The drug that Equillium licensed from India-based pharma giant Biocon has received authorization for emergency use in that country in patients hospitalized with COVID-19. The treatment, itolizumab, reduced mortality in a 30-person open-label randomized controlled trial in which the goal was to avoid or address a dangerous inflammatory response to the virus called cytokine release … Continue reading “After Biologic COVID-19 Drug OK’d in India, Equillium Plans a US Test”
Category: National
The 2020 National Xconomy Awards
The 2020 National Xconomy Awards honors the top individuals, companies, and organizations that make the country’s life sciences ecosystem the most vibrant and innovative in the world. Building on the popularity and strength of the 2017-2019 Xconomy Awards Boston and the 2019 Xconomy Awards San Diego, we are launching our first National Xconomy Awards in … Continue reading “The 2020 National Xconomy Awards”
Roche, Blueprint Medicines Team Up Again in $775M RET Cancer Drug Pact
A Blueprint Medicines cancer drug candidate currently under FDA review will have the marketing muscle of Roche behind it if it wins regulatory approval. The two companies are partnering on the drug, pralsetinib, a targeted cancer therapy developed for lung and thyroid cancers characterized by abnormalities in a gene called RET. According to deal terms … Continue reading “Roche, Blueprint Medicines Team Up Again in $775M RET Cancer Drug Pact”
New Xconomy Podcast & Special Report Feature Boston Biophama Leaders on Digital Health
Miss Xconomy’s Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health event or want to revisit the insightful content? Our new podcast and special report package the highlights for you. Listen to the podcast or download the report today. The podcast includes expert panels on: The convergence of data supporting emerging therapies Navigating approaches in a complex regulatory environment Managing the … Continue reading “New Xconomy Podcast & Special Report Feature Boston Biophama Leaders on Digital Health”
Amgen Doubles Down on BeiGene Collaboration, Investing $421M More
At the year’s start Thousand Oaks, CA-based Amgen closed a strategic collaboration with BeiGene, investing $2.8 billion to gain a presence in what’s becoming an ever-more essential market for global drug development. The investment earned it an R&D pact and ownership of about one-fifth of the Chinese oncology drug company. Now the firm has snapped … Continue reading “Amgen Doubles Down on BeiGene Collaboration, Investing $421M More”
3 Biotech IPOs Together Rake In Over a Half Billion to Advance Treatments
Three biotech companies collectively raised $584 million in their initial public offerings last week, continuing a streak that has the healthcare sector playing a leading role in the robust level of market activity this summer. Of the three companies, the one with investigational therapies that haven’t yet begun tests in humans raised the most. South … Continue reading “3 Biotech IPOs Together Rake In Over a Half Billion to Advance Treatments”
Bio Roundup: Blackstone’s Billions, Biogen Finishes Filing, Novavax at “Warp Speed” & More
Cash flowed throughout the life sciences ecosystem this week as Blackstone (NYSE: [[ticker:BX]]) raised a record-setting life sciences fund, companies of all stages announced new financings, and money continued to find its way to those working on efforts to treat or prevent COVID-19. Financiers poured $100 million or more into at least three biotechs, a … Continue reading “Bio Roundup: Blackstone’s Billions, Biogen Finishes Filing, Novavax at “Warp Speed” & More”
Sanofi Pays Kymera $150M to Kick Off Protein Degrader Partnership
Kymera Therapeutics has signed a deal with French biopharma Sanofi to advance two potential treatments for immune-inflammatory diseases that leverage the Cambridge, MA-based company’s research into protein degradation, the natural mechanism cells use to get rid of unwanted proteins. Drug developers are eager to leverage that cellular recycling system to create new treatments because it … Continue reading “Sanofi Pays Kymera $150M to Kick Off Protein Degrader Partnership”
NFlection Looks to Erase NF1 Tumors With Drug That Only Goes Skin Deep
The first drug for neurofibromatosis type 1 (NF1) is available to patients following the FDA’s approval of the AstraZeneca treatment earlier this year. Biotech startup NFlection Therapeutics is vying to be runner-up, but its founders say they can eventually win out with a drug that takes a different approach than the commercialized pill while also … Continue reading “NFlection Looks to Erase NF1 Tumors With Drug That Only Goes Skin Deep”
VelosBio Tacks on $137M to Advance Its ROR1-Targeting Cancer Antibody Drugs
Dave Johnson has known UC San Diego physician and cancer reseacher Thomas Kipps for nearly 20 years. Now Johnson, CEO of San Diego-based cancer drug developer VelosBio, has secured $137 million to accelerate the company’s goal of developing targeted therapies based on an antibody program developed by Kipps that homes in on tumors with a … Continue reading “VelosBio Tacks on $137M to Advance Its ROR1-Targeting Cancer Antibody Drugs”
Biogen Alzheimer’s Drug in FDA’s Court Following Completion of Filing
By early September Biogen—plus the many scientists, patients, and investors following the saga of its controversial Alzheimer’s drug aducanamab—should know whether the FDA plans to review the Cambridge, MA biotech’s experimental brain disease treatment. The company announced Wednesday that its submission to the FDA, pieces of which it has been submitting on a rolling basis, … Continue reading “Biogen Alzheimer’s Drug in FDA’s Court Following Completion of Filing”
The 2020 National Xconomy Awards Expands, Goes Virtual & Reopens Nomination Period
The 2020 National Xconomy Awards – celebrating the best in biotech innovation and entrepreneurship – just got bigger! We’re excited to announce the expansion of the 2020 National Xconomy Awards. Presented in a digital format, the 2020 awards program will begin on Sept. 8 with daily Meet the Finalists webcasts leading up to the … Continue reading “The 2020 National Xconomy Awards Expands, Goes Virtual & Reopens Nomination Period”
Foghorn Therapeutics Inks Chromatin-Targeting Cancer Deal with Merck
One way that a cell regulates which genes in its DNA are expressed and when is by altering the structure of the fibers that are formed by the genetic material and associated proteins, packaging that’s referred to as chromatin. Foghorn Therapeutics, which emerged in 2018 with plans to discover and develop new cancer drugs by … Continue reading “Foghorn Therapeutics Inks Chromatin-Targeting Cancer Deal with Merck”
Novavax Gets $1.6B in Operation Warp Speed Funding for COVID-19 Vaccine
The federal government’s Operation Warp Speed has made its biggest financing award yet, promising $1.6 billion to a Maryland biotech to help advance its investigational COVID-19 vaccine and ready millions of doses in preparation for its possible success. Gaithersburg, MD-based Novavax, which has never before brought a product to market, announced the federal award Tuesday. … Continue reading “Novavax Gets $1.6B in Operation Warp Speed Funding for COVID-19 Vaccine”
Vor Nabs $110M to Spare Healthy Cells From Targeted Cancer Drugs
Targeted therapies for treating cancer are designed to attack one or more proteins known to be on the surface of cancerous cells—but they don’t discriminate when they come across healthy cells expressing those same proteins. Vor Biopharma, an oncology company launched by Boston biotech PureTech Health in 2016, has raised $110 million in private financing … Continue reading “Vor Nabs $110M to Spare Healthy Cells From Targeted Cancer Drugs”
PacBio CEO, CFO Plan Retirements and More People on the Move
Here’s a look back at some of the life science industry’s executive appointments, departures, and retirements from recent weeks: —Pacific Biosciences (NASDAQ: [[ticker:PACB]]) CEO Michael Hunkapiller and Chief Financial Officer Susan Barnes are retiring. —Moderna (NASDAQ: [[ticker:MRNA]]) appointed Ray Jordan as chief corporate affairs officer. —Aridis Pharmaceuticals (NASDAQ: [[ticker:ARDS]]) appointed Hasan Jafri its chief medical officer. … Continue reading “PacBio CEO, CFO Plan Retirements and More People on the Move”
On Heels of $100M Financing, Annexon Bio Aims to Tack On More Via IPO
The same week Annexon Biosciences announced it had raised $100 million in private financing to advance its research of antibody drugs to treat neurodegeneration, the company filed paperwork with regulators indicating its intention to tap the public markets, too. The South San Francisco-based company has two clinical-stage product candidates, both of which are designed to … Continue reading “On Heels of $100M Financing, Annexon Bio Aims to Tack On More Via IPO”
Bristol Myers Pays Dragonfly $55M to Bring NK Cells to Neuro Diseases
Bristol Myers Squibb likes what it sees from the immune cell research of Dragonfly Therapeutics so far—enough to pay $55 million to add multiple sclerosis and neuroinflammation to their ongoing partnership. The alliance came to New York-based Bristol (NYSE: [[ticker:BMY]]) via its acquisition of Celgene last year. The original 2017 deal covered the development of … Continue reading “Bristol Myers Pays Dragonfly $55M to Bring NK Cells to Neuro Diseases”
MEI Pharma, Helsinn Scuttle Cancer Drug Trial After Miss on Efficacy
MEI Pharma and its Swiss partner Helsinn are ending a Phase 3 study of an investigational cancer drug for patients with acute myeloid leukemia (AML) after an interim analysis indicated it was unlikely to meet the trial’s main goal of helping patients live longer. San Diego-based MEI (NASDAQ: [[ticker:MEIP]]), licensed the compound, pracinostat, from a … Continue reading “MEI Pharma, Helsinn Scuttle Cancer Drug Trial After Miss on Efficacy”
Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients
Fast enrollment of the right patient populations will be critical to quickly conducting Phase III trials of COVID-19 vaccines and this will likely mean taking concerted steps to reach out to populations that can be harder to recruit for clinical trials, drug industry leaders said on a recent New York Academy of Sciences webinar. Moderna … Continue reading “Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients”
Data Quantity, Complexity Drives Use of AI in Drug Discovery and Testing
The quantity of data about medicines, diseases, and biology is growing. So too, are the number of companies that employ artificial intelligence in drug discovery. Most of the low-hanging fruit in drug research has already been picked, and the industry is clamoring to make sense of the new data, according to Jeffrey Lu, CEO and … Continue reading “Data Quantity, Complexity Drives Use of AI in Drug Discovery and Testing”
Annexon Adds On $100M to Advance Antibodies to Treat Neurodegeneration
Annexon Biosciences, a biotech founded in late 2014 by former Elan Pharmaceuticals executives, has added $100 million to its coffers to move its two clinical-stage programs along and to continue advancing its preclinical pipeline. The South San Francisco-based company is developing drugs for patients with autoimmune and neurodegenerative disorders that are caused by an abnormal … Continue reading “Annexon Adds On $100M to Advance Antibodies to Treat Neurodegeneration”
BioNTech’s mRNA COVID-19 Vaccine Shows Early Signs of Sparking Immunity
[Updated 7/2/2020, 9:27 a.m. See below.] A BioNTech messenger RNA vaccine candidate for COVID-19 has shown in a small study that it can elicit an immune response to the novel coronavirus. The 45-patient US study tested three doses of the experimental mRNA vaccine, BNT162b1, along with a placebo. Early results now available show higher levels … Continue reading “BioNTech’s mRNA COVID-19 Vaccine Shows Early Signs of Sparking Immunity”
Amylyx Adds $30M to Press On With Neuro Drug for ALS, Alzheimer’s
[Updated, 4:54 p.m.] Amylyx Pharmaceuticals’ two-pronged approach to neurodegenerative diseases has shown promise in amyotrophic lateral sclerosis (ALS) testing and the company now has $30 million to complete a separate clinical trial in Alzheimer’s disease. The Series B round of financing announced Wednesday was led by Morningside Ventures, a firm that had previously invested in … Continue reading “Amylyx Adds $30M to Press On With Neuro Drug for ALS, Alzheimer’s”
Bolt Bio Adds $93.5M to Move Ahead Immune-Stimulating Cancer Drugs
Ten months ago Randy Schatzman was appointed CEO of cancer drug developer Bolt Biotherapeutics, and tasked with getting its first drug candidate into the clinic, building out its C-suite, and raising more money. On Wednesday Schatzman checked the last box on that priority list, closing a $93.5 million Series C financing round from a group … Continue reading “Bolt Bio Adds $93.5M to Move Ahead Immune-Stimulating Cancer Drugs”
Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases
The blood-brain barrier protects the functioning of that essential organ, but it’s also a hurdle to delivering neurological drugs. Italy’s Chiesi Group has agreed to pay Guilford, CT-based Bioasis Technologies $3 million up front to use the preclinical firm’s technology to facilitate the delivery of enzymes across the blood-brain barrier to treat neurological symptoms associated … Continue reading “Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases”
Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder
Ultragenyx Pharmaceutical won FDA approval Tuesday for a therapy that treats a group of rare metabolic disorders that render the body unable to convert certain fats—such as those found in olive oil, fish, and nuts—into energy. People who have long-chain fatty acid oxidation disorders (LC-FAOD) typically manage the condition with dietary changes or by taking … Continue reading “Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder”
Goldfinch Raises $100M for Kidney Drug Studies Now, Perhaps an IPO Later
Goldfinch Bio, a biotech company employing genetic analysis to develop new medicines for kidney diseases, has raised $100 million to bring its lead drug candidate into mid-stage clinical trials. The Series B round of financing was led by Eventide Asset Management. Cambridge, MA-based Goldfinch is taking a big data approach to kidney disease drug discovery … Continue reading “Goldfinch Raises $100M for Kidney Drug Studies Now, Perhaps an IPO Later”
Code for Cures: Life Sciences Thrives on San Francisco’s Software Heritage
A growing population of people with software experience plus an interest in life sciences is boosting drug development in the San Francisco Bay Area, according to panelists at an Xcelerating event. Innovation in the San Francisco Bay Area may first bring to mind tech behemoths like Facebook and Google. But some drug development companies in … Continue reading “Code for Cures: Life Sciences Thrives on San Francisco’s Software Heritage”
Roche Gets FDA OK for Injectable Version of Breast Cancer Drug
A new version of a combination drug marketed by Roche for early-stage and metastatic breast cancer with a specific genetic signature received FDA approval Monday for a formulation that can be delivered in minutes rather than an hour or more. The antibody combo, delivered alongside IV chemotherapy, is intended for women with breast cancer that … Continue reading “Roche Gets FDA OK for Injectable Version of Breast Cancer Drug”
FDA Again Dings Heron’s Opioid Alternative Over “Nonclinical Issues”
Heron Therapeutics revealed Monday that its investigational non-opioid drug for treating postoperative pain has again been rejected by the FDA. The San Diego company’s HTX-011 is an extended-release solution of bupivacaine, a local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug. Heron (NASDAQ: [[ticker:HRTX]]) positioned it as a pain management option that could contribute to a … Continue reading “FDA Again Dings Heron’s Opioid Alternative Over “Nonclinical Issues””
FDA Says “No” to Intercept Pharma’s NASH Drug, Asks for More Data
The FDA has rejected an Intercept Pharmaceuticals drug developed to treat the fatty liver disorder nonalcoholic steatohepatitis, more commonly referred to as “NASH.” New York-based Intercept (NASDAQ: [[ticker:ICPT]]) said Monday that the agency’s complete response letter for obeticholic acid (OCA) stated that its review found that the investigational NASH drug’s benefit “remains uncertain” and does … Continue reading “FDA Says “No” to Intercept Pharma’s NASH Drug, Asks for More Data”
New Xconomy Special Report: Biopharma and Tech Innovators Summer 2020
Even during the most difficult of times, the life science sector continues to push forward with innovation. The recent rapid progression of drug development, diagnostic tests, and healthcare tools has propelled us into new territory that was unthinkable – or even unknown – just a decade ago. While other sectors beg for bailouts, biopharma has remained … Continue reading “New Xconomy Special Report: Biopharma and Tech Innovators Summer 2020”
With Peanut Patch in FDA Purgatory, DBV Plans Layoffs to Stretch Cash
DBV Technologies still expects to receive an FDA decision in early August for its peanut allergy patch. But on Friday the company, which is headquartered in the southern outskirts of Paris, said it would start layoffs and scale down its drug development activities to save cash in case the radio silence it says it has … Continue reading “With Peanut Patch in FDA Purgatory, DBV Plans Layoffs to Stretch Cash”
Eye Inflammation Dooms AbbVie Wet AMD Drug to an FDA Rejection
The FDA has rejected an investigational AbbVie drug for the “wet” form of age-related macular degeneration, dealing a setback to the company’s bid to wrest market share from blockbuster drugs currently used to treat the condition. According to AbbVie (NYSE: [[ticker:ABBV]]), the FDA’s complete response letter states that the drug, abicipar pegol, caused a high … Continue reading “Eye Inflammation Dooms AbbVie Wet AMD Drug to an FDA Rejection”
Artiva Bio Raises $78M to Broaden Access to Cancer Cell Therapies
Creating cell therapies for cancer is a complex process. The business case for them has proven tricky, too. Biotech veterans Tom Farrell and Peter Flynn have teamed up to start a new San Diego company that aims to develop allogeneic, or off-the-shelf, cell-based immunotherapies using natural killer (NK) cells that can be manufactured at scale … Continue reading “Artiva Bio Raises $78M to Broaden Access to Cancer Cell Therapies”
Bio Roundup: Gilead’s Pionyr Grab, Relay to IPO, Unicorn Sana & More
Uncertainty related to the continued spread of the pandemic continued to consume most of the oxygen in the room this week, but life sciences news outside of that arena continued apace. Once considered all but shuttered, the IPO market again saw an active week between new public debuts and more companies joining the queue. Indeed, … Continue reading “Bio Roundup: Gilead’s Pionyr Grab, Relay to IPO, Unicorn Sana & More”
CSL Behring Bolsters Hemophilia Lineup With Deal for uniQure’s Gene Therapy
CSL Behring is joining the chase for a genetic treatment for hemophilia by acquiring a uniQure gene therapy that’s already in late-stage testing. King of Prussia, PA-based CSL Behring is paying $450 million up front to acquire the uniQure (NASDAQ: [[ticker:QURE]]) asset, etranacogene dezaparvovec (“EtranaDez” for short), the companies announced late Wednesday. Netherlands-based uniQure will … Continue reading “CSL Behring Bolsters Hemophilia Lineup With Deal for uniQure’s Gene Therapy”
FDA Official: New “Playbook” Needed for CMC Reviews of Gene Therapy Products
A “new playbook” is needed to ensure consistent chemistry, manufacturing, and controls (CMC) reviews for gene therapy products, the lack of which is hindering the development of these products, asserted a top official at the US Food and Drug Administration . “Now is the time to get things right” asserted Peter Marks, director of the … Continue reading “FDA Official: New “Playbook” Needed for CMC Reviews of Gene Therapy Products”
Relay Lays $200M IPO Plan to Fund Tests of Protein Motion Cancer Drugs
Sophisticated computational tools have guided Relay Therapeutics in its efforts to develop new drugs based on analysis of the movement and shape of disease-causing proteins. Now the Cambridge, MA, biotech is looking to tap the public markets to bulk up company coffers and get its two lead drug candidates into mid-stage clinical trials as potential … Continue reading “Relay Lays $200M IPO Plan to Fund Tests of Protein Motion Cancer Drugs”
La Jolla Pharma Steps In With Better Offer, Wins Tetraphase Bidding War
It’s common for antibiotics developers to run into financial trouble these days but what’s unusual is seeing a bidding war erupt for one of them. The competition for Tetraphase Pharmaceuticals now has a new winner: La Jolla Pharmaceutical. San Diego-based La Jolla (NASDAQ: [[ticker:LJPC]]) has pledged to pay Tetraphase shareholders $43 million in cash now … Continue reading “La Jolla Pharma Steps In With Better Offer, Wins Tetraphase Bidding War”
AsclepiX Emerges With $35M and an Eye Drug Challenger to Eylea, Lucentis
The body’s natural process for healing wounds has led AsclepiX Therapeutics to a novel approach to treating diseases of the eye. The startup is now gearing up to test its technology in humans, and it has raised $35 million in Series A financing to support its research. Cuts and scrapes in the skin spark the … Continue reading “AsclepiX Emerges With $35M and an Eye Drug Challenger to Eylea, Lucentis”
Reneo Readies for Global Test of Drug for Rare Mitochondrial Disease
Reneo Pharmaceuticals has encouraging results from an early trial of a compound it is advancing for rare diseases characterized by impaired mitochondria—our cells’ energy generators—and the company says it is now designing a large global study of its drug candidate. Headed by president and CEO Niall O’Donnell (pictured), the San Diego-based company launched last year … Continue reading “Reneo Readies for Global Test of Drug for Rare Mitochondrial Disease”
Gilead Grabs Option to Acquire Pionyr & Its Clinic-Bound Immunotherapies
Effective checkpoint inhibitors facilitate immune cells’ ability to recognize and target tumors. But for some patients this approach to treating cancer doesn’t work. Pionyr Immunotherapeutics aims to help those people by developing antibody drugs that take a new approach toward boosting the body’s anti-tumor efforts. Now, as Pionyr prepares to ask the FDA to clear … Continue reading “Gilead Grabs Option to Acquire Pionyr & Its Clinic-Bound Immunotherapies”
Invitae Makes a Precision Oncology Push With $886M Deal for ArcherDx
Cancer treatment is increasingly moving toward targeted therapies based on the genetics of a patient’s tumor and Invitae is ensuring it gets its share of this growing market with a deal to acquire precision oncology startup ArcherDx. San Francisco-based Invitae announced Monday that it has agreed to pay $886 million for ArcherDx—$325 million in cash … Continue reading “Invitae Makes a Precision Oncology Push With $886M Deal for ArcherDx”
Sarepta Inks Codiak Deal to Explore Combining Exosomes, Muscle Meds
Tiny, naturally occurring particles called exosomes shuffle molecular payloads between cells, facilitating intercellular communication. Codiak Biosciences’ focus is using those nanoparticles to more safely deliver a range of medicines to specific cell types. Now the Cambridge, MA-based biotech has teamed up with neuromuscular disease drug developer Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) to explore using its engineered … Continue reading “Sarepta Inks Codiak Deal to Explore Combining Exosomes, Muscle Meds”
This Week’s AI & Drug Discovery Conference Xcelerating Life Sciences San Francisco Features insitro, Atomwise, twoXAR, InterVenn, Engine Biosciences & More
Join Xconomy online this Thursday, June 25 for Xcelerating Life Sciences San Francisco: The AI, Big Data, and R&D Boom forum and networking event to explore the latest technology and business trends in AI and drug development through the lens of some of the Bay Area’s top life science leaders and rising stars. Artificial intelligence, … Continue reading “This Week’s AI & Drug Discovery Conference Xcelerating Life Sciences San Francisco Features insitro, Atomwise, twoXAR, InterVenn, Engine Biosciences & More”
Shattuck Labs Nabs $118M for Cancer Drugs Like Keytruda, But Better
Checkpoint inhibitors do one thing: release the molecular brake that keeps immune cells from recognizing and targeting tumors. This cancer immunotherapy approach has saved countless lives and turned drugs from Merck and Bristol Myers Squibb into blockbuster products. But what if a single drug could block checkpoint proteins while simultaneously sparking an anti-tumor response? That’s … Continue reading “Shattuck Labs Nabs $118M for Cancer Drugs Like Keytruda, But Better”
Timing Is an Essential Element of Cell & Gene Therapy Product Development
The science underpinning the latest investigational cell and gene therapies is complex enough. But the rapid advance of technologies that support development of these kinds of drugs presents logistical considerations, too. “Drug development is an interesting process because it takes five to 10 years to get a drug to market and invariably, somewhere along that … Continue reading “Timing Is an Essential Element of Cell & Gene Therapy Product Development”
Bio Roundup: A Royal IPO, Akili Arrives, Orca Bio Surfaces & More
The biggest life sciences deal this week involves a company that doesn’t discover or develop drugs, or even sell them. Yet its mark is found on pharmaceutical products spanning the entire sector. Royalty Pharma (NASDAQ: [[ticker:RPRX]]) acquires the royalty rights for drugs. Most of those royalties are for products that are already approved, but the … Continue reading “Bio Roundup: A Royal IPO, Akili Arrives, Orca Bio Surfaces & More”