David Setboun has been appointed executive vice president and chief operating officer of Brainstorm Cell Therapeutics (NASDAQ: [[ticker:BCLI]]). He is joining New York-based Brainstorm from Life Biosciences, where he was vice president of corporate development, strategy and business. Setboun’s experience also includes positions at Biogen (NASDAQ: [[ticker:BIIB]]), AstraZeneca (NYSE: [[ticker:AZN]]), and Eli Lilly (NYSE: [[ticker:LLY]]). … Continue reading “Brainstorm Cell Therapeutics Names Setboun Chief Operating Officer”
Category: New York
Celularity to Test Natural Killer Cell Therapy for Cancer Against COVID
Celularity, a New Jersey company developing experimental cancer treatments derived from human placentas, has received the FDA’s blessing to kick off human testing of its lead immunotherapy for cases of COVID-19 disease. The trial, designed to evaluate Celularity drug candidate CYNK-001, will enroll about 100 patients with COVID-19 infection causing pneumonia. Those enrolled will receive … Continue reading “Celularity to Test Natural Killer Cell Therapy for Cancer Against COVID”
Aspen Neuro Adds $70M to Test Parkinson’s Cell Therapy in the Clinic
Parkinson’s disease patients experience progressive breakdown of their neurons, cells essential to movement and mental function. Aspen Neuroscience, a biotech working to develop a therapy that would reprogram those patients’ own living cells in ways that would allow the cells to reconstruct their damaged neural networks, has raised $70 million in a Series A financing … Continue reading “Aspen Neuro Adds $70M to Test Parkinson’s Cell Therapy in the Clinic”
Axsome Plans to Try Again After Failure in Treatment-Resistant Depression
An experimental Axsome Therapeutics drug for treatment-resistant depression has fallen short of the main goal of a late-stage test. But the company says the pill is showing enough promise to warrant trying another Phase 3 study. Axsome (NASDAQ: [[ticker:AXSM]]) tested its drug, AXS-05, in patients with major depressive disorder who had previously failed to respond … Continue reading “Axsome Plans to Try Again After Failure in Treatment-Resistant Depression”
Bio Roundup: Clinical Trials Paused, New MS Drug, Kallyope’s Cash & More
Finding and enrolling patients for clinical trials is always challenging. The coronavirus pandemic has made it nearly impossible. Fallout from the spread of COVID-19 infections led several companies to declare this week that they would stop enrolling patients in clinical trials or postpone studies that have not yet started. Eli Lilly (NYSE: [[ticker:LLY]]) said that … Continue reading “Bio Roundup: Clinical Trials Paused, New MS Drug, Kallyope’s Cash & More”
FDA Approves Bristol Myers MS Drug, But Pandemic Will Delay Launch
A multiple sclerosis drug that came to Bristol Myers Squibb via its acquisition of Celgene last year was approved Thursday but don’t expect it to reach patients any time soon. The company says the drug’s launch will be delayed due to the coronavirus pandemic. The Bristol (NYSE: [[ticker:BMY]]) drug, ozanimod (Zeposia), is one of the … Continue reading “FDA Approves Bristol Myers MS Drug, But Pandemic Will Delay Launch”
Oncology Needs Combo Therapies & More Data Analysis, Says Bio-Europe Spring Panel
Future improvements in cancer care are most likely to stem from combinations therapies and data-driven prevention efforts, as well as breakthrough drugs. That’s the message life sciences experts shared this week during a webcast on the topic of “oncology’s next decade” recorded for the BIO-Europe Spring partnering conference. The event is produced by EBD Group, … Continue reading “Oncology Needs Combo Therapies & More Data Analysis, Says Bio-Europe Spring Panel”
Kallyope Gains $112M to Move “Gut-Brain Axis” Programs to the Clinic
Kallyope, one of New York’s best funded biotechs, has secured more than $100 million to move two of its programs into the clinic—including its most advanced, an experimental drug designed to treat obesity. The company was founded in 2015 with $44 million to leverage new learnings about the “gut-brain axis”—pings of communication between our guts … Continue reading “Kallyope Gains $112M to Move “Gut-Brain Axis” Programs to the Clinic”
Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing
Aimmune Therapeutics Inc. is navigating a host of new challenges as it launches Palforzia, the first peanut allergy immunotherapy to be approved by the US Food and Drug Administration. Most notably, it must get physician practices and individual allergists certified to administer the treatment. Aimmune (NASDAQ: AIMT) president and CEO Jayson Dallas talked to our sister … Continue reading “Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing”
Investors Shaken by Coronavirus Sow Seeds of M&A, Financing Slowdown
The coronavirus pandemic is narrowing the avenues open to biotechs for financing their endeavors, according to some industry veterans. “I think that fear of losing out has pretty much gone out the window right now,” said Equillium (NASDAQ: [[ticker:EQ]]) CEO Bruce Steel in a phone interview with Xconomy, speaking generally of investor appetite. “I think … Continue reading “Investors Shaken by Coronavirus Sow Seeds of M&A, Financing Slowdown”
FDA Rejects Boehringer Ingelheim, Eli Lilly Drug for Type 1 Diabetes
A type 2 diabetes drug marketed by Boehringer Ingelheim and Eli Lilly has fallen short of a bid to expand the medicine’s approval to patients who have type 1 diabetes. The FDA on Friday rejected the application for the drug, empagliflozin (Jardiance), for use in addition to insulin as a treatment for type 1 diabetes … Continue reading “FDA Rejects Boehringer Ingelheim, Eli Lilly Drug for Type 1 Diabetes”
Bio Roundup: Coronavirus Diagnostics, Therapeutics, Vaccines & More
The past week brought a sea change in many of our daily lives as the impact of the continued spread of the novel coronavirus altered how we work and play as communities around the world attempt to slow its spread. Xconomy, as always, is focused on the stories coming out of the life sciences community. … Continue reading “Bio Roundup: Coronavirus Diagnostics, Therapeutics, Vaccines & More”
As the Commercial Real Estate Market Slumps, Look for a More Tenant-Friendly Future
The following sponsored content was submitted by commercial real estate brokerage firm Hughes Marino: The story of the “canary in the coal mine” is an advanced warning of danger. The metaphor originates from when miners used to carry caged canaries while at work; if the air in the mine became toxic, the canary would die … Continue reading “As the Commercial Real Estate Market Slumps, Look for a More Tenant-Friendly Future”
Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More
The financial markets are tumbling, event cancellations are mounting, and sports leagues are suspending their seasons. March Madness is in full swing but not in any way that people wanted or expected. The World Health Organization this week declared that the COVID-19 outbreak was serious enough to classify as pandemic. The toll on public health … Continue reading “Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More”
Kymera Closes $102M Round to Bring Protein-Busting Drugs to the Clinic
Reuse and recycle is more than an environmental slogan. It’s also a succinct description of how cells deal with old or damaged proteins. Kymera Therapeutics is developing drugs that use this cyclical cellular process to treat disease, and it has raised $102 million to move into clinical testing next year. The Series C round of … Continue reading “Kymera Closes $102M Round to Bring Protein-Busting Drugs to the Clinic”
Genmab Taps Bristol Myers Veteran Mancini as Chief Operating Officer
Genmab (NASDAQ: [[ticker:GMAB]]) has appointed Anthony Mancini to serve as executive vice president and chief operating officer. Mancini is joining Copenhagen, Denmark-based Genmab from Bristol Myers Squibb (NYSE: [[ticker:BMY]]), where he is senior vice president and head of US innovative medicines. When he starts at Genmab on March 23, he will be based in New … Continue reading “Genmab Taps Bristol Myers Veteran Mancini as Chief Operating Officer”
Cushing’s Disease Drug That Novartis Sold to Recordati Nabs FDA Nod
A Cushing’s disease drug whose rights Novartis sold to Italy-based Recordati last year now has FDA approval. Cushing’s disease is a rare disorder in which the adrenal glands make too much of a hormone called cortisol. The Novartis (NYSE: [[ticker:NVS]]) drug, osilodrostat (Isturisa), is intended to block an enzyme key to cortisol production. The FDA … Continue reading “Cushing’s Disease Drug That Novartis Sold to Recordati Nabs FDA Nod”
Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street
Cell therapies and antibody drugs grab much of the attention and investment in cancer drug development but the scientists at Zentalis Pharmaceuticals contend that there’s a place for small molecules too. Now the biotech is preparing for an initial public stock offering to advance its pipeline, which includes a lead candidate in testing in combination … Continue reading “Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street”
Bio Roundup: Gilead’s $4.9B Deal, COVID-19 Collabs, IPO Plans & More
Last month, Gilead Sciences CEO Daniel O’Day announced plans to introduce 10 “transformative medicines” over the next 10 years. Acquisitions would help meet that ambitious goal, and this week Gilead announced one of them: a nearly $5 billion deal for cancer immunotherapy developer Forty Seven. Forty Seven’s lead CD47-blocking drug—the company is named after the … Continue reading “Bio Roundup: Gilead’s $4.9B Deal, COVID-19 Collabs, IPO Plans & More”
Melinta’s Chapter 11 Auction Draws No Bids, Deerfield to Get Assets
The assets of Melinta Therapeutics will go to creditor Deerfield Management after no bidders for the company emerged, the antibiotics developer announced Wednesday. Under a court-approved Chapter 11 bankruptcy plan, any bids for the company were due by March 2. An auction was scheduled for March 6 in the event any bids were submitted. But … Continue reading “Melinta’s Chapter 11 Auction Draws No Bids, Deerfield to Get Assets”
Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic
Cancer immunotherapy’s use can be limited by its side effects throughout the body. Xilio Therapeutics is developing technology that selectively activates a therapy’s potent cancer-killing activity specifically at the tumor and it has raised $100.5 million to advance two programs to clinical testing. The financing was led by Takeda Ventures. Along with the new cash, … Continue reading “Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic”
Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More
Clinical trials have historically hewn to a rigid format. A trial is designed, conducted according to that design, and then results are analyzed. Making changes in the midst of the study was a no-no. In recent years, regulators have showed openness to clinical trial designs intended to make drug testing more efficient. We’ll get to … Continue reading “Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More”
Passage Bio’s IPO Raises $216M to Fund Gene Therapy Studies
Gene therapy developer Passage Bio priced its initial public offering at $18 per share, raising $216 million—72 percent more than it originally planned to raise. Earlier this month Passage filed to offer 7.4 million shares, but later increased that to 10 million, then 12 million, shares that sold at the high end of its $16 … Continue reading “Passage Bio’s IPO Raises $216M to Fund Gene Therapy Studies”
Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK
[Updated 2/28/2020, 2:45 p.m. See below.] A Biohaven Pharmaceutical migraine drug has won FDA approval, clearing the way to the market for a new treatment option for the millions of people who suffer from the debilitating condition. The Biohaven (NYSE: [[ticker:BHVN]]) drug rimegepant (Nurtec) was developed for acute migraine in adults, treating a migraine attack … Continue reading “Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK”
Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected
As Esperion Therapeutics steered its cholesterol-lowering drug through clinical testing and regulatory review, CEO Tim Mayleben did something unusual for a pharmaceutical executive: he spoke openly about price. Specifically, he talked about how inexpensive the drug would be. As early as two years ago, Mayleben said an FDA-approved Esperion (NASDAQ: [[ticker:ESPR]]) drug would cost patients … Continue reading “Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected”
NGM Bio’s NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data
In what looks to be a transformative year for potential treatments of nonalcoholic steatohepatitis, the liver disease better known as NASH, another biotech has revealed that its experimental drug appears to improve the condition compared to a placebo. NGM Biopharmaceuticals (NASDAQ: [[ticker:NGM]]) revealed preliminary data on Monday showing that 22 percent of patients who received … Continue reading “NGM Bio’s NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data”
Lundbeck’s Alder Bio Bet Pays Off With FDA Approval of Migraine Drug
A migraine drug that Lundbeck added to its pipeline via its nearly $2 billion acquisition of Alder BioPharmaceuticals won FDA approval on Friday. The drug, eptinezumab (Vyepti), is part of a new class of antibody therapies developed to prevent migraine attacks before they start. These drugs block calcitonin gene-related peptide (CGRP), a protein associated with … Continue reading “Lundbeck’s Alder Bio Bet Pays Off With FDA Approval of Migraine Drug”
Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More
The price of insulin, a life-saving treatment discovered a century ago, has been a flashpoint amid the broader drug pricing debate. The FDA is trying to tame high insulin prices by encouraging price competition. The FDA has historically regarded insulin as a drug. But insulin isn’t a chemical drug, it’s made from biological material. Under … Continue reading “Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More”
Five Prime, Bristol Pancreatic Cancer Drug Combo Fails Phase 2 Test
A year ago Five Prime Therapeutics cut a fifth of its workforce to save money as its worked to advance its clinical-stage drugs for solid tumor cancers. On Tuesday the company (NASDAQ: [[ticker:FPRX]]) said one of those drugs, cabiralizumab, a Five Prime antibody that Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) was testing in combination with its cancer immunotherapy … Continue reading “Five Prime, Bristol Pancreatic Cancer Drug Combo Fails Phase 2 Test”
Agile Therapeutics Wins FDA Nod for Twirla Contraceptive Patch
A contraceptive patch developed by Agile Therapeutics was awarded FDA approval late Friday, clearing the way for a new birth control option to reach the market. The Agile (NASDAQ: [[ticker:AGRX]]) product, called Twirla, deliver delivers a combination of hormones via a proprietary skin patch applied once a week. It’s the first FDA approved product for the … Continue reading “Agile Therapeutics Wins FDA Nod for Twirla Contraceptive Patch”
Immmunomedics Taps MedCo Veteran Loretta Itri as Chief Medical Officer
Immunomedics (NASDAQ: [[ticker:IMMU]]) has appointed Loretta Itri to serve as chief medical officer. Itri was most recently executive vice president of global health sciences & regulatory affairs at The Medicines Company. Her experience also includes roles at Genta, Johnson & Johnson (NYSE: [[ticker:JNJ]]), Ortho Biotech, and Roche. Morris Plains, NJ-based Immunomedics is awaiting an FDA … Continue reading “Immmunomedics Taps MedCo Veteran Loretta Itri as Chief Medical Officer”
Bio Roundup: Goodbye Belviq, LogicBio on Hold, Revolution’s IPO & More
Drugs typically go through three phases of clinical testing to support an application for FDA approval. It’s easy to overlook Phase 4, which takes place after a drug reaches the market. Post-marketing studies aim to identify side effects not observed in the first three phases of testing. They also evaluate how a therapy works over … Continue reading “Bio Roundup: Goodbye Belviq, LogicBio on Hold, Revolution’s IPO & More”
Eisai Pulls Weight Loss Drug From Market After FDA Flags Cancer Risks
Eisai is withdrawing weight-loss drug lorcaserin after a post-marketing study found a higher incidence of cancer in patients who took the medicine. The FDA said Thursday that its request for removal of the product from the market is voluntary, but Eisai has already started the process for doing so. The withdrawal follows an FDA alert … Continue reading “Eisai Pulls Weight Loss Drug From Market After FDA Flags Cancer Risks”
Two Big Pharma Alliances End in Nixed Deals. Here’s What Happened.
Pfizer and Merck are each cutting ties with a smaller clinical-stage biotech after experimental drugs being developed under separate alliances fell short in human testing. Pfizer (NYSE: [[ticker:PFE]]) is walking away from a partnership with GlycoMimetics (NASDAQ: [[ticker:GLYC]]) a Rockville, MD-based company developing drugs for diseases where carbohydrates play a role. In 2011, Pfizer paid … Continue reading “Two Big Pharma Alliances End in Nixed Deals. Here’s What Happened.”
Biohaven Drug Fails Anxiety Study, Data in OCD and More Still to Come
An experimental Biohaven Pharmaceutial therapy intended to treat anxiety has failed in a late-stage study, the first of four shots that the company is taking with the drug to try to address neurological disorders. The results released Monday for Biohaven (NASDAQ: [[ticker:BHVN]]) drug troriluzole were for generalized anxiety disorder, a persistent feeling of worry or … Continue reading “Biohaven Drug Fails Anxiety Study, Data in OCD and More Still to Come”
Eli Lilly, Roche Drugs Fail to Move Needle in Genetically Driven Alzheimer’s
Two experimental drugs from Eli Lilly and Roche have failed a clinical trial testing them as treatments for a form of Alzheimer’s disease caused by certain genetic mutations, the companies reported Monday. The study, sponsored by Washington University, tested the drugs in patients who have an early onset, inherited form of Alzheimer’s called autosomal dominant. … Continue reading “Eli Lilly, Roche Drugs Fail to Move Needle in Genetically Driven Alzheimer’s”
Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More
The president’s State of the Union address was wide-ranging, as they tend to be, but those who tuned in heard mention of two hot health policy topics: price transparency and drug pricing reform. President Trump asserted that an executive order he signed last year directing various federal agencies to come up with new rules requiring … Continue reading “Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More”
Ichnos Sciences Appoints Gabriela Gruia as Chief Development Officer
Ichnos Sciences named Gabriela Gruia as its chief development officer. Gruia was most recently senior vice president and head of regulatory affairs for the Novartis (NYSE: [[ticker:NVS]]) oncology business. Her experience includes previous roles at Pharmacia and Pfizer (NYSE: [[ticker:PFE]]). The Paramus, NJ, company is a spinout of Indian company Glenmark Pharmaceuticals that debuted in … Continue reading “Ichnos Sciences Appoints Gabriela Gruia as Chief Development Officer”
Xcelerating Life Sciences New York
Stay at the forefront of New York’s burgeoning life science ecosystem that is fueling today’s biotech investment and & partnership opportunities New York has been laying the groundwork to welcome a state-of-the-art biopharma community with the space, financial backing, and intellectual capital for building companies. Medical centers, academic institutions, and government support are all being … Continue reading “Xcelerating Life Sciences New York”
Xcelerating Life Sciences Philadelphia (interactive online event)
Engage with Philadelphia’s growing cell and gene therapy ecosystem, explore promising investment and partnership opportunities, and align the latest trends and technologies with your business Philadelphia is committed to becoming the next center for biotech innovation. The area already offers a strong biopharma foundation, world-class medical centers, academic institutions, entrepreneurial and partnership opportunities, and room … Continue reading “Xcelerating Life Sciences Philadelphia (interactive online event)”
Merck Charts an R&D-Focused Course Starting With a $6.5B Spinoff
Merck is corralling products representing $6.5 billion in sales and spinning them off into a separate company, a strategic bet that focusing the remaining business on developing innovative new medicines will drive future growth. The new company will take Merck’s women’s health business, older medicines that have lost patent protection, and biosimilars—drugs that are close … Continue reading “Merck Charts an R&D-Focused Course Starting With a $6.5B Spinoff”
Bristol-Myers, BioMotiv Pact Leads to a New Fibrosis-Focused Startup
Bristol-Myers Squibb is still digesting the commercialized and clinical-stage assets that came with its $74 billion acquisition of Celgene, but the pharmaceutical giant has also been making moves to feed its pipeline with compounds at earlier points of development. An alliance that Bristol struck up with pharmaceutical accelerator BioMotiv last year now has its first … Continue reading “Bristol-Myers, BioMotiv Pact Leads to a New Fibrosis-Focused Startup”
Passage Bio Plans IPO as Three Gene Therapies Approach the Clinic
A year ago Passage Bio launched with $115.5 million and plans to advance a handful of gene therapies discovered at the University of Pennsylvania. Now the Philadelphia-based biotech is preparing to join the public markets and raise millions more to move its three lead programs into the clinic. Want more cell and gene therapy content? … Continue reading “Passage Bio Plans IPO as Three Gene Therapies Approach the Clinic”
Insmed Drug for Rare Pulmonary Disorder Meets Phase 2 Goals
Rare disease drug developer Insmed on Monday revealed data from a mid-stage trial of its daily pill for adults with non-cystic fibrosis bronchiectasis, a severe chronic pulmonary disorder with no FDA-approved therapies. Patients with chronic inflammatory lung diseases end up with an overabundance of white blood cells called neutrophils in their airways. The Insmed drug, … Continue reading “Insmed Drug for Rare Pulmonary Disorder Meets Phase 2 Goals”
Discovery Labs Converts ex-GSK King of Prussia Site into R&D “Colony”
The MLP Ventures-funded Discovery Labs says it is “bending the rules” in its efforts to stimulate R&D at the former GlaxoSmithKline site through a limited governance financial model. In April 2018, GlaxoSmithKline (NYSE: [[ticker:GSK]]) sold its R&D campus in King of Prussia, PA, to private Philadelphia-based life science and real estate investment company MLP Ventures … Continue reading “Discovery Labs Converts ex-GSK King of Prussia Site into R&D “Colony””
Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy
An Aimmune Therapeutics drug developed to treat peanut allergy won FDA approval late Friday—the first time the agency has approved an oral immunotherapy for a food allergy. The Aimmune (NASDAQ: [[ticker:AIMT]]) drug, Palforzia, was developed to desensitize patients to peanuts. The FDA decision covers patients between the ages of 4 and 17 who have a … Continue reading “Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy”
Bio Roundup: Mammoth Moves, Black Diamond’s Pop, Ohana’s Debut & More
If this week is any indication, the steady march of life science companies to Wall Street will continue in 2020. Black Diamond Therapeutics is leading the way, having raised $201 million from its IPO. In its first day of trading, the cancer drug developer watched its shares soar more than 108 percent. Black Diamond’s stock … Continue reading “Bio Roundup: Mammoth Moves, Black Diamond’s Pop, Ohana’s Debut & More”
BIO Report: More Work Needed to Improve Diversity at Biotech Firms
Some companies that belong to the Biotechnology Industry Organization (BIO), a large industry trade group, convene diverse hiring committees, seek out representation among their suppliers and vendors, and are led by executives that talk regularly about the importance of an inclusive workforce. Others have no women or people of color as employees, gather no data … Continue reading “BIO Report: More Work Needed to Improve Diversity at Biotech Firms”
Annovis Bio Gets $12M in IPO to Target Trio of Neurotoxic Proteins
A Philadelphia-area biotech is developing therapies for neurodegenerative diseases it says have the potential to perform better than others by targeting multiple proteins involved in the brain’s breakdown. Now the company, Berwyn, PA-based Annovis Bio, has raised $12 million in an initial public offering to advance clinical development of its lead therapy in patients with … Continue reading “Annovis Bio Gets $12M in IPO to Target Trio of Neurotoxic Proteins”
Decibel Therapeutics Strikes a Balance, Adding Regenerative Med Focus
Decibel Therapeutics emerged four years ago aiming to build a pipeline of medicines for various forms of hearing loss. One of those drugs is in the clinic. Others were shelved. And some of the company’s resources are now focusing on regenerative therapies addressing the inner ear. The recent pipeline changes are accompanied by a corporate … Continue reading “Decibel Therapeutics Strikes a Balance, Adding Regenerative Med Focus”