It will be difficult to compare Moderna, Inc. and Pfizer Inc.’s coronavirus vaccines based on their Phase 3 study designs, some vaccines experts said. “Both trials appeared to be well designed,” based on publicly available information, said Ira Longini, co-director of the Center for Statistics and Quantitative Infectious Diseases Emerging Pathogens Institute at the University … Continue reading “Moderna, Pfizer Protocols May Make COVID Vaccines Hard to Compare”
Category: National
GlaxoSmithKline Multiple Myeloma Drug Earns FDA’s First Anti-BCMA Nod
Patients with advanced multiple myeloma have a new treatment option with the FDA’s approval of a GlaxoSmithKline drug that targets B-cell maturation antigen, a protein found on the surface of cancerous plasma cells. The agency OK’d the London-based pharma giant’s cancer drug, belantamab mafodotin (Blenrep), based on the results of a study in which patients … Continue reading “GlaxoSmithKline Multiple Myeloma Drug Earns FDA’s First Anti-BCMA Nod”
G1 Vets Launch Arc Therapeutics to Take on New Cancer Target
Three early employees of G1 Therapeutics have launched a new oncology-focused company and raised $6 million to move a preclinical program licensed from their former employer into the clinic. The startup, Research Triangle Park, NC-based Arc Therapeutics, is headed by Patrick Roberts (pictured above), who most recently served as the head of translational medicine at … Continue reading “G1 Vets Launch Arc Therapeutics to Take on New Cancer Target”
Biogen to Pay Denali $1B to Partner on Parkinson’s Drug & Other Neuro Meds
Denali Therapeutics has selected a brain-penetrating Parkinson’s disease drug candidate to advance to late-stage testing, and Biogen is paying $1 billion to kick off a partnership on that compound and potentially others. According to terms of the deal announced Thursday, the companies will co-develop the small molecule, dubbed DNL151. Biogen (NASDAQ: [[ticker:BIIB]]) also gains options … Continue reading “Biogen to Pay Denali $1B to Partner on Parkinson’s Drug & Other Neuro Meds”
IgGenix Grabs $10M to Advance Antibody Treatments for Allergies
About six months after the FDA approved the first treatment for peanut allergy, a new biotech, IgGenix, has raised $10 million to discover antibodies that could address that and other common allergies. The six-person startup, which is based out of the Johnson & Johnson (NYSE: [[ticker:JNJ]]) JLABS incubator in South San Francisco, raised the Series … Continue reading “IgGenix Grabs $10M to Advance Antibody Treatments for Allergies”
As Patients Pivot to Telehealth, Teladoc & Livongo Plan $18.5B Tie-Up
Telemedicine giant Teladoc Health is buying health technology company Livongo Health in an $18.5 billion cash and stock deal that comes as the COVID-19 pandemic drives patients to seek ways to manage their health from home. Teladoc (NYSE: [[ticker:TDOC]]) provides “virtual healthcare services” that give patients the ability to visit with a doctor remotely. Most … Continue reading “As Patients Pivot to Telehealth, Teladoc & Livongo Plan $18.5B Tie-Up”
GentiBio Joins Cell Therapy Chase With $20M and New Treg Technology
One of the challenges facing cell therapy developers is collecting enough cells to produce a viable treatment. It’s a particularly pronounced problem for therapies employing regulatory T cells (Tregs), a type of immune cell that’s relatively scarce in the blood, says GentiBio CEO Adel Nada. Some biotech companies are developing Treg cell therapies from a … Continue reading “GentiBio Joins Cell Therapy Chase With $20M and New Treg Technology”
Still Stuck on Adhesion Issues, FDA Rejects DBV’s Peanut Allergy Patch
A skin patch developed by DBV Technologies to desensitize peanut allergy sufferers to the allergen over time has been rejected by the FDA, which says the French company needs to change its design and run another clinical trial testing the modified version if it wants the treatment reviewed again. DBV (NASDAQ: [[ticker:DBVT]]), which has its … Continue reading “Still Stuck on Adhesion Issues, FDA Rejects DBV’s Peanut Allergy Patch”
CymaBay PBC Drug Hits Phase 3 Goals With Signs of Side Effect Advantage
CymaBay Therapeutics’ investigational drug seladelpar succeeded in a late-stage trial in patients with primary biliary cholangitis (PBC), producing results that suggest it could have a key side effect advantage compared to a drug currently used to treat the rare liver disease. Patients with PBC, which damages the bile ducts of the liver, are initially treated … Continue reading “CymaBay PBC Drug Hits Phase 3 Goals With Signs of Side Effect Advantage”
AbbVie Walks From Voyager R&D Pact Spanning Alzheimer’s, Parkinson’s
A partnership between Voyager Therapeutics and AbbVie developing gene therapies for Alzheimer’s and Parkinson’s disease has ended without a drug for either disease reaching human testing. Voyager (NASDAQ: [[ticker:VYGR]]) announced the termination of the research pact after market close Monday. The Cambridge, MA-based biotech is keeping full rights to its technology for using engineered viruses … Continue reading “AbbVie Walks From Voyager R&D Pact Spanning Alzheimer’s, Parkinson’s”
MorphoSys, Incyte Get Early FDA Nod for Antibody Alternative to CAR-T
A MorphoSys antibody drug developed for diffuse large B-cell lymphoma (DLBCL) has won FDA approval, providing an alternative to cumbersome and risky CAR-T therapies to treat the cancer. The late Friday approval for the drug, tafasitamab (Monjuvi), covers adults whose DLBCL has relapsed or has not responded to an earlier treatment. MorphoSys (NASDAQ: [[ticker:MOR]]), a … Continue reading “MorphoSys, Incyte Get Early FDA Nod for Antibody Alternative to CAR-T”
Kymera Therapeutics Unveils IPO Pitch for Protein Degradation
Kymera Therapeutics has a pipeline of preclinical drug candidates that use an experimental approach to get rid of disease-causing proteins and it’s now looking to tap the public markets to finance tests of the technology in humans. In paperwork submitted to the Securities and Exchange Commission on Friday, Kymera set a $100 million goal for … Continue reading “Kymera Therapeutics Unveils IPO Pitch for Protein Degradation”
Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More
The biotech IPO market is buzzing but Cerevel Therapeutics is showing that there’s more than one path to the public markets. This week the neuroscience drug developer reached a deal to merge with publicly traded Arya Sciences Acquisition Corp II. If you’ve never heard of Arya (NASDAQ: [[ticker:ARYBU]]), it’s a shell company that Perceptive Advisors … Continue reading “Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More”
Novartis Pays $75M to Get Hands on Sangamo’s Zinc Fingers for Drug R&D
Another biopharma has signed up to use Sangamo Therapeutics’ gene editing technology to develop therapies that can address disease by heightening or depressing a gene’s activity level. Sangamo on Thursday announced that Novartis (NYSE: [[ticker:NVS]]) had agreed to shell out $75 million up front to leverage the biotech’s genome regulation technology to treat certain neurodevelopmental … Continue reading “Novartis Pays $75M to Get Hands on Sangamo’s Zinc Fingers for Drug R&D”
Arcutis Taps Verrica’s Burnett to Succeed Retiring Chief Medical Officer
Patrick Burnett is joining Arcutis Biotherapeutics (NASDAQ: [[ticker:ARQT]]) as its chief medical officer following the retirement of Howard Welgus, who has held the role since the company’s founding in 2016. Burnett was most recently CMO at dermatology therapeutics developer Verrica Pharmaceuticals (NASDAQ: [[ticker:VRCA]]), whose investigational topical therapy for molluscum contagiosum was rejected by the FDA earlier this month. … Continue reading “Arcutis Taps Verrica’s Burnett to Succeed Retiring Chief Medical Officer”
AlloVir’s IPO Raises $276M to Test Cell Therapies in Transplant Patients
AlloVir is the latest biotech company to go public, raising about $276.3 million to pull its cell therapies off the shelf and run multiple clinical trials testing them in stem cell and organ transplant patients. On Thursday, Cambridge, MA-based AlloVir (NASDAQ: [[ticker:ALVR]]) priced its offering of 16.25 million shares at $17 apiece, the midpoint of its … Continue reading “AlloVir’s IPO Raises $276M to Test Cell Therapies in Transplant Patients”
Amid Boom Days for Biotech, Inhibrx Lines Up Another IPO Effort
Public investors are betting big on biotechs, and Inhibrx is looking to capitalize on the industry’s recent resurgence of initial public offerings. The La Jolla, CA-based company, which is developing drugs for cancer and a rare respiratory disease, has again applied for a listing on the Nasdaq, a filing that comes more than a year … Continue reading “Amid Boom Days for Biotech, Inhibrx Lines Up Another IPO Effort”
Roche Pays $120M for Rights to UCB’s Tau-Targeting Alzheimer’s Drug
As the Alzheimer’s disease world continues to closely follow the development of therapies that break up clumps of beta amyloid on patients’ brains, Roche is placing a bet on another approach via a deal that secures rights to a clinical-stage UCB compound that targets tau, another protein associated with the neurodegenerative disorder. According to terms … Continue reading “Roche Pays $120M for Rights to UCB’s Tau-Targeting Alzheimer’s Drug”
2020 National Xconomy Awards Finalists Announced
After receiving and reviewing nearly 600 entries spanning 10 award categories, Xconomy is thrilled to announce the 2020 Xconomy National Awards Finalists. Since 2017, the mission of Xconomy’s annual awards programs has been to provide the industry a moment to pause, recognize, and honor the very best the life sciences has to offer – the … Continue reading “2020 National Xconomy Awards Finalists Announced”
Omega Therapeutics Lands $85M to Tap Into “Control Room” of Biology
The promise of gene therapies and gene-editing drugs is a long-lasting treatment that’s potentially a cure. But making permanent genetic changes means any accompanying problems could be long-lasting as well, says Omega Therapeutics CEO Mahesh Karande. Omega is developing technology that takes a more nuanced approach to genomic medicine. Instead of fixing or replacing faulty … Continue reading “Omega Therapeutics Lands $85M to Tap Into “Control Room” of Biology”
Nura Bio Debuts With $73M and Plan to Develop “Neuroprotective” Drugs
Damage to axons, the slender tendrils through which nerve cells communicate, is an early indication of several neurological diseases. Nura Bio, which formed around new research into a mechanism underlying axonal degeneration, made its public debut Wednesday with a $73 million financing round and a chief executive who has experience shepherding multiple drug development programs … Continue reading “Nura Bio Debuts With $73M and Plan to Develop “Neuroprotective” Drugs”
Thrive Adds $257M, Plans Pivotal Trial of Early Cancer Detection Test
Thrive Earlier Detection, one of the companies vying to be the first to commercialize a blood test that can uncover cases of cancer before symptoms arise, has raised $257 million and announced plans to evaluate its CancerSEEK test in a registrational study. Many cancers grow silently, and once malignant cells are discovered a patient’s prognosis … Continue reading “Thrive Adds $257M, Plans Pivotal Trial of Early Cancer Detection Test”
Pfizer, BioNTech Choose Full Spike Protein for Pivotal Vaccine Test
Pfizer and BioNTech’s COVID-19 vaccine research started with multiple approaches—four shots on the messenger RNA goal. The partners have narrowed their choices to one for pivotal testing, and that candidate takes the same tack as other companies trying to address the novel coronavirus. BNT162b2, the vaccine candidate that Pfizer (NYSE: [[ticker:PFE]]) and BioNTech (NASDAQ: [[ticker:BNTX]]) … Continue reading “Pfizer, BioNTech Choose Full Spike Protein for Pivotal Vaccine Test”
Telehealth Firm AristaMD Adds $24M to Link Primary Docs With Specialists
Telemedicine isn’t just another way to connect patients with doctors. AristaMD has carved out a niche in connecting doctors with, well, other doctors. The San Diego-based telehealth company’s software links primary care physicians and medical specialists through virtual consultations, communication that is intended to reduce healthcare costs by slimming down the number of referrals made … Continue reading “Telehealth Firm AristaMD Adds $24M to Link Primary Docs With Specialists”
AstraZeneca to Pay $1B to Team Up With Daiichi Sankyo Again in Cancer
AstraZeneca’s partnership with Daiichi Sankyo led to FDA approval of an antibody cancer drug late last year. Now the British pharmaceutical giant is paying $1 billion up front to join forces on another antibody drug addressing a different cancer target. The deal announced Monday calls for AstraZeneca (NYSE: [[ticker:AZN]]) to share in the development and, … Continue reading “AstraZeneca to Pay $1B to Team Up With Daiichi Sankyo Again in Cancer”
Clinical Trial Diversity Isn’t Just a Moral Issue–It’s a Scientific Imperative
The lack of diversity in clinical trials is a serious problem that’s persisted for decades. Black Americans—who make up 20 percent of US multiple myeloma patients and are twice as likely to be diagnosed—have only accounted for 4.5 percent of participants in multiple myeloma trials since 2003. Asian Americans—who make up nearly 6 percent of … Continue reading “Clinical Trial Diversity Isn’t Just a Moral Issue–It’s a Scientific Imperative”
Gilead Gets Another CAR-T Approval, This Time for Mantle Cell Lymphoma
The FDA on Friday approved a Gilead Sciences drug developed for treating mantle cell lymphoma, paving the way for the company to commercialize its second cancer cell therapy. Approval for the drug, brexucabtagene autoleucel (Tecartus), covers patients whose cancer has relapsed or has not responded to earlier treatments. Gilead (NASDAQ: [[ticker:GILD]]) added the therapy to … Continue reading “Gilead Gets Another CAR-T Approval, This Time for Mantle Cell Lymphoma”
Bio Roundup: Jazz Drug OK’d, Gilead’s Bet, Moderna Patent Decision & More
EQRx launched in January during the JP Morgan Healthcare Conference with an audacious pledge to create 10 new drugs in as many years and then sell them at “dramatically” lower prices than existing medicines. But it offered few specifics about how it would achieve those goals. This week, drug licensing deals it made with two … Continue reading “Bio Roundup: Jazz Drug OK’d, Gilead’s Bet, Moderna Patent Decision & More”
FDA Lifts CymaBay Drug Hold, Tests to Resume in Rare Liver Disease PBC
The FDA has lifted a hold on clinical trials for an experimental CymaBay Therapeutics drug in three liver diseases, clearing the way for tests to resume in all of them. But the company won’t be pressing forward in the biggest one, NASH, at least for now. The clinical hold on the drug, seladelpar, stemmed from … Continue reading “FDA Lifts CymaBay Drug Hold, Tests to Resume in Rare Liver Disease PBC”
Jazz Pharma Gets FDA Nod for New Drug to Treat Narcolepsy Symptoms
[Corrected 7/23/20, 10:13 am. See below.] Jazz Pharmaceuticals has received FDA approval for a narcolepsy drug that it has developed as a lower-sodium successor to its biggest moneymaker, a treatment that was first approved in 2002 to reduce attacks of muscle weakness associated with the disease. That drug, sodium oxybate (Xyrem), was first OK’d to reduce … Continue reading “Jazz Pharma Gets FDA Nod for New Drug to Treat Narcolepsy Symptoms”
Vesigen Nabs $28M to Wrap “ARMMS” Around Large Molecule Drug Delivery
It’s not enough for a cell or gene therapy to reach a cell, it must also get inside it to access most of the validated drug targets. Vesigen Therapeutics is developing technology that could best other approaches at penetrating the cellular membrane, and it launched on Wednesday with $28.5 million to advance its research. The … Continue reading “Vesigen Nabs $28M to Wrap “ARMMS” Around Large Molecule Drug Delivery”
Seer Raises $55M to Commercialize Tools to Analyze the Proteome
Illumina led the genomics revolution, developing tools that have changed how scientists discover drugs and how clinicians treat patients. Startup Seer is making the case that its technology for analyzing the proteome—the complement of proteins that cells, tissues, and organs produce—will take it to the head of the proteomics field. On Wednesday the Redwood City, … Continue reading “Seer Raises $55M to Commercialize Tools to Analyze the Proteome”
Olema Adds $54M to Start Human Tests of Breast Cancer Drug Candidate
Olema Oncology has raised $54 million to advance its lead drug candidate into human tests, having been working in stealth since 2007 to develop a daily pill to treat women with breast cancer whose disease is driven by the hormone estrogen. San Francisco-based Olema announced Wednesday that the Series B financing round will allow it to start … Continue reading “Olema Adds $54M to Start Human Tests of Breast Cancer Drug Candidate”
Freeline Therapeutics and Checkmate Pharma Make Opening IPO Moves
The biotech IPO queue has added two more companies. Freeline Therapeutics and Checkmate Pharmaceuticals have each filed the regulatory paperwork to offer shares to the public. Freeline is raising cash to ensure that its lead program, a prospective hemophilia B gene therapy, keeps pace in the race to develop and commercialize a genetic treatment for … Continue reading “Freeline Therapeutics and Checkmate Pharma Make Opening IPO Moves”
Elevation Oncology Debuts With $32.5M to Develop Targeted Cancer Drugs
Elevation Oncology formed last year with $32.5 million in a Series A financing round led by the initial investor in Loxo Oncology, a company that blazed a trail developing cancer therapies based on genetic signature rather than tumor origin. On Tuesday the New York-based biotech emerged from stealth aiming to follow in Loxo’s path. It … Continue reading “Elevation Oncology Debuts With $32.5M to Develop Targeted Cancer Drugs”
Roche, Jnana Enter Drug R&D Alliance Targeting Metabolism’s Gatekeepers
Scientists know that proteins called solute carrier (SLC) transporters move substances important to metabolism across cellular membranes. But can drugs effectively hit these proteins to treat disease? Roche is paying startup Jnana Therapeutics $40 million to find out. The alliance announced Tuesday focuses on the discovery and preclinical development of drugs for immunological and neurological … Continue reading “Roche, Jnana Enter Drug R&D Alliance Targeting Metabolism’s Gatekeepers”
Gilead Sciences Splashes Out $300M for Tizona Stake & Option to Acquire
Gilead Sciences has made its second deal in as many months that puts the company first in line to acquire a biotech developing cancer immunotherapies. On Tuesday the Foster City, CA-based company said it would pay $300 million to South San Francisco-based Tizona Therapeutics for a 49.9 percent stake plus the option to later acquire … Continue reading “Gilead Sciences Splashes Out $300M for Tizona Stake & Option to Acquire”
Acadia Halts Work on Depression Drug After Late-Stage Trial Failure
Acadia Pharmaceuticals received the FDA’s OK for pimavanserin (Nuplazid), the first drug approved to treat hallucinations and delusions associated with Parkinson’s disease, in 2016. Since then, the San Diego company has looked to expand its use into other indications, with mixed results. That trend continued Monday when Acadia (NASDAQ: [[ticker:ACAD]]) reported it would end its … Continue reading “Acadia Halts Work on Depression Drug After Late-Stage Trial Failure”
Forge Bio’s Combo Model for Gene Therapies Attracts $40M in Funding
Forge Biologics has something rare for most early-stage biotech startups: revenue from customers. Now it has $40 million to expand its model, which places contract manufacturing alongside the development of its own gene therapies, the most advanced of which is being readied for tests in humans. From operations in Columbus, OH, Forge makes gene therapies … Continue reading “Forge Bio’s Combo Model for Gene Therapies Attracts $40M in Funding”
GSK Pays CureVac $328M in mRNA Vaccines Pact—Excluding COVID-19
GlaxoSmithKline is expanding its capabilities in messenger RNA (mRNA) research through a new alliance with CureVac spanning up to five programs targeting infectious disease pathogens. In addition to mRNA vaccines, those programs could also be antibody therapies. GSK (NYSE: [[ticker:GSK]]) is paying CureVac a total of £260 million (about $328 million) to kick off the … Continue reading “GSK Pays CureVac $328M in mRNA Vaccines Pact—Excluding COVID-19”
Exalys Launches With $15M to Treat Postoperative Delirium & More
Venture capitalists like nothing more than pattern matching, and Domain Associates has identified one it especially prefers: licensing drug candidates from a Japanese biopharma and setting up a US company to move it through testing until Big Pharma starts nosing around. It’s a roadmap the VC firm, which has offices in San Diego and Princeton, … Continue reading “Exalys Launches With $15M to Treat Postoperative Delirium & More”
MeiraGTx, J&J See Phase 3 Test Ahead for Vision Loss Gene Therapy
A gene therapy being jointly developed by MeiraGTx and Johnson & Johnson to treat an inherited disease of the retina that leads to blindness improved patients’ vision after six months, data that the companies say is enough to move the potentially long-lasting treatment into pivotal testing. The condition, called X-linked retinitis pigmentosa, is part of … Continue reading “MeiraGTx, J&J See Phase 3 Test Ahead for Vision Loss Gene Therapy”
Two Days, Six IPOs, and $1B Raised for Biotech Research & More
Summer’s arrival hasn’t slowed the momentum of the biotech IPO market. Wall Street this week welcomed six new life science industry companies, which collectively raised more than $1 billion in their stock market debuts. Relay Therapeutics (NASDAQ: [[ticker:RLAY]]) notched the biggest biotech IPO of the week, raising $400 million. Investor interest in the Cambridge, MA-based … Continue reading “Two Days, Six IPOs, and $1B Raised for Biotech Research & More”
The Xcelerate Keynote Series – Part of Biotech Week Boston
Presented by Xconomy, the Xcelerate Keynote Series at Biotech Week Boston places a spotlight on industry visionaries who are moving the needle in patient outcomes. As life sciences, healthcare, and drug development are undergoing unprecedented change, the keynote speakers will share insights on how their sectors are adapting to challenges, how to combat potential disruptive … Continue reading “The Xcelerate Keynote Series – Part of Biotech Week Boston”
Bio Roundup: Moderna Publishes, Life Science Cash, AdComm Votes & More
If it seems like biotech investments have defied the financial headwinds of the pandemic, maybe it’s because they have. In the second quarter, 16 of the top 25 largest early-stage venture capital deals were investments in life science companies. The figures come from the National Venture Capital Association and financial research firm Pitchbook. This week … Continue reading “Bio Roundup: Moderna Publishes, Life Science Cash, AdComm Votes & More”
Adimab Spinout Adagio Raises $50M for Coronavirus Antibody R&D
There’s a hard and fast rule at Adimab, a company that makes money by discovering and optimizing antibodies to pass off to drug development companies: Don’t compete with the customers. So, when its antibody science group produced a portfolio of anti-coronavirus antibodies, the Lebanon, NH-based company decided to spin off the assets into a new … Continue reading “Adimab Spinout Adagio Raises $50M for Coronavirus Antibody R&D”
Mallinckrodt’s Kidney Failure Drug Narrowly Wins Backing of FDA Panel
An experimental Mallinckrodt Pharmaceuticals drug for a rare type of kidney failure has won the support of an FDA advisory panel by the thinnest of margins. The committee of mostly physicians concluded that the benefits of the drug, terlipressin, outweigh its safety risks as a treatment for hepatorenal syndrome type 1 (HRS-1), and panelists voted … Continue reading “Mallinckrodt’s Kidney Failure Drug Narrowly Wins Backing of FDA Panel”
Moderna Publishes Early COVID-19 Vaccine Data, Preps for Phase 3 Test
Moderna’s COVID-19 vaccine candidate stimulated production of antibodies to the novel coronavirus in all of the patients tested in an early-stage study, and the company says the data support the selection of which dose to test in a pivotal clinical trial slated to begin at the end of July. When the Cambridge, MA-based company initially … Continue reading “Moderna Publishes Early COVID-19 Vaccine Data, Preps for Phase 3 Test”
Last Chance for Xconomy Awards Nominations – Deadline is Friday, July 17
Have you had your say yet? The 2020 National Xconomy Awards represent the very best our life science industry has to offer. It is our privilege to recognize emerging companies and technologies, highlight groundbreaking business collaborations and strategies, celebrate corporate responsibility and diversity, and promote the innovation that delivers new therapeutics and better health to all. Finalists … Continue reading “Last Chance for Xconomy Awards Nominations – Deadline is Friday, July 17”
Dewpoint, Merck Team Up to Tackle HIV Using Condensate Know-How
Dewpoint Therapeutics has signed its second biopharma partnership, teaming up with Merck to explore the potential of using its discoveries around “droplets” of biomolecules that form inside cells to create a new HIV treatment. The companies’ aim is an ambitious one: develop a drug candidate that could prove curative, rather than suppress the infection as … Continue reading “Dewpoint, Merck Team Up to Tackle HIV Using Condensate Know-How”