Sage Therapeutics is cutting workers who sell its only commercialized drug in a corporate reorganization that it says allows it to focus on clinical-stage compounds, including a depression treatment that failed a pivotal test late last year. The corporate shakeup will eliminate the jobs of 340 employees, or about 53 percent of its staff, Sage … Continue reading “Sage Restructuring Halves Staff, Turns Focus to Failed Depression Drug”
Category: National
Creating Consistent Value in Biotech Without Diluting Stakeholders
One of the greatest challenges for pre-commercial biotech companies is consistently generating capital necessary for operating costs and for R&D of new products that provide value to stakeholders, both for investors and patients. At OSE Immunotherapeutics we implemented a business model that allows us to be one of the rare French biotech companies without commercial … Continue reading “Creating Consistent Value in Biotech Without Diluting Stakeholders”
Interactive, Online Xcelerating Life Sciences Boston Event Set for May 13
In the Boston biotech hub, much progress has been made advancing digital health, but significant scientific, technological, financial, and regulatory challenges remain. Join us May 13, 2020 for our Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health interactive online event to learn the latest trends, and network with leading entrepreneurs, scientists, and investors. Agenda includes expert … Continue reading “Interactive, Online Xcelerating Life Sciences Boston Event Set for May 13”
Millendo May Restructure After Prader-Willi Drug Fails Pivotal Test
Millendo Therapeutics is considering a corporate reorganization after its lead drug, an investigational treatment for a rare genetic condition characterized by unrelenting hunger, did not perform better than a placebo in a pivotal trial. The Ann Arbor, MI-based company said Monday that the drug, livoletide, did not meet the goal of the Phase 2b study … Continue reading “Millendo May Restructure After Prader-Willi Drug Fails Pivotal Test”
Menlo’s Itching Drug Racks Up Two More Trial Failures, Program Ends
An itching drug that was a key part of the merger of Menlo Therapeutics and Foamix Pharmaceuticals has failed two late-stage studies, leading to a halt on further development of the compound. The Menlo (NASDAQ: [[ticker:MNLO]]) drug, serlopitant, was being tested in two Phase 3 clinical trials as a treatment for the itching associated with … Continue reading “Menlo’s Itching Drug Racks Up Two More Trial Failures, Program Ends”
GSK, Vir Team Up in COVID-19 Pact Aiming to Reach the Clinic in Months
GlaxoSmithKline has agreed to invest $250 million in infectious disease specialist Vir Biotechnology to launch a COVID-19 R&D alliance that the companies say could advance two experimental therapies to clinical testing this summer. The partnership will leverage antibody technology from Vir (NASDAQ: [[ticker:VIR]]) and genomics expertise from GSK (NYSE: [[ticker:GSK]]). The companies will work together … Continue reading “GSK, Vir Team Up in COVID-19 Pact Aiming to Reach the Clinic in Months”
Xconomy Releases Coronavirus Special Report on Containing the Pandemic Through Innovation & Investment
Based on the latest news and analysis, as well as conversations from industry experts during the Combatting Coronavirus live panel at BIO-Europe Spring®, Xconomy’s free special report delivers the latest COVID-19 news from the frontlines as top biotech and investment players offer their best plans and current progress in stemming and ultimately defeating the current … Continue reading “Xconomy Releases Coronavirus Special Report on Containing the Pandemic Through Innovation & Investment”
Dynacure Adds $55M As RNA-Targeted Muscle Disorder Drug Enters Clinic
Last month French biotech Dynacure dosed the first patient in an early-stage trial of its lead drug candidate, a treatment for a group of rare genetic muscle disorders. Now the company, which also has an office in Philadelphia, has landed a €50 million ($55 million) Series C financing round to move that investigational antisense medicine, … Continue reading “Dynacure Adds $55M As RNA-Targeted Muscle Disorder Drug Enters Clinic”
Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies
Fate Therapeutics has signed an agreement with Janssen Biotech to develop new cancer cell therapies that are derived from stem cells and landed $100 million up front as part of the global collaboration deal. The San Diego-based biotech has built a pipeline of experimental cell therapies that use induced pluripotent stem cells (iPSCs) to create … Continue reading “Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies”
Zentalis Upsizes IPO, Raising $165M for Cancer Drug Clinical Trials
The global economic crash means the window for initial public stock offerings is all but closed but that didn’t stop Zentalis Phamaceuticals from pushing through. The clinical-stage drug developer priced its IPO late Thursday, raising $165.2 million in its stock market debut. Zentalis was able to sell more shares than it expected, and at a … Continue reading “Zentalis Upsizes IPO, Raising $165M for Cancer Drug Clinical Trials”
Bio Roundup: Biotech Billions, COVID-19 R&D, Zolgensma’s Path & More
The coronavirus pandemic has shaken the global economy, but three life sciences venture capital firms this week announced new funds totaling nearly $3 billion. ARCH Venture Partners led the pack, adding two funds totaling $1.46 billion to its war chest. Flagship Pioneering bagged $1.1 billion, and venBio Partners reeled in $394 million. Flagship CEO Noubar … Continue reading “Bio Roundup: Biotech Billions, COVID-19 R&D, Zolgensma’s Path & More”
VenBio Partners Bags $394M to Back More Medicine-Making Biotechs
Investors worried about a recession like venBio Partners’ risk-mitigated approach to venture capital investing. That approach has led new limited partners to join earlier backers in putting nearly $400 million into the San Francisco-based firm’s new fund. VenBio announced Friday it closed its third fund, raising $394 million which it plans to invest using the … Continue reading “VenBio Partners Bags $394M to Back More Medicine-Making Biotechs”
Flagship Adds $1.1B for New Meds, More AI, & “Health Security”
Flagship Pioneering founder and CEO Noubar Afeyan didn’t know a global pandemic was in the cards for 2020 when he and his team laid out three new thematic areas of focus for the company last fall. One proved eerily prescient: The notion of “health security,” or the development of new products and therapies to treat … Continue reading “Flagship Adds $1.1B for New Meds, More AI, & “Health Security””
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”
Iteos Therapeutics Adds $125M to Advance Next-Gen Immunotherapies
Immunotherapies called checkpoint inhibitors have helped change the way a number of cancers are treated by blocking a tumor cell’s ability to hide from the immune system. Some patients don’t respond, however, or develop resistance to these drugs. Iteos Therapeutics has raised $125 million to advance new cancer treatments it is developing to target two … Continue reading “Iteos Therapeutics Adds $125M to Advance Next-Gen Immunotherapies”
Vir Advances Antibodies Against COVID-19, CEO Leads BIO’s Coronavirus Outreach
Scrip talked to George Scangos about his dual roles in the pandemic response, helming Vir as the company tests antibody and siRNA approaches while working with BIO to facilitate coronavirus collaborations. George Scangos made a surprising shift when the former Biogen CEO left the world of big biotech to lead an infectious disease-focused start-up. Vir … Continue reading “Vir Advances Antibodies Against COVID-19, CEO Leads BIO’s Coronavirus Outreach”
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”
Pandion Pulls In $80M as Ulcerative Colitis Drug Advances in Clinic
Pandion Therapeutics emerged in 2018 aiming to reach clinic trials in two years testing its biologic drugs in autoimmune and inflammatory disorders. The company now has $80 million to support a lead program in early-stage testing and a pipeline of potential treatments. Access Biotechnology and Boxer Capital led the Series B round of funding announced … Continue reading “Pandion Pulls In $80M as Ulcerative Colitis Drug Advances in Clinic”
Aptinyx Moves Ahead With PTSD Therapy Study, Pauses 3 Other Trials
Neurological drug developer Aptinyx has stopped enrollment in three of the four mid-stage trials it is conducting due to impacts from the coronavirus pandemic. The Evanston, IL-based company disclosed the decision Monday in its report of fourth quarter and full year 2019 financial results. Aptinyx (NASDAQ: [[ticker:APTX]]), which is advancing three clinical-stage drug candidates that … Continue reading “Aptinyx Moves Ahead With PTSD Therapy Study, Pauses 3 Other Trials”
A Baby’s Milestones and the Next Steps for Novartis in Gene Therapy
[Updated 4/10/2020, 3:24 p.m. See below.] Cameron Hewitt’s family celebrates the anniversary of her life not once, but twice yearly: Besides her September birthday, they commemorate a day in March—the anniversary of two-year-old Cameron receiving the gene therapy that gave her a new shot at life. Cameron was born with spinal muscular atrophy (SMA), a … Continue reading “A Baby’s Milestones and the Next Steps for Novartis in Gene Therapy”
Tapping Into the Innovation Grid: J&J, Data, and a Shifting Healthcare Focus
Johnson & Johnson’s global head of external innovation says there needs to be a shift in how healthcare research is funded to focus on early detection and curing rather than managing diseases. “When you look at the investment in research in the pharma industry, it’s all designed to treat established diseases,” William Hait, global head … Continue reading “Tapping Into the Innovation Grid: J&J, Data, and a Shifting Healthcare Focus”
Biohaven’s Acute Migraine Drug Bests Placebo in Prevention Study
Biohaven Pharmaceutical’s FDA-approved pill to treat migraine attacks is showing that it can prevent such headaches too. According to preliminary results from a late-stage trial released Monday, the Biohaven drug beat a placebo at reducing the average number of days per month patients with chronic and episodic migraine experienced the debilitating condition. The FDA OK’d … Continue reading “Biohaven’s Acute Migraine Drug Bests Placebo in Prevention Study”
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”
San Diego Biotech Entrepreneurs, Innovation Lead to “Maturing” Ecosystem
The local biotech ecosystem is growing up thanks to its innovative science and collaborative ecosystem, advantages that put it nearly on par with the nation’s top life science regions, according to industry veterans. San Diego has long been considered a second-tier primary biopharma hub in terms of number of companies and venture capital raised, falling … Continue reading “San Diego Biotech Entrepreneurs, Innovation Lead to “Maturing” Ecosystem”
Sanofi Adds mRNA COVID-19 Vaccine Bet Through Translate Bio Alliance
Sanofi is joining the array of companies pursuing a COVID-19 vaccine based on messenger RNA (mRNA), an experimental genetic technology intended to coax the body’s cells into producing proteins that treat a disease or spark immunity to one. Sanofi (NYSE: [[ticker:SNY]]) announced Friday that it will develop COVID-19 vaccine candidates with Translate Bio (NASDAQ: [[ticker:TBIO]]), … Continue reading “Sanofi Adds mRNA COVID-19 Vaccine Bet Through Translate Bio Alliance”
Equillium Continues Graft-Versus-Host Disease Trial, Pauses 2 Others
Equillium has halted two clinical trials of its lead drug candidate out of an “abundance of caution” related to the coronavirus outbreak but continues to enroll in a third, which is evaluating the antibody as a treatment for acute graft-versus-host disease. The decision made by the San Diego biotech, revealed in its annual report filed … Continue reading “Equillium Continues Graft-Versus-Host Disease Trial, Pauses 2 Others”
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”
Forge Inks Roche Deal For Antibiotic Aimed at Drug-Resistant Infections
Forge Therapeutics has reached a deal with Roche to support development of an antibiotic for drug-resistant bacterial lung infections. The partnership announced this week gives the Swiss pharmaceutical giant the option to license the antibiotic from San Diego-based Forge. The preclinical biotech will retain control of the program, FG-LpxC LUNG, until Roche decides whether to … Continue reading “Forge Inks Roche Deal For Antibiotic Aimed at Drug-Resistant Infections”
With $80M, ReCode Looks to Advance RNA Therapies for Lung Diseases
Two companies working on treatments for rare genetic lung diseases have combined efforts and raised $80 million to bring into human testing next year two investigational treatments that use types of RNA to tweak mutated proteins. Dallas company ReCode Therapeutics and Menlo Park, CA-based TranscripTx have merged under the ReCode name and leadership of CEO … Continue reading “With $80M, ReCode Looks to Advance RNA Therapies for Lung Diseases”
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”
Regenacy Pharma Raises $30M for Nerve Function Restoring Treatments
Regenacy Pharmaceuticals, a biotech formed as part of Celgene’s acquisition of Acetylon Pharmaceuticals in late 2016, has raised $30 million in Series A financing to move its lead program into a Phase 2 proof-of-concept trial this year. The Waltham, MA-based company is developing treatments to address the underlying cause of peripheral neuropathies—a form of nerve … Continue reading “Regenacy Pharma Raises $30M for Nerve Function Restoring Treatments”
AstraZeneca Joins RNAi Mix, Pledging $80M to Silence Therapeutics
After years of research, technology for silencing a gene—stopping it from producing a disease-causing protein—has reached patients. AstraZeneca is now angling for a position in this burgeoning field through an alliance with Silence Therapeutics, a biotech developing such gene-silencing drugs. According to deal terms announced Wednesday, AstraZeneca (NYSE: [[ticker:AZN]]) will pay London-based Silence (LON: [[ticker:SLN]]) … Continue reading “AstraZeneca Joins RNAi Mix, Pledging $80M to Silence Therapeutics”
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”
CytomX Lands $80M to Kick Off Cancer Drug R&D Pact With Astellas
CytomX Therapeutics is teaming up with Astellas Pharma in a research and development alliance focused on developing new cancer immunotherapies based on its antibody technology. Under deal terms announced late Monday, Astellas is paying CytomX (NASDAQ: [[ticker:CTMX]]) $80 million up front. South San Francisco-based CytomX will conduct and finance the research up to the selection … Continue reading “CytomX Lands $80M to Kick Off Cancer Drug R&D Pact With Astellas”
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”
Keros Outlines IPO Plans Amid Markets Rocked by Coronavirus Pandemic
Keros Therapeutics, a biotech which raised more than $50 million this month in venture capital, is now looking to tap the public markets for additional cash amid a time of historic tumult. The Lexington, MA-based company, is a clinical-stage biotech that aims to develop new treatments for patients with blood and musculoskeletal disorders by developing … Continue reading “Keros Outlines IPO Plans Amid Markets Rocked by Coronavirus Pandemic”
UCSD, 5 Diagnostic Makers Partner to Ramp COVID-19 Testing Capacity
A group of scientists and physicians at UC San Diego Health and the UCSD School of Medicine has arranged a partnership with five diagnostics markers that it says will bring the health system’s capacity to test for coronavirus to as many as 1,500 tests daily sometime in early April. Amid a lack of available tests … Continue reading “UCSD, 5 Diagnostic Makers Partner to Ramp COVID-19 Testing Capacity”
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”
Eureka Partners With Lyell to Tackle Tricky Solid Tumor Cell Therapies
Eureka Therapeutics, which has been developing methods to facilitate the development of cell therapies that can treat solid cancers, has raised $45 million to prove out its technologies in the clinic. To enhance its chances of success, the Emeryville, CA-based company has struck an agreement to work with Lyell Immunopharma, another San Francisco Bay Area … Continue reading “Eureka Partners With Lyell to Tackle Tricky Solid Tumor Cell Therapies”
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”
How San Diego Biotech Leaders Are Adapting to Coronavirus Concerns
Three hundred Takeda employees from the Japanese pharma giant’s California research center have been working from home for 10 days straight. Neurocrine Biosciences, one of the few commercial-stage biotechs in town, is working to ensure the animals housed in its vivarium are appropriately minded. Ciara Kennedy, CEO of clinical-stage antifungal therapy developer Amplyx, is facing … Continue reading “How San Diego Biotech Leaders Are Adapting to Coronavirus Concerns”
Fears Of Recession Mount As Coronavirus Declared A Pandemic
Investor sentiment still backing growth for pharma and biotech sectors, but the length and severity of COVID-19’s impact globally has yet to be seen. Confirmation that the coronavirus has reached pandemic status on 11 March has darkened the mood worldwide, raising fears about the rapid spread of the disease outside China, and increasing chances of … Continue reading “Fears Of Recession Mount As Coronavirus Declared A Pandemic”
AbCellera’s Coronavirus “Neutralizing” Antibody Leads Enter Screening
Vancouver-based biotech AbCellera Biologics has identified more than 500 antibodies that could potentially be turned into medicines to treat the SARS-CoV-2 novel coronavirus. Now scientists at the National Institutes of Health (NIH), with which the company has been working to prepare medical countermeasures for pandemic outbreaks, are testing the candidates to determine which are most … Continue reading “AbCellera’s Coronavirus “Neutralizing” Antibody Leads Enter Screening”
Qiagen Juices RNA Extraction Kit Capacity to Feed Coronavirus Test Needs
Dutch molecular diagnostics company Qiagen said Tuesday it would “dramatically” ramp up production of the components needed for the RNA extraction kits used to detect the novel coronavirus in a patient sample. Isolating genetic material from a biological sample is a key step in the testing process, which has not been widespread in the US … Continue reading “Qiagen Juices RNA Extraction Kit Capacity to Feed Coronavirus Test Needs”
The Benefits and Impact of Later In-Licensing Deals for Biopharma
Biopharma firms are in-licensing candidates later according to an industry expert, who says the trend is impacting the contract development and manufacturing sector. In-licensing—the practice of paying for rights to develop and commercialize a product discovered by another company—is a widely used strategy in the biopharmaceutical industry. According to a recent report in Nature, the … Continue reading “The Benefits and Impact of Later In-Licensing Deals for Biopharma”
Novo Nordisk Pauses 3 Clinical Trials Testing Hemophilia Therapy
On Monday Danish company Novo Nordisk announced it would stop treating patients enrolled in clinical trials evaluating an investigational hemophilia drug it developed after three of those receiving the drug reported “thrombotic events.” Hemophilia, an inherited blood disorder, is characterized by low levels of proteins called clotting factors, which help patients’ blood to clot appropriately. … Continue reading “Novo Nordisk Pauses 3 Clinical Trials Testing Hemophilia Therapy”
UC San Diego Health Develops COVID-19 Test, Begins Testing Patients
The UC San Diego Health System has developed a diagnostic test that can determine whether a patient has contracted the novel coronavirus in about eight hours. Developed under guidance that the FDA published roughly two weeks ago amid the severe shortage of tests for the viral illness, COVID-19, UCSD Health developed and validated an in-house … Continue reading “UC San Diego Health Develops COVID-19 Test, Begins Testing Patients”