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”
Category: Indiana
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”
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”
Eli Lilly Drug Acquired in Armo Deal Fails Pancreatic Cancer Test
An experimental drug that was the centerpiece of a $1.6 billion Eli Lilly acquisition last year has now failed a pivotal test in pancreatic cancer. Eli Lilly (NYSE: [[ticker:LLY]]) said Wednesday that patients treated with its drug candidate pegilodecakin, plus chemotherapy, did not live longer than patients treated with chemotherapy alone, falling short of the … Continue reading “Eli Lilly Drug Acquired in Armo Deal Fails Pancreatic Cancer Test”
FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades
Eli Lilly won FDA approval for a migraine drug on Friday, giving the pharmaceutical giant a second medication that addresses the condition that causes millions of people to experience severe headaches and other debilitating symptoms. The FDA approved the drug, lasmiditan (Reyvow), as a treatment for acute migraine; it’s meant to be taken after the … Continue reading “FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades”
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?”
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”
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”
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”
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”
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”
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?”
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”
Herceptin Inventors, Immunology Pioneers Take Home 2019 Lasker Awards
This year’s Lasker Awards, the US’s most prestigious biomedical honor, are going to five scientists whose work led to a critical breast cancer treatment and significant basic research advances that have helped pave the way for immunotherapy. H. Michael Shepard, Dennis Slamon, and Axel Ullrich won the Lasker-DeBakey Clinical Medical Research Award for inventing trastuzumab … Continue reading “Herceptin Inventors, Immunology Pioneers Take Home 2019 Lasker Awards”
Your Car Is Hackable—Here Are Three Steps You Can Take
We’re used to protecting the information on our smartphones by keeping strong passwords and setting a lock screen. But fewer people know about the importance of protecting the information in their vehicles. Earlier this year, the automotive shopping website CarGurus asked 1,020 consumers questions about common security practices and the risks of connected cars. Here … Continue reading “Your Car Is Hackable—Here Are Three Steps You Can Take”
At Big Lung Cancer Meeting, Lights Shine on KRAS, Drug Combos & More
The treatment landscape for lung cancer has shifted significantly over the past few years, and more changes could be on the way. At the World Conference on Lung Cancer in Barcelona this weekend a number of drug makers trotted out some of their latest advances in immunotherapy, targeted pills, drug combinations, and more. Xconomy rounded … Continue reading “At Big Lung Cancer Meeting, Lights Shine on KRAS, Drug Combos & More”
Bio Roundup: MedCo’s Pricing Plan, Vertex’s Gamble, uBiome Undone
Being first to market with a new type of drug brings advantages. The first mover sets the bar for what physicians, payers, and patients can expect of that medicine and how much it costs. It grabs market share that followers have to steal away. But the first mover isn’t infallible if someone else has something … Continue reading “Bio Roundup: MedCo’s Pricing Plan, Vertex’s Gamble, uBiome Undone”
With FDA’s Eye on JAK Drugs, Concert Moves One Ahead For Hair Loss
Despite the safety concerns that have recently emerged for class of drugs known as JAK inhibitors, their reach continues to grow. The latest example comes from Concert Pharmaceuticals, which is racing the drug giant Pfizer to develop a medicine for a common skin disease that causes hair loss. Concert (NASDAQ: [[ticker:CNCE]]) is disclosing this morning … Continue reading “With FDA’s Eye on JAK Drugs, Concert Moves One Ahead For Hair Loss”
Bio Roundup: Cholesterol Check, J&J’s Opioid Hit, AbbVie’s Flop & More
You might be camping, barbecuing, or sleeping on Monday. It’s Labor Day, after all. But in Paris, this cardiologist will be in a conference center, walking an audience through a slide deck packed with Phase 3 data for a new cholesterol-lowering drug, inclisiran. Inclisiran’s owner, the Medicines Co., jumped the presentation by a week, promising … Continue reading “Bio Roundup: Cholesterol Check, J&J’s Opioid Hit, AbbVie’s Flop & More”
New PCSK9 Cholesterol Drug Faces Tough Foe. (Hint: Not Cholesterol.)
[Updated 8/26/19, 10:30am. See below.] Remember when the new wave of expensive cholesterol-lowering drugs—known as PCSK9 inhibitors—was supposed to give the healthcare system a financial heart attack? Far from it. Four years after approval the two PCSK9 blockers on the market have yet to crack $1 billion in annual sales, combined, thanks to a gloves-off … Continue reading “New PCSK9 Cholesterol Drug Faces Tough Foe. (Hint: Not Cholesterol.)”
Bio Roundup: Sarepta’s Stumble, Opioid Suits, Shkreli’s Legacy & More
Biotech news tends to slow down in August but the past seven days have been busy for regulatory decisions. Three drugs and two devices won FDA nods. Not all companies were as fortunate. Several biotechs reported failed clinical trials or unfavorable FDA decisions. The most notable one might be the rejection of a Sarepta Therapeutics … Continue reading “Bio Roundup: Sarepta’s Stumble, Opioid Suits, Shkreli’s Legacy & More”
Elanco’s $7.6B Deal With Bayer Bolsters Pets, Farm Animals Footprint
Elanco Animal Health, the veterinary sector’s fourth-largest company measured by revenue, is poised to leap to number two through a $7.6 billion cash and stock deal for Bayer’s animal health unit. The acquisition will help Elanco boost its business selling products for farm animals. But Elanco (NYSE: [[ticker:ELAN]]) notes that Bayer, which sells the popular … Continue reading “Elanco’s $7.6B Deal With Bayer Bolsters Pets, Farm Animals Footprint”
Bio Roundup: Zolgensma Fallout, Duchenne Redux, Ebola Boost & More
We learned last week that the FDA was investigating Novartis for manipulating animal data related to its $2 million-a-dose gene therapy Zolgensma. The activity took place at AveXis, the firm Novartis bought for $8.7 billion in 2018, and Novartis reportedly knew but failed to report it to the FDA before the agency approved Zolgensma in … Continue reading “Bio Roundup: Zolgensma Fallout, Duchenne Redux, Ebola Boost & More”
Four New Drugs Are Around the Corner. Here’s What You Need to Know.
[Updated, 3:40 pm ET, see below] The Food and Drug Administration approved 59 new drugs last year, a record for the agency which over the years has swung back and forth between tight control and leniency. We are in the midst of perhaps the agency’s most permissive era ever, thanks to its openness to speed … Continue reading “Four New Drugs Are Around the Corner. Here’s What You Need to Know.”
On Target Laboratories Taps Philips Healthcare’s Barys for CEO
Christopher Barys has been appointed CEO of On Target Laboratories. Barys is also joining the West Lafayette, IN-based company’s board of directors. He succeeds former CEO Martin Low. Barys comes to On Target from Philips Healthcare, where he led the company’s image guided therapy group. Barys’s experience also includes positions at Medtronic (NYSE: [[ticker:MDT]]) and … Continue reading “On Target Laboratories Taps Philips Healthcare’s Barys for CEO”
Inari Reaps $89M and Eyes Global Farm Markets for Gene-Edited Seeds
Plant genetics startup Inari, which is developing crop varieties that produce higher yields and use fewer resources, has raised $89 million to advance its research toward the US and international markets. Corn, soybean, wheat, and tomatoes are the Cambridge, MA-based company’s initial target crops. CEO Ponsi Trivisvavet says the company aims to launch several products … Continue reading “Inari Reaps $89M and Eyes Global Farm Markets for Gene-Edited Seeds”
Bio Roundup: Pfizer’s Future, CRISPR in Patients, Drug Imports & More
[Corrected 12:55 p.m. ET. See below.] Acquisitions made Pfizer what it is today: the world’s biggest drug maker measured by revenue. But as the company maps its future, CEO Albert Bourla is breaking some of that legacy apart. Blockbuster drugs such as Viagra, which was discovered in-house, and Lipitor, which came via acquisition, are currently … Continue reading “Bio Roundup: Pfizer’s Future, CRISPR in Patients, Drug Imports & More”
Elanco Boosts Vaccine Portfolio With $60M Prevtec Acquisition
One of the most serious threats to a young farm pig’s life is a type of gut infection that can quickly turn deadly. Elanco Animal Health has acquired a Canadian biotechnology startup that has commercialized a line of vaccines developed to protect pigs from the infection. Elanco (NYSE: [[ticker:ELAN]]) announced Thursday that it paid approximately … Continue reading “Elanco Boosts Vaccine Portfolio With $60M Prevtec Acquisition”
White House Floats Canadian Import Plan But Excludes Many Costly Drugs
[Updated, 6:18 p.m. ET. See below.] The Trump administration unveiled Wednesday a long-awaited plan to import cheaper medications from Canada and other countries. The US Department of Health and Human Services says the two proposals are part of the administration’s strategy to curb high prescription-drug prices, which has often been short on action despite the … Continue reading “White House Floats Canadian Import Plan But Excludes Many Costly Drugs”
Mark Levin Named Xconomy’s 2019 Lifetime Achievement Award Winner in Boston
We at Xconomy are excited to announce that we are honoring Mark Levin, co-founder and partner at Third Rock Ventures, with our 2019 Lifetime Achievement Award in Boston. The award recognizes Levin’s extensive contributions to the biotech industry and to the Boston life sciences ecosystem. Levin built Millennium Pharmaceuticals—inspiring a generation of future executives/entrepreneurs along … Continue reading “Mark Levin Named Xconomy’s 2019 Lifetime Achievement Award Winner in Boston”
Duchenne Advocates Start Casimir, Aiming to Capture Missing Data
Three years ago, the FDA made one of the most polarizing decisions in its history. It approved a drug for the rare genetic disease Duchenne muscular dystrophy on the slimmest of evidence, a watershed moment that caused a highly publicized rift within the agency. In the midst of it all were parents who pushed hard … Continue reading “Duchenne Advocates Start Casimir, Aiming to Capture Missing Data”
Bio Roundup: Leiden’s Exit, Depression Data, a New Pricing Bill & More
What will the legacy be of Jeff Leiden, the longtime CEO of Vertex Pharmaceuticals? Vertex surprised Wall Street this week by announcing Leiden’s seven-year run will end next spring. In some ways, his legacy is already written. He steered Vertex through a crisis when its hepatitis C business was squashed by competition, in no small … Continue reading “Bio Roundup: Leiden’s Exit, Depression Data, a New Pricing Bill & More”
As Castle Bio Jumps on IPO Train, Industry Trends Suggest Slowdown
Castle Biosciences is joining the public markets through a $64 million IPO that will support cancer tests that help doctors make treatment decisions. On Wednesday evening, Castle priced its offering of 4 million shares at $16 apiece, which was the high end of its targeted price range. The Friendswood, TX, company had previously planned to … Continue reading “As Castle Bio Jumps on IPO Train, Industry Trends Suggest Slowdown”
The Entrepreneurial Potential of Cannabis
Recreational marijuana is now legal here in Massachusetts and it seems that everywhere you look, people are excited to create business ventures around it. But, like any other business endeavor, research, planning, and discipline are essential – maybe even more so given the legal and regulatory issues involved with cannabis. As of now, marijuana is fully legal … Continue reading “The Entrepreneurial Potential of Cannabis”
Could Facebook’s Crypto Break Financial System? Congress Airs Fears
In late 2017, a federal watchdog unit assigned a working group to keep an eye on cryptocurrencies such as Bitcoin, and to sound an alert if those alternate currencies showed signs of becoming a risk to the stability of the US financial system. Soaring prices of Bitcoin and other so-called digital tokens were attracting investments … Continue reading “Could Facebook’s Crypto Break Financial System? Congress Airs Fears”
Bio Roundup: Opioid Exposé, Gilead’s Gambit, Life Science IPOs & More
The opioid crisis reaches all corners of the nation, and newly released data this week revealed how the growth of the epidemic tracked with a massive increase in the production and distribution of these drugs. From 2006 to 2012, the number of pills distributed to pharmacies increased by more than 50 percent. In total, 76 … Continue reading “Bio Roundup: Opioid Exposé, Gilead’s Gambit, Life Science IPOs & More”
Genmab, Mirum Pharma & Fulcrum Raise $653M in Wall Street Debuts
Initial public offerings took a brief summer break the week of Independence Day, but healthcare IPO activity resumed this week as three more companies joined the US public markets. Here’s a recap of the biotech companies that priced IPOs Wednesday evening. —Genmab is different from the other life science companies that joined the public markets … Continue reading “Genmab, Mirum Pharma & Fulcrum Raise $653M in Wall Street Debuts”
Narrowing AI: A Useful Context for AI Innovation, Opportunity, and Investment
I was asked recently if there was a meaningful analog to AI – its pervasiveness, its transformative potential, its power – in the annals of technology, and I answered with a straight face: “Yes. The Wheel. The Printing Press. Electricity. The Internet.” I truly believe AI is going to be that big, if not bigger, … Continue reading “Narrowing AI: A Useful Context for AI Innovation, Opportunity, and Investment”
Bio Roundup: Michael Becker, Suzanne Eaton, Gene Therapy Moves & More
The life science and healthcare worlds are vast. We often talk about impact in terms of millions of patients and billions of dollars. But these worlds can be small, too. It seems at times we’re never far removed from any one person, through their published papers, social media connections, friends, colleagues, or people they’ve mentored. … Continue reading “Bio Roundup: Michael Becker, Suzanne Eaton, Gene Therapy Moves & More”
Amgen, Novartis BACE Inhibitor Joins List of Failed Alzheimer’s Drugs
Amgen and Novartis are stopping work on an experimental Alzheimer’s disease drug after an early look at clinical data showed worsening cognitive function in patients. The interim results announced Thursday were part of a pre-planned review of data from two pivotal clinical trials testing the drug, umibecestat. Based on that review, Amgen (NASDAQ: [[ticker:AMGN]]) and … Continue reading “Amgen, Novartis BACE Inhibitor Joins List of Failed Alzheimer’s Drugs”
Trump Kills His Administration’s Plan to End Secret Drug Rebates
Donald Trump’s criticism of high drug prices began during the 2016 presidential campaign and continued through his presidency, perhaps most famously just before his inauguration when he said that drug companies were “getting away with murder.” This week has underlined the gap between the administration’s rhetoric and results. Most strikingly, the White House said last … Continue reading “Trump Kills His Administration’s Plan to End Secret Drug Rebates”
Honeywell Spinout Resideo Adds to Smart Home Cache, Opens Austin HQ
Austin—[Corrected 11:14 a.m. See below.] Doorbells, thermostats, refrigerators, and more—everything in the modern home is becoming a smart, connected device. (You can even monitor your kitty’s litter box habits with the Litter Robot 3!) There are many other, less frequently discussed appliances that businesses are pitching homeowners on as connected devices, such as air conditioning units … Continue reading “Honeywell Spinout Resideo Adds to Smart Home Cache, Opens Austin HQ”
How Do YOU Think the Internet Will Evolve? A Sampling of Your Tweets
[Editor’s note: This is part of a series examining the internet’s first 50 years and predicting the next half century. Join Xconomy and World Frontiers Forum on July 16 for Net@50, an event exploring the internet’s past and future.] For my feature article “Special Report 2069: Predicting the Internet’s Next 50 Years,” I asked my Twitter … Continue reading “How Do YOU Think the Internet Will Evolve? A Sampling of Your Tweets”
Future of the Internet: What Scares Networking Pioneer Radia Perlman
[Editor’s note: This is part of a series examining the internet’s first 50 years and predicting the next half century. Join Xconomy and World Frontiers Forum on July 16 for Net@50, an event exploring the internet’s past and future.] Bob Metcalfe co-invented Ethernet, the communications standard still used for most local on-site networking, but Radia Perlman … Continue reading “Future of the Internet: What Scares Networking Pioneer Radia Perlman”
Why Ethernet Inventor Bob Metcalfe is an Internet Optimist
[Editor’s note: This is part of a series examining the internet’s first 50 years and predicting the next half century. Join Xconomy and World Frontiers Forum on July 16 for Net@50, an event exploring the internet’s past and future.] Right alongside Moore’s Law, which describes the exponential growth in computing power since the 1960s, there’s Metcalfe’s … Continue reading “Why Ethernet Inventor Bob Metcalfe is an Internet Optimist”
Bio Roundup: Duchenne Race, Warren v. Gottlieb, A $599 Genome & More
As we pause to celebrate the 4th of July, another birthday is top of mind: A third baby whose embryonic DNA was edited by Chinese scientist He Jiankui. As Xconomy reported in November, He hinted about a second pregnancy after his infamous revelation of twins altered with CRISPR gene editing tools. That second pregnancy—a third … Continue reading “Bio Roundup: Duchenne Race, Warren v. Gottlieb, A $599 Genome & More”
Ex-Apple UX Guru Don Norman Calls for Replacing the Internet
[Editor’s note: This is part of a series examining the internet’s first 50 years and predicting the next half century. Join Xconomy and World Frontiers Forum on July 16 for Net@50, an event exploring the internet’s past and future.] No one has done more than Donald Norman to teach us that every piece of hardware … Continue reading “Ex-Apple UX Guru Don Norman Calls for Replacing the Internet”