If you’re keeping track, FDA drug approvals have been on a tear in the past month with several decisions coming well ahead of their targeted dates. And then there’s Sarepta Therapeutics. Late Thursday, the FDA announced approval of the Cambridge, MA, biotech’s drug for Duchenne muscular dystrophy in patients who have a specific mutation. The … Continue reading “Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More”
Category: Seattle
Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink
Iterum Therapeutics’ bid to bring patients a new antibiotic that’s safer than currently available drugs has fallen short of the main efficacy goal of a late-stage clinical trial. But the company is pinning its hopes on another Phase 3 study that will report data early next year. Iterum (NASDAQ: [[ticker:ITRM]]) reported preliminary Phase 3 data … Continue reading “Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink”
Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More
It’s been a roller-coaster year for those hoping for new drugs to treat Alzheimer’s disease, a leading cause of death with rising treatment costs and no clear answer yet as to its cause. Clearing proteins, such as amyloid and tau, was once seen as the top contender for stopping or slowing neurodegeneration. Costly failures forced … Continue reading “Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More”
Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption
Editor’s note: This is Part 2 of a two-part post about innovation in digital health, co-authored by Rob Coppedge, CEO of Echo Health Ventures. Read Part 1 here. The Path Forward Between Echo Health Ventures and Blue Cross and Blue Shield of North Carolina, we work deeply on both sides of these partnerships and have perspective … Continue reading “Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption”
Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal
[Updated 12/4/19, 4:01 p.m. ET. See below.] Veracyte, a company whose tests help physicians make treatment decisions, is adding technology from NanoString to the fold to expand its diagnostic capabilities. South San Francisco-based Veracyte (NASDAQ: [[ticker:VCYT]]) announced Tuesday that it has reached a deal for global rights to develop and commercialize diagnostics based on the … Continue reading “Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal”
Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down
Editor’s note: This is Part 1 of a two-part piece on innovation in digital health, co-authored by Bryony Winn, chief strategy and innovation officer at Blue Cross and Blue Shield of North Carolina. Read Part 2 here. More than 6,500 people descended on HLTH in Las Vegas in late October to “solve the most pressing … Continue reading “Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down”
A Safer CRISPR? Cyrus, Broad Institute Look to Quell Concerns
Cyrus Biotechnology and the Broad Institute of MIT and Harvard have teamed up to make gene editing with the CRISPR-Cas9 technology safer. The multi-target collaboration, specific details of which are not being disclosed, aims to address longstanding concerns surrounding gene editing: some patients might be predisposed to an immune reaction to the DNA-cutting enzyme Cas9. … Continue reading “A Safer CRISPR? Cyrus, Broad Institute Look to Quell Concerns”
Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More
Bristol-Myers Squibb this week completed its acquisition of Celgene, a $74 billion deal that creates a pharmaceutical juggernaut. And all it took was the largest asset sale ever required by federal antitrust regulators. As the Federal Trade Commission reviewed Bristol’s (NYSE: [[ticker:BMS]]) deal to acquire Celgene, anti-inflammatory drug apremilast (Otezla) emerged as a sticking point. … Continue reading “Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More”
Biopharma Execs Remain Optimistic Despite Political Headwinds
Drug pricing debates and uncertainty associated with Brexit are the issues most likely to keep biopharmaceutical executives awake at night. Nevertheless, senior figures remain optimistic about the industry’s prospects in 2020. These are among the major findings of a survey of 500 industry leaders and investors conducted by investment bank Jefferies. “Nearly half of respondents … Continue reading “Biopharma Execs Remain Optimistic Despite Political Headwinds”
Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More
Lung injuries connected to the use of electronic cigarettes have topped 2,000 and killed 40 people, according to the Centers for Disease Control and Prevention. It’s still unclear whether the cases are tied to legally sold products or devices modified by e-cigarette users, but the CDC this week identified a “potential toxin of concern”—Vitamin E … Continue reading “Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More”
Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio
The list of activities our smartphones can control grows daily. Transfer money? It’s simple. Order groceries? That, too. Turn off the bedroom lights? Check. How about contraception? Advancing new forms of birth control is a central focus at Daré Bioscience (NASDAQ: [[ticker:DARE]]), a San Diego-based biopharma company that’s built a pipeline of experimental devices and … Continue reading “Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio”
Neuroscience Is Taking the Spotlight at Xconomy’s Bay Area Xchange
These are heady times for neuroscience research. Startups developing new approaches to brain disorders are raising money to advance their discoveries toward clinical trials. One failed neuro drug is getting another shot. On Nov. 19 in San Francisco, we’ll hold the latest in our Xchange event series. What’s Next in Neuroscience Therapies will take a … Continue reading “Neuroscience Is Taking the Spotlight at Xconomy’s Bay Area Xchange”
Bio Roundup: Feds Sue Gilead, Biogen Eyes China, CRISPR’d Kidneys & More
During the state of the union address this year, President Trump pledged to end HIV transmission within the next decade. A key part of that plan is an HIV prevention drug made by Gilead Sciences. That drug has now become the center of a patent dispute between the Foster City, CA, drug maker and the … Continue reading “Bio Roundup: Feds Sue Gilead, Biogen Eyes China, CRISPR’d Kidneys & More”
3 Changes We Should Make to Address the Gender Pay Gap in Medicine
Women in medicine earn about 20 percent less than men. That is a problem for multiple reasons. It is, of course, not fair to the women who go through the same training and have the same skills as their male counterparts. Worse still, if well-qualified women are discouraged from entering the profession because of this … Continue reading “3 Changes We Should Make to Address the Gender Pay Gap in Medicine”
AstraZeneca Chooses China for R&D and AI Centers, $1B Biotech Fund
AstraZeneca says it will establish centers for drug research and artificial intelligence development in China. The pharmaceutical giant has also set up a $1 billion fund to foster biotech innovation in that country. The move—which was announced at the China International Import Expo this week—will see AstraZeneca found a global R&D center in Shanghai’s central … Continue reading “AstraZeneca Chooses China for R&D and AI Centers, $1B Biotech Fund”
GE Healthcare Opens Startup Labs at Former AstraZeneca UK R&D Site
The doors have opened at a GE Healthcare-supported open-access lab for startups at AstraZeneca’s former global center for oncology research and development at Alderley Park, the largest bioscience research campus in the UK. The AstraZeneca (NYSE: [[ticker:AZN]]) site in Macclesfield, UK, housed 3,500 staff and was instrumental in developing a number of its cancer drugs … Continue reading “GE Healthcare Opens Startup Labs at Former AstraZeneca UK R&D Site”
Biotech Roundup: Novartis on Hold, AMAG Vote, Neuro News & More
The brain has stymied many efforts to develop new neuroscience drugs, leading a number of big pharmaceutical companies to pull back on such R&D work. This week, Amgen joined them. Amgen (NASDAQ: [[ticker:AMGN]]) is ending its research and early development programs in neuroscience, the company announced during a conference call to discuss third-quarter financial results. … Continue reading “Biotech Roundup: Novartis on Hold, AMAG Vote, Neuro News & More”
FDA Halts Novartis Gene Therapy Study Amid Animal Safety Concerns
Novartis must stop enrollment of a clinical trial testing its gene therapy for a rare, muscular disorder after safety concerns surfaced in data from an animal study. The FDA put a partial clinical hold on a Phase 1/2 study testing the therapy, Zolgensma, Novartis (NYSE: [[ticker:NVS]]) announced Wednesday. The decision doesn’t halt the study entirely; … Continue reading “FDA Halts Novartis Gene Therapy Study Amid Animal Safety Concerns”
Bio Roundup: Biogen’s Reversal, FDA Moves Fast, a CF Cocktail & More
Earlier this year, it seemed that companies testing Alzheimer’s disease treatments based on a long-held hypothesis as to its cause—brain deposits of a protein called beta amyloid—were giving up the ghost. Biogen (NASDAQ: [[ticker:BIIB]]) was among them. The drug maker had stopped testing of a drug developed to target amyloid plaque after a Phase 3 … Continue reading “Bio Roundup: Biogen’s Reversal, FDA Moves Fast, a CF Cocktail & More”
SeaGen to Seek FDA Nod After Breast Cancer Drug Hits Goals of Key Study
An experimental breast cancer drug from Seattle Genetics is headed for FDA review after the company reported a pivotal clinical trial met its main goals. The company has been testing tucatinib as a treatment for advanced or metastatic breast cancer with abnormally high levels of a protein called human epidermal growth factor receptor 2 (HER2), … Continue reading “SeaGen to Seek FDA Nod After Breast Cancer Drug Hits Goals of Key Study”
Bio Roundup: Ichnos Emerges, Beyond CAR-T, BridgeBio Bails & More
New brand-name drugs typically grab the life science headlines. A venture capital firm will invest tens of millions to develop one and a pharmaceutical company hopes to recoup hundreds of millions by selling it. But a shortage of one particular chemotherapy is showing the crucial role generic drugs play in healthcare. This week, The New … Continue reading “Bio Roundup: Ichnos Emerges, Beyond CAR-T, BridgeBio Bails & More”
Nuance & Microsoft Team Up on Conversational AI for Doctors’ Offices
Nuance Communications’ plan to lighten the clerical burden on physicians is coming into focus, and it involves an assist from tech giant Microsoft. Nuance (NASDAQ: [[ticker:NUAN]]), the 27-year-old speech recognition technology pioneer, in February revealed it’s developing a device that would sit in exam rooms and listen to conversations between doctors and patients. The system’s … Continue reading “Nuance & Microsoft Team Up on Conversational AI for Doctors’ Offices”
Vir Bio’s IPO Brings In $143M for Tests of Hepatitis B Drug and More
Vir Biotechnology has joined the public markets, raising $142.9 million to support clinical tests of its infectious disease drugs. The San Francisco firm offered 7.1 million shares priced at $20 each, which was the low end of the $20 to $22 range that it had planned. Vir shares are expected to start trading later today … Continue reading “Vir Bio’s IPO Brings In $143M for Tests of Hepatitis B Drug and More”
Bio Roundup: Nobel Prizes, Placebo Effect Rises, ICER’s Fire & More
Congrats to this year’s Nobel Prize winners in medicine… although, we have to ask: For the US researchers who are honored, isn’t there something crushing about a call in the middle of the night from Sweden, interrupting a dream about the perfect protein-protein interaction? Wouldn’t it be more logical for the committee to wait until … Continue reading “Bio Roundup: Nobel Prizes, Placebo Effect Rises, ICER’s Fire & More”
The Placebo Effect Is Hobbling New Psychiatric Drugs. What Can Stop It?
Sixteen years ago, Kim Witczak’s husband died by his own hand, turning her world upside down. He had just begun taking an antidepressant off-label for insomnia, and she believes an undisclosed side effect of the drug drove him to suicide. Compelled to act, she became an advocate for tougher safety standards. Witczak now sits on … Continue reading “The Placebo Effect Is Hobbling New Psychiatric Drugs. What Can Stop It?”
Five Years After Y Combinator First Admits Biotechs, They’re Dug In
Five years ago, the big tech incubator Y Combinator started to welcome life sciences companies into its sizable startup classes, which had previously nurtured entrepreneurs in information technology almost exclusively. That opening to biotech startups in 2014 was controversial at the time. Some observers simply wondered what kind of guidance a deeply tech-focused accelerator could … Continue reading “Five Years After Y Combinator First Admits Biotechs, They’re Dug In”
Nobel Prize in Medicine Goes to 3 Who Showed How Cells Sense Oxygen Levels
Oxygen’s importance in cellular processes has long been known. But the work to understand how cells sense and adapt to changes in oxygen levels has led to medical insights and potential treatments for anemia, cancer, and more—and today, it has turned into the 2019 Nobel Prize in Medicine. William Kaelin Jr., Sir Peter Ratcliffe, and … Continue reading “Nobel Prize in Medicine Goes to 3 Who Showed How Cells Sense Oxygen Levels”
Fetch Rewards Grabs $25M, Plans to Double Staff as Growth Accelerates
Fetch Rewards’ pivot seems to be paying off. The Madison, WI-based mobile app startup has pulled in $25 million from investors to help it capitalize on a surge of new users and business partners. The fresh funding was revealed in a document filed this week with the SEC. The money comes from Greycroft and E.ventures, … Continue reading “Fetch Rewards Grabs $25M, Plans to Double Staff as Growth Accelerates”
Bio Roundup: PARP Progress, A New Commish, IPO-Palooza & More
It’s been a strange up and down ride for PARP inhibitors, a relatively new class of cancer drugs. Named for the tumor protein they target, PARPs rebounded after a big clinical setback in 2011 and have been at the center of many buyouts and big alliances—Pfizer and Medivation, GlaxoSmithKline and Tesaro, AstraZeneca and Merck. Four … Continue reading “Bio Roundup: PARP Progress, A New Commish, IPO-Palooza & More”
Icosavax Lands $51M to Bring Vaccine for Respiratory Virus to Clinic
Many vaccines are made from either a weakened virus or a protein taken from a virus. But so far, scientists haven’t had much luck developing such vaccines for respiratory syncytial virus (RSV), which causes an infection that is typically mild but can become deadly in infants and older adults. Icosavax is taking a different route … Continue reading “Icosavax Lands $51M to Bring Vaccine for Respiratory Virus to Clinic”
Nuance Spinout Cerence Vies With Tech Giants in Voice-AI for Auto
A new mobility company, Cerence, is making its public-market debut Wednesday, and its first CEO, Sanjay Dhawan, says he’s been meeting with more than 50 investors in recent weeks to talk up its prospects. Cerence is a spinout from pioneering speech recognition company Nuance Communications (NASDAQ: [[ticker:NUAN]]), and it will carry on the work of … Continue reading “Nuance Spinout Cerence Vies With Tech Giants in Voice-AI for Auto”
We’re Beginning to Realize the Cloud’s Full Potential at the Edge
Amazon Web Services (AWS), the first “public cloud” offering third-party data storage and compute services, launched in March 2006, and by 2012, there were multiple credible competitors. The hype was strong. Back then, cloud evangelists were predicting that essentially everything in the enterprise data center would migrate to one of just a few public clouds. … Continue reading “We’re Beginning to Realize the Cloud’s Full Potential at the Edge”
ESMO 2019: PARP and Prostate, SeaGen’s Win, KRAS Update & More
The European Society for Medical Oncology meeting has wrapped up in Barcelona, the last major clinical cancer conference until December’s annual ASH meeting for blood diseases. We’ve highlighted a few top stories for you. Amid all the fuss over cell, gene, and immunotherapies these days, an old-fashioned small-molecule class of drug called PARP inhibitors have … Continue reading “ESMO 2019: PARP and Prostate, SeaGen’s Win, KRAS Update & More”
Biotech Roundup: Vaping Toll Rises, NASH News, Akcea Shakeup & More
Lung injuries linked to electronic cigarettes have topped 800 cases, including 12 deaths, according to the Centers for Disease Control and Prevention. Public health officials aren’t sure whether the injuries are from legally sold products made by companies such as Juul, or from black-market items such as those that allow users to “vape” the active … Continue reading “Biotech Roundup: Vaping Toll Rises, NASH News, Akcea Shakeup & More”
Report: IPO Activity Picking Back Up Following Quiet, Volatile Q3
While the headlines may be dominated by news of WeWork putting its IPO on hold after reports about its questionable corporate governance, the overall initial public offering market is doing just fine. So far, 127 US companies went public in the first nine months of the year and the amount they raised already topped three … Continue reading “Report: IPO Activity Picking Back Up Following Quiet, Volatile Q3”
Amazon Launches Virtual Clinic to Help Its Employees Get Healthcare
Amazon has created a new service where its employees can get treatment and advice for non-emergency health issues, according to a website the tech giant recently brought online. Amazon (NASDAQ: [[ticker:AMZN]]) says the program, Amazon Care, combines telemedicine services, in-person visits with licensed clinicians, and prescription medication delivery. Amazon Care is currently “being piloted for … Continue reading “Amazon Launches Virtual Clinic to Help Its Employees Get Healthcare”
Drug Pricing: Innovation, Investment, and the Public Good
The US biotech and life sciences industry has a long and proud history of driving medical innovations that have improved healthcare outcomes across a wide range of diseases and the overall quality of life for people worldwide. For too long, however, the industry’s narrative has been dominated and defined by partisans with a specific agenda … Continue reading “Drug Pricing: Innovation, Investment, and the Public Good”
Katerra To Make Ultra-Strong Wood Panels at New Factory in WA
[Updated 9/23/19, 6:29 pm. See below.] Construction tech firm Katerra, a 4-year-old Bay area startup with a big fundraising total, a big backer, and big ambitions, officially opened a big factory today in eastern Washington state. Katerra’s activities in the construction field range from project management software and design to the manufacture of pre-fabricated structural … Continue reading “Katerra To Make Ultra-Strong Wood Panels at New Factory in WA”
An Entrepreneur’s Quest to Make Seattle a Genome Sciences Hub
Ivan Liachko turned postdoctoral research at the University of Washington into a company whose genomics tools are now found in laboratories researching human, animal, and plant health. His firm, Phase Genomics, was one of the first startups to come out of UW’s genome sciences department. As a first-time entrepreneur working from UW’s incubator more than … Continue reading “An Entrepreneur’s Quest to Make Seattle a Genome Sciences Hub”
Enough with the Insanity. We Need to Fix Cybersecurity Now
The year 2019 has been another dreadful period for cyberattacks. The most notorious lowlights include: —More than 40 municipalities, including Baltimore, Albany and 22 cities in Texas alone, have seen their computer systems crippled by ransomware attackers demanding millions of dollars. —In one of the largest data breaches ever, a hacker broke into a Capital One server with a … Continue reading “Enough with the Insanity. We Need to Fix Cybersecurity Now”
Bio Roundup: Pelosi’s Reveal, Alder’s Deal, Biogen’s Fails & More
Boston, San Francisco, and a few other metro areas might dominate the US life sciences, but some weeks, all bio-related eyes are on the nation’s capital. Health concerns about vaping continue to mount, and the feds could get involved. Meanwhile, try to find someone in the federal government who isn’t involved in the drug-price debate. … Continue reading “Bio Roundup: Pelosi’s Reveal, Alder’s Deal, Biogen’s Fails & More”
Amazon Sets Electric Vehicle, Carbon Footprint Goals Amid Criticism
Amazon unveiled a new series of ambitious, long-term sustainability goals on Thursday that would continue the company’s efforts to make its operations more environmentally friendly. Under what Amazon (NASDAQ: [[ticker:AMZN]]) has dubbed “The Climate Pledge,” the tech giant said it has ordered 100,000 electric delivery vehicles from Rivian, a Michigan startup Amazon has backed previously. … Continue reading “Amazon Sets Electric Vehicle, Carbon Footprint Goals Amid Criticism”
Pelosi, Dems Unveil Price Plan: Are 25 Drugs Enough for Negotiation?
With the 2020 election just over a year away, House Speaker Nancy Pelosi (D-CA) has unveiled the Democratic Party’s answer to public discontent over high prescription drug prices. A preview of the plan was leaked last week. Today’s announcement doesn’t stray far. The new plan would have the U.S. Department of Health and Human Services … Continue reading “Pelosi, Dems Unveil Price Plan: Are 25 Drugs Enough for Negotiation?”
Gilliland to Step Down as Head of Fred Hutch in 2020
Gary Gilliland, who has led Seattle’s Fred Hutchinson Cancer Research Center as president and director for the past four-plus years, plans to step down in 2020, the nonprofit organization announced Tuesday. He joined the research center, which is often abbreviated as Fred Hutch, in 2015. Under his leadership, the organization has increased its endowment and … Continue reading “Gilliland to Step Down as Head of Fred Hutch in 2020”
Innovations in Healthcare – Xconomy Seattle Life Science Forum – Nov. 6, 2019
Join Xconomy at the new Building Cure on the Seattle Children’s Research Institute campus for an interactive program exploring what’s needed – and what’s next – in the world of healthcare research and innovation. Attendees will hear from those who are pioneering new approaches that are helping to save lives, improve treatments, and drive new … Continue reading “Innovations in Healthcare – Xconomy Seattle Life Science Forum – Nov. 6, 2019”
Lundbeck Paying Nearly $2B for Alder to Follow Migraine Rivals to Market
Denmark’s neuroscience-focused pharma firm Lundbeck has agreed to pay $1.95 billion to acquire Seattle-based Alder BioPharmaceuticals to boost its late-stage pipeline and biologics capabilities. Barely a year at the helm, Lundbeck CEO Deborah Dunsire (pictured) is making her second major acquisition as she continues to look for new growth drivers to offset generics erosion of … Continue reading “Lundbeck Paying Nearly $2B for Alder to Follow Migraine Rivals to Market”
Why Menlo Ventures Backed Construction Tech Firm Fieldwire
[Corrected 9/17/2019, 8:58 a.m, and 9/18/19, 4:53 p.m. See below.] Fieldwire, whose mobile app helps builders and construction crews coordinate their work, announced today it has lined up a total of $33.5 million across two newly disclosed fundraising rounds. The San Francisco-based construction tech company says it raised $8.5 million in a Series B funding … Continue reading “Why Menlo Ventures Backed Construction Tech Firm Fieldwire”
Bio Roundup: Award Winners, Lung Data, Dems on Drug Pricing & More
For decades, advanced lung cancer was a quick death sentence. That’s no longer a given, thanks in part to the arrival of immunotherapy. If a medical meeting in Barcelona this week was any indication, more help could be on the way. Targeted medicine isn’t new to lung cancer, but only a fraction of patients have … Continue reading “Bio Roundup: Award Winners, Lung Data, Dems on Drug Pricing & More”
As More Grocers Embrace Tech, Swiftly Snags $15M to Launch in Seattle
[Updated 9/12/19 1:10 p.m. See below.] Swiftly, a Seattle-based startup developing software to provide discounts and rewards for buying goods at grocery stores, exited stealth mode this week with an announcement it has raised more than $15 million in outside investment. The company, which has been keeping many details about its business under wraps, launched in … Continue reading “As More Grocers Embrace Tech, Swiftly Snags $15M to Launch in Seattle”
After First Look at House Drug Plan, Stocks Rise Slightly
The first details of the long-awaited House Democrat plan to lower drug prices leaked out Monday night, with elements that have long been anathema to the biopharma industry and its supporters in Washington. While the world digested the details Tuesday, however, biopharma investors didn’t seem fazed. Some individual companies saw shares dip, but the biopharma … Continue reading “After First Look at House Drug Plan, Stocks Rise Slightly”