COVID-19’s spread has clamped down on a lot of economic activity, including the work of developing and testing new medicines. But the FDA isn’t showing signs of slowing down, at least when it comes to drugs filed for accelerated approval. The regulator signed off on three such drugs in the past week. These approvals are … Continue reading “Bio Roundup: Fast FDA Approvals, Biogen Delays, ORIC’s IPO & More”
Category: San Diego
Synthorx’s Shawver Joins Silverback Therapeutics as New Top Exec
Veteran biotech executive Laura Shawver is taking over as CEO at Silverback Therapeutics, joining the cancer drug developer as it is poised to move its first compound into the clinic. The Wednesday announcement comes three months after French firm Sanofi (NYSE: [[ticker:SNY]]) closed its $2.5 billion acquisition of La Jolla, CA-based Synthorx, the biotech Shawver … Continue reading “Synthorx’s Shawver Joins Silverback Therapeutics as New Top Exec”
Why 2020 Is Pivotal for Microbiome Drug R&D (Or Maybe 2021, Given COVID-19)
The start of a potentially big biomedical breakthrough is blooming within all of us. Drug research aiming to turn bacteria into microbiome therapies now spans programs aiming to address gut disorders, autism, cancer, and more. Given the number of late-stage and mid-stage studies expected to report data in 2020—assuming they stay on track amid the … Continue reading “Why 2020 Is Pivotal for Microbiome Drug R&D (Or Maybe 2021, Given COVID-19)”
New COVID-19 Special Reports Explore Clinical Research During the Pandemic
Two new special reports on Xconomy Insight provide an expert view on how companies can sustain clinical trials during the COVID-19 crisis. “Decentralized Clinical Trials: The Call for a New Paradigm” and “Sustaining Clinical Research During the Crisis” offer the latest trends and technologies companies can use to keep business running as smooth as possible. … Continue reading “New COVID-19 Special Reports Explore Clinical Research During the Pandemic”
COVID-19 Vax Efforts Aim to Balance Speed, Efficacy in Race to Market
If Peter Marks had a magic wand to perfect the sophisticated process that takes a new vaccine from idea to reality, the US could have a way to prevent some people from COVID-19 infection in nine months to one year. In the real world, the journey to a vaccine OK’d under emergency guidelines is more … Continue reading “COVID-19 Vax Efforts Aim to Balance Speed, Efficacy in Race to Market”
Bio Roundup: Alnylam’s Billions, COVID-19 Vaccines, Moma Debuts & More
The public markets are moving erratically, but Alnylam Pharmaceuticals showed this week that selling equity isn’t the only way for biotech companies to raise cash. Late last year Alnylam (NASDAQ: [[ticker:ALNY]]) began exploring potential royalty deals for inclisiran, a drug that uses RNA interference to lower cholesterol. Alnylam had sold the drug’s development and commercialization … Continue reading “Bio Roundup: Alnylam’s Billions, COVID-19 Vaccines, Moma Debuts & More”
With Harvard Tech and $5M, PIC Therapeutics Takes Aim at Cancer
Some of the targets in cancer research are visible and well known, but they’re hard to hit with new drugs all the same. PIC Therapeutics is developing medicines aiming for one particularly elusive group of proteins, and the startup’s early research has attracted financial support from some prominent names in the life sciences industry. PIC … Continue reading “With Harvard Tech and $5M, PIC Therapeutics Takes Aim at Cancer”
GSK and Sanofi Team Up on COVID-19 Vaccine, Aim for Clinic This Year
[Updated, 3:13 p.m. See below.] Pharmaceutical giants GlaxoSmithKline and Sanofi are teaming up on COVID-19 research, aiming to combine their respective technologies in a new vaccine that could start clinical trials in coming months. The full details of the agreement, which was announced Tuesday, are still being finalized. But the companies say the vaccine would … Continue reading “GSK and Sanofi Team Up on COVID-19 Vaccine, Aim for Clinic This Year”
Arcturus Poised to Move Liver Drug, COVID-19 Vaccine Into Clinic
Messenger RNA drug developer Arcturus Therapeutics is ready to kick off its first-ever human trials this year, beginning clinical evaluation of its lead drug candidate and testing a vaccine designed to target the novel coronavirus. The San Diego biotech on Monday announced it had received the FDA’s OK to enter into the clinic with ARCT-810, … Continue reading “Arcturus Poised to Move Liver Drug, COVID-19 Vaccine Into Clinic”
Biotech Roundup: GSK’s Ante, Shakeup at Sage, Telehealth’s Rise & More
The COVID-19 pandemic has stopped enrollment in many clinical trials and postponed the start of others but there is still life in the life sciences sector. The coronavirus research is expected. It’s the other activity that might come as a surprise. Two biotech companies have gone public in the past week; each upsized its offering and … Continue reading “Biotech Roundup: GSK’s Ante, Shakeup at Sage, Telehealth’s Rise & More”
Pfizer, BioNTech Say mRNA COVID-19 Vaccine Trials May Start This Month
Multiple COVID-19 vaccine candidates that use a new technology called messenger RNA are now being readied for clinical trials that Pfizer and BioNTech plan to start in coming weeks. The partnership pairs the mRNA vaccine technology of BioNTech (NASDAQ: [[ticker:BNTX]]) with the vaccine and clinical trial experience of Pfizer (NYSE: [[ticker:PFE]]). The companies said Thursday … Continue reading “Pfizer, BioNTech Say mRNA COVID-19 Vaccine Trials May Start This Month”
Organovo Future Unclear After Shareholders Reject Tarveda Merger
A planned merger between struggling 3-D “bioprinter” Organovo and Tarveda Therapeutics, a privately held cancer drug developer looking to join the public markets through a reverse merger, has fallen through. Organovo (NASDAQ: [[ticker:ONVO]]) management announced in mid-December that its board of directors and Tarveda’s had approved the companies’ combination. But Organovo shareholders, who under the … Continue reading “Organovo Future Unclear After Shareholders Reject Tarveda Merger”
Roche Pays $190M to Start RNA Drug Alliance With Arrakis Therapeutics
Some diseases have proven difficult to address using conventional tools of drug discovery that target disease-causing proteins. Roche is placing a $190 million bet on Arrakis Therapeutics, a startup whose technology aims for RNA—carriers of the genetic instructions that make these proteins in the first place. The cash, an upfront payment to Waltham, MA-based Arrakis, … Continue reading “Roche Pays $190M to Start RNA Drug Alliance With Arrakis Therapeutics”
Inovio Begins Experimental COVID-19 Vaccine Tests in Healthy Volunteers
Inovio Pharmaceuticals, one of the biotechs developing a vaccine to prevent COVID-19, has received the FDA’s OK to start testing its candidate in healthy volunteers. The Plymouth Meeting, PA-based company, which also conducts research in San Diego, plans to enroll as many as 40 adults across two trial locations. Inovio (NASDAQ: [[ticker:INO]]) said Monday it … Continue reading “Inovio Begins Experimental COVID-19 Vaccine Tests in Healthy Volunteers”
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”
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”
Locana Adds Assembly Biosciences’ Mackison as Chief Business Officer
Locana has appointed Micah Mackison as its chief business officer to lead business development and corporate communications. Mackison most recently led business development efforts at Assembly Biosciences (NASDAQ: [[ticker:ASMB]]) as senior vice president, corporate development and strategy. Previously he led healthcare transactions at Jabil as senior director, corporate investment, and served as head of corporate … Continue reading “Locana Adds Assembly Biosciences’ Mackison as Chief Business Officer”
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””
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”
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”
Viracta Adds Nordic Nanovector’s Lisa Rojkjaer as Chief Medical Officer
Viracta Therapeutics has appointed Lisa Rojkjaer as its chief medical officer to oversee the clinical-stage precision oncology company’s efforts to advance treatments targeting virus-associated cancers. Rojkjaer, who will start with the company on May 1, most recently served in the same role at Nordic Nanovector, a precision oncology company in Oslo, Norway. Previously she held … Continue reading “Viracta Adds Nordic Nanovector’s Lisa Rojkjaer as Chief Medical Officer”
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”
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”
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”
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”
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”
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”
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”
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”
Xcelerating Life Sciences San Diego Will Be Delivered Digitally
At Xconomy, we are here to serve the global biotech community and help biotech and pharma companies connect, do business, and find investment opportunities. We take this role seriously, and over the last week we have been engaged with many of you on how to deliver the value that Xcelerating Life Sciences San Diego provides … Continue reading “Xcelerating Life Sciences San Diego Will Be Delivered Digitally”
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”
Roche Trial of Ionis Huntington’s Disease Drug Halted After Side Effects
A 20-patient Phase 1 study of an RNA drug discovered by Ionis Pharmaceuticals that is being tested as a treatment for Huntington’s disease by Roche was suspended after two reports of infections related to a device used to take samples of cerebral spinal fluid during the trial. The suspension doesn’t appear to be related to … Continue reading “Roche Trial of Ionis Huntington’s Disease Drug Halted After Side Effects”
ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers
With one investigational cancer drug in Phase 1 testing and a second one approaching the clinic, ORIC Pharmaceuticals is looking to tap the public markets for funds to finance that research. The company, which has set a preliminary target of about $86 million for its initial public offering, is looking to list on the Nasdaq … Continue reading “ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers”
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”
Halozyme Therapeutics Appoints SutroVax’s Elaine Sun as New CFO
Halozyme Therapeutics (NASDAQ: [[ticker:HALO]]) this week appointed Elaine Sun as its senior vice president and chief financial officer. Sun, who starts March 2, succeeds Laurie Stelzer, who joined Halozyme as CFO in 2015. Stelzer recently resigned to pursue another employment opportunity, according to Halozyme. Sun was most recently as chief financial officer and chief strategy … Continue reading “Halozyme Therapeutics Appoints SutroVax’s Elaine Sun as New CFO”
Takeda Bases PvP Biologics Buyout on Promising Early Celiac Drug Data
About three years ago fledgling San Diego-based startup PvP Biologics announced a $35 million deal with Takeda Pharmaceutical that gave the Japan pharma giant rights to acquire the company down the line. That day is here. Takeda (NYSE: [[ticker:TAK]]) acquired the company for an undisclosed amount up front, plus up to $330 million in payments … Continue reading “Takeda Bases PvP Biologics Buyout on Promising Early Celiac Drug Data”
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”
Turning Point Taps eFFECTOR’s Reich as Its Chief Scientific Officer
Precision oncology company Turning Point Therapeutics (NASDAQ: [[ticker:TPTX]]) on Thursday said it has appointed Siegfried Reich as executive vice president and chief scientific officer. Reich, whose new role starts March 2, was most recently senior vice president of research at another San Diego-based cancer drug developer, eFFECTOR Therapeutics, which he co-founded. Reich’s experience includes time … Continue reading “Turning Point Taps eFFECTOR’s Reich as Its Chief Scientific 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”
Ionis Pharma’s Joseph Baroldi Joins Avidity as Chief Operating Officer
Avidity Biosciences has appointed Joseph Baroldi to serve as its chief operating officer. He joins San Diego-based Avidity from Ionis Pharmaceuticals (NASDAQ: [[ticker:IONS]]), where he was vice president of business development. Avidity, which closed a $100 million Series C round of funding in November, is developing antisense-oligonucleotide antibody drugs. Its lead therapeutic candidate is a … Continue reading “Ionis Pharma’s Joseph Baroldi Joins Avidity as Chief Operating Officer”