Novartis has decided to dissolve its group that has been working on a cutting-edge therapy to treat cancer. In an internal email obtained by Endpoints, the head of the healthcare giant’s cell and gene therapies unit, Usman “Oz” Azam told the group that “things don’t always work out as envisioned.” Novartis spokeswoman Julie Masow confirmed … Continue reading “Novartis Disbands T Cell Group But Promises To Press Ahead In CAR-T Race”
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.
Denali Adds $130M To Fuel Neurosci Deals, First Clinical Trial
Neuroscience startup Denali Therapeutics said Thursday it has added $130 million in privately-raised cash, in part to push a drug program into clinical trials in Europe. The South San Francisco, CA-based firm, unveiled last year with former Genentech neuroscientists at the helm and $217 million from investors, has already used some of its funding in … Continue reading “Denali Adds $130M To Fuel Neurosci Deals, First Clinical Trial”
In Wake Of Infamous Biotech Party, 20 Women Join New Exec Training
[Updated 8/24/16, 1 a.m. See below.] A new program to prepare high-ranking women in the biotech industry for corporate board seats has unveiled its first class of 20. In other circumstances the five-day workshop, scheduled this fall at George Washington University in the nation’s capital, might go unnoticed among the sea of executive training programs … Continue reading “In Wake Of Infamous Biotech Party, 20 Women Join New Exec Training”
Bio Roundup: FDA Says No, PCSK9 Value Fight, CRISPR Intrigue & More
When the Olympics roll around, many watchers get into a sport they previously hadn’t thought much about. This time for me, it’s volleyball. The men’s and women’s games, both indoor and beach versions, are fast, aggressive, with lightning-quick adjustments and subtle teamwork required every time a ball is dug out and popped in the air. … Continue reading “Bio Roundup: FDA Says No, PCSK9 Value Fight, CRISPR Intrigue & More”
In Cholesterol Drug Price Fight, Real Message Is “Wait Til Next Year”
The authors of a study published Tuesday in the Journal of the American Medical Association argue that the new wave of cholesterol-fighting drugs, hailed as a big medical step forward when they launched last year, should cost 70 percent less than their current list price to be worth the trouble prescribing them. The drugs’ owners, … Continue reading “In Cholesterol Drug Price Fight, Real Message Is “Wait Til Next Year””
As U.S. Looks to Launch Precision Health Study, Google’s Role Emerges
The U.S. government has ambitious plans for a long-term health study with one million Americans, and one of the world’s most powerful tech companies has a big part to play, including the storage of all the data on its “cloud” servers. Google’s parent company Alphabet (NASDAQ: [[ticker:GOOG]]) and its wholly owned biotech R&D group, Verily … Continue reading “As U.S. Looks to Launch Precision Health Study, Google’s Role Emerges”
GSK, Verily Team Up For Electro-Implants That Monitor, Treat Patients
Three years ago, international drug firm GlaxoSmithKline (NYSE: [[ticker:GSK]]) unveiled a new effort to create tiny implantable devices that would use electricity, not drugs, to alter the course of a range of diseases. Today GSK and Verily Life Sciences, the biotech unit of Google’s parent company Alphabet (NASDAQ: [[ticker:GOOG]]), said they would start a new … Continue reading “GSK, Verily Team Up For Electro-Implants That Monitor, Treat Patients”
Biotech Roundup: Gilead Slump, Celgene Goes Trump, Hemo Data & More
Quarterly biopharma earnings added a little heat to the already high summer temperatures. Amongst several companies to report this week, the biggest news came from Gilead Sciences (NASDAQ: [[ticker:GILD]]), whose hepatitis C drugs have become some of the top revenue producers in the industry. But the company said this week that sales of Sovaldi and … Continue reading “Biotech Roundup: Gilead Slump, Celgene Goes Trump, Hemo Data & More”
At Alzheimer’s Meeting, Firms Take Page From Silver Linings Playbook
The big drug news from the annual Alzheimer’s Association meeting this week involved companies that have found silver linings in otherwise gloomy data—a recurrent theme in Alzheimer’s clinical work. The trials are expensive, so companies are loathe to write them off completely, and the social urgency of finding new treatments encourages data analysis that is … Continue reading “At Alzheimer’s Meeting, Firms Take Page From Silver Linings Playbook”
Kadmon Raises $75M In IPO Despite Friendly Terms For Its Lenders
Kadmon Holdings tempered its expectations and managed to go public late Wednesday, despite its founders’ criminal history and a heavy debt load. New York-based Kadmon raised $75 million by selling 6.25 million shares at $12 each. But to get there, it had to sell more shares at a lower price. It had initially aimed for … Continue reading “Kadmon Raises $75M In IPO Despite Friendly Terms For Its Lenders”
As Purdue Pushes Life Sciences, Foundation Seeks $10M For New Fund
A foundation affiliated with Purdue University in West Lafayette, IN, is raising $10 million for a new venture fund that would help the school’s spinouts. That doesn’t seem like much, but Indiana companies received $53 million in total venture funding last year. Assuming Purdue’s spinouts stay local—according to the school, 75 percent of those founded … Continue reading “As Purdue Pushes Life Sciences, Foundation Seeks $10M For New Fund”
Biotech Roundup: Hellos, Goodbyes, “Cures” Delays And Trial News
The week started on a reflective note. Our San Diego editor Bruce Bigelow penned a personal goodbye to entrepreneur Larry Bock, who died last week of pancreatic cancer at the age of 56. And then the news flowed, from a fast reprieve for Juno Therapeutics to no mercy for Elizabeth Holmes. There were other goodbyes: … Continue reading “Biotech Roundup: Hellos, Goodbyes, “Cures” Delays And Trial News”
FDA Lets Juno Jump Back Into T-Cell Trial, Minus One Chemo Drug
The FDA has allowed Juno Therapeutics to resume a high profile clinical trial of a cutting-edge cancer therapy less than a week after the trial was halted, Juno (NASDAQ: [[ticker:JUNO]]) announced this afternoon. The news has bumped its share price 25 percent in after-hours trading Tuesday. The Seattle biotech firm revealed last week the recent … Continue reading “FDA Lets Juno Jump Back Into T-Cell Trial, Minus One Chemo Drug”
Caveats But No “Quicksand” In Sage’s Positive Postpartum Trial Data
[Updated 7/12/16, 4:07 p.m., with final share price. See below.] Sage Therapeutics has avoided the “great quicksand of drug development” for now. That was Sage CEO Jeff Jonas’s description of depression a couple months ago in a conversation with Xconomy. Today, Sage (NASDAQ: [[ticker:SAGE]]) is reporting positive Phase 2 data in postpartum depression, an often … Continue reading “Caveats But No “Quicksand” In Sage’s Positive Postpartum Trial Data”
With Bugs As Drugs, Evelo CEO Plans Immune, Cancer Trials in 2017
While the Obama administration wants to dedicate a tiny sliver of the federal budget to microbiome research, a growing number of startups—often with the backing of international corporations—are racing to turn microbiome research into health products. The Cambridge, MA-based firm Evelo Biosciences wants to harness live bacteria as cancer and immune-disease treatments. Evelo, which launched … Continue reading “With Bugs As Drugs, Evelo CEO Plans Immune, Cancer Trials in 2017”
Biotech Roundup: Fighting Addiction, Obama Precision, Juno Deaths & More
This week started with celebrations of America’s birthday, and it has been dominated—biotech-wise—by America’s government. The Obama administration continued its high-profile involvement in the life sciences by updating its Precision Medicine Initiative, easing limits on doctors who want to fight opioid addiction, and stopping a clinical trial in one of the hottest biomedical fields, cancer … Continue reading “Biotech Roundup: Fighting Addiction, Obama Precision, Juno Deaths & More”
Recruitment Goal In Obama Precision Med Study: 1M in 3 or 4 Years
The Obama administration’s push to sign up one million Americans for a long-term health study will start in New York, Pittsburgh, Chicago, and Tucson, AZ, top health officials said today. National Institutes of Health director Francis Collins (pictured) and FDA commissioner Rob Califf spoke on a call this afternoon to update the Precision Medicine Initiative, … Continue reading “Recruitment Goal In Obama Precision Med Study: 1M in 3 or 4 Years”
Biotech Roundup: Moonshots, Pink Slips, Gilead, Brexit & More
The word of the week was “moonshot,” as U.S. Vice President Joe Biden’s cancer initiative convened a summit in Washington, DC. At the gathering, Biden took verbal shots at scofflaw cancer researchers and at drug prices, while the FDA said it would take a shot at restructuring the way it evaluates oncology products. Gilead Sciences … Continue reading “Biotech Roundup: Moonshots, Pink Slips, Gilead, Brexit & More”
Riding Moonshot, FDA Will Revamp Its Cancer Practice. To What End?
As part of a national cancer “moonshot” initiative led by Vice President Joe Biden, the FDA said Wednesday it would retool the way it evaluates cancer treatments and tests. But to what end? The goals of the FDA’s new Oncology Center of Excellence remain vague, as does its structure. In a speech Wednesday morning at … Continue reading “Riding Moonshot, FDA Will Revamp Its Cancer Practice. To What End?”
Amid Brexit Fallout, U.K.-Listed PureTech Debuts Speech Diagnosis Firm
[Updated 6/28/16, 12:50pm. See below.] PureTech Health starts companies in cutting-edge areas of biomedical science and often owns them outright. Its latest aims to create software that listens for warning signs of depression in people’s speech patterns. The unveiling of the firm, called Sonde Health, comes at a curious time for Boston-based PureTech. Shares of … Continue reading “Amid Brexit Fallout, U.K.-Listed PureTech Debuts Speech Diagnosis Firm”
Pharma, Data Veteran Stephen Friend Bites At Apple’s Health Offer
Consumer tech giant Apple, which has spent considerable effort positioning its products as health and fitness helpers, has just hired someone who knows Big Pharma and Big Data. Stephen Friend, a veteran of drug R&D and, more recently, a nonprofit effort to foster more collaborative biomedical research and more data sharing, is joining Apple (NYSE: … Continue reading “Pharma, Data Veteran Stephen Friend Bites At Apple’s Health Offer”
Federal Oversight Group Has Complaints But Says Yes To CRISPR Trial
[Updated, 6/21/16, 5:40pm. See below.] Despite worries about conflict of interest, a National Institutes of Health committee that oversees the use of gene therapy and other cutting edge biomedical technologies voted today to let researchers move ahead with a landmark clinical trial. Depending on timing, it could be the first to use the gene editing … Continue reading “Federal Oversight Group Has Complaints But Says Yes To CRISPR Trial”
Sean Parker To Fund CRISPR Trial, And Other Gene Edit Milestones
[Corrected, 6/21/06, 10:49 am. See below.] Internet billionaire Sean Parker’s new cancer immunotherapy institute didn’t waste time putting its $250 million to use in unexpected ways. The San Francisco-based institute, part of a massive philanthropic effort by former Facebook president Parker (pictured), is backing an experimental cancer treatment tweaked with the gene editing technology CRISPR-Cas9. … Continue reading “Sean Parker To Fund CRISPR Trial, And Other Gene Edit Milestones”
Biotech Roundup: Kadmon Debt, Hemo Data, Loose Lips & More
Familiar biotech names—not necessarily familiar for the right reasons—made news this week in biotech. Data from a hematology conference stoked dreams of approval, though still on a far horizon, for a couple drug makers. Long anticipated, Walgreens officially cut ties with Theranos, and the FDA both gave and denied approvals. You think a Game 7 … Continue reading “Biotech Roundup: Kadmon Debt, Hemo Data, Loose Lips & More”
Rgenix Raises $33M, Preps Cancer Trial For Drug Shelved By GSK
Rgenix, a biotech spun out of New York’s Rockefeller University by three brothers, has reeled in a $33 million Series B financing as it preps its top drug candidate, a cancer immunotherapy agent, to enter clinical trials. The drug, known as RGX-104, was once shelved at GlaxoSmithKline (NYSE: [[ticker:GSK]]) because of side effects. But Rgenix’s … Continue reading “Rgenix Raises $33M, Preps Cancer Trial For Drug Shelved By GSK”
Kadmon Seeks IPO With Unusual Terms That Benefit Waksal, Debt Holders
After more than a year of not-very-subtle hints of IPO intentions, Kadmon Holdings, the biotech founded by former ImClone Systems CEO Sam Waksal, made it official Friday. Already in the spotlight in part because of Waksal’s previous criminal history—he was convicted of several felony charges related to insider trading in 2002 and 2003—the New York-based … Continue reading “Kadmon Seeks IPO With Unusual Terms That Benefit Waksal, Debt Holders”
With First Drug Approved, Intercept Taps Kapadia As New CFO
Intercept Pharmaceuticals (NASDAQ: [[ticker:ICPT]]) of New York has a new product on the market, its first, with last month’s approval of obeticholic acid (Ocaliva) to treat a rare liver disease. Now it also has a new CFO. Sandip Kapadia, a veteran of Swiss drug giant Novartis, will take over for Barbara Duncan on July 1, … Continue reading “With First Drug Approved, Intercept Taps Kapadia As New CFO”
In Race to Relief, Amgen Touts New But Incomplete Migraine Data
A quartet of drugs that could prevent migraine headaches, not just treat the symptoms, are competing to get to market. Amgen (NASDAQ: [[ticker:AMGN]]) of Thousand Oaks, CA, announced Wednesday that its candidate, dubbed erenumab, met the main goal of a 667-patient mid-stage study. If a larger Phase 3 test that should wrap up soon also … Continue reading “In Race to Relief, Amgen Touts New But Incomplete Migraine Data”
No PhD, “No Fear”: Alice Zhang, 27, Aims Software At Neuro Diseases
It’s impossible to sum up a person with a word, a sentence, or even a paragraph. We all contain multitudes. But if a picture of 27-year-old biotech CEO Alice Zhang could emerge from a single line, it might be her response when asked to describe her first time through the whirlwind of the annual J.P. … Continue reading “No PhD, “No Fear”: Alice Zhang, 27, Aims Software At Neuro Diseases”
Guardant Health Maps Cautious Plans For Blood-Based Cancer Screening
Clinicians today can analyze a cancer patient’s tumor using a blood sample, a so-called liquid biopsy. But using blood tests to screen seemingly healthy people for early signs of a host of cancers is still a largely hypothetical proposition—and turning that idea into a reality is a much bigger challenge. Grail, which is backed by … Continue reading “Guardant Health Maps Cautious Plans For Blood-Based Cancer Screening”
Biotech Roundup: Deals Gone Wrong, Ethical Red Flags & Bay Goodbyes
It was fitting this week that, in the lead-up to two of biomedicine’s biggest self-celebrations, we were served ample reminder of the industry’s expensive decisions gone wrong. This weekend, much of academia and industry involved in cancer will gather in Chicago for the annual American Society of Clinical Oncology conference. Thousands of others will head … Continue reading “Biotech Roundup: Deals Gone Wrong, Ethical Red Flags & Bay Goodbyes”
With One Trial Shelved And Another Failed, StemCells To Shut Down
StemCells (NASDAQ: [[ticker:STEM]]) has decided to close up shop after its most advanced therapy didn’t do enough in a Phase 2 trial to improve people with spinal cord injuries. The one-time stem cell pioneer will wind down operations with $5.5 million in the bank, as of May 31, it said in a statement this morning. … Continue reading “With One Trial Shelved And Another Failed, StemCells To Shut Down”
Intercept’s Liver Drug Wins FDA Approval To Treat Rare Disease
[Updated, 5/31/16, see below] The FDA ended a busy week by giving a thumbs-up late Friday to obeticholic acid as a treatment for primary biliary cirrhosis, a rare disease in which a patient’s own immune system attacks the liver. Obeticholic acid, to be marketed under the brand Ocaliva, is being developed by Intercept Pharmaceuticals (NASDAQ: … Continue reading “Intercept’s Liver Drug Wins FDA Approval To Treat Rare Disease”
Busy FDA Week Ends With Two Drug Approvals: Another Might Be on Way
The new FDA commissioner Robert Califf told a conference audience this week that he expected “a flood” of new treatments in the near future. Perhaps he meant the following few days. His agency approved two drugs to close out the week, and another decision is due by Sunday. The FDA announced late Friday afternoon that … Continue reading “Busy FDA Week Ends With Two Drug Approvals: Another Might Be on Way”
With Recruits Coming, Precision Med Effort Pledges $142M For Biobank
The Obama administration’s ambitious long-term health study, dubbed the Precision Medicine Initiative, has tapped the Mayo Clinic to build a repository for biological samples collected from the study’s participants. Through the National Institutes of Health, the administration has awarded $142 million over five years to the Rochester, MN-based Mayo Clinic for the so-called “biobank,” which … Continue reading “With Recruits Coming, Precision Med Effort Pledges $142M For Biobank”
FDA Commish Califf to Big Data Crowd: Flood Of New Treatments Coming
New FDA commissioner Robert Califf said Wednesday that the recent spike in drug approvals is no temporary phenomenon, thanks to a better understanding of biology and continued adoption of sophisticated technology throughout healthcare. “I predict we’ll see of a flood of effective treatments”—not just drugs but combinations of drugs and data-enabled devices—“and we’ll have to … Continue reading “FDA Commish Califf to Big Data Crowd: Flood Of New Treatments Coming”
Gilead Brings Back Kevin Young, Former Commercial Exec, As New COO
Gilead Sciences (NASDAQ: [[ticker:GILD]]) has brought back former top executive Kevin Young as chief operating officer. Young spent the past two years as an advisor to the Foster City, CA-based drug maker, and before that was its EVP of commercial operations for ten years. Young’s return fills a gap left by Paul Carter, who replaced … Continue reading “Gilead Brings Back Kevin Young, Former Commercial Exec, As New COO”
The Biotech Roundup: Immunotherapy Ups And Downs, Gene Deals & More
A quick housekeeping note: Starting this week, we are combining our East Coast and West Coast biotech roundups into a single weekly post that will also include highlights from our other cities and regions, including Texas, Michigan, Wisconsin, and Xconomy’s latest bureau, Indiana. As with our bygone coastal roundups, this new national roundup is not … Continue reading “The Biotech Roundup: Immunotherapy Ups And Downs, Gene Deals & More”
In Immuno-Oncology’s Latest Win, FDA OK’s Genentech Drug
South San Francisco, CA-based Genentech, a division of international health giant Roche, announced today the U.S. approval of its drug atezolizumab (Tecentriq) for the most common form of bladder cancer. Nearly 77,000 new cases of the cancer, called urothelial carcinoma, will occur in the U.S. this year, and it will cause more than 16,000 deaths, … Continue reading “In Immuno-Oncology’s Latest Win, FDA OK’s Genentech Drug”
Armed With Patent, Foundation Med Sues Diagnostic Rival Guardant
[Updated, 1:15 pm ET and 7:53pm ET, see below] Cambridge, MA-based Foundation Medicine (NASDAQ: [[ticker:FMI]]), which analyzes tumor and blood samples from cancer patients and provides suggestions for potential genetically targeted medicines, is suing rival diagnostic firm Guardant Health. The patent infringement suit comes swiftly on the heels of Foundation receiving a patent for its … Continue reading “Armed With Patent, Foundation Med Sues Diagnostic Rival Guardant”
Foundation Med Gets U.S. Patent For Cancer Analysis
Cambridge, MA-based Foundation Medicine (NASDAQ: [[ticker:FMI]]) has built a business on analyzing cancer patient biopsies for the specific genetic alterations that might be fueling their disease. Now Foundation says, in a press release this morning, that it has received a U.S. patent that covers the “fundamental claims” of its technology. It’s not immediately clear if … Continue reading “Foundation Med Gets U.S. Patent For Cancer Analysis”
Aduro Takes Hit On Pancreatic Cancer Trial Miss, But Shares Rebound
Trading of Aduro BioTech shares was halted earlier today as the drug maker said patients with advanced pancreatic cancer taking a combination of its immunotherapies in a clinical trial did not fare as well as those on standard chemotherapy. Due to the disappointing results, Berkeley, CA-based Aduro (NASDAQ: [[ticker:ADRO]]) will shelve its work on third-line … Continue reading “Aduro Takes Hit On Pancreatic Cancer Trial Miss, But Shares Rebound”
White House Wants to Spend $121M on National Microbiome Initiative
The Obama administration announced this morning a public-private initiative to study the collections of microorganisms that live on or in humans and practically everywhere else on Earth. More than 100 other institutions are joining the administration with funding and resources in what’s being billed as the National Microbiome Initiative. The microbiome has become a subject … Continue reading “White House Wants to Spend $121M on National Microbiome Initiative”
Bankrupt Biotech KineMed Owes More Than $1M To Gates, Others
KineMed spent years trying to help drug companies and other researchers pinpoint how to best attack a disease. Despite multiple deals with big names in pharma and academia, the business didn’t work. KineMed, of Emeryville, CA, filed for Chapter 11 bankruptcy last week, which means it wants protection from creditors while it comes up with … Continue reading “Bankrupt Biotech KineMed Owes More Than $1M To Gates, Others”
Across The Board: Ideas To Narrow Biotech’s Gender Gap
The evidence is piling up. Companies with more women in charge are better businesses. So why are so many biotechs still led mainly by men? Saira Ramasastry, a former Merrill Lynch analyst, is now a Bay Area consultant on the boards of three biotechs, including Sangamo Biosciences (NASDAQ: [[ticker:SGMO]]). Having benefited from female mentors such … Continue reading “Across The Board: Ideas To Narrow Biotech’s Gender Gap”
CRISPR Drug Maker Intellia Therapeutics Sells $108M In IPO Shares
The latest biopharmaceutical company testing Wall Street’s belief in the promise of gene modification has gone public. Intellia Therapeutics (NASDAQ: [[ticker:NTLA]]) of Cambridge, MA, which owns rights to an important but disputed piece of the CRISPR-Cas9 gene editing technology, sold 6 million shares at $18 each this evening to raise $108 million. Its stock will … Continue reading “CRISPR Drug Maker Intellia Therapeutics Sells $108M In IPO Shares”
One Year After Gaffe, Acadia Gains FDA Nod For Parkinson’s Drug
Last year’s shakeup and mea culpa at San Diego’s Acadia Pharmaceuticals (NASDAQ: [[ticker:ACAD]]) has paid off. The FDA said late today it has approved Acadia’s pimavanserin (Nuplazid), a treatment for psychosis associated with Parkinson’s disease. Acadia stumbled badly last year, as Xconomy reported here. The former CEO Uli Hacksell unexpectedly left the company, taking the … Continue reading “One Year After Gaffe, Acadia Gains FDA Nod For Parkinson’s Drug”
With CRISPR in Humans On The Horizon, Will the Public Back Intellia?
An icy March wind was blowing across the Charles River, but in the laboratory of Intellia Therapeutics, the 1970s soft-rock hit “Summer Breeze” was blasting. Chief scientific officer Tom Barnes apologized. “Usually it’s heavy metal,” he said. He pointed out a window to a local tower, visible over the Cambridge, MA rooftops, rising from a … Continue reading “With CRISPR in Humans On The Horizon, Will the Public Back Intellia?”
Sanford Weill Gives $185M To Expand Neuroscience Research at UCSF
With the largest philanthropic gift ever to the University of California, San Francisco, controversial Wall Street titan Sanford “Sandy” Weill and his wife Joan will put their stamp on neurosciences work at UCSF’s Mission Bay campus. The $185 million gift from the Weill Family Foundation will help build a 270,000 square-foot research center, which has … Continue reading “Sanford Weill Gives $185M To Expand Neuroscience Research at UCSF”
Immunotherapy, Global Health & More At Seattle’s Life Sci Disruptors
Our annual life sciences forum in Seattle is coming up on May 2 at the Fred Hutchinson Cancer Research Center, and we’re looking forward to an afternoon of discussions that tap into the city’s biotech and public health expertise. You can peruse the newly updated agenda here, but I’d like to share some of the … Continue reading “Immunotherapy, Global Health & More At Seattle’s Life Sci Disruptors”