A new drug for patients who have a hard time controlling their asthma could be nearing an FDA review. Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]) and partner Sanofi this morning are touting results this morning from a 1,902-patient Phase 3 study called Liberty Asthma Quest. In it, their injectable antibody drug dupilumab (Dupixent), already approved … Continue reading “Regeneron Touts Success in Big Asthma Drug Study, Plans FDA Filing”
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.
Bio Roundup: RNAi Drama, Immunotherapy Data, Lasker Winners & More
The summer doldrums are over. Biotech news came at a breakneck pace this week both before and after Labor Day, starting with the surprise resignation of Novartis’s top executive just days after the Swiss company notched an historic FDA approval. From there, the week featured big headlines, both good and bad, from several trials in … Continue reading “Bio Roundup: RNAi Drama, Immunotherapy Data, Lasker Winners & More”
Levin, Holtzman, 183 Other Bio Leaders Urge White House to Preserve DACA
Biotech CEOs Jeremy Levin and Steve Holtzman are continuing their recent push to spur the life sciences industry to speak out against government policies it doesn’t agree with. Levin, CEO of Ovid Therapeutics (NASDAQ: [[ticker:OVID]]) and Holtzman, the head of Decibel Therapeutics, co-authored a letter to the Trump administration and congressional leaders asking them to … Continue reading “Levin, Holtzman, 183 Other Bio Leaders Urge White House to Preserve DACA”
On Eve of Big Data Reveal, Patient Death Stalls Alnylam Hemophilia Drug
After years of ups and downs, RNA interference is as close as it’s ever been to producing its first drug. But the field’s roller coaster ride hit another bump this morning: Alnylam Pharmaceuticals is suspending development of an experimental hemophilia drug after a patient in a clinical trial died from brain swelling. It’s a setback … Continue reading “On Eve of Big Data Reveal, Patient Death Stalls Alnylam Hemophilia Drug”
NextCODE Reloads With $240M, Eyes IPO, As Genomic Data Demand Grows
Is the time finally right for companies trying to manage and store vast amounts of genomic data? The story of Wuxi NextCODE appears to make that case. The successor to an Icelandic genomics company that struggled through a bankruptcy, NextCODE was sold to China’s Wuxi Pharmatech for $65 million in 2015, and has now closed … Continue reading “NextCODE Reloads With $240M, Eyes IPO, As Genomic Data Demand Grows”
Seeking to Cash in For Investors Again, Rhythm Pharma Files For IPO
Most biotechs pursue either a sale or an IPO to reward their investors. Rhythm Pharmaceuticals is now trying to accomplish both. A year after Rhythm funneled a stomach drug into a subsidiary and sold it to Allergan for $200 million, the Boston-based company—developing a different drug for rare forms of obesity—has filed for an IPO. … Continue reading “Seeking to Cash in For Investors Again, Rhythm Pharma Files For IPO”
As Key Data Loom, Nobel Winner Mello Reflects on RNAi “Sci-Fi” Story
The story feels like a Hollywood flick, not reality—at least to University of Massachusetts Medical School molecular medicine professor and Nobel Prize winner Craig Mello. Nearly 20 years ago, Mello, Stanford University pathologist Andrew Fire, and their colleagues co-discovered RNA interference, a method of switching off or “silencing” genes before they can make potentially damaging … Continue reading “As Key Data Loom, Nobel Winner Mello Reflects on RNAi “Sci-Fi” Story”
Catch Dragonfly, IFM, Tesaro at “Disruptors” on Sept. 28
How do you succeed not once, but twice in biotech? How do you push a scientific idea forward without any venture capital? And how does one even begin trying to scour the globe for a diamond–in-the-rough cancer drug that has slipped through the cracks? These questions underlie the three stories Xconomy has lined up for … Continue reading “Catch Dragonfly, IFM, Tesaro at “Disruptors” on Sept. 28″
Patient Death Triggers FDA Hold For Cellectis’s “Off the Shelf” CAR-T
[Corrected, 9/18/17, see below] The FDA has forced Cellectis to shut down two Phase 1 trials it has been running to test an “off the shelf” type of cell therapy—a stinging setback to the France- and New York-based company’s aspirations to leapfrog other developers of CAR-T, a type of cancer immunotherapy that the FDA just … Continue reading “Patient Death Triggers FDA Hold For Cellectis’s “Off the Shelf” CAR-T”
Otonomy Scraps Hearing Loss Drug After Phase 3 Flop, Shares Routed
Investment in experimental drugs for hearing loss, long an untapped field in the pharmaceutical industry, may be picking up, but drugs that actually help with these disorders remain elusive. One of the closest contenders suffered a big setback today, as Otonomy revealed that a drug it has been developing for Meniere’s disease, a condition defined … Continue reading “Otonomy Scraps Hearing Loss Drug After Phase 3 Flop, Shares Routed”
Will Merck Seek FDA Filing For Heart Drug After Lackluster Results?
News from Merck this morning on a large trial known as Reveal might signal the end of the road for a once-promising group of cholesterol-lowering medicines. It all depends on what New York drug giant Merck (NYSE: [[ticker:MRK]]) intends to do now that it has the results of the four-year, 30,449-patient trial, which tested a … Continue reading “Will Merck Seek FDA Filing For Heart Drug After Lackluster Results?”
FDA Refuses to Review Acorda Parkinson’s Drug, Shares Tumble
The heat is on Acorda Therapeutics once again. Months after Acorda lost a key group of patents, the FDA has declined to review, at least for now, an experimental Parkinson’s disease drug that is critical to the company’s future. Acorda (NASDAQ: [[ticker:ACOR]]) said this morning that the FDA has sent the Ardsley, NY, company a … Continue reading “FDA Refuses to Review Acorda Parkinson’s Drug, Shares Tumble”
Gilead Makes Long-Awaited Splash With $12B Bet on Kite, Cell Therapy
Investors have been waiting for years for Gilead Sciences to make another big splash. This morning, it finally did, agreeing to buy Kite Pharma for close to $12 billion in a significant bet on the success of an emerging, cutting edge type of cancer immunotherapy known as CAR-T. Gilead (NASDAQ: [[ticker:GILD]]), of Foster City, CA, … Continue reading “Gilead Makes Long-Awaited Splash With $12B Bet on Kite, Cell Therapy”
Stand Up to “Bully” Trump: Bio CEOs Levin, Holtzman Call to Their Peers
Biotech CEOs Jeremy Levin and Steve Holtzman have watched the violence in Charlottesville, VA, and its continuing aftermath with disgust. But they aren’t just upset about the rally, the violence and death, and President Trump’s equivocating blame of “many sides.” Levin, of Ovid Therapeutics (NASDAQ: [[ticker:OVID]]), and Holtzman, of Decibel Therapeutics, have been disappointed with … Continue reading “Stand Up to “Bully” Trump: Bio CEOs Levin, Holtzman Call to Their Peers”
FDA Clears Way for Filing on Psych Drug From Intra-Cellular, Shares Climb
The FDA has just lowered a key barrier standing between Intra-Cellular Therapies and potential approval of an experimental schizophrenia drug. Now the question is whether the mixed set of data the company has accrued to support the program will be good enough for regulators. Intra-Cellular (NASDAQ: [[ticker:ITCI]]) said the FDA has finished looking over responses … Continue reading “FDA Clears Way for Filing on Psych Drug From Intra-Cellular, Shares Climb”
Near The East River, Plans Emerge For NY’s Next Life Science Center
At a time when biotech incubators and shared spaces are beginning to multiply in Manhattan, work on what could rank among the city’s largest biotech centers—if it can all come together—is just getting underway. According to Paul Wexler, a longtime healthcare-focused real estate broker, construction should begin next year on what is being called the … Continue reading “Near The East River, Plans Emerge For NY’s Next Life Science Center”
Bio Roundup: Frazier v. Trump, Data Dumps, New York Steps & More
The CEO of a major U.S. pharmaceutical company was in the news this week, but for a change not because of the cost of drugs. Merck CEO Kenneth Frazier (pictured) was the first of what quickly became a line of CEOs to exit President Trump’s manufacturing council, leading to its dissolution altogether. Frazier was widely … Continue reading “Bio Roundup: Frazier v. Trump, Data Dumps, New York Steps & More”
On the Hudson, Two Developers Open NYC’s Latest Bio Startup Space
Two real estate developers, Taconic Investment Partners and Silverstein Properties, have unveiled plans to bring about 150,000 square feet of new wet lab space online on the West Side of Manhattan, the latest effort in an ongoing quest in New York City to provide startup biotech companies a local home to form and grow. Taconic … Continue reading “On the Hudson, Two Developers Open NYC’s Latest Bio Startup Space”
Latest Immunotherapy Setback: Bristol Drugs Stumble in Kidney Cancer
The recent stumbles for cancer immunotherapy—specifically, combinations of treatments meant to help boost its effectiveness—continued late Tuesday with some disappointing news from one of the leaders in the field, Bristol-Myers Squibb. Bristol (NYSE: [[ticker:BMY]]) said that a Phase 3 trial testing two of its immunotherapies together in newly diagnosed kidney cancer patients, a study called … Continue reading “Latest Immunotherapy Setback: Bristol Drugs Stumble in Kidney Cancer”
Jounce Taps Ex-Ariad Dealmaker, Cole, as CBO
Cambridge, MA-based cancer drug developer Jounce Therapeutics (NASDAQ: [[ticker:JNCE]]) has named Hugh Cole its new chief business officer and head of corporate development. Cole was previously a top dealmaker at Ariad Pharmaceuticals and was a Shire executive for seven years before that. Takeda acquired Ariad for $5.2 billion in January.
Ophthotech’s Final Try at Combo Eye Drug Comes up Short
It wasn’t too long ago that Ophthotech was running a group of clinical trials being perhaps as closely watched as any in the ophthalmology field, studies that had a chance to change the way a common form of vision loss, age-related macular degeneration (AMD), is treated. But those days are a distant memory now. All … Continue reading “Ophthotech’s Final Try at Combo Eye Drug Comes up Short”
GSK Hands Nerve Drug Back to Ionis as RNA Battle Heats Up
A race is on to bring two new RNA-based drugs for a rare, debilitating nerve disease called familial amyloid polyneuropathy (FAP). And GlaxoSmithKline has just dropped out of it. This morning, Ionis Pharmaceuticals (NASDAQ: [[ticker:IONS]]) said that it has regained full rights, from GSK, to a drug called inotersen, which the Carlsbad, CA, company expects … Continue reading “GSK Hands Nerve Drug Back to Ionis as RNA Battle Heats Up”
Startup Builders, IPO Closers & More: Meet Xconomy’s CEO Award Finalists
There are many ways to stand out as a biotech CEO, from getting a company started in the first place to pushing its first drug over the finish line. Those differences are what we noticed when going through the nominations from you, the readers, for the top Boston biotech CEO, as part of the first-ever … Continue reading “Startup Builders, IPO Closers & More: Meet Xconomy’s CEO Award Finalists”
For Parkinson’s, Two New Drugs Coming As Prevail Gets Started in NY
A drug that actually slows or reverses the brain damage inflicted by Parkinson’s disease, rather than just alleviates its often debilitating symptoms, remains elusive. But Prevail Therapeutics, a startup just launched in New York, has become the latest to try. This morning, the Silverstein Foundation, a nonprofit organization formed by OrbiMed partner Jonathan Silverstein, announced … Continue reading “For Parkinson’s, Two New Drugs Coming As Prevail Gets Started in NY”
NxStage Medical Sells to Dialysis Giant Fresenius for $2B
German dialysis giant Fresenius is paying $2 billion to acquire NxStage Medical, a Lawrence, MA-based developer of products for patients dealing with kidney failure. Fresenius is paying $30 a share for NxStage (NASDAQ: [[ticker:NXTM]]), a roughly 28 percent premium to the company’s $23.14 closing price on Friday. That price represents an all-time high for NxStage: … Continue reading “NxStage Medical Sells to Dialysis Giant Fresenius for $2B”
Bio Roundup: CRISPR Advances, Obamacare Lives, FDA Nods & More
Gene editing took an important step this week when a group of U.S. researchers used CRISPR-Cas9 technology to correct a genetic error in dozens of human embryos without complications. It’s a significant achievement, but amidst the hype, it’s worth cautioning just how much work has to be done before the technology leads to a safe … Continue reading “Bio Roundup: CRISPR Advances, Obamacare Lives, FDA Nods & More”
IFM Gets $300M Bristol Buyout, Plans Second Strike With New Spinout
Bristol-Myers Squibb this afternoon is acquiring a young startup, IFM Therapeutics, in an unusual deal that will also see the big drugmaker get a chance to own rights in a new company the biotech is spinning out as well. New York-based Bristol (NYSE: [[ticker:BMY]]) will pay $300 million up front for IFM, which will give … Continue reading “IFM Gets $300M Bristol Buyout, Plans Second Strike With New Spinout”
With FDA Nod, Agios, Celgene Get Speedy OK For Blood Cancer Drug
[Updated, 2:10 pm ET, see below] The FDA approved a new blood cancer drug today. Called enasidenib (Idhifa), it’s the latest therapy sold by Celgene, the big cancer drugmaker from Summit, NJ. But the news is significant for other reasons. The drug is the first product to come from the labs of Agios Pharmaceuticals (NASDAQ: … Continue reading “With FDA Nod, Agios, Celgene Get Speedy OK For Blood Cancer Drug”
Homology Med Bags $83.5M More, Fueling Push For Gene Editing Twist
One day after the release of a Nature Medicine paper warning of the potential hazards of testing CRISPR-Cas9 gene editing in humans, Homology Medicines, a startup advancing a different genetic surgery technique, has just grabbed a big round of funding to make its own clinical push. Homology, of Bedford, MA, wrapped up an $83.5 million … Continue reading “Homology Med Bags $83.5M More, Fueling Push For Gene Editing Twist”
Bio Roundup: GOP Drama, Immunotherapy Setbacks, Pharma Revamps
Two failed cancer studies this week provided a fresh reminder how little researchers and clinicians understand about immunotherapy’s vagaries: why it works for some people and not for others. The results, in lung cancer and head-and neck cancer, add to recent failures in multiple myeloma and bladder cancer and splash cold water on a sector … Continue reading “Bio Roundup: GOP Drama, Immunotherapy Setbacks, Pharma Revamps”
Immunotherapy Shakeup: AstraZeneca Inks Merck Deal as Drug Combo Fails
Despite all the great progress made harnessing the immune system to fight cancer, there is still much work to be done to maximize its potential. The latest evidence: disappointing results today from a roughly 1,100-patient study called “Mystic,” a highly anticipated trial from AstraZeneca testing a combination of immunotherapies in newly diagnosed lung cancer patients. … Continue reading “Immunotherapy Shakeup: AstraZeneca Inks Merck Deal as Drug Combo Fails”
Tetraphase Claws Back From Failed Study, Eyes FDA Filing With New Data
New data have given new life to Tetraphase Pharmaceuticals (NASDAQ: [[ticker:TTPH]]), which now has a shot to bring an experimental antibiotic to market despite a failed trial in the past. The Watertown, MA, company reported positive results late Tuesday in a 500-patient Phase 3 study of its lead antibiotic, eravacycline, in patients with complicated intra-abdominal … Continue reading “Tetraphase Claws Back From Failed Study, Eyes FDA Filing With New Data”
Biogen, Opening Bottlenecks, Sees Spine Drug Sales, Shares Rise
Another quarter is in the books for Biogen’s nusinersen (Spinraza), the first ever approved drug for spinal muscular atrophy. And despite the drug’s high price and the logistical bottlenecks involved in rolling it out in treatment centers across the country, the Cambridge, MA, company is starting to gain traction. Biogen (NASDAQ: [[ticker:BIIB]]) reported $203 million … Continue reading “Biogen, Opening Bottlenecks, Sees Spine Drug Sales, Shares Rise”
Boston Is Arguably the Heart of Biotech. But Who Makes It So? Have Your Say.
By the end of this year, for the first time, patients with certain deadly types of blood cancer might have a new option, CAR-T cell therapy, to prolong their life. Immunotherapy could further entrench itself as a mainstay of cancer treatment. Newer drugmaking methods—RNA interference and gene therapy—could get their first ever FDA reviews. Multiple … Continue reading “Boston Is Arguably the Heart of Biotech. But Who Makes It So? Have Your Say.”
Bio Roundup: Trumpcare Is Mean, SCOTUS Says Go, Merck’s Myeloma No
What exactly does the American Health Care Act, the Republican proposal to replace Obamacare, currently look like? Few people know, because the Senate version is being negotiated behind closed doors in Washington D.C. without any public hearings. We do know President Trump now thinks the version of the AHCA that squeaked through the House is … Continue reading “Bio Roundup: Trumpcare Is Mean, SCOTUS Says Go, Merck’s Myeloma No”
Patient Network Group Says Majority of Members Want To Keep Obamacare
A U.S. patient networking group called PatientsLikeMe has dipped its toe in the waters of public opinion, asking its members what they think of the healthcare policy fight. There are many caveats, but the numbers trend in the same direction that other national polls have found—a shift towards more acceptance of the Affordable Care Act, … Continue reading “Patient Network Group Says Majority of Members Want To Keep Obamacare”
Flagship Adds Veteran J.P. Morgan Banker, Berenson, as Exec Partner
Cambridge, MA-based Flagship Pioneering has named Stephen Berenson, the former vice chairman of investment banking at J.P. Morgan, as an executive partner. Berenson serve on the boards of certain select Flagship startups, and help the firm’s companies grow their networks and raise cash.
Alexandria Debuts NY’s Latest Bio Incubator With 13 Startups in Tow
A new startup incubator has just opened in Manhattan this morning, adding to a growing list of facilities meant to help support seedling New York City biotechs. LaunchLabs, first announced by Alexandria Real Estate Equities a year ago, officially opened its doors and revealed the 13 startups that will grow there. LaunchLabs is a 15,000-square-foot … Continue reading “Alexandria Debuts NY’s Latest Bio Incubator With 13 Startups in Tow”
In a Myeloma Setback, Merck Halts Studies Due to Patient Deaths
[Corrected, 11:10 a.m. ET, see below] Immunotherapy drugs known as checkpoint inhibitors have started to change how a variety of cancers are treated, but they have yet to break through in multiple myeloma, a progressive cancer of the bone marrow. There was a setback on that front today. Merck (NYSE: [[ticker:MRK]]) Monday afternoon paused enrollment … Continue reading “In a Myeloma Setback, Merck Halts Studies Due to Patient Deaths”
Regulus Dumps Two Drugs, AstraZeneca Sends Back Another, Shares Fall
It’s been a tough run for Regulus Therapeutics, and things haven’t gotten any better this morning. Regulus is scrapping two programs, and AstraZeneca has kicked back a third drug to boot, sending Regulus shares down to their lowest levels ever. San Diego, CA-based Regulus (NASDAQ: [[ticker:RGLS]]) said this morning that it will stop development of … Continue reading “Regulus Dumps Two Drugs, AstraZeneca Sends Back Another, Shares Fall”
Dragonfly, Tyler Jacks’s Disney-Backed Startup, Gets $33M in Celgene Deal
Dragonfly Therapeutics, a stealthy startup formed by well-known cancer researchers on both coasts and backed by a high-powered group of family offices, has inked its first partnership. Celgene, of Summit, NJ, is paying Dragonfly $33 million up front for the chance to co-develop up to four blood cancer drugs. The deal is a modest bet … Continue reading “Dragonfly, Tyler Jacks’s Disney-Backed Startup, Gets $33M in Celgene Deal”
“It’s Shame On Us If We Blow It”: Highlights From NY Seizes the Momentum
Mike Foley, a drug industry veteran and director of the Tri-Institutional Therapeutics Discovery Institute, has a pointed message for the New York life sciences industry: Don’t waste the moment. Changing the course of New York biotech has been a saga that dates back to the 1990s, and as Xconomy has detailed, progress has been made … Continue reading ““It’s Shame On Us If We Blow It”: Highlights From NY Seizes the Momentum”
Ex-Inotek Exec to Lead Flex Pharma as Westphal Steps Down
Christoph Westphal has stepped down as the CEO of Flex Pharma (NASDAQ: [[ticker:FLKS]]). William McVicar, a former Inotek Pharmaceuticals executive and currently Flex’s president of R&D, will serve as Flex’s interim CEO. Westphal, who helped form the company, will remain chairman.
Precision Steps: Can Loxo Drug Help Broaden Use of Cancer DNA Tests?
When the FDA last week approved Merck’s cancer drug pembrolizuamb (Keytruda) for tumors with a specific genetic signature, regardless of what body part they originated in, it was a watershed moment for oncology and a victory for the concept of precision medicine. But Merck isn’t alone; others are following suit with similar plans, and their … Continue reading “Precision Steps: Can Loxo Drug Help Broaden Use of Cancer DNA Tests?”
Bio Roundup: ASCO Combo Frenzy, Maine’s Free DNA Tests, Sema4 & More
Over the next four days, the Second City will be the center of the biomedical world. The American Society of Clinical Oncology’s annual meeting in Chicago brings together thousands of researchers from across the globe to discuss the latest progress in the war against cancer. On tap this year: the crush of immunotherapy drug combinations, … Continue reading “Bio Roundup: ASCO Combo Frenzy, Maine’s Free DNA Tests, Sema4 & More”
Sema4, Eric Schadt’s Genomics Startup, Spins Out of Sinai to Raise Cash
[Updated, 9:30 p.m. ET, see below] Eric Schadt has been incubating a genomic data project within the Icahn School of Medicine at Mount Sinai for more than five years. Today, the product of that work, a 300-plus employee startup called Sema4, has formally left the nest. Sema4 today spun out of Mount Sinai as a … Continue reading “Sema4, Eric Schadt’s Genomics Startup, Spins Out of Sinai to Raise Cash”
Bitterman Jumps From Polaris to Atlas to Build More Bio Startups
Kevin Bitterman has left Polaris Partners, where he spent more than a decade helping build biotech companies, to become a partner at another Boston-area life sciences venture firm, Atlas Venture. Bitterman was the founding CEO of Editas Medicine (NASDAQ: [[ticker:EDIT]]), Visterra, and Morphic Therapeutic, helped co-found Genocea Biosciences (NASDAQ: [[ticker:GNCA]]), and is also the chairman … Continue reading “Bitterman Jumps From Polaris to Atlas to Build More Bio Startups”
As Big Cancer Trials Ramp Up, Grail Goes Global, Merges With Cirina
Grail, the Illumina (NASDAQ: [[ticker:ILMN]]) spinout aiming to develop a blood test that can detect cancer at its earliest stages, has gone global. The Menlo Park, CA, startup, is merging with China’s Cirina, a privately held company co-founded by a pioneer in the field of blood-based diagnostics, Dennis Lo. Grail, which recently raised a record … Continue reading “As Big Cancer Trials Ramp Up, Grail Goes Global, Merges With Cirina”
At the Alexandria Center Tomorrow: Can NY Biotech Seize the Moment?
A few weeks ago at the annual NewYorkBio conference, Xconomy asked a variety of folks about the state of New York biotechnology in 2017: is the momentum that has been gathering in life sciences in New York still building, or has it stalled? Their answers were mixed. Some expressed frustration with some of the same … Continue reading “At the Alexandria Center Tomorrow: Can NY Biotech Seize the Moment?”
On ASCO’s Eve, Experts Fret Over Backlash to Cancer Combo Frenzy
When thousands of cancer researchers from around the world gather in Chicago this weekend for the American Society of Clinical Oncology’s annual meeting, drugs that fight tumors by boosting a patient’s immune system will take center stage, as they have in previous years. But the stage is more crowded, as researchers have begun in earnest … Continue reading “On ASCO’s Eve, Experts Fret Over Backlash to Cancer Combo Frenzy”