Agios Pharmaceuticals has been developing two experimental drugs for anemia. For a couple of years, the company has said it would eventually move the better one forward and leave the other behind. As it turns out, the FDA has made the decision an easy one. Agios (NASDAQ: [[ticker:AGIO]]) said this afternoon it has scrapped AG-519, … Continue reading “After FDA Hold, Agios Quickly Scraps One Anemia Drug, Turns to Another”
Author: Ben Fidler
Ben is former Xconomy Deputy Editor, Biotechnology. He is a seasoned business journalist that comes to Xconomy after a nine-year stint at The Deal, where he covered corporate transactions in industries ranging from biotech to auto parts and gaming. Most recently, Ben was The Deal’s senior healthcare writer, focusing on acquisitions, venture financings, IPOs, partnerships and industry trends in the pharmaceutical, biotech, diagnostics and med tech spaces. Ben wrote features on creative biotech financing models, analyses of middle market and large cap buyouts, spin-offs and restructurings, and enterprise pieces on legal issues such as pay-for-delay agreements and the Affordable Care Act. Before switching to the healthcare beat, Ben was The Deal's senior bankruptcy reporter, covering the restructurings of the Texas Rangers, Phoenix Coyotes, GM, Delphi, Trump Entertainment Resorts and Blockbuster, among others. Ben has a bachelor’s degree in English from Binghamton University.
NY Bio Surge Continues as De Blasio Unveils $500M, 10-Year Life Sci Plan
[Updated w/comments, new information, 3:45 p.m. ET, see below] Over the last two days, city and state governments in New York have combined to commit a total of $1.15 billion to the development of the life sciences industry in the Empire State, the largest biotech bet in its history. Today is New York City’s turn. … Continue reading “NY Bio Surge Continues as De Blasio Unveils $500M, 10-Year Life Sci Plan”
New York State Hatches Sprawling $650M Plan to Foster Biotech
New York Governor Andrew Cuomo announced on Monday a $650 million initiative to support the development of biotech in the state of New York, where life science businesses have had trouble for years gaining a foothold despite a strong core of biomedical research work in New York City and beyond. The plan involves three main … Continue reading “New York State Hatches Sprawling $650M Plan to Foster Biotech”
Ophthotech Eye Drug Fails Badly in Pivotal Test, Shares Crumble
Ophthalmologists were keeping a close eye on an experimental drug from Ophthotech called pegpleranib (Fovista). Succeed, and the drug might change how a common form of vision loss, age related macular degeneration (AMD), is treated—and shine an even brighter spotlight on ophthalmologists already in the crosshairs of insurers and the federal government. That won’t happen, … Continue reading “Ophthotech Eye Drug Fails Badly in Pivotal Test, Shares Crumble”
Amyloid Hypothesis Lives On—Solanezumab, Too, Despite “Siren Song”
When Eli Lilly (NYSE: [[ticker:LLY]]) reported the day before Thanksgiving, that its Alzheimer’s treatment solanezumab failed to significantly improve the condition of people with a mild form of the disease, some observers immediately called it a final blow for the drug. After all, it had also failed to improve a broader range of patients with … Continue reading “Amyloid Hypothesis Lives On—Solanezumab, Too, Despite “Siren Song””
Voyager’s Gene Therapy for Parkinson’s Shows Promise in Small Study
Voyager Therapeutics this afternoon is providing very early evidence that an experimental gene therapy it’s been developing might have a chance to help patients with Parkinson’s disease for whom standard treatment is no longer working well. Cambridge, MA-based Voyager (NASDAQ: [[ticker:VYGR]]) is disclosing interim data from a small, open-label, Phase 1 trial among volunteers with … Continue reading “Voyager’s Gene Therapy for Parkinson’s Shows Promise in Small Study”
ASH Roundup: CAR-T Shuffle, Hemophilia Updates, Checkpoint Progress & More
Two years ago at the American Society of Hematology conference, excitement, not blood, was running in the streets of San Francisco. The cancer immunotherapy known as CAR-T was the star of the show, thanks to dazzling early data that showed more patients than not saw their leukemias and lymphomas knocked into remission by the living, … Continue reading “ASH Roundup: CAR-T Shuffle, Hemophilia Updates, Checkpoint Progress & More”
Fresh Off ASH Data, Spark Teams With Selecta to Boost Gene Therapies
As a group of experimental gene therapies—potentially long-lasting, if not permanent treatments—for the blood disease hemophilia continue to creep through clinical testing, a few things have become clear. They’re helping patients produce meaningful amounts of the blood-clotting proteins they lack for increasingly long periods of time. But they also may not work for everybody. Spark … Continue reading “Fresh Off ASH Data, Spark Teams With Selecta to Boost Gene Therapies”
Acetylon Crafts New Buyout Deal With Celgene, Spins Out Startup Regenacy
[Updated, 12/5/16, see below] Earlier this year, Celgene passed on an exclusive option to buy Acetylon Pharmaceuticals. But surprisingly, the two companies have come up with a new deal instead. Celgene agreed Friday to acquire just a portion of the assets of the Boston company, which will spin the rest of its assets into a … Continue reading “Acetylon Crafts New Buyout Deal With Celgene, Spins Out Startup Regenacy”
Bluebird Names COO, Taps Shire Exec To Lead Euro Ops
Cambridge, MA-based Bluebird Bio (NASDAQ: [[ticker:BLUE]]) has named Susanna High, formerly of Alnylam Pharmaceuticals and Millennium Pharmaceuticals, its chief operating officer. Andrew Obenshain, a veteran of Shire and Genzyme before that, will lead Bluebird’s operations in Europe.
SF Digital Health VC Suennen Joins GE Ventures
Lisa Suennen has been named a managing director at GE Ventures, according to her blog. Suennen co-founded Psilos Group almost two decades ago before starting up her own consulting firm, Venture Valkyrie, in 2014. According to her blog, Suennen will now be “back on the front lines of venture capital investing,” doing deals in health IT, … Continue reading “SF Digital Health VC Suennen Joins GE Ventures”
This Week in Drug Pricing and Post-Election Healthcare Policy News
Healthcare news has been coming fast and furious in the fallout of the election, particularly this week. Read on below for the latest on the 21st Century Cures Act, the Trump Administration’s latest nominees, and a biopharma CEO’s warning to his peers on drug pricing. IN WASHINGTON… —The House of Representatives passed a sweeping healthcare … Continue reading “This Week in Drug Pricing and Post-Election Healthcare Policy News”
Bio Roundup: CAR-T Ups & Downs, Lilly’s Failure, Myeloma & More
We’ve packed some extra stuffing into the roundup this week to account for some burnt turkey delivered by biopharma in the few days before Thanksgiving—starting with Eli Lilly’s failed gamble in Alzheimer’s disease. Lilly wasn’t alone, however. Several companies, among them Juno Therapeutics, Arrowhead Pharmaceutials, and Nivalis Therapeutics, have had some bad news for investors … Continue reading “Bio Roundup: CAR-T Ups & Downs, Lilly’s Failure, Myeloma & More”
In Year of CAR-T Trouble, Can Bluebird, Penn Make Headway in Myeloma?
Several drugs have been approved to treat multiple myeloma, a cancer of the bone marrow, in recent years. But it remains a nasty, persistent disease. Most everyone relapses. Two rival groups, Bluebird Bio and researchers at the University of Pennsylvania, are presenting data in coming days to make a case that a cutting-edge therapy known … Continue reading “In Year of CAR-T Trouble, Can Bluebird, Penn Make Headway in Myeloma?”
With $19M, Axial Becomes Latest Startup to Target Gut-Brain Connection
We’re still a long way from understanding how the trillions of bacteria that live in and on our bodies, known collectively as the human microbiome, affect our health and well-being. Despite those unknowns, a steady drip of companies have launched in recent years to explore those links and make drugs for a range of diseases. … Continue reading “With $19M, Axial Becomes Latest Startup to Target Gut-Brain Connection”
Amicus Shares Fall On Another Bump in Rough Road To U.S. Fabry Nod
After more than a decade of ups and downs, Amicus Therapeutics in May won its first drug approval, of Fabry disease pill migalastat (Galafold), in Europe. But the Cranbury, N.J. company won’t see the drug sold in the U.S. for at least a few more years. Amicus (NASDAQ: [[ticker:FOLD]]) said this afternoon that the FDA … Continue reading “Amicus Shares Fall On Another Bump in Rough Road To U.S. Fabry Nod”
Amyloid Hypothesis Takes a Hit As Lilly’s Alzheimer’s Drug Fails Again
Weeks earlier than expected, Eli Lilly delivered news this morning that will affect not just millions of patients with Alzheimer’s disease but also will rekindle fierce debate about the underlying cause of the memory-robbing disorder. Eli Lilly (NYSE: [[ticker:LLY]]) said that solanezumab, an experimental Alzheimer’s drug, failed a long-anticipated, high-stakes Phase 3 trial known as … Continue reading “Amyloid Hypothesis Takes a Hit As Lilly’s Alzheimer’s Drug Fails Again”
Acorda Leans on Parkinson’s Drugs After Post-Stroke Study Fails
Acorda Therapeutics has tried for some time to expand the use of its flagship drug, dalfampridine (Ampyra). Demonstrating that it could help people walk better after suffering a stroke was perhaps its biggest opportunity. But the Ardsley, NY, company is now scrapping those plans altogether. Acorda (NASDAQ: [[ticker:ACOR]]) said this morning it will no longer … Continue reading “Acorda Leans on Parkinson’s Drugs After Post-Stroke Study Fails”
Syntimmune Taps Ex-Boehringer, Pfizer Exec as New CEO
New York-based Syntimmune has named David de Graaf, a former Boehringer-Ingelheim and Pfizer executive, its president and CEO. The startup has also appointed Burt Adelman, the former research chief of Dyax and previously Biogen, to its board of directors. Adelman was named a senior adviser to Syntimmune as well.
Regeneron: It’s Still Wait Until 2017 For Big Heart Drug Study
With the American Heart Association’s annual meeting in New Orleans underway this week, there’s been plenty of talk about the prospects of so-called PCSK9 inhibitors, a new class of cholesterol lowering drugs that has struggled to gain traction in the market. Though evidence is being accumulated to prove their worth, the biggest piece of proof—data … Continue reading “Regeneron: It’s Still Wait Until 2017 For Big Heart Drug Study”
Keeping Lead in Migraine Drug Race, Amgen Touts Data, Preps FDA Filing
The first of a new group of drugs meant to prevent migraines, not just treat their symptoms, could be headed for FDA review next year. Amgen (NASDAQ: [[ticker:AMGN]]), of Thousand Oaks, CA, said Wednesday that an experimental drug named erenumab succeeded in the second of two Phase 3 trials—a 955-patient study in people with “episodic” … Continue reading “Keeping Lead in Migraine Drug Race, Amgen Touts Data, Preps FDA Filing”
With New Data, Medicines Co. Takes Long-Lasting Heart Drug to Phase 3
The Medicines Co. and Alnylam Pharmaceuticals released new data today supporting a potentially longer lasting alternative to the widely hyped wave of cholesterol-fighting drugs that hit the market in 2015. But it’ll take more clinical testing, and likely several years, before the drug’s potential and commercial viability are proven. Today at the American Heart Association’s … Continue reading “With New Data, Medicines Co. Takes Long-Lasting Heart Drug to Phase 3”
Struggling UniQure Cuts Gene Therapies, Jobs, in Big Restructuring
UniQure may have been the first company to win approval of a gene therapy, but that hasn’t translated to commercial success or a booming share price. Now it’s cutting jobs and restructuring to try to gain some momentum. Amsterdam- and Lexington, MA-based UniQure (NASDAQ: [[ticker:QURE]]) said this morning that it’s completed a strategic review, and … Continue reading “Struggling UniQure Cuts Gene Therapies, Jobs, in Big Restructuring”
Corbus Shares Climb on Early Data For Inflammation Drug
Shares of Corbus Pharmaceuticals skyrocketed this morning after the company said an experimental drug it’s been developing for a variety of autoimmune diseases succeeded in the first of several Phase 2 trials. Norwood, MA-based Corbus (NASDAQ: [[ticker:CRBP]]) said the drug, resunab, helped improve the condition of patients with diffuse systemic sclerosis—a severe form of scleroderma, … Continue reading “Corbus Shares Climb on Early Data For Inflammation Drug”
Bio Roundup: Trump’s Triumph, Election Fallout, CRISPR Arguments & More
The presidential election ended with Donald Trump’s stunning victory and Republican retention of the House and Senate. Now, the U.S. healthcare sector will try to figure out what it all means. Drug company stocks got a boost with the defeat of Hillary Clinton, a vocal critic of drug prices. But Trump’s plans are unclear. Will … Continue reading “Bio Roundup: Trump’s Triumph, Election Fallout, CRISPR Arguments & More”
New Data Show Biogen, Ionis Drug Might Help More With Rare Spine Disease
Up until this point, studies of an experimental drug from Biogen and Ionis Pharmaceuticals had focused on patients with the most severe form of a rare, potentially deadly genetic disorder called spinal muscular atrophy. But new data released this morning show that the therapy, known as nusinersen (Spinraza), could have a much broader reach. Biogen … Continue reading “New Data Show Biogen, Ionis Drug Might Help More With Rare Spine Disease”
New Data Show Power, Limits of Bluebird’s Gene Therapy For Blood Diseases
Bluebird Bio is releasing new data this morning that speak to both the potential and the limitations of a gene therapy it’s been developing for two deadly blood diseases, sickle cell disease and beta-thalassemia. The data, from abstracts for presentations that will be given at the annual meeting of the American Society of Hematology in … Continue reading “New Data Show Power, Limits of Bluebird’s Gene Therapy For Blood Diseases”
Verastem Takes a Low-Cost Flier on Infinity’s Blood Cancer Drug
It wasn’t too long ago that a blood cancer drug from Infinity Pharmaceuticals was worth an up front, $275 million from AbbVie. But two years and some disappointing trial results later, Verastem has scooped it up at a fraction of the cost. Verastem (NASDAQ: [[ticker:VSTM]]), a Boston company developing stem cell drugs for cancer, has … Continue reading “Verastem Takes a Low-Cost Flier on Infinity’s Blood Cancer Drug”
Celldex, Aiming For More Cancer Drug Combos, Pays $62.5M For Kolltan
Celldex Therapeutics has been trying to bounce back ever since its lead drug, a cancer vaccine, fell short in clinical trials earlier this year. Today it has acquired privately held Kolltan Pharmaceuticals to help with that plan. Hampton, NJ, and Needham, MA-based Celldex is paying Kolltan shareholders with $62.5 million worth of Celldex stock. The … Continue reading “Celldex, Aiming For More Cancer Drug Combos, Pays $62.5M For Kolltan”
With Reverse Merger, Miragen to Go Public, Get $40M Boost From Investors
For privately held biotechs, IPOs are the most common road to the public markets, but they’re not the only way. Reverse merging with a shell company is an alternate path, and that’s how Miragen Therapeutics is headed to the Nasdaq. Boulder, CO-based Miragen, a developer of drugs that utilize microRNA—small molecular regulators of gene expression—has … Continue reading “With Reverse Merger, Miragen to Go Public, Get $40M Boost From Investors”
Bayer, CRISPR Tap Sanofi Exec, Burns, to Run Gene Editing Venture
Bayer and CRISPR Therapeutics (NASDAQ: [[ticker:CRSP]]) have named James Burns the president and CEO of Cambridge, MA-based Casebia Therapeutics, a joint venture the two companies created to develop gene editing drugs for blood disorders, blindness, and heart disease. Burns has been at Sanofi/Genzyme for three decades, and most recently ran the company’s North American R&D … Continue reading “Bayer, CRISPR Tap Sanofi Exec, Burns, to Run Gene Editing Venture”
On Front Lines Of Price Dispute, Eye Doctors Wary of New Drug Data
Drugs that treat a form of vision loss known as age related macular degeneration aren’t just big business. They’re also a controversial part of the national debate over high drug prices, and their increased use has put ophthalmologists in the crosshairs of insurers, the federal government, and the press. “Retina practices are under significantly increased … Continue reading “On Front Lines Of Price Dispute, Eye Doctors Wary of New Drug Data”
New York Institutions, VCs Team up to Build Drug Discovery “Bridge”
[Updated, 11:10 a.m. ET, see below] New York biotech has historically lagged behind more established life sciences hubs like Boston and San Francisco, but collaborations between its research institutions have helped the city start to move forward. Another step in that direction was taken this morning, with the launch of what’s being called Bridge Medicines. … Continue reading “New York Institutions, VCs Team up to Build Drug Discovery “Bridge””
Third Rock Gets $616M to Grow New Crop of Biotech Startups
Third Rock Ventures is known for making big bets on risky science, and over the past decade a number of those gambles have paid off for its shareholders. That success has helped the Boston firm close on a new $616 million fund, its largest ever. Third Rock is announcing that it’s wrapped up its fourth … Continue reading “Third Rock Gets $616M to Grow New Crop of Biotech Startups”
Bio Roundup: Drug Pricing, Cystic Fibrosis Showdown, Myovant & More
The 2016 election is (thankfully) almost here, and as one biotech analyst noted this week, a possible Democratic victory is to blame for a big October sell-off in biotech stocks. Since Donald Trump’s infamous “Access Hollywood” tape was released on October 7, Leerink Partners analyst Geoffrey Porges wrote, biotech investors have lost $50 billion. The … Continue reading “Bio Roundup: Drug Pricing, Cystic Fibrosis Showdown, Myovant & More”
Boston’s Life Science Disruptors: The Photos
How did one of the ambitious gene editing startups in biotech come together? What lessons does Harvard University professor and biotech veteran Vicki Sato have about closing the gender gap after spending “most of her career” as the only woman in the room? And what would it take to get organ systems on tiny microchips … Continue reading “Boston’s Life Science Disruptors: The Photos”
With Insider Help, Ra Pharma Upsizes IPO, Bags $92M
The IPO market has been much more discerning about biotechs in 2016 than it was during the 2013-2015 boom. But Wall Street investors embraced Ra Pharmaceuticals Tuesday evening, enabling the Cambridge, MA-based company to close an even bigger IPO than it had hoped for. Ra raised close to $92 million in the offering. The company … Continue reading “With Insider Help, Ra Pharma Upsizes IPO, Bags $92M”
Safety Issue Triggers Partial FDA Hold for Aduro Bio
Aduro Biotech ran into some trouble earlier this year when one of its cancer immunotherapies failed a clinical trial. Now the Berkeley, CA, company has a safety problem and a clinical trial delay to deal with. Aduro (NASDAQ: [[ticker:ADRO]]) said this morning that one of the patients in its ongoing clinical trials of CRS-207, a … Continue reading “Safety Issue Triggers Partial FDA Hold for Aduro Bio”
BlackThorn Emerges With $40M, New Weapons Against Neuro Disorders
For three years, a group of investors and experienced neuroscience executives have been stealthily advancing one of the more ambitious new startups in neurology, called BlackThorn Therapeutics. Today they’re finally shedding a little light on what they’ve been up to. As Xconomy reported last year, South San Francisco, CA-based BlackThorn was spun out of Scripps … Continue reading “BlackThorn Emerges With $40M, New Weapons Against Neuro Disorders”
At NY Life Sci 2021, Yancopoulos, Dunn & More to Ponder NYC’s Bio Future
Five years is a long time. But in New York biotech it might as well be a century given how fast things are changing. Back in 2011, Xconomy held an event called New York Life Sciences 2031. In light of a major initiative by city, university, and industry leaders to spur the local life sciences … Continue reading “At NY Life Sci 2021, Yancopoulos, Dunn & More to Ponder NYC’s Bio Future”
After “Hubris” and Its HCV Collapse, Can Vertex Avoid Same Mistakes?
Five years ago, in November 2011, a company from Princeton, NJ, called Pharmasset shared news that would have an impact on millions of people around the world with hepatitis C. Its experimental drug PSI-7977 had quickly cleared the virus from 40 patients, with minimal side effects, and they had stayed infection-free. If the data held … Continue reading “After “Hubris” and Its HCV Collapse, Can Vertex Avoid Same Mistakes?”
Early Data for Celgene’s Oral Crohn’s Drug Gets Mixed Reaction
Celgene late Sunday provided more details on one of the more important drugs in its pipeline, a pill the Summit, NJ, company is developing for inflammatory bowel disease. Analysts on Wall Street are mixed on the clinical results. The data, which Celgene is presenting at United European Gastroenterology Week in Vienna, Austria, are an early … Continue reading “Early Data for Celgene’s Oral Crohn’s Drug Gets Mixed Reaction”
Weeks After Deal, FDA Slaps Clinical Hold on Regeneron/Teva Pain Drug
Regeneron Pharmaceuticals has seen its share of ups and downs over the years developing a drug for chronic pain that could represent an alternative to addictive opioids. And another roadblock just emerged this morning. Regeneron (NASDAQ: [[ticker:REGN]]) and partner Teva Pharmaceutical Industries (NYSE: [[ticker:TEVA]]) said this morning that safety issues have prompted the FDA to … Continue reading “Weeks After Deal, FDA Slaps Clinical Hold on Regeneron/Teva Pain Drug”
Ex-Celgene Dealmaker Tom Daniel Charts a New Course Advising Biotechs
For close to a decade, Tom Daniel and George Golumbeski comprised perhaps one of the best-known dealmaking duos in biopharma, striking a slew of alliances that established Summit, NJ-based Celgene as one of the more creative, nimble biotech partners in the business. “We think alike,” Daniel says. “We can pretty much finish each other’s sentences.” … Continue reading “Ex-Celgene Dealmaker Tom Daniel Charts a New Course Advising Biotechs”
Following Merger, Salzman Steps in as Adverum Bio CEO
Menlo Park, CA-based Adverum Biotechnologies (NASDAQ: [[ticker:ADVM]]) has named Amber Salzman, the company’s president and chief operating officer, its new CEO. Salzman takes over for Paul Cleveland, who will now serve as Adverum’s executive chairman. Adverum was formed out of the February merger between Avalanche Biotechnologies and Annapurna Therapeutics. Salzman co-founded Annapurna, once known as … Continue reading “Following Merger, Salzman Steps in as Adverum Bio CEO”
Bio Roundup: Bristol & Illumina Blues, Sickle Cell News & More
On Aug. 4, shares of Bristol-Myers Squibb closed at $75.32. Today, shares are worth just over $50. That means in three months, Bristol has lost a third of its value, equivalent to about $40 billion in market capitalization. The reason? One failed clinical trial has left rival Merck in the lead position to have what … Continue reading “Bio Roundup: Bristol & Illumina Blues, Sickle Cell News & More”
With Upgraded Tech, Bluebird Updates Regulatory Path For Gene Therapy
After flying high for a few years, Bluebird Bio has dealt with some adversity. Limitations emerged late last year for a gene therapy the company was developing for the blood diseases beta-thalassemia and sickle cell disease, and shares took a beating. Ever since then, the Cambridge, MA, company has been working to improve its technology. … Continue reading “With Upgraded Tech, Bluebird Updates Regulatory Path For Gene Therapy”
Ex-Alnylam Exec Sorensen Heads to Codiak Bio
Woburn, MA-based Codiak Biosciences has named Benny Sorensen its vice president and head of clinical development. Sorensen, who will report to Codiak CEO Doug Williams, was most recently a senior director of clinical research at Alnylam Pharmaceuticals (NASDAQ: [[ticker:ALNY]]).
Checkpoints In Lung Cancer, and Other Oncology News From Europe
The European Society for Medical Oncology’s annual conference wraps up in Copenhagen today. We’ve seen updates on heavyweight immunotherapy programs, potential options for patients with advanced breast cancer, and more. Here’s a quick roundup of the major news. LUNG CHECKS ESMO provided more evidence that the treatment of lung cancer is changing fast. Going into … Continue reading “Checkpoints In Lung Cancer, and Other Oncology News From Europe”
Defying Patient Pressure, Anthem Says No to Sarepta’s Duchenne Drug
A few weeks ago, Xconomy spoke with analysts and patient advocates who considered it unlikely that insurers would balk at a potential price of $300,000 a year for eteplirsen (Exondys 51), the first approved drug for Duchenne muscular dystrophy. That’s largely been the case so far, but today a significant outlier emerged—Anthem, one of the … Continue reading “Defying Patient Pressure, Anthem Says No to Sarepta’s Duchenne Drug”