's lymphoma, a cancer of the blood and lymphatic system.

Invitrogen to buy Applied, creating a biotech giant: Invitrogen, a Carlsbad company started in its founder's garage in 1987, will become one of the world's largest biotechnology companies with its acquisition yesterday of scientific instrument maker Applied Biosystems Inc.

Glivec misses target in clinical study: Clinical trials have failed to show that a cancer drug made by Novartis is more effective in higher doses, the pharmaceutical company said Friday.

FDA may require cancer-risk labeling on J&J drug: An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer risks.

Invitrogen to buy Applied Biosystems for $6.4B: Invitrogen has agreed to pay $6.4 billion in cash and stock for Applera's Applied Biosystems Group, the companies said Thursday.

Amylin gets a boost as latest drug weighs in: Amylin Pharmaceuticals' shares rebounded yesterday after the San Diego company released positive results for the once-weekly version of its diabetes drug, Byetta.

Mylan inks supply deal for generic of Teva MS drug: Mylan Inc said Tuesday it signed a licensing and supply deal for a generic version of Teva Pharmaceutical Industries Ltd's big-selling Copaxone multiple sclerosis treatment, and Teva shares fell nearly 3 percent.

Glaxo axes 350 jobs in overhaul of drug research: GlaxoSmithKline Plc is axing around 350 jobs in research and development as part of an ongoing restructuring programme, Europe's biggest drugmaker said on Wednesday.

J&J, Schering arthritis drug effective in trials: An experimental treatment for rheumatoid arthritis being developed by Johnson & Johnson and Schering-Plough Corp appeared to be effective and very safe in three late-stage trials, the companies said Tuesday.

Roche, Ipsen launch pivotal trial of diabetes drug: Roche Holding AG and Ipsen SA said Monday they plan to launch a pivotal trial of experimental diabetes drug taspoglutide after it was shown to improve blood sugar control in a mid-stage trial.

Interim data positive on Vertex hepatitis C drug: Vertex Pharmaceuticals Inc Monday reported positive interim results from a mid-stage study of its closely watched experimental hepatitis C medicine in patients who failed to respond to prior treatment, sending its shares up 4 percent.

Sequenom shares soar on results: Shares of San Diego genetics analysis company Sequenom jumped more than 20 percent yesterday after the company reported its noninvasive prenatal test to screen maternal blood for Down syndrome was effective in all samples, exceeding analysts' expectations.

Wyeth heartworm drug makes limited return in U.S.: Wyeth will return its Proheart 6 heartworm drug for dogs to the U.S. market with restrictions to minimize side effects, U.S. health officials said Thursday.

Novartis buys drug firm Protez for up to $400 million: Novartis AG has bought privately held U.S. biotech company Protez Pharmaceuticals in a deal worth up to $400 million, giving it rights to an antibiotic which could be used to fight superbugs such as MRSA.

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Qualcomm and Nokia make deal over fees: Qualcomm resolved a nearly three-year, unprecedented challenge to its royalty-based business model yesterday when the world's largest phone maker, Nokia, agreed to cease hostilities and sign on the dotted line.

Technology

FCC vote trickling in on XM-Sirius merger: A Federal Communications Commission member who sought further concessions in a pending satellite radio buyout has withdrawn his offer after it failed to draw support.

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