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”
Category: New York
FDA Again Halts Solid Bio’s Duchenne Gene Therapy Clinical Trial
The FDA has stopped a clinical trial testing a Solid Biosciences gene therapy for Duchenne muscular dystrophy after a patient developed complications associated with the experimental treatment. Cambridge, MA-based Solid Bio says the problems deemed to be related to the gene therapy included an immune system reaction, a decrease in red blood cells, kidney injury, … Continue reading “FDA Again Halts Solid Bio’s Duchenne Gene Therapy Clinical Trial”
Roche Challenger to Biogen’s SMA Drug Succeeds in Pivotal Study
A Roche drug in development as a treatment for spinal muscular atrophy achieved the main goals of a key study, helping to build the case that the drug could challenge a Biogen therapy already approved for the rare disorder. Roche announced Monday that its drug, risdiplam, met the main goal of showing improvement according to … Continue reading “Roche Challenger to Biogen’s SMA Drug Succeeds in Pivotal Study”
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”
Looking to Level Up in NASH, Novo Nordisk Licenses Ube Drug Candidate
Danish diabetes giant Novo Nordisk took another step this week in its efforts to establish a presence in nonalcoholic steatohepatitis, or NASH, a metabolic disorder closely related to diabetes that is anticipated to become the leading cause of liver transplants in the US in coming years. The company Thursday announced it had inked a deal … Continue reading “Looking to Level Up in NASH, Novo Nordisk Licenses Ube Drug Candidate”
Anemia Drug From Acceleron Pharma and Celgene Wins FDA Approval
[Updated 6:41 p.m. See below.] A drug that Celgene and Acceleron Pharma developed to treat low red blood cell levels in patients who have a rare blood disorder now has regulatory clearance to enter the market. The FDA on Friday approved luspatercept (Rebloyzl) for patients who have beta thalassemia, an inherited disorder that leads to … Continue reading “Anemia Drug From Acceleron Pharma and Celgene Wins FDA Approval”
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”
Halozyme to Restructure After Pancreatic Cancer Drug Fails in Phase 3
An experimental Halozyme Therapeutics treatment for pancreatic cancer has failed a pivotal study, and the company is stopping further development of the drug and closing its oncology operations as part of a corporate restructuring. Halozyme (NASDAQ: [[ticker:HALO]]) announced Monday that its drug, PEGPH20, did not meet a Phase 3 study’s main goal of improving how … Continue reading “Halozyme to Restructure After Pancreatic Cancer Drug Fails in Phase 3”
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”
With Ex-Medivation Exec Hung at Helm, Nuvation Nabs $275M for Cancer
Nuvation Bio peeked out from stealth mode Monday to reveal $275 million in financing and an executive team stacked with biotech veterans. The cancer drug developer, which has offices in New York and San Francisco, is led by founder, president, and CEO David Hung, the former chief executive who steered Medivation to a $14.3 billion … Continue reading “With Ex-Medivation Exec Hung at Helm, Nuvation Nabs $275M for Cancer”
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”
Acorda Cuts Staff 25% and Restructures to Keep Focus on Parkinson’s Drug
Acorda Therapeutics is laying off about one quarter of its staff in order to save money and focus its remaining resources on commercializing a Parkinson’s disease drug that launched earlier this year. Ardsley, NY-based Acorda (NASDAQ: [[ticker:ACOR]]) said late Wednesday that it expects the workforce cuts will save $21 million annually. Most of the cuts … Continue reading “Acorda Cuts Staff 25% and Restructures to Keep Focus on Parkinson’s Drug”
Biogen Reverses Course on Alzheimer’s Drug Analysis, Plans FDA Filing
Six months after Biogen stopped work on a closely watched experimental Alzheimer’s disease treatment, the neuroscience drug developer is reviving it with plans to file for FDA approval. Aducanumab’s Phase 3 failure in March was viewed as yet another nail in the coffin for the so-called “amyloid hypothesis”—the theory that by breaking up or clearing … Continue reading “Biogen Reverses Course on Alzheimer’s Drug Analysis, Plans FDA Filing”
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”
Healx Bags $56M to Advance Affordable, AI-Based Orphan Drugs
Atomico, a European venture capital firm, has helped persuade Cambridge, UK-based Healx to return to the capital market a year earlier than anticipated. The biotech has just raised $56 million in Series B funding to bankroll its mission to use AI and machine learning to create affordable rare disease treatments. It is not surprising that … Continue reading “Healx Bags $56M to Advance Affordable, AI-Based Orphan Drugs”
Alexion to Buy Achillion in $930M Marriage of Rare Disease Drug Firms
Alexion Pharmaceuticals is acquiring Achillion Pharmaceuticals for $930 million, a deal that could strengthen its position providing treatments for a rare blood disorder. According to financial terms announced Wednesday, Boston-based Alexion (NASDAQ: [[ticker:ALXN]]) will pay $6.30 per share of Achillion (NASDAQ: [[ticker:ACHN]]) stock, which is an 80 percent premium to Achillion’s closing stock price on … Continue reading “Alexion to Buy Achillion in $930M Marriage of Rare Disease Drug Firms”
Led by Gilead Veteran Riva, Glenmark’s Ichnos Steps Out on Its Own
Glenmark Pharmaceuticals, which has made generic drugs for about four decades, on Tuesday formally spun off its drug R&D unit as an independent business aiming to advance a handful of novel molecules the Indian company has developed in recent years. The new company, called Ichnos Sciences, emerges with a clinical-stage pipeline that has experimental treatments … Continue reading “Led by Gilead Veteran Riva, Glenmark’s Ichnos Steps Out on Its Own”
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”
Catch Duchenne Patient Power, Phil Sharp & More Next Week at The Broad
How did Phil Sharp, a kid from a small farm in Kentucky, become a Nobel prize winner and one of the godfathers of the biotech industry? How did Christine McSherry turn her youngest son’s devastating diagnosis into a crusade that aided in the approval of a drug for his disease? Sharp (pictured above) and McSherry … Continue reading “Catch Duchenne Patient Power, Phil Sharp & More Next Week at The Broad”
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”
Akcea, Fresh Off C-Suite Shakeup, Dishes Heart Drug to Pfizer for $250M
Pfizer this morning bought an experimental heart disease drug from Akcea therapeutics, the first move made by the Ionis Pharmaceuticals spinout since the company overhauled its management team last month. Pfizer will pay Akcea (NASDAQ: [[ticker:AKCA]]) and parent Ionis (NASDAQ: [[ticker:IONS]]) $250 million up front for rights to AKCEA-ANGPTL3-Lrx, an RNA-based medicine currently in a … Continue reading “Akcea, Fresh Off C-Suite Shakeup, Dishes Heart Drug to Pfizer for $250M”
Unpack Digital Health’s Progress & Pitfalls at X·CON on Oct. 22
Digital health is having a moment, thanks to a convergence of increasingly sophisticated computing technologies, a more favorable regulatory environment, and growing buy-in from hospitals, insurers, and patients. But plenty of challenges and questions remain. Join Xconomy on Oct. 22 for an elite conference that will help industry stakeholders better understand the most promising opportunities … Continue reading “Unpack Digital Health’s Progress & Pitfalls at X·CON on Oct. 22”
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”
Three Biotechs Raise $320M in IPOs, Two Others Pass on Wall Street
With five biotech IPOs on the calendar, this week was expected to be a big one. Three companies ended up making Wall Street debuts, raising a combined $320 million, led by Viela Bio. But two other firms didn’t like the market conditions and decided against going public for now. Here’s a recap of the week’s … Continue reading “Three Biotechs Raise $320M in IPOs, Two Others Pass on Wall Street”
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”
Biogen’s Ehlers Leaving for Apple Tree, Steps Into Limelight as CEO
Michael Ehlers, Biogen’s executive vice president of research and development, is leaving for a job in venture capital and an opportunity to lead a gene therapy startup. Ehlers has been appointed chief scientific officer and venture partner of New York-based Apple Tree Partners. He’ll also become CEO of one of the firm’s portfolio companies, Limelight … Continue reading “Biogen’s Ehlers Leaving for Apple Tree, Steps Into Limelight as CEO”
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”
Meissa Scores $30M to Test Vaccine for Dangerous Respiratory Virus
No vaccine is yet available for respiratory syncytial virus (RSV), which causes lung infections that, while usually mild, can be deadly for very young children. Biotech startup Meissa Vaccines, which aims to fill that treatment gap, announced today it raised $30 million to fund early-stage clinical trials for its experimental RSV vaccine. Morningside Ventures, a … Continue reading “Meissa Scores $30M to Test Vaccine for Dangerous Respiratory Virus”
Enanta Steps Forward in NASH Race, With Unclear Prospects
Enanta Pharmaceuticals late Wednesday became the latest of a number of companies to tout an emerging potential therapy for nonalcoholic steatohepatitis, the fatty liver disease that is fast becoming a global epidemic. But it’s unclear whether the experimental treatment can stand out from the crowd. Enanta (NASDAQ: [[ticker:ENTA]]) said the higher of two tested doses of … Continue reading “Enanta Steps Forward in NASH Race, With Unclear Prospects”
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”
Hookipa Pharma Names Christine Baker CBO, Roman Necina CTO
Christine Baker has joined Hookipa Pharma (NASDAQ: [[ticker:HOOK]]) as chief business officer, the same position she held at EpicentRx. New York-based Hookipa also appointed Roman Necina chief technology officer. Necina, who is currently a senior vice president for technical development and chief strategist at Takeda Pharmaceutical (NYSE: [[ticker:TAK]]), will start at Hookipa in November. The … Continue reading “Hookipa Pharma Names Christine Baker CBO, Roman Necina CTO”
CyberFortress Adds $3M Seed Round for Cybersecurity Insurance Tech
San Antonio—[Updated 12:22 p.m. See below.] CyberFortress, a cybersecurity company focused on the insurance industry, closed a $3 million seed funding round co-led by New York venture firm Greycroft and Austin, TX-based LiveOak Venture Partners. Founded in 2018 in San Antonio, CyberFortress is still developing its product, which will insure e-commerce businesses. The company’s plans … Continue reading “CyberFortress Adds $3M Seed Round for Cybersecurity Insurance Tech”
MedCo Preps for FDA Filing as Cholesterol Drug Clears Last Two Tests
The Medicines Co. this morning inched closer to bringing a twice-yearly cholesterol-lowering drug to market, touting a positive result in two more Phase 3 studies. Without providing details, MedCo (NASDAQ: [[ticker:MDCO]]) said that the experimental medicine, inclisiran, hit all of its main and secondary goals in two Phase 3 studies called ORION-9 and ORION-10. Like … Continue reading “MedCo Preps for FDA Filing as Cholesterol Drug Clears Last Two Tests”
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”
Flagship’s Omega Aims to Take Epigenetic Drugs a Step Further
A biotech startup called Omega Therapeutics debuts this morning touting a new approach to developing medicines based on epigenetics, a field of research that has tantalized drug makers for years but produced mixed results. Can the fledgling company surpass previous efforts and develop epigenetic drugs for a slew of different diseases? Cambridge, MA-based Omega was … Continue reading “Flagship’s Omega Aims to Take Epigenetic Drugs a Step Further”
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”
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?”
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”
BACEless: Eisai, Biogen Pull Plug on Alzheimer’s Drug in Final Stage
Add another once-promising Alzheimer’s disease drug to the scrap heap. Eisai and Biogen (NASDAQ: [[ticker:BIIB]]) are halting a Phase 3 test after an independent safety review concluded the risks of experimental Alzheimer’s drug elenbecestat outweigh the benefits. The companies did not explain what the independent board found. Some drugs that work the same way have … Continue reading “BACEless: Eisai, Biogen Pull Plug on Alzheimer’s Drug in Final Stage”
Cloudflare’s $525M IPO Emboldens Already-Confident Internet Booster
[Updated 9/13/19, 11:40 am ET. See below.] Cloudflare has had its share of controversy, and is in a market with a wide range of more established competitors, from Amazon Web Services and Google Cloud to Cisco Systems and Palo Alto Networks. But the business software company still felt confident enough that Wall Street would welcome … Continue reading “Cloudflare’s $525M IPO Emboldens Already-Confident Internet Booster”