One down, one to go, and a lot of questions left unanswered. A panel of FDA advisors voted 13-3 today to recommend that the agency give the green light to alirocumab (Praluent), one of two new cholesterol-lowering injectable drugs the panel is reviewing this week. Beyond the main positive vote, however, some panelists also indicated … Continue reading “Advisors to FDA: Approve New Cholesterol Drug, But With Caveats”
Author: Alex Lash
I've spent nearly all my working life as a journalist. I covered the rise and fall of the dot-com era in the second half of the 1990s, then switched to life sciences in the new millennium. I've written about the strategy, financing and scientific breakthroughs of biotech for The Deal, Elsevier's Start-Up, In Vivo and The Pink Sheet, and Xconomy.
Take a Grain of Salt (Or Two) With New Cholesterol Drug Predictions
My mother always warned me never to start a column with a reference to management consultants. Sorry, Mom. Cover your eyes. But anyone else with personal health or personal finance interest in the latest cholesterol-fighting drugs, read on. Two years ago, three McKinseyites published a study about forecasts for drug sales. The upshot: To predict … Continue reading “Take a Grain of Salt (Or Two) With New Cholesterol Drug Predictions”
West Coast Biotech Roundup: Regulus, Ardelyx, Juno, Sangamo & More
While a big slice of the oncology world was packed into a Chicago conference center earlier this week for the American Society for Clinical Oncology conference, other news happened, too. In San Diego, Regulus lost a CEO, and in the Bay Area, Ardelyx said goodbye to a big partner. In Seattle, Juno kept churning out … Continue reading “West Coast Biotech Roundup: Regulus, Ardelyx, Juno, Sangamo & More”
ASCO Roundup: Checkpoints, Pushback Against Prices, CAR-T & More
As has been the case the past few years, the annual American Society of Clinical Oncology meeting, which just wrapped up in Chicago, was the latest referendum on immunotherapy. But this year, not only did the meeting feature scientific developments for these new types of cancer fighters that rev up patients’ immune systems, but it … Continue reading “ASCO Roundup: Checkpoints, Pushback Against Prices, CAR-T & More”
Want Immunotherapy Stock? One Guy’s Index Could Become Tradable Fund
In March, independent investor Brad Loncar unveiled a homebrewed stock index, created to track the red-hot cancer immunotherapy field. If he gets his way, there will soon be a publicly traded fund to go with it. Loncar, who lives in the Kansas City suburb of Lenexa, KS, announced this morning his index will form the … Continue reading “Want Immunotherapy Stock? One Guy’s Index Could Become Tradable Fund”
At Exelixis, Morrissey Dreams Of Getting the Band Back Together
Mike Morrissey is a self-described meticulous planner. Last fall, when the CEO of cancer drug developer Exelixis saw dismal data crush hopes of having his flagship drug cabozantinib (Cometriq) approved in prostate cancer, he already had the next move in place: 160 layoffs, or 70 percent of the company. “We spent four or five months … Continue reading “At Exelixis, Morrissey Dreams Of Getting the Band Back Together”
Gold Bugs? Seres Files For First IPO of Human Microbiome Era
What was it Sigmund Freud said? In dreams, feces is actually a symbol of money. Seres Therapeutics of Cambridge, MA, is about to put that notion to the test. The biotech has filed to go public, looking to tap the public markets on the momentum of its first product, a mixture of bacterial spores derived … Continue reading “Gold Bugs? Seres Files For First IPO of Human Microbiome Era”
Juno, Editas To Collaborate On CRISPR-Juiced Cancer Immunotherapy
The gene editing technology CRISPR-Cas9 might be prompting major ethical questions about its use in altering human intelligence and appearance, but biotech startups are now pushing it forward as a way to make better cancer therapies. In the second deal of its kind, Juno Therapeutics (NASDAQ: [[ticker:JUNO]]) of Seattle has tapped CRISPR-Cas9 experts Editas Medicine, … Continue reading “Juno, Editas To Collaborate On CRISPR-Juiced Cancer Immunotherapy”
Bluebird Adds to CAR-T Arsenal With Five Prime Antibody Deal
[Updated 5/27/15 12:45 pm. See below.] Bluebird Bio is expanding its technology reach with antibodies from Five Prime Therapeutics as part of its plan to develop next-generation cancer therapies. Cambridge, MA-based Bluebird (NASDAQ: [[ticker:BLUE]]) specializes in gene therapy, and its progress treating sickle cell disease and beta-thalassemia, both rare blood disorders, is one of the … Continue reading “Bluebird Adds to CAR-T Arsenal With Five Prime Antibody Deal”
After Orexigen Gaffe, What Role for Drugs Amid Obesity Crisis?
Two recent happenings prompted this column. First, Orexigen Therapeutics drew fire from, well, nearly everyone earlier this month for an improper release of data related to its weight-loss drug Contrave. The second happening is Memorial Day weekend. I’m assuming you, like me, did not spend the long weekend hunting and gathering, sharpening your arrowheads, and … Continue reading “After Orexigen Gaffe, What Role for Drugs Amid Obesity Crisis?”
West Coast Biotech Roundup: Illumina, Veracyte, Otonomy, Kite & More
Out west this week, the news flow was breezy. There were a sprinkling of diagnostics showers led by Illumina, which is in a patent fight with a Roche subsidiary, and Veracyte, which presented promising data for its lung test. It also seemed to be a week for pharma collaborations. Two pairs of partners signed pacts, … Continue reading “West Coast Biotech Roundup: Illumina, Veracyte, Otonomy, Kite & More”
West Coast Biotech Roundup: Orexigen, Denali, Nant, ASCO & More
This week’s roundup has an elevation change. In San Diego, Orexigen Therapeutics, maker of a weight-loss drug, dug itself deep into a hole with the FDA, its clinical collaborators, and its business partners. In San Francisco, Denali Therapeutics debuted with a mountain of cash to tackle neurodegenerative diseases. L.A. billionaire and partial Laker owner Patrick … Continue reading “West Coast Biotech Roundup: Orexigen, Denali, Nant, ASCO & More”
On Big Brain Day, Allen Institute Debuts Neuron “Periodic Table”
The biotech world has brains on their mind today with the launch of Denali Therapeutics, a mega-startup with lofty goals of developing drugs for Alzheimer’s and other neurodegenerative diseases. A big problem in finding treatments for those diseases is how little we know about the brain itself. One group making those explorations and sharing them … Continue reading “On Big Brain Day, Allen Institute Debuts Neuron “Periodic Table””
Denali Rises With $217M and Genentech Alumni to Fight Brain Diseases
A group of investors is betting $217 million that a new drug company led by three Genentech alumni can break the frustrations of what, to now, has been a Sisyphean task: Finding treatments for the world’s most vexing neurodegenerative diseases, including Alzheimer’s and Parkinson’s. The new startup, Denali Therapeutics, is debuting today with Marc Tessier-Lavigne … Continue reading “Denali Rises With $217M and Genentech Alumni to Fight Brain Diseases”
Talking Cure? For Cancer Immunotherapy, Still Many Rivers to Cross
Cancer is a humbling thing: Our own cells gone bad, killing us from the inside, and so often able to rebound from attack or avoid it entirely. There has been progress fighting some types of cancers, but in no way equal to the resources (or rhetoric) the human race has aimed at the problem. On … Continue reading “Talking Cure? For Cancer Immunotherapy, Still Many Rivers to Cross”
Bay Area Fund, Aligned With UC, Raises New To Cash To Seed Biotechs
Mission Bay Capital has raised a $25 million seed stage biotech fund, the San Francisco-based group said Monday. It will continue to help Bay Area startups, often germinated at one of three local University of California campuses, get off the ground. The new fund is small by typical life science venture standards, but it’s more … Continue reading “Bay Area Fund, Aligned With UC, Raises New To Cash To Seed Biotechs”
West Coast Biotech Roundup: Adaptive, Gilead, Juno, aTyr & More
[Corrected 5/8/15, 6:48 pm. See below.] Out west this week there was news, there was an event, and there was coincidence. It just happened that two executives who spoke at Xconomy’s annual Seattle biotech forum Wednesday represented local companies, Adaptive Biotechnologies and Juno Therapeutics, in this week’s news. (Xconomy Seattle editor Ben Romano was there … Continue reading “West Coast Biotech Roundup: Adaptive, Gilead, Juno, aTyr & More”
Adaptive Reels in Whopping $195M For Immuno-Sequencing Work
[Updated, 5/7/15, 11:10 am ET] Adaptive Biotechnologies of Seattle is continuing its busy year, announcing this morning it has reeled it $195 million in financing from a group of new investors. The big cash haul comes four months after the sequencing company, which specializes in understanding the immune system, raised $94 million to help buy … Continue reading “Adaptive Reels in Whopping $195M For Immuno-Sequencing Work”
Waksal’s Kadmon Spins Out Gene Therapy Group But Keeps Details Close
As it heads toward an IPO try, New York biotech Kadmon is lightening its load. The firm announced today it has spun out a gene-therapy subsidiary and expects it to have four products in clinical trials next year with a focus on eye disease. The spinout, Kadmon Gene Therapy Holdings, or KGT, will be run … Continue reading “Waksal’s Kadmon Spins Out Gene Therapy Group But Keeps Details Close”
West Coast Biotech Roundup: Kythera, Amgen, Otonomy, Versant & More
West Coast news this week was dominated by thumbs. Amgen, Otonomy, and Kythera all got a regulatory thumbs-up for their products. Some thumbs were down, however. Celladon’s cardiovascular gene therapy missed two big goals in a late-stage trial. Meanwhile, San Francisco-based Versant Ventures had a big week, announcing a sale of one portfolio company in … Continue reading “West Coast Biotech Roundup: Kythera, Amgen, Otonomy, Versant & More”
Preeclampsia Test Developer Carmenta Bought For Undisclosed Sum
Any expectant parent knows that preeclampsia—a kind of high blood pressure during pregnancy—is a dreaded possibility. It can be fatal for mother and baby, and it can be difficult to diagnose. Matthew Cooper (pictured) knows the danger all too well, nearly losing his wife to the condition in 2005. Seven years later, he started a … Continue reading “Preeclampsia Test Developer Carmenta Bought For Undisclosed Sum”
Celgene, Versant Shake Again, Cut $30M Deal For Toronto Biotech
Celgene (NASDAQ: [[ticker:CELG]]) is paying $30 million for the right to acquire a brand-new biotech, Northern Biologics, that is the first product of a Toronto incubator that the big Summit, NJ, drugmaker has helped fund. Northern is developing protein therapies, using monoclonal antibodies to treat cancer and fibrotic disease. It got its first funding in … Continue reading “Celgene, Versant Shake Again, Cut $30M Deal For Toronto Biotech”
In Venture Reinvention, Versant Sees Gains Amid Biotech Boom Times
There’s not much ice in San Francisco, where I grew up, so hockey metaphors often go right over my head. But I can’t resist noting that Versant Ventures, led by a former hockey player, has made big line changes this decade to be able to skate another day, while many of its biotech venture peers … Continue reading “In Venture Reinvention, Versant Sees Gains Amid Biotech Boom Times”
West Coast Biotech Roundup: Juno, Genervon, Tekmira, DNANexus & More
The West Coast this week is home to news about a new immuno-oncology combination, a tiny step forward in Ebola, and a whole lot of hullabaloo over a tiny L.A. biotech developing a drug for Lou Gehrig’s disease (ALS). Let’s get to the roundup. —Juno Therapeutics (NASDAQ: [[ticker:JUNO]]) of Seattle and the AstraZeneca (NYSE: [[ticker:AZN]]) … Continue reading “West Coast Biotech Roundup: Juno, Genervon, Tekmira, DNANexus & More”
To Find Combos, Presage Debuts Drug-Test Device In Cancer Patients
Fighting cancer often comes down to finding the right combination of drugs. But it’s difficult, impractical, and even unsafe to test ever-growing permutations of those cocktails. Presage Biosciences has been working for seven years on a new way to efficiently test anti-cancer combinations. Today the Seattle biotech reported in Science Translational Medicine that its unusual … Continue reading “To Find Combos, Presage Debuts Drug-Test Device In Cancer Patients”
With Fresh $14M, Tal Seeks Answers About Magnetic Depression Relief
The first antidepressant drugs were discovered by happenstance in the 1950s when experimental tuberculosis treatments unexpectedly brightened patients’ moods. Happy accidents have happened in the medical device field, too, and Tal Medical of Boston has reeled in $14 million in Series B funding to push one forward. Tal is developing a treatment for severe depression … Continue reading “With Fresh $14M, Tal Seeks Answers About Magnetic Depression Relief”
Here’s The Agenda for Seattle Biotech Seizes The Momentum, May 6
A quick reminder that on May 6 I’ll be hosting our annual Seattle biotech forum, Seattle Biotech Seizes the Momentum, a half-day of discussion, debate, and interviews with the local community’s top biotech and life science leaders. We’ve just posted the agenda. Check it out here. The afternoon features one-on-one talks with Gary Gilliland, the … Continue reading “Here’s The Agenda for Seattle Biotech Seizes The Momentum, May 6”
West Coast Biotech Roundup: CRISPR, Doudna, Aduro, Amgen, NEA & More
Berkeley, CA, is famous as the birthplace of the Free Speech Movement, led by Mario Savio, and the modern foodie movement, led by godmother Alice Waters. What about the gene editing movement? Jennifer Doudna, one of the scientists behind the technology known as CRISPR/Cas9, is a biochemist at the University of California, Berkeley. She was … Continue reading “West Coast Biotech Roundup: CRISPR, Doudna, Aduro, Amgen, NEA & More”
Doudna, Berkeley Gain Expert’s Backing In CRISPR Patent Fight
Jennifer Doudna is urging caution in the use of genetic manipulation. But she and her colleagues are also fighting for ownership of the scientific tools that make it possible. Through Doudna’s employer, the University of California, Berkeley, the biochemist and her colleagues are forging ahead with a patent fight, bolstered with documents published Monday, over … Continue reading “Doudna, Berkeley Gain Expert’s Backing In CRISPR Patent Fight”
Big Day For Biotech IPOs as Aduro More Than Doubles In Price
[Updated 4/15/15, 7:14pm. See below.] Aduro Biotech (NASDAQ: [[ticker:ADRO]]) kept the immunotherapy bulls running Wednesday after raising $119 million in its initial public offering. Berkeley, CA-based Aduro sold 7 million shares at $17 apiece, a price that has more than doubled in its first trading day on the Nasdaq, pushing past $38 in late trading. … Continue reading “Big Day For Biotech IPOs as Aduro More Than Doubles In Price”
Join Us May 6 at the Hutch to Discuss Seattle Biotech’s Wild Ride
Fresh off Xconomy’s most successful biotech forum ever last week in Boston, we’re getting ready to meet that challenge on May 6 in Seattle for Seattle Biotech Seizes the Momentum, a half-day of discussion, debate, and interviews with the local community’s top biotech and life science leaders. There’s so much to talk about. You can … Continue reading “Join Us May 6 at the Hutch to Discuss Seattle Biotech’s Wild Ride”
Pop That Bubble: 5 Reasons Biotech Needs A Different Metaphor
Back in April 2011, at a biotech conference in San Francisco, a panel convened to discuss how hard it was to build biotech companies that could push through long, costly clinical trials before a drug comes to market. One panelist hedged to say, well, at least the financial reticence had a silver lining: there was … Continue reading “Pop That Bubble: 5 Reasons Biotech Needs A Different Metaphor”
West Coast Biotech Roundup: Juno, Tekmira, True North, aTyr & More
We’ll move in geographic fashion through the roundup this week, starting in the Pacific Northwest, where Juno Therapeutics won a patent fight and found a new headquarters. Further south, the Bay Area hosted an IPO and several other financings, and down San Diego way, aTyr Pharma joined the IPO queue. It’s Friday, and we’re roundup-ready. … Continue reading “West Coast Biotech Roundup: Juno, Tekmira, True North, aTyr & More”
Clocking In Next Year, Juno’s New HQ Keeps A Hand On Seattle History
Biotech folks in Seattle have real estate on their minds. Last week, the giant “Helix” campus in the Interbay neighborhood, once expected to be a local biotech anchor for decades, was nabbed by online travel site Expedia. This week, rising biotech star Juno Therapeutics (NASDAQ: [[ticker:JUNO]]) ended its quest for new headquarters, announcing a seven-year … Continue reading “Clocking In Next Year, Juno’s New HQ Keeps A Hand On Seattle History”
With $35M Infusion, True North Moves Rare Disease Drug Into Clinic
True North Therapeutics has raised a $35 million Series B venture round to push its top product, a potential treatment for several rare diseases, through a series of early clinical tests, the company said today. The South San Francisco, CA-based biotech is developing a treatment for autoimmune diseases, which occur when the body’s own defense … Continue reading “With $35M Infusion, True North Moves Rare Disease Drug Into Clinic”
Juno, Novartis End CAR-T Patent Fight, With Juno A Little Richer
Juno Therapeutics (NASDAQ: [[ticker:JUNO]]) and Novartis (NYSE: [[ticker:NVS]]) are cancer immunotherapy rivals, but Juno now has a rooting interest in Novartis’s success. The two companies said today they have avoided a trial and settled a patent dispute around a specific bit of genetic engineering shared by some of their products that use what’s known as … Continue reading “Juno, Novartis End CAR-T Patent Fight, With Juno A Little Richer”
From Iceland to White House, Precision Medicine’s Promises & Hurdles
[Updated and corrected, 4/5/15, 6:51 pm. See below.] There is talk, and there is action. In the drive toward healthcare tailored for smaller and smaller groups of people, there was both last week, and both illustrated not just the promise of precision medicine, but the long haul until that promise is fulfilled. First, Iceland’s deCODE … Continue reading “From Iceland to White House, Precision Medicine’s Promises & Hurdles”
In New Gene-Editing World, Doudna Applies Both Brake and Gas Pedal
Jennifer Doudna of the University of California, Berkeley, led the group of 18 scientists who published a letter last week in Science magazine calling for urgent discussions on efforts to change the DNA of sperm, eggs, and embryos—known collectively as the human germline. Through the work of Doudna and others, what once seemed like science … Continue reading “In New Gene-Editing World, Doudna Applies Both Brake and Gas Pedal”
West Coast Biotech Roundup: Amgen/deCODE, Calico, Orexigen & More
For sheer volume, San Diego carries the week’s West Coast biotech news, with everything from trial failures (Lpath, MEI Pharma) to stock sales and deals (Retrophin, Vical, Mast) to good product news (Orexigen, Conatus). For scientific impact, however, Amgen tips the scales with the big publication of Icelandic genomic data from its subsidiary DeCode Genetics. … Continue reading “West Coast Biotech Roundup: Amgen/deCODE, Calico, Orexigen & More”
Seattle’s Gilliland, Nelsen, Hood, Franklin & More to Gather May 6
Last May, real estate company Jones Lang LaSalle’s report on Seattle’s life science economy had mixed news. The number of businesses was up, but jobs were down. Lake Union, Seattle’s “life sciences epicenter,” was getting more crowded and rents were quickly on the rise. It’s been quite a year since then. Biotech has had an … Continue reading “Seattle’s Gilliland, Nelsen, Hood, Franklin & More to Gather May 6”
Flagship Ventures Raises Sails for $537M Fund, Its Largest to Date
Flagship Ventures of Cambridge, MA, a major early-stage biotech investor, said today it has closed a $537 million fund, the largest in the firm’s 15-year history. Flagship initially set out to match the $269 million of its previous fund, Flagship senior managing partner and CEO Noubar Afeyan (pictured) said, but biotech momentum changed those plans. … Continue reading “Flagship Ventures Raises Sails for $537M Fund, Its Largest to Date”
His Attacker Found Guilty, UCSD’s Steve Dowdy “Not Looking Back”
Former biotech executive Hans Petersen was found guilty of two counts of attempted murder Wednesday in San Diego. One of his targets, the University of California, San Diego scientist Steve Dowdy, says it’s time to move on. “[It’s the] end of a tragic story for us, but we’re not looking back anymore, only forward,” he … Continue reading “His Attacker Found Guilty, UCSD’s Steve Dowdy “Not Looking Back””
Biogen Drug Shows Early Promise in Slowing Alzheimer’s Decline
Drug maker Biogen Idec is one step closer to a breakthrough in the Alzheimer’s disease field. For the first time, an experimental treatment seems to both clear out the telltale clumps of protein called beta amyloid from the brains of Alzheimer’s patients and—more important—slow down those patients’ cognitive decline. At a medical conference in Nice, … Continue reading “Biogen Drug Shows Early Promise in Slowing Alzheimer’s Decline”
West Coast Biotech Roundup: Juno, Nektar, Kite, Glooko & More
Out west this week, Bay Area clinical data carried the day. Nektar got bad news from a Phase 3 breast cancer trial, but Pharmacyclics, about to become (a very expensive) part of AbbVie, kept rolling with lymphoma/leukemia data so good that reviewers voted to release it early. Vancouver was also abuzz, as Bill Gates spoke … Continue reading “West Coast Biotech Roundup: Juno, Nektar, Kite, Glooko & More”
Glooko Gets $16M Injection to Upgrade Digital Diabetes Product
Digital health firm Glooko has a new round of cash to expand its diabetes management product, but it’s not ready to say how much the product is actually helping diabetics. The Palo Alto, CA-based company has raised a $16.5 million Series B round, led by Canaan Partners. With the cash, Glooko will add more ways … Continue reading “Glooko Gets $16M Injection to Upgrade Digital Diabetes Product”
In Mental Health Therapy, Cautious Steps Toward the Pharmacodigital
[Corrected 3/17/15, 7:55 pm. See below.] The phrase “better living through chemistry,” derived from an old DuPont corporate slogan, has accumulated all kinds of ironic and wink-wink connotations over the decades. But there’s a fascinating revival and upgrade underway. For people with debilitating mental health problems, many researchers, doctors, and businesspeople think the new phrase … Continue reading “In Mental Health Therapy, Cautious Steps Toward the Pharmacodigital”
West Coast Biotech Roundup: Apple, 23andMe, Amgen, Acadia & More
A is for all the news up and down the West Coast this week, and much of that news was both about bio and tech. Apple launched an iPhone-based medical research platform, 23andMe has hired a former Genentech star to turn its genomic database into a drug discovery platform, and Google is expanding its genomic … Continue reading “West Coast Biotech Roundup: Apple, 23andMe, Amgen, Acadia & More”
23andMe Adds On: More About The Gene-Test Maker’s Drug R&D Ambitions
As I reported earlier, 23andMe today announced its intention to pursue pharmaceutical R&D, in addition to its business selling direct-to-consumer genetic test kits. To lead its new drug research group, it has tapped Richard Scheller, the longtime head of research at Genentech and a distinguished neuroscientist. Scheller wasn’t available to talk today, but after posting … Continue reading “23andMe Adds On: More About The Gene-Test Maker’s Drug R&D Ambitions”
23andMe Pharma? That’s the Plan, Says the Genetic Test Maker
[Updated 3/12/15, 4:52pm. See below.] From data gatherer to drug developer. That’s the bold step Silicon Valley genomic data firm 23andMe wants to take, and it announced this morning it has hired Richard Scheller, formerly Genentech’s top researcher, to lead the way. It’s dramatic news, but it’s also not surprising. Dramatic, because 23andMe recently had … Continue reading “23andMe Pharma? That’s the Plan, Says the Genetic Test Maker”
At Acadia, “Mistakes Were Made,” A Drug Is Delayed & the CEO Is Out
On Tuesday, Acadia Pharmaceuticals dropped out of two conferences and its stock price jumped, apparently because investors thought an acquisition was coming. Not quite. Instead San Diego-based Acadia (NASDAQ: [[ticker:ACAD]]) said today it would delay asking the FDA to approve its main product, and that its CEO, Uli Hacksell (pictured), had resigned. Acadia shares fell … Continue reading “At Acadia, “Mistakes Were Made,” A Drug Is Delayed & the CEO Is Out”