[Note: Ben Fidler co-authored this report.] This weekend, San Diego will host the annual American Society of Hematology conference, the largest U.S. medical gathering to get the latest on blood diseases, and a venue for updates on some of the most cutting-edge biotechnologies that only a few years ago seemed like science fiction. Using the … Continue reading “ASH 2018: A Guide to the Latest for Blood-Borne Cancers and More”
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.
Deeper Dive: Amarin Fish-Oil Study Gives Eager Doctors More to Ponder
Two months ago, the medical community was all abuzz over a big clinical study that showed a prescription fish-oil supplement could reduce the risk of heart disease. Today, a fuller look at the data presents a more nuanced picture. Doctors working on the REDUCE-IT trial, which enrolled more than 8,000 people, published the full set … Continue reading “Deeper Dive: Amarin Fish-Oil Study Gives Eager Doctors More to Ponder”
Bashing Rival’s Pharma Record, Troubled Menendez Keeps NJ Senate Seat
Running a successful pharmaceutical business apparently isn’t a big selling point for New Jersey voters. The state voted today to re-elect Senator Bob Menendez, a Democrat, and cast aside his GOP challenger Bob Hugin, the former CEO of Celgene (NASDAQ: [[ticker:CELG]]), one of the world’s most valuable drug companies. As Election Day turned to Wednesday, … Continue reading “Bashing Rival’s Pharma Record, Troubled Menendez Keeps NJ Senate Seat”
Bio Roundup: Depression Drug Dashed, Peek at ASH, CRISPR Worry & More
The gene-editing technology CRISPR-Cas9 is opening up new research avenues all the time, such as giving drug developers a cheaper, faster way to knock out genes in tumor cells. Studies of CRISPR-Cas9 to treat human disease are about to start, too. But will our immune systems, already on alert for common infections by the bacteria … Continue reading “Bio Roundup: Depression Drug Dashed, Peek at ASH, CRISPR Worry & More”
To Boost Cancer Pipeline, Gilead Bets at Least $50M on Startup Tango
Gilead Sciences is paying tiny Tango Therapeutics $50 million to tap into the startup’s cancer drug program, adding to what has been so far an expensive, but not yet lucrative, foray into cancer immunotherapy for Gilead. Cambridge, MA-based Tango is still in the early phases of looking for cancer drugs by exploiting a well-known tumor … Continue reading “To Boost Cancer Pipeline, Gilead Bets at Least $50M on Startup Tango”
Fresh Data Add More Confusion to Eisai-Biogen Alzheimer’s Drug
Three months after controversial data suggested an Alzheimer’s drug could slow the mental decline of the disease, the drug’s owners tried to bolster their argument today that the good news over the summer was not a statistical illusion. The drug in question is dubbed BAN2401, and it’s being co-developed by Biogen (NASDAQ: [[ticker:BIIB]]) of Cambridge, … Continue reading “Fresh Data Add More Confusion to Eisai-Biogen Alzheimer’s Drug”
ESMO ’18: Precision Meds, Breast, Lung, and More from the Cancer Front
[Ben Fidler co-authored this report.] The European Society for Medical Oncology is wrapping up its annual conference today, replete with clinical data from cancer’s front lines. We’ve sorted the headlines into a few big categories: immunotherapy combinations, breast cancer, lung cancer, the growing class of drugs called PARP inhibitors, and new drugs that treat tumors … Continue reading “ESMO ’18: Precision Meds, Breast, Lung, and More from the Cancer Front”
A Year Early, Merck Touts Good Kidney Cancer News to Push Rival BMS
Merck could soon join rival Bristol-Myers Squibb in making immunotherapy an option for kidney cancer patients who have never had treatment before. Merck (NYSE: [[ticker:MRK]]) reported today that its blockbuster drug pembrolizumab (Keytruda) has hit its marks much earlier than expected in an 861-person Phase 3 study called Keynote-426. Merck tested a combination of pembrolizumab … Continue reading “A Year Early, Merck Touts Good Kidney Cancer News to Push Rival BMS”
Bio Roundup: BIO Diversity, Allogene IPO, CRISPR In Utero & More
Nearly four years after investors snapped up new shares of Juno Therapeutics in a $265 million IPO, cancer immunotherapy remains a hot ticket. Like Juno, Allogene Therapeutics just pulled in a massive IPO haul, nearly $300 million. And like Juno, Allogene is working with a live immune-cell treatment called CAR-T, but it is harvesting cells … Continue reading “Bio Roundup: BIO Diversity, Allogene IPO, CRISPR In Utero & More”
BIO Has Big Diversity Goals. Does It Have the Means to Reach Them?
Whether from embarrassing parties or sobering surveys, the biotech gender gap problem has made plenty of headlines the past couple years. The industry’s largest trade group, the Biotechnology Industry Organization (BIO), is trying to encourage its more than 1,000 member companies to do better. Last winter, BIO posted diversity goals for the industry to hit … Continue reading “BIO Has Big Diversity Goals. Does It Have the Means to Reach Them?”
FDA’s Latest Cancer Approval Underscores Immunotherapy Nobel Prize
The FDA is not only approving a lot more drugs these days, it seems to have also developed a sense of dramatic timing. Late last Friday, the agency approved its seventh checkpoint inhibitor, a type of cancer drug that blocks a tumor’s ability to hide from the immune system. Less than 72 hours later, two … Continue reading “FDA’s Latest Cancer Approval Underscores Immunotherapy Nobel Prize”
Bio Roundup: Little Rhody, More for Migraine, Opioid Bills & More
The U.S. Senate had a rare moment of agreement, overwhelmingly passing a package of opioid-related bills. Up the East Coast, life-science players in Rhode Island are working to bring different local factions together and boost the state’s economy. Across the country, a similar effort is underway in Los Angeles. There were also plenty of headlines … Continue reading “Bio Roundup: Little Rhody, More for Migraine, Opioid Bills & More”
In Boston’s Shadow, Rhode Island Fights for Life Science Jobs, Respect
[Updated 9/19/18, 3:40 p.m. See below.] Tiny Rhode Island and its capital city Providence have always punched above their weight, for better or for worse. Better: Little Rhody’s founder Roger Williams, fleeing religious persecution in 17th-century puritanical Massachusetts, was one of America’s first abolitionists and created the concept of the separation of church and state. … Continue reading “In Boston’s Shadow, Rhode Island Fights for Life Science Jobs, Respect”
U.S. Court Affirms Broad’s CRISPR Patent; No Word of Berkeley Appeal
On the heels of a federal court victory, the Broad Institute of Harvard and MIT is calling for the end of a long and winding legal fight over the ownership of the landmark genome editing system CRISPR-Cas9. The widespread ability for humans to manipulate their own DNA and that of many other organisms has arrived, … Continue reading “U.S. Court Affirms Broad’s CRISPR Patent; No Word of Berkeley Appeal”
Sangamo 1st to Show Human Gene-Editing Results. Investors Say ‘Meh.’
The first results from a landmark study of gene editing in humans came out today, and investors panned the study’s sponsor, Sangamo Therapeutics. The very early returns—from only four patients still in the midst of the study—are from a gene-manipulation technology called zinc finger nucleases, which is wholly owned by Richmond, CA-based Sangamo (NASDAQ: [[ticker:SGMO]]). … Continue reading “Sangamo 1st to Show Human Gene-Editing Results. Investors Say ‘Meh.’”
Bio Roundup: Pfizer’s Rare Results, U.K.’s CAR-T No, IPO Go-Go & More
Before you head out for the final summer getaway, catch up on the week’s headlines. Pfizer upped the ante in the field of transthyretin amyloidosis (ATTR) treatment, where competition to treat the rare disease has grown increasingly complex. We’ll start with what was—and wasn’t—in Pfizer’s data release Monday, top up with more ATTR news, then … Continue reading “Bio Roundup: Pfizer’s Rare Results, U.K.’s CAR-T No, IPO Go-Go & More”
FDA Gives Thumbs-Down to Rare Disease Drug from Ionis, Akcea
The FDA has rejected the rare-disease drug volanesorsen (Waylivra), which is being developed by Ionis Pharmaceuticals (NASDAQ: [[ticker:IONS]]) and its subsidiary Akcea Therapeutics (NASDAQ: [[ticker:AKCA]]). Ionis, based in San Diego, and Akcea, in Cambridge, MA, had high hopes for approval after a committee of outside experts in May recommended the drug by a 12-8 vote. … Continue reading “FDA Gives Thumbs-Down to Rare Disease Drug from Ionis, Akcea”
Eyeing Approval, Pfizer Touts Tafamidis Study, but Details Lacking
[Updated, 8/28/18, 1:30pm ET. See end of story.] Drug giant Pfizer (NYSE: [[ticker:PFE]]) could soon join a budding U.S. competition to treat the rare disease transthyretin amyloidosis, in which a common protein goes haywire and builds up into dangerous deposits in the heart and nerves. Pfizer today presented results from a late-stage study of its … Continue reading “Eyeing Approval, Pfizer Touts Tafamidis Study, but Details Lacking”
After Launching Women’s Mentor Network, Lisa Suennen Sets Sail from GE
Lisa Suennen, a high-profile life-sciences investor, is leaving a top post at GE Ventures after two years. Based in the San Francisco Bay Area, Suennen is widely known for her investment work as well as her writing—her blog is called “Venture Valkyrie“—and podcasting about people, companies, and industry trends, notably the gender equity gap among … Continue reading “After Launching Women’s Mentor Network, Lisa Suennen Sets Sail from GE”
Rare-Disease Hackathon Leads to $3M for Health Data Startup RDMD
When tech entrepreneur Onno Faber learned he had an extremely rare genetic disease with no available treatments, he leaned on his tech skills and organized a Silicon Valley “hackathon” in 2017 to dig into his own DNA and perhaps help others with his condition. Faber can now lean on a few million dollars. The company … Continue reading “Rare-Disease Hackathon Leads to $3M for Health Data Startup RDMD”
Bio Roundup: Big Approvals, ICER Influence, Drug-Price Pushback & More
[Updated 8/17/18, 10:21 a.m. See below.] We’ll start the roundup this week with two drug approvals that came late last Friday. Both were landmarks for the companies receiving the nod, Alnylam Pharmaceuticals and Amicus Therapeutics. We also saw a new biotech emerge in the muggy New York heat, a couple deals for new flu vaccines, … Continue reading “Bio Roundup: Big Approvals, ICER Influence, Drug-Price Pushback & More”
Bio Roundup: Alnylam’s Moment, Read on Rebates, Skinny Plans & More
Millions of people might be on vacation as we hit the dog days, but drug makers and politicians aren’t taking a break from the gamesmanship over high drug prices. After two years of blowing smoke, the Trump administration is threatening action on a few fronts, including against the powerful middlemen known as PBMs that decide … Continue reading “Bio Roundup: Alnylam’s Moment, Read on Rebates, Skinny Plans & More”
Verge Genomics Nabs $32M For Computation-Heavy Neuro Drug Discovery
Two years after making her first-ever rounds of business meetings at the J.P. Morgan healthcare conference, Alice Zhang has steered her biotech startup, Verge Genomics, into a $32 million Series A financing. Zhang (pictured) was notable then and now for her age—few biotech CEOs are under 30—and for her career path. She walked away from … Continue reading “Verge Genomics Nabs $32M For Computation-Heavy Neuro Drug Discovery”
EU Regulators Approve Akcea’s Inotersen. FDA Decisions Are Next.
Akcea Therapeutics (NASDAQ: [[ticker:AKCA]]) has beaten rival Alnylam Pharmaceuticals (NASDAQ: [[ticker:ALNY]]) to a first drug approval, getting the nod for its drug inotersen (Tegsedi) in the European Union. Akcea and Alnylam, both of Cambridge, MA, are developing treatments for the rare genetic disease transthyretin amyloidosis, or ATTR. It stems from a gene mutation that causes … Continue reading “EU Regulators Approve Akcea’s Inotersen. FDA Decisions Are Next.”
Nimbus Hires Adrian Ray, a 15-Year Gilead Veteran, as New SVP
Nimbus Therapeutics of Cambridge, MA, has hired Adrian Ray as senior vice president of discovery biology as it advances its immunology and oncology pipeline. Ray comes from Gilead Sciences (NASDAQ: [[ticker:GILD]]), where he spent 15 years, most recently as senior director of clinical research. Nimbus and Foster City, CA-based Gilead are familiar with each other. … Continue reading “Nimbus Hires Adrian Ray, a 15-Year Gilead Veteran, as New SVP”
Down the Stretch: Akcea, Alnylam Face Reality Checks as FDA Dates Loom
More details from two drug programs up for approval this year to treat a rare genetic disease emerged yesterday, published in side-by-side papers in the New England Journal of Medicine. In one sense, the new papers hold no surprises, but they reinforce the similarities and differences between the closely watched drugs, one from Akcea Therapeutics … Continue reading “Down the Stretch: Akcea, Alnylam Face Reality Checks as FDA Dates Loom”
Bio Roundup: Dunsire’s Danish, Price Hikes, Rare-Disease Race & More
[Corrected, 7/6/18, 1:26 pm. See below.] Xconomy was dumbstruck this week, and not by the fireworks overhead. Our friend and one of our earliest employees, San Diego editor Bruce Bigelow, died suddenly last weekend. Bruce covered everything—and everyone—in San Diego’s innovation scene, including the life sciences. Some of our favorite stories of his sprang from … Continue reading “Bio Roundup: Dunsire’s Danish, Price Hikes, Rare-Disease Race & More”
Lundbeck Reaches Across Atlantic, Picks Dunsire for CEO Post
Deborah Dunsire, a veteran of Boston’s biotech scene, is taking off. Specifically, she’s taking the top job at Danish pharma firm Lundbeck, according to an announcement this morning. The move comes only a year after Dunsire said she would lead 30-employee XTuit Pharmaceuticals of Waltham, MA, a preclinical cancer company. At the time, she told … Continue reading “Lundbeck Reaches Across Atlantic, Picks Dunsire for CEO Post”
Study: Blood Test for Prostate Cancer Can Guide Therapy, Extend Lives
Blood tests for cancer, known as liquid biopsies, have become available in recent years to guide treatments for people already diagnosed. But how useful are they? A paper published last week in the journal JAMA Oncology makes the case that one such test, Oncotype DX AR-V7 Nucleus Detect, might be worth its $3,980 price tag. … Continue reading “Study: Blood Test for Prostate Cancer Can Guide Therapy, Extend Lives”
GBT Eyes Fast Nod for Sickle Cell Drug but Won’t Use Patient-Reported Data
Global Blood Therapeutics hasn’t finished testing its treatment for sickle cell disease, but the South San Francisco, CA-based company thinks it can get a fast-track approval for the once-a-day pill, voxelotor, from the FDA. That was the company’s message this morning when it presented results from the first half of its key Phase 3 study, … Continue reading “GBT Eyes Fast Nod for Sickle Cell Drug but Won’t Use Patient-Reported Data”
Helix Expands Real-World and Online Footprint with HumanCode Deal
Helix, which runs an online outlet for products based on customer DNA, has bought HumanCode, one of the app makers that contributes to its store. Denver-based HumanCode makes BabyGlimpse, which shows couples genetic traits that they might pass on to their children; and DNA Passport, which the company calls a “starter kit” to explore one’s … Continue reading “Helix Expands Real-World and Online Footprint with HumanCode Deal”
For Sickle Cell, a Complex Disease, New Drugs Could Bring Complex Costs
Cassandra Trimnell has sickle cell disease. She also loves to travel. For her 30th birthday last year, she and her husband planned a trip to Indonesia, and she figured she would be fine. Growing up in Iowa, she was sick all the time, in and out of hospitals with severe pain episodes, or “crises,” and … Continue reading “For Sickle Cell, a Complex Disease, New Drugs Could Bring Complex Costs”
Bio Roundup: Wrapping ASCO, Dreaming IPO, Rebooting Axovant & More
Most of the cancer news this week happened at the massive ASCO meeting in Chicago. But not all, as we’ll see in a moment. Also this week, Biogen and Eisai reported good news about an Alzheimer’s drug, but with plenty of caveats. Axovant Sciences, which hit the skids last year because of a massive Alzheimer’s … Continue reading “Bio Roundup: Wrapping ASCO, Dreaming IPO, Rebooting Axovant & More”
Drugs OK’d To Hit Tumor Genes Still a Basket of One. Are More Coming?
[Corrected 6/4/18, 1:53 a.m. ET. See below.] One year ago, the FDA made biomedical history. A cancer drug, pembrolizumab (Keytruda), was approved to treat tumors with a specific genetic fingerprint regardless of their location in the body. It was the first tissue-agnostic approval of a cancer drug, and it was a big shift for the … Continue reading “Drugs OK’d To Hit Tumor Genes Still a Basket of One. Are More Coming?”
Bio Roundup: ASCO Abstracts, Migraine Drug Prices & “Blueprint” Fallout
There’s nothing abstract about a 20 percent jump in a company’s stock price. But yeah, that happened to Loxo Oncology when it released data previews for its American Society for Clinical Oncology presentations; the meeting starts in two weeks in Chicago. Wednesday was ASCO abstract day, and we’ll round up the headliners below, all with … Continue reading “Bio Roundup: ASCO Abstracts, Migraine Drug Prices & “Blueprint” Fallout”
“Wrong to Toast”: Broad’s Lander Sorry for Tribute to DNA Pioneer Watson
Amid backlash, renowned geneticist Eric Lander, the Broad Institute president and founding director, apologized today for his toast over the weekend to DNA structure co-discoverer James Watson (pictured) on the occasion of Watson’s 90th birthday. Watson has not been shy about expressing racist, anti-Semitic, and sexist views over the years. For example, in a 2007 … Continue reading ““Wrong to Toast”: Broad’s Lander Sorry for Tribute to DNA Pioneer Watson”
Beam Therapeutics Spotlights CRISPR 2.0 with Precise Gene Editor, $87M
The founders of CRISPR-Cas9 startup Editas Medicine have gotten a jump on the next version of CRISPR gene editing. Scientists from Harvard University, Massachusetts General Hospital, and the Broad Institute are behind Beam Therapeutics, which today announced a $87 million Series A round to turn a more precise version of CRISPR into human medicine. The … Continue reading “Beam Therapeutics Spotlights CRISPR 2.0 with Precise Gene Editor, $87M”
Will New Study Cut Guesswork for Depression Medicine Prescriptions?
[Updated 5/7/18, 5pm ET. See below.] Genetic testing that helps guide more precise cancer treatment is making its way into standard practice in major U.S. medical centers. Could the same eventually be true for depression? One test maker thinks it has finally gathered enough evidence to convince psychiatrists to order its product and make more … Continue reading “Will New Study Cut Guesswork for Depression Medicine Prescriptions?”
Home Tests in Mind, Doudna Startup Races Rivals in CRISPR Diagnostics
[Updated 4/26/18, 2:20pm ET. See below.] The gene-editing technology CRISPR-Cas9 has captured the world’s attention with the possibility of fixing tough diseases and altering human traits. While experimental medicine, ethical worries, and an epic patent battle have attracted most of the headlines, the field’s pioneers have advanced new types of CRISPR to detect and diagnose … Continue reading “Home Tests in Mind, Doudna Startup Races Rivals in CRISPR Diagnostics”
FDA Pumps the Brakes on Epizyme’s Top Cancer Drug Tazemetostat
Epizyme (NASDAQ: [[ticker:EPZM]]) said Monday that a pediatric patient taking its experimental cancer drug tazemetostat developed a new cancer, different than the one tazemetostat had been treating. The secondary cancer, a lymphoma, spurred the Food and Drug Administration to halt all new enrollment in tazemetostat trials. The drug is being tested in Phase 1 and … Continue reading “FDA Pumps the Brakes on Epizyme’s Top Cancer Drug Tazemetostat”
Bio Roundup: Hope for Lungs, Bradner’s Complaint, FDA Nods & More
The biggest news this week was in oncology, hands down. Merck showed that its immunotherapy pembrolizumab (Keytruda) might become a common option for many patients newly diagnosed with advanced lung cancer, but the bigger picture is that the field is moving fast. While pembrolizumab notched the headline-grabbing data, others are also working to develop options … Continue reading “Bio Roundup: Hope for Lungs, Bradner’s Complaint, FDA Nods & More”
Cancer Wrap: Blueprint, Checkmate, More AACR News & Phase 3 Blues
The big headlines from the American Association for Cancer Research meeting in Chicago were all about the battle over the latest lung cancer data, and for good reason. Lung cancer remains the deadliest cancer, but the Phase 3 data suggest that treatment options for some of the direst cases could soon rapidly expand. There were … Continue reading “Cancer Wrap: Blueprint, Checkmate, More AACR News & Phase 3 Blues”
For More Lung Cancer Patients, the Promise of No Chemo Looms Larger
[Editor’s note: Ben Fidler co-authored this report.] A decade from now, it’s possible that immunotherapy will have made a big dent in lung cancer, which is by far the deadliest type of the disease. Drugs from several companies have worked their way forward, initially for patients who have failed chemotherapy, and now, in some cases, … Continue reading “For More Lung Cancer Patients, the Promise of No Chemo Looms Larger”
Bio Roundup: Ex-Kiters Say Allo, NASH Cash & Data, Alkermes No & More
Happy Friday, everyone. We’ll start this week with biotech deals, one featuring a couple of CAR-T heavyweights who have re-emerged after selling Kite Pharma for $12 billion. They will try to shepherd to market a different type of the promising cancer immunotherapy: allogeneic T cells that come from donors, not from a patient’s own blood. … Continue reading “Bio Roundup: Ex-Kiters Say Allo, NASH Cash & Data, Alkermes No & More”
Fatty Liver Disease Now Global, Terns Pharma Aims for NASH in China
In the race to treat the fatty liver disease known as NASH, brought on by the modern obesity epidemic, much of the attention has focused on the U.S. But a new biotech company is looking at China. Terns Pharma has raised $30 million from the Asian venture arm of Eli Lilly (NYSE: [[ticker:LLY]]) and said … Continue reading “Fatty Liver Disease Now Global, Terns Pharma Aims for NASH in China”
Ex-Kite Execs Resurface with $300M and Control of Pfizer CAR-T Cells
Arie Belldegrun and David Chang steered Kite Pharma last year to a historic FDA approval and a $12 billion bear hug from Gilead Sciences. Now they’ve re-emerged with a new startup, Allogene, which has $300 million in backing and the rights to a CAR-T cell therapy program which is quite different from the one they … Continue reading “Ex-Kite Execs Resurface with $300M and Control of Pfizer CAR-T Cells”
TCR² Raises $125M to Move Ahead with Its Cell Therapy, CAR-T’s Cousin
TCR² Therapeutics has raised a $125 million Series B round to push ahead with live, cancer-fighting T cells. T cell receptor (TCR) therapies, the firm’s area of focus, have not progressed as far as higher-profile CAR-T treatments, despite similarities. Few TCRs have advanced into clinical studies, while two CAR-T cell therapies, one from Novartis (NYSE: … Continue reading “TCR² Raises $125M to Move Ahead with Its Cell Therapy, CAR-T’s Cousin”
Charged With Fraud, Theranos CEO Elizabeth Holmes Cuts Deal with Feds
Charged with what the U.S. Securities and Exchange Commission called “massive fraud,” Theranos CEO Elizabeth Holmes has cut a deal with the agency. The SEC charged Holmes and the firm’s former president Ramesh “Sunny” Balwani with “an elaborate, years-long fraud,” in which they raised $700 million dollars from investors and enjoyed a multibillion-dollar valuation by … Continue reading “Charged With Fraud, Theranos CEO Elizabeth Holmes Cuts Deal with Feds”
No Self-Editing: Biohacker Josiah Zayner Can’t Stop Living Out Loud
Gene editing has arrived. Of the various forms of the technology, CRISPR-Cas9 is the easiest to use, and it’s already showing up in summer camps and school science labs near you. That would be middle schools. When everyone can edit an organism’s genes, how will the world change? Should we be worried? National security officials … Continue reading “No Self-Editing: Biohacker Josiah Zayner Can’t Stop Living Out Loud”
Bio Roundup: Trump Health, Cholesterol Wars, 23andMe OK & More
Trump administration health officials were out on the stump this week, talking tough about drug prices and healthcare value, encouraging the private sector to take the lead but letting everyone know the federal government is willing to push. In the debate over high drug prices, arguably no class of drug has been punished more by … Continue reading “Bio Roundup: Trump Health, Cholesterol Wars, 23andMe OK & More”