Tuesday, July 31, 2012

CMC Biologics to buy Xoma's former manufacturing facility

Xoma Corp.'s Berkeley manufacturing facility is getting a new operator. CMC Biologics, a Copenhagen-based contract manufacturing company, said Tuesday that it will buy the 31,000-square-foot, large-scale manufacturing operations formerly used by Berkeley-based Xoma (NASDAQ: XOMA) as well as other assets. Financial terms of the deal were not disclosed. CMC also did not say how many people who worked at the facility under Xoma would be employed by the new owner.

InSite Vision starts late-stage trial of cataract surgery drug

InSite Vision Inc. has started enrolling patients in a Phase III trial of a drug to reduce pain and inflammation after cataract surgery. The Alameda company (OTC BB: INSV) will enroll about 240 patients in the two-arm trial of ISV-303, or BromSite, the company said Tuesday. Results from this first of two late-stage BromSite trials are expected in late 2012 or early 2013.

BMS, Prosetta ink HIV drug research deal

Prosetta Antiviral's Vishwanath Lingappa.
Bristol-Myers Squibb Co. and Prosetta Antiviral Inc. -- one of San Francisco's oldest biotech companies -- signed a multi-year drug discovery and development deal that initially targets the AIDS virus, the companies said Tuesday. Financial terms of the deal were not disclosed, but Prosetta will receive an upfront payment and research funding from Bristol-Myers Squibb (NYSE: BMY). Prosetta also will be eligible for milestone payments and royalties on worldwide sales, if any drugs emerge from the deal.

A.P. Pharma adds Robert Rosen to board

A.P. Pharma Inc. said Tuesday it has added Robert Rosen to its board of directors. The Redwood City-based (OTCBB:APPA.OB) specialty pharmaceutical company said Rosen is managing partner of Scotia Nordic LLC. Before that he was global head of oncology at Bayer HealthCare.

Researchers: Medivation's failed Alzheimer's drug deserves another shot

Medivation Inc.'s failed Alzheimer's drug Dimebon deserves a second chance, a group of researchers say. Dimebon in March 2010 flamed out in a Phase III trial that disappointed Alzheimer's disease patients and their advocates, leading San Francisco-based Medivation (NASDAQ: MDVN) to squash a planned space expansion and lay off employees. Medivation, which was working with Pfizer Inc. (NYSE: PFE) on Dimebon, has bounced back in spectacular style under CEO David HungIts prostate cancer drug enzalutamide is under priority review by the Food and Drug Administration, and its stock has crested $100 per share, a 520 percent increase in the past nine months. Now an international team, led by researchers at Mount Sinai School of Medicine in New York, believes that Dimebon, too, may be in line for a comeback.

Drug developer CytomX expands Series B by $11 million, looks to make key hires


CytomX Therapeutics Inc. expanded its $41 million Series B financing round byadding $11 million from venture capital firmCanaan Partners. The South San Francisco company, which in September 2010 raised $30 million from Third Rock Ventures and Roche Venture Fund, is developing highly targeted antibodies, which it calls Probodies. Those potential cancer and inflammatory disease treatments unmask their antibody-drug payloads only when they enter the "microenvironment" of diseases.

FibroGen wins orphan designation for IPF drug

FibroGen Inc.'s mid-stage experimental treatment for the lung-scarring disease idiopathic pulmonary fibrosis was granted orphan drug designation. The drug, FG-3019, is a human monoclonal antibody designed to inhibit connective tissue growth factor, a protein that plays an important role in the build up of excessive fibrous tissue in diseases like IPF.

Monday, July 30, 2012

23andMe seeks FDA clearance of DNA analysis test

Consumer genetic testing company 23andMe Inc. submitted paperwork to the Food and Drug Administration for clearance of its personal genome service, it said Monday. It is the first step toward 510(k) clearance for medical devices, the Mountain View company said on its "The Spittoon" blog. The company also said it believes it is the first direct-to-consumer genetic testing service to publicly acknowledge that it is trying to win FDA clearance.

Ultragenyx raises $15 million

Ultragenyx Prsident and CEO Emil Kakkis.
Orphan drug developer Ultragenyx Pharmaceutical Inc. has gathered $15.1 million toward a goal of raising $30.1 million, according to a Securities and Exchange Commission filing Monday. The Novato company, started by former BioMarin Pharmaceutical Inc. Chief Medical Officer Emil Kakkis, has won orphan drug designation for two drugs from the Food and Drug Administration as well as from European drug regulators.

Health Care Heroes: Srivastava teaching hearts to heal themselves

Deepak Srivasta of the Gladstone Institutes.
If you have a heart attack today, you’re far more likely to survive than you would have only a decade ago. The problem is that your heart may be irrevocably damaged, causing you to have trouble climbing stairs, walking or even crossing the street. You may also be headed for heart failure. But an astonishing discovery by Deepak Srivastava and his team at the Gladstone Institutes offers hope that heart damage may one day be reversible.

Health Care Heroes: Therapist's invention helps patients keep their balance

As a physical therapist, Cindy Gibson-Horn treats patients with mobility issues. Her biggest breakthrough came while helping Mary Spencer, who suffers from multiple sclerosis. Spencer kept falling backwards while walking or standing. Gibson-Horn reasoned that if she could provide a counterweight, Spencer’s balance might improve. Gibson-Horn invented a product called Balance Wear — a vest with weighted pockets that can be a life-changer for people with severe balance problems. The placement and size of the weights vary with each patient. The vests are sold by Motion Therapeutics, based in San Francisco.

Friday, July 27, 2012

CIRM awards $151 million to push stem cell treatments toward human trials

California's stem cell research funding agency doled out $151 million in new funding to move potential therapies closer to human testing, but awarded nearly $100 million less than it had planned to give. Only one of the seven so-called "disease team" awards from the California Institute for Regenerative Medicine, or CIRM, went to industry. That was a $20 million grant for Newark-based Stem Cells Inc. for a spinal cord injury treatment.

Biotech Day: Friday morning's national biotech news

From the 40 business journals of American City Business Journals …

Harvard gets DARPA grant to develop 'human on a chip' (Boston Business Journal/Mass High Tech)
The Wyss Institute for Biologically Inspired Engineering at Harvard Universityannounced recently it will receive $37 million from the Defense Advanced Research Projects Agency to develop technology that studies the human physiology. The five-year project will be led by Wyss Founding Director, Donald Ingber, M.D., Ph.D. and Wyss faculty member, Kevin Kit Parker, Ph.D. in conjunction with Wyss researchers and a multidisciplinary team of collaborators, a statement reads.

Researchers launch two cancer trials with Exelixis' 'cabo' (San Francisco Business Times)
Researchers at Memorial Sloan Kettering Cancer Center and Massachusetts General Hospital have launched separate trials using Exelixis Inc.'s experimental cancer-fighting drug cabozantinib.

Siluria raises $30M to convert methane to chemicals, fuel (San Francisco Business Times)
Siluria Technologies has raised another $30 million in venture capital to move toward commercialization of its methane-to-chemicals conversion technology. The company, located in the Fibrogen building in San Francisco’s Mission Bay, has raised $63 million since its founding four years ago. Two new investors led the latest round: Russian firm Bright Capital and Vulcan Capital in Seattle. (San Francisco Business Times subscription required.)

The push is on for a healthy pace at the FDA (Baltimore Business Journal)
Potential medical treatments can languish for years as the U.S. Food and Drug Administration grapples with increasing responsibilities and decreased funding, according to area biotech executives, who are hopeful that recent legislation will help grease the skids at the federal agency. (Baltimore Business Journal subscription required.)

Lannett again at odds with FDA (Philadelphia Business Journal)
Lannett Co. Inc., a Northeast Philadelphia generic drug maker, is again tangled up in a Food and Drug Administration directive concerning older medicines. Earlier this month, the FDA issued a notice instructing companies to stop manufacturing and distributing certain unapproved painkillers that contain oxycodone. (Philadelphia Business Journal subscription required.)

Regeneron's $75M expansion would create 110 jobs (The Business Review)
Expansion plans at Regeneron Pharmaceuticals Inc. call for a $75 million investment that would create at least 110 jobs in East Greenbush—or at competing overseas locations. Regeneron is riding early success of a new drug to treat macular degeneration, which leads to blindness. Analysts see the drug as a viable commercial product, a major milestone for a company that has built a cumulative loss of $1.3 billion during its 24 years in business. (The Business Review subscription required.)

Alimera Sciences OKs $40M stock offering (Atlanta Business Chronicle)
Alimera Sciences Inc. inked a securities purchase agreement with a group of institutional investors for a $40 million stock sale. The offering is 1 million shares at $40 a piece. Atlanta-based Alimera (Nasdaq: ALIM) is a biopharmaceutical company that specializes in research, development and commercialization of prescription ophthalmic pharmaceuticals. (Atlanta Business Chronicle subscription required.)

KV Pharma CEO's pay more than doubled in fiscal 2012 (St. Louis Business Journal)
KV Pharmaceutical Co. President and CEOGregory Divis Jr. earned $976,270 in the fiscal year ended March 31, more than double the $385,102 he was paid in fiscal 2011, according to a proxy statement the company filed Thursday with the Securities and Exchange Commission.

Genentech's Lucentis recommended for approval for diabetic eye disease (San Francisco Business Times)
An FDA advisory panel recommended Thursday that Genentech Inc.'s eye drug Lucentis be approved for some diabetes patients who have lost their sight. Already approved for age-related macular degeneration, Lucentis' approved use could extend to patients with diabetic macular degeneration if the Food and Drug Administration approves the new application by Aug. 10.

Vaxin moving biotech company from Birmingham to Maryland (Birmingham Business Journal)
Vaxin Inc., a biotech company spun from research at the University of Alabama at Birmingham, has moved from Innovation Depot to a new home in Maryland as it continues development of vaccines for the flu and anthrax.

Boston Scientific CEO explains quarterly loss, lowered guidance (Boston Business Journal)
Shares in Boston Scientific Corp. (NYSE: BSX) were down more than 6 percent Thursday afternoon, reaching a new 52-week low, after the company delivered a disappointing second quarter earnings report. The Natick, Mass.-based medical device maker swung to a net loss of $3.4 billion for the most recent quarter, due largely to a one-time, non-cash goodwill impairment charge of the same size, associated with its European unit.

Covidien shares rise on revenue growth (Boston Business Journal)
Shares in Covidien plc (NYSE: COV) were up more than 4 percent Thursday afternoon, after the company released earnings that showed revenue growth of 3 percent for the quarter, year over year. The company’s medical device division had even larger revenue growth, 8 percent year over year. Investors are especially encouraged because other large firms in the space, including Boston Scientific Corp. (NYSE: BSX) and Johnson & Johnson (NYSE:JNJ) have lately struggled to grow medical device revenue.

Vitae CEO Jeff Hatfield.
Biotech CEO: Sarbanes-Oxley audits stand in way of IPO (The Business Journals)
Sunday will mark the 10th anniversary of the signing of the Sarbanes-Oxley Act, a financial reporting law prompted by accounting scandals at Enron and WorldCom. The biggest complaint businesses have about the law is the cost of complying with Section 404(b), which requires an external audit of a public company’s internal controls. The CEO of a small biotechnology company explained to Congress this week why this requirement is keeping companies like his from going public.

Gladstone repositions for more science, recognition, cash (San Francisco Business Times)
The Gladstone Institutes now belong to Sandy WilliamsScience, fundraising and operations are locked into Williams’ vision nearly two years after he started remaking the 33-year-old San Francisco biomedical research organization as only its second president. But there’s more to come as the Gladstone Institutes make a push to solidify leading positions in HIV, stem cell and brain disease research by evangelizing about the work, beefing up stipends to attract and keep the best researchers, and launching a $25 million initiative around HIV and aging. (San Francisco Business Times subscription required.)

UCSF, chancellor shifting to Mission Bay (San Francisco Business Times)
UCSF Chancellor Susan Desmond-Hellmann will move into a new office building at Mission Bay, signaling a shift in the school’s center of gravity from Parnassus Avenue to its growing research campus. The University of California, San Francisco, in December will start work on the $94 million, six-story, 251,000-square-foot building, which will have shared workspaces and no traditional offices. That goes for Desmond-Hellmann as well. (San Francisco Business Times subscription required.)

Worthington biotech park gets first tenant (Minneapolis/St. Paul Business Journal)
Bioverse Inc., a Pipestone-based company that makes products to clean lakes of pollutants and agricultural runoff, is moving into a newly developed biotech park in Worthington, Minn.

Maryland, Virginia biotech funding down from last year (Baltimore Business Journal)
Biotech firms in Maryland and Virginia landed $91.7 million in venture funding for the first half of this year. Figures from the National Venture Capital Associationshowed a big drop from the $148.5 million raised in the same period of 2011, but it was still a stronger first-half showing than in any of the three years before that. (Baltimore Business Journal subscription required.)

Alabama NIH funding decline may get worse (Birmingham Business Journal)
The number and value of coveted National Institutes of Health grants in Alabama have both decreased in recent years, and experts say the trend might get even worse due to federal budget cuts. (Birmingham Business Journal subscription required.)

Accera grows, thanks to milkshake formula for Alzheimer's patients (Denver Business Journal)
Accera employed 15 people at its Broomfield headquarters when Holger Kunze became the biotech’s new CEO and president in January. Today, it has doubled to 30 employees there and expects to have as many as 140 nationwide by spring. The torrid growth is driven by Accera Inc.’s new backing from NestlĂ©. The Swiss food giant bought a 60 percent stake in Accera to back its product called Axona, a milkshake invented to help bolster the mental functions of patients with mild-to-moderate Alzheimer’s disease. (Denver Business Journal subscription required.)

United Therapeutics revenue up 22 percent (Washington Business Journal)
Silver Spring-based United Therapeutics Corp. saw higher sales of its cardiopulmonary hypertension drugs last quarter, but rising expenses left profits little changed.

Mylan launches anti-fungal drug (Pittsburgh Business Times)
Mylan Pharmaceuticals Inc., a subsidiary of Canonsburg-based drug maker Mylan Inc., has received final approval from the Food and Drug Administration to market itraconazole, a drug used to treat fungal infections, the company announced on Friday. Itraconazole is the generic version of Sporanox, a Janssen Pharmaceutical Inc. product.

Device maker hopes to make life easier for dentists (Cincinnati Business Courier)
DC2 Technologies is seeking an initial six-figure investment to fund additional market research, product refinement and development, advertising and marketing and staff payroll. The company founders have consulted with Cincinnati-based Market Research Services Inc. for preliminary market study design and cost estimates. (Cincinnati Business Courier subscription required.)

Top of the List: Baltimore biotech companies (Baltimore Business Journal)

Health Care Heroes: Family history inspires kidney matchmaking software

David Jacobs.
David Jacobs was recovering from a successful kidney transplant in 2006 when he and his doctor had a fateful conversation. Jacobs, a successful Silicon Valley tech pioneer who had worked at Macromedia, longed to help other kidney patients. Why, he asked, did hospitals not have better software programs to match kidney donors with people waiting for a transplant? His doctor, Steve Katznelson, a kidney specialist at California Pacific Medical Center, suggested that Jacobs draw on his engineering background to build one. Frustrated with the number of living kidney donors turned away from donation due to incompatibility, they came up with the idea for the software later called Matchmaker.

UCSF, chancellor shifting to Mission Bay

UCSF Chancellor Susan Desmond-Hellmann will move into a new office building at Mission Bay, signaling a shift in the school’s center of gravity from Parnassus Avenue to its growing research campusThe University of California, San Francisco, in December will start work on the $94 million, six-story, 251,000-square-foot building, which will have shared workspaces and no traditional offices. That goes for Desmond-Hellmann as well.

Gladstone repositions for more science, recognition, cash

Gladstone President Sandy Williams.
The Gladstone Institutes now belong to Sandy Williams. Science, fundraising and operations are locked into Williams’ vision nearly two years after he started remaking the 33-year-old San Francisco biomedical research organization as only its second president. But there’s more to come as the Gladstone Institutes make a push to solidify leading positions in HIV, stem cell and brain disease research by evangelizing about the work, beefing up stipends to attract and keep the best researchers, and launching a $25 million initiative around HIV and aging.

Siluria raises $30 million to convert methane to chemicals, fuel

Siluria Technologies has raised another $30 million in venture capital to move toward commercialization of its methane-to-chemicals conversion technologyThe company, located in the FibroGen building in San Francisco’s Mission Bay, has raised $63 million since its founding four years ago. Two new investors led the latest round: Russian firm Bright Capital and Vulcan Capital in Seattle.

Thursday, July 26, 2012

Researchers launch two cancer trials with Exelixis' 'cabo'

Exelixis CEO Michael Morrissey.
Researchers at Memorial Sloan Kettering Cancer Center and Massachusetts General Hospital have launched separate trials using Exelixis Inc.'s experimental cancer-fighting drug cabozantinib. South San Francisco-based Exelixis (NASDAQ: EXEL) said Thursday that Dr.Naiyer Rizvi, a lung cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, is working on a Phase II trial in non-small cell lung cancer patients. Also, Anuj Mahindra of Massachusetts General Hospital in Boston, is conducting a pilot Phase I trial in patients with relapsed or refractory multiple myeloma.

Genentech's Lucentis recommended for approval for diabetic eye disease

An FDA advisory panel recommended Thursday that Genentech Inc.'s eye drug Lucentis be approved for some diabetes patients who have lost their sight. Already approved for age-related macular degeneration, Lucentis' approved use could extend to patients with diabetic macular degeneration if the Food and Drug Administration approves the new application by Aug. 10.

Hyperion Therapeutics prices IPO below proposed range

Hyperion Therapeutics Inc. said Thursday it has priced 5 million shares of its common stock at $10 per share in its initial public offering. This is below a proposed range of $11 to $13 per share. The company had initially planned to offer 4.3 million shares to raise $50 million. The South San Francisco-based biopharmaceutical company is expected to start trading on the Nasdaq Global Select Market under the ticker symbol "HPTX" on Thursday, with the offering closing Tuesday of next week.

Biotech Day: Thursday morning's national biotech news

From the 40 business journals of American City Business Journals …

Genzyme ordered to pay $50M to settle patent dispute (Boston Business Journal)

Cambridge, Mass.-based Genzyme Corp., a subsidiary of French drug maker Sanofi (NYSE: SNY), has been ordered to pay $50 million to privately-held New Jersey-based biotechnology company Shelbyzyme LLC. The payment is to settle allegations that Genzyme infringed one of Shelbyzyme’s patents in selling the Fabry disease drug, Fabrazyme.

The path Anido will take as NuPathe CEO (Philadelphia Business Journal)
Armando Anido said his first order of business as the new CEO of NuPathe Inc.will be to go out and raise money for the Conshohocken, Pa., biopharmaceutical company.

Related story: Area drug firm's founder/CEO resigns (Philadelphia Business Journal)

NuPathe Inc. said Wednesday the company’s co-founder and CEO Jane Hollingsworth has resigned. It has appointed the former CEO of another Philadelphia-area drug company — Armando Anido, who had led Auxilium — to replace her.

Chimerix strikes drug licensing deal with Merck (Triangle Business Journal)

Research Triangle Park-based Chimerix Inc. has entered into a license agreement that grants Merck & Co. Inc. exclusive worldwide rights to its new HIV drug. Merck (NYSE: MRK) will be responsible for both development and commercialization of the drug. In return, Chimerix will receive a $17.5 million payment and will be eligible to receive up to $151 million in milestones, as well as royalties on future sales.

NantPharma gets $125M investment from Blackstone (Los Angeles Business)

NantPharma, owned by Dr. Patrick Soon-Shiong’s NantWorks LLC, has received a $125 million investment from private equity firm Blackstone. NantPharma makes biologically derived pharmaceuticals and operates a number of drug manufacturing and research facilities around the country.

QR Pharma begins human testing of Alzheimer's treatment (Philadelphia Business Journal)

QR Pharma initiated the first human clinical trial of the company’s compound bisnorcymserine, a potential treatment of Alzheimer’s disease. The phase-I study will evaluate the safety and tolerability of the new drug candidate in a small group of older healthy adults.

State awards U of M Medical Devices Center $1 million (Minneapolis/St. Paul Business Journal)
The University of Minnesota Medical Devices Center will build a new facility on the school's West Bank campus, thanks to a $1.08 million grant from the Minnesota Department of Employment of Economic Development (DEED).

Corindus wins FDA nod for robotic heart procedure (Boston Business Journal)

Corindus Vascular Robotics has won clearance from the U.S. Food and Drug Administration for its robotic-assisted percutaneous coronary intervention system. The Natick, Mass.-based, privately held medical device company developed the CorPath system to allow doctors to perform the heart procedures, designed to reopen blocked arteries, from a remote cockpit location.

Greatbatch Q2 net income takes fall as sales climb (Buffalo Business First)
Greatbatch Inc. reported second-quarter profit dropped to $3.85 million from $8.55 million a year ago at despite record sales. The implantable medical device manufacturer (NYSE: GB) said sales increased 14 percent to $166.5 million, from $146.5 million in the 2010 second quarter.

Wednesday, July 25, 2012

Biotech Day: Wednesday morning's national biotech news wrap

From the 40 business journals of American City Business Journals …

Bluebird Bio raises $60M with Shire for gene therapies (Boston Business Journal)
Cambridge biotech Bluebird Bio has raised $60 million in a Series D financing, the company reports. Shire plc (Nasdaq: SHPGY) was a strategic investor on the round, which brought in Deerfield Partners, RA Capital, Ramius Capital Group and two undisclosed "blue chip public investment funds," Bluebird announced in a news release.

Gladstone, film maker Jesse Dylan collaborate as research institute rebrands (San Francisco Business Times)
The times they are a-changin’ at the Gladstone Institutes, thanks in part to a Dylan. The San Francisco biomedical research organization said Tuesday that it is launching a new website, tweaking its name and teaming with award-winning film maker Jesse Dylan on a series of short films about Gladstone scientists, supporters and patients who benefit from research. Dylan, the son of legendary singer-songwriter Bob Dylan, with his film company Wondros won an Emmy Award for its 2008 “Yes We Can” presidential campaign ad about Barack Obama. 

BioCryst gets good news on gout treatment (Triangle Business Journal)
Durham-based drug company BioCryst on Tuesday announced positive clinical trial results for its proposed gout treatment ulodesine. The phase two trials of ulodesine were consistent with previously reported findings and that means BioCryst will continue to push the drug forward – but the company may not be doing it alone.

Medivation nets $10M as prostate cancer drug moves toward approval (San Francisco Business Times)
Medivation Inc. landed $10 million from partner Astellas Pharma Inc. after the Food and Drug Administration said the San Francisco drug developer's late-stage experimental prostate cancer treatment will get a priority review. The milestone payment to San Francisco-based Medivation (NASDAQ: MDVN) is based on the FDA's acceptance of the company's new drug application, Medivation said Tuesday.

Medicago earns $1M milestone payment for flu vaccine (Triangle Business Journal)
Canadian drug company Medicago has earned a $1 million milestone payment after producing more than 10 million doses of the H1N1 flu vaccine in one month – a feat accomplished at its Durham facility. The product completion was a key milestone under an agreement with the Defense Advanced Research Projects Agency to test capabilities in the event of a deadly flu outbreak.

Cynosure hits 52-week high on record revenue (Boston Business Journal)
Aesthetic medical device company Cynosure (Nasdaq: CYNO) saw its shares surge more than 12 percent, to a new 52-week high, on news that the company’s revenues for the second quarter grew 50 percent year over year. The Westford, Mass., company booked revenue of $39.6 million in the second quarter of 2012, up from $26.3 million for the same period in 2011.

Genentech's Lucentis restores diabetic vision loss, FDA says (San Francisco Business Times)
Genentech Inc.'s eye drug Lucentis improved the vision of people with a type of blindness associated with diabetes, drug regulators said in a report Tuesday, according to the news agency BloombergThe report came in advance of a Food and Drug Administration advisory committee meeting Thursday in which Genentech hopes to expand the use of Lucentis from wet age-related macular degeneration to patients with diabetic macular edema.

Life sciences company bringing 25 jobs to Florida (South Florida Business Journal)
Life science company Somahlution will move from Fargo, N.D., to Jupiter, where it could create 25 jobs over three years, the Business Development Board of Palm Beach County announced Tuesday. The developmental-stage company has secured a 13,000-square-foot facility for its headquarters, research and development and laboratory space.

Emergent Technologies-based Caisson Biotech names CEO (Austin Business Journal)
Caisson Biotech LLC, a company funded and managed by Austin-based Emergent Technologies Inc., has named a new president and CEOGlenn Nedwin has been tapped to lead the Oklahoma City-based biopharmaceutical company that creates patented drug delivery technology, according to a press release.

Tuesday, July 24, 2012

Genentech's Lucentis restores diabetic vision loss, FDA says

Genentech Inc.'s eye drug Lucentis improved the vision of people with a type of blindness associated with diabetes, drug regulators said in a report Tuesdayaccording to the news agency Bloomberg. The report came in advance of a Food and Drug Administration advisory committee meeting Thursday in which Genentech hopes to expand the use of Lucentis from wet age-related macular degeneration to patients with diabetic macular edema.

Medivation nets $10 million as prostate cancer drug moves toward approval

Medivation Inc. landed $10 million from partner Astellas Pharma Inc. after the Food and Drug Administration said the San Francisco drug developer's late-stage experimental prostate cancer treatment will get a priority review. The milestone payment to San Francisco-based Medivation (NASDAQ: MDVN) is based on the FDA's acceptance of the company's new drug application, Medivation said Tuesday.

Gladstone, Jesse Dylan collaborate as research institute rebrands

The times they are a-changin’ at the Gladstone Institutes, thanks in part to a Dylan. The San Francisco biomedical research organization said Tuesday that it is launching a new website, tweaking its name and teaming with award-winning film maker Jesse Dylan on a series of short films about Gladstone scientists, supporters and patients who benefit from research. Dylan, the son of legendary singer-songwriter Bob Dylan, with his film company Wondros won an Emmy Award for its 2008 “Yes We Can” presidential campaign ad about Barack Obama. 

Biotech Day: Tuesday morning's national biotech news

From the 40 business journals of American City Business Journals …

Shareholders seek to block Human Genome Sciences buyout (Baltimore Business Journal)
Two shareholders of Human Genome Sciences Inc. have filed a lawsuit to blockthe acquisition by GlaxoSmithKlineThe class-action complaint says the company failed to give stockholders a “meaningful chance to review material information” about the offer, according to documents filed in the U.S. District Court in Delaware. The lawsuit also seeks a temporary restraining order on the deal.
A closely watched Alzheimer's drug trial failed a late-stage test, Pfizer Inc. said MondayThe trial is the first of four with bapineuzumab by Pfizer partner Janssen Alzheimer Immunotherapy R&D LLC of South San Francisco. The trial of the intravenous drug focused on patients with mild-to-moderate Alzheimer's disease who carry a specific genotype called ApoE4.
Cerulean Pharma launches ovarian cancer trial (Boston Business Journal)
Cerulean Pharma Inc., a privately held developer of cancer drugs delivered by tiny nanoparticles, has launched a Phase 2 study of its lead drug candidate in ovarian cancer patients who are resistant to some other drugs. The ovarian cancer study is targeting patients whose cancer has advanced despite treatment with standard platinum therapy.


Chronic-pain drug developer Relmada raises $3 million (Philadelphia Business Journal)
Relmada Therapeutics raised $3 million in a private stock sale, according to documents filed with the Securities and Exchange Commission Monday. The Blue Bell, Pa., clinical-stage pharmaceutical company is specializing in developing prescription products used to manage chronic pain.

Cancer drug combo of Nexavar and Tarceva fails late-stage trial (San Francisco Business Times)
Nexavar, the blockbuster cancer drug from Bayer HealthCare and Onyx Pharmaceuticals Inc., failed a late-stage trial that looked at combining the drug with the Genentech-developed Tarceva in patients with advanced liver cancer. Onyx and Bayer said in a press release Monday that combining Nexavar and Tarceva tablets in the 720-patient, Phase III trial did not improve overall survival of patients with hepatocellular carcinoma, or HCC. The trial compared the combination therapy to Nexavar alone.

Jeffrey Boily.
Up Close: Jeffrey Boily, CEO of the Center for Animal Health Innovation (Kansas City Business Journal)
Jeffrey Boily is CEO of the Center for Animal Health Innovation, an Olathe research advocate the Kansas Bioscience Authoritycreated last year to help academic and private-enterprise researchers identify the most promising animal health breakthroughs and turn them into saleable products. (Kansas City Business Journal subscription required.)

Integra Group bought by Ohio-based NAMSA (Minneapolis/St. Paul Business Journal)
The Integra Group, a medical research firm with about 50 employees, has been sold to North American Science Associates Inc. for an undisclosed amount. Northwood, Ohio-based NAMSA has about 550 employees, including those from Integra. The company provides testing and consulting services to medical-device makers.

Halo signs license agreement with University of North Dakota (Los Angeles Business)
Halo Healthcare Inc. has signed a definitive license agreement with the University of North Dakota to develop biomarkers for the early detection of breast cancer.

OneWorld Health's Ponni Subbiah.
Pfizer veteran to lead nonprofit drug developer OneWorld Health (San Francisco Business Times)
OneWorld Health named Dr. Ponni Subbiah as its first global program leader, responsible for the South San Francisco nonprofit's drug development portfolio. Subbiah is a 15-year veteran of Pfizer Inc., where she most recently was vice president of global access within the world's largest drugmaker's emerging markets business unit. She will join OneWorld Health on Aug. 1.

BioHealth Innovation adds staff, space in quest to help Maryland companies win more funding (Baltimore Business Journal)
BioHealth Innovation Inc. is adding staff and office space to expand its operations in central Maryland. The Rockville-based organization has created a new position, director of innovation programs, to lead the organization’s effort to help Maryland companies get a greater share of federal funding intended for near-commercialization projects.

Arizona biotech leader Jeff Morhet dies in plane crash in Colorado (Phoenix Business Journal)
Jeff Morhet, 43, who was active in Arizona’s biotechnology industry, died in a plane crash July 21. He was flying his CJ-6A airplane with his oldest son Jack, 9, when the plane crashed and both were killed.

St. Pete medical device company wins $4M patent infringement verdict (Tampa Bay Business Journal)
A St. Petersburg medical device company won a $4 million jury verdict in a patent case where the Ohio Willow Wood Co. was found to have willfully broken patents on 13 different products. Since the infringement was willful, the judge has an option to increase the jury’s verdict to as much as $12 million to ALPS South LLC.


KV Pharma receives another delisting notice (St. Louis Business Journal)
KV Pharmaceutical Co. officials said the company has been notified by the New York Stock Exchange that it is below listing standard criteria due to the company’s average market capitalization being less than $50 million over a 30-day trading period and its stockholder’s equity being less than $50 million.