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”
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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”
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”
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”
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”
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”
Sherlock Bio’s Don Haut Joins AskBio as Chief Business Officer
Gene therapy developer Asklepios BioPharmaceutical (AskBio) has appointed Don Haut to serve as its chief business officer, the same position he held most recently at Sherlock Biosciences. His experience also includes business development roles at Histogenics, The Medicines Company, Smith & Nephew, and 3M (NYSE: [[ticker:MMM]]). Nearly a year ago, Research Triangle Park, NC-based AskBio raised … Continue reading “Sherlock Bio’s Don Haut Joins AskBio as Chief Business Officer”
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”
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”
BioCryst Pharma Appoints Anthony Doyle Chief Financial Officer
Anthony Doyle has been named chief financial officer of BioCryst Pharmaceuticals (NASDAQ: [[ticker:BCRX]]). He is joining the Durham, NC, rare disease drug developer from Worldwide Clinical Trials, where he has been CFO since 2014. His experience also includes several roles at General Electric (NYSE: [[ticker:GE]]). BioCryst is awaiting an FDA decision for berotralstat, a treatment … Continue reading “BioCryst Pharma Appoints Anthony Doyle Chief Financial Officer”
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”
Bioventus CEO Tony Bihl to Retire, Ken Reali Appointed Successor
Bioventus has announced that CEO Tony Bihl will retire on April 30. The Durham, NC-based company has appointed Ken Reali as his successor. He will also join the privately held firm’s board of managers starting on April 20. Reali is coming to Bioventus from Utah-based Clinical Innovations, where he is president and CEO. His experience … Continue reading “Bioventus CEO Tony Bihl to Retire, Ken Reali Appointed Successor”
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”
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”
Bio Roundup: Coronavirus Diagnostics, Therapeutics, Vaccines & More
The past week brought a sea change in many of our daily lives as the impact of the continued spread of the novel coronavirus altered how we work and play as communities around the world attempt to slow its spread. Xconomy, as always, is focused on the stories coming out of the life sciences community. … Continue reading “Bio Roundup: Coronavirus Diagnostics, Therapeutics, Vaccines & More”
As the Commercial Real Estate Market Slumps, Look for a More Tenant-Friendly Future
The following sponsored content was submitted by commercial real estate brokerage firm Hughes Marino: The story of the “canary in the coal mine” is an advanced warning of danger. The metaphor originates from when miners used to carry caged canaries while at work; if the air in the mine became toxic, the canary would die … Continue reading “As the Commercial Real Estate Market Slumps, Look for a More Tenant-Friendly Future”
Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More
The financial markets are tumbling, event cancellations are mounting, and sports leagues are suspending their seasons. March Madness is in full swing but not in any way that people wanted or expected. The World Health Organization this week declared that the COVID-19 outbreak was serious enough to classify as pandemic. The toll on public health … Continue reading “Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More”
Pfizer’s Gupta Joins G1 Therapeutics as Chief Commercial Officer
G1 Therapeutics (NASDAQ: [[ticker:GTHX]]) has appointed Soma Gupta to serve as its chief commercial officer. She was most recently vice president of global marketing for rare disease at Pfizer (NYSE: [[ticker:PFE]]). Durham, NC-based G1 has submitted a rolling application for FDA approval of its lead drug, trilacilib, as a treatment for patients with small cell … Continue reading “Pfizer’s Gupta Joins G1 Therapeutics as Chief Commercial Officer”
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”
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”
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”
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”
Ligand’s Icagen Deal Brings Neuro, CF Assets Plus Partnering Potential
Ligand Pharmaceuticals is adding neurological disease and cystic fibrosis programs to its pipeline through a deal to acquire assets from drug discovery company Icagen. San Diego-based Ligand (NASDAQ: [[ticker:LGND]]) is paying $15 million up front for the “core assets” of Icagen’s Durham, NC operations. The neuroscience program is being developed under a partnership with Roche … Continue reading “Ligand’s Icagen Deal Brings Neuro, CF Assets Plus Partnering Potential”
Two Big Pharma Alliances End in Nixed Deals. Here’s What Happened.
Pfizer and Merck are each cutting ties with a smaller clinical-stage biotech after experimental drugs being developed under separate alliances fell short in human testing. Pfizer (NYSE: [[ticker:PFE]]) is walking away from a partnership with GlycoMimetics (NASDAQ: [[ticker:GLYC]]) a Rockville, MD-based company developing drugs for diseases where carbohydrates play a role. In 2011, Pfizer paid … Continue reading “Two Big Pharma Alliances End in Nixed Deals. Here’s What Happened.”
Eli Lilly, Roche Drugs Fail to Move Needle in Genetically Driven Alzheimer’s
Two experimental drugs from Eli Lilly and Roche have failed a clinical trial testing them as treatments for a form of Alzheimer’s disease caused by certain genetic mutations, the companies reported Monday. The study, sponsored by Washington University, tested the drugs in patients who have an early onset, inherited form of Alzheimer’s called autosomal dominant. … Continue reading “Eli Lilly, Roche Drugs Fail to Move Needle in Genetically Driven Alzheimer’s”
Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More
The president’s State of the Union address was wide-ranging, as they tend to be, but those who tuned in heard mention of two hot health policy topics: price transparency and drug pricing reform. President Trump asserted that an executive order he signed last year directing various federal agencies to come up with new rules requiring … Continue reading “Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More”
Aerami Therapeutics Appoints Timm Crowder Chief Operating Officer
Timm Crowder has joined Aerami Therapeutics as its chief operating officer, the same role he held most recently at Spyryx Biosciences. His experience also includes positions at GlaxoSmithKline (NYSE: [[ticker:GSK]]) and Oriel Therapeutics. Durham, NC-based Aerami is developing aerosol formulations of drugs that are administered via its “smart inhaler” technology. The company’s lead product candidate, … Continue reading “Aerami Therapeutics Appoints Timm Crowder Chief Operating Officer”
Titan Medical’s Cash Crunch Stalls Plans to Get Surgical Robot to FDA
Titan Medical didn’t meet its goal of submitting its robotic surgical system for FDA clearance by the end of 2019. Now the company says it needs another $85 million to get its medical device to the finish line or it might have to put itself up for sale. The robotic systems developer spelled out the … Continue reading “Titan Medical’s Cash Crunch Stalls Plans to Get Surgical Robot to FDA”
United Therapeutics Drug Flunks Small Cell Lung Cancer Clinical Trial
An effort to expand use of a United Therapeutics oncology drug to the treatment of small cell lung cancer has fallen short. United Therapeutics (NASDAQ: [[ticker:UTHR]]) announced Monday that a Phase 2/3 study testing dinutuximab (Unituxin) did not meet the main goal of helping patients live longer. The Silver Spring, MD-based company says full data … Continue reading “United Therapeutics Drug Flunks Small Cell Lung Cancer Clinical Trial”
Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy
An Aimmune Therapeutics drug developed to treat peanut allergy won FDA approval late Friday—the first time the agency has approved an oral immunotherapy for a food allergy. The Aimmune (NASDAQ: [[ticker:AIMT]]) drug, Palforzia, was developed to desensitize patients to peanuts. The FDA decision covers patients between the ages of 4 and 17 who have a … Continue reading “Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy”
Bio Roundup: Mammoth Moves, Black Diamond’s Pop, Ohana’s Debut & More
If this week is any indication, the steady march of life science companies to Wall Street will continue in 2020. Black Diamond Therapeutics is leading the way, having raised $201 million from its IPO. In its first day of trading, the cancer drug developer watched its shares soar more than 108 percent. Black Diamond’s stock … Continue reading “Bio Roundup: Mammoth Moves, Black Diamond’s Pop, Ohana’s Debut & More”
BIO Report: More Work Needed to Improve Diversity at Biotech Firms
Some companies that belong to the Biotechnology Industry Organization (BIO), a large industry trade group, convene diverse hiring committees, seek out representation among their suppliers and vendors, and are led by executives that talk regularly about the importance of an inclusive workforce. Others have no women or people of color as employees, gather no data … Continue reading “BIO Report: More Work Needed to Improve Diversity at Biotech Firms”
Third Time’s the Charm as Acceleron Drug Shows Early Promise in PAH
Sotatercept was one of the first compounds to emerge from the labs of Acceleron Pharma, but it became a forgotten piece of the company’s pipeline. Passed over as a candidate to treat a rare blood disorder and stalled in tests in chronic kidney disease, little was expected of the drug. The drug’s prospects have changed … Continue reading “Third Time’s the Charm as Acceleron Drug Shows Early Promise in PAH”
BioIntelliSense Debuts “Sticker” Sensor to Capture Patient Data Remotely
Subtle changes can presage a worsening of a chronic condition, but symptoms may not become apparent to a patient until it’s time to call an ambulance. BioIntelliSense, a Denver-based digital health startup, has developed a wearable sensor meant to monitor patients’ vital signs remotely and provide near real-time data that clinicians can use to identify … Continue reading “BioIntelliSense Debuts “Sticker” Sensor to Capture Patient Data Remotely”
Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report
Biopharmaceutical companies focused on advanced therapies are changing industry R&D, manufacturing, and supply chain models according to KPMG. The audit, tax, and advisory services firm shared details of the trend in its Healthcare & Life Sciences Outlook report, explaining that for companies developing cell, gene, and nucleic acid-based therapies, innovation is a necessity. “As pharmaceutical … Continue reading “Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report”
Life Sciences IPOs Target Collective Raise of More Than $600M This Week
So far this year four privately held companies have made the transition to trading on the public markets. By month’s end, five more are anticipated to join the class of 2020 initial public offerings—and four of those are in life sciences, according to IPO research firm Renaissance Capital. Two are clinical-stage biotechs: Cambridge, MA-based Black … Continue reading “Life Sciences IPOs Target Collective Raise of More Than $600M This Week”
Bio Roundup: Coronavirus Concerns, Sarepta’s CRL, Eye Drug OK’d & More
Company news slowed somewhat this week, perhaps as some took the federal Martin Luther King Jr. Day holiday away from the office and others recovered from back-to-back meetings and late nights at the JP Morgan Healthcare Conference. However, a new coronavirus believed to stem from Wuhan, China, captured the attention of the world healthcare community. … Continue reading “Bio Roundup: Coronavirus Concerns, Sarepta’s CRL, Eye Drug OK’d & More”
Bio Roundup: EQRx’s Ambitions, Nektar No Vote, New Frazier Fund & More
Perhaps the most talked-about news at the JP Morgan Healthcare Conference this week was a new startup that launched with $200 million and an ambitious claim that its first drug would be approved within five years, and 10 in total within as many years. Cambridge, MA-based EQRx contends it will be able achieve its goals … Continue reading “Bio Roundup: EQRx’s Ambitions, Nektar No Vote, New Frazier Fund & More”
BioCryst Pharma Promotes Charles Gayer to Chief Commercial Officer
BioCryst Pharmaceuticals (NASDAQ: [[ticker:BCRX]]) has promoted Charles Gayer to chief commercial officer. Gayer joined the Durham, NC-based drug developer in 2015 as vice president of global strategic marketing. His experience also includes positions at Talecris and GlaxoSmithKline (NYSE: [[ticker:GSK]]). BioCryst is preparing for the expected commercial launch of berotralstat, a drug that has been submitted … Continue reading “BioCryst Pharma Promotes Charles Gayer to Chief Commercial Officer”
FDA Panel Votes Down Nektar Opioid Painkiller, Asks for More Data
[Updated 1/15/2020, 8:51 a.m. See below.] As the nation grapples with the ongoing opioid crisis, an FDA advisory panel on Tuesday unanimously voted against recommending approval of a Nektar Therapeutics painkiller that would add a new compound to the drug class—even though it was designed to reduce the risk of abuse. Some members of the … Continue reading “FDA Panel Votes Down Nektar Opioid Painkiller, Asks for More Data”
Biotech Roundup: Drug Pricing Promises, Bone Disease Data, IPO Plans & More
A letter signed by 215 people involved in the biopharma industry, including CEOs and investors, published Wednesday promised to put the “interests of patients first.” Six CEOs, including five who run public companies, co-authored the letter. Signatories agreed to what they dubbed a New Commitment to Patients, a list of “core principals and actions” promising … Continue reading “Biotech Roundup: Drug Pricing Promises, Bone Disease Data, IPO Plans & More”
Bio Roundup: FDA Approvals, Intrexon’s Shift, Melinta Bankruptcy & More
In the week leading up to Christmas, six drugs won FDA approvals. The decisions covered insomnia, migraine, and several different forms of cancer. The FDA’s final tally for the year totaled 48 new drug approvals. If you’re keeping score, that compares with 59 approvals in 2018 and 46 in 2017. Most of the nods went to … Continue reading “Bio Roundup: FDA Approvals, Intrexon’s Shift, Melinta Bankruptcy & More”
No More Fish or Fruit: Intrexon Turns SynBio Focus to Human Health
Intrexon has spent two decades designing and building DNA sequences for applications in healthcare, food, energy, and the environment. Going forward, the synthetic biology company will focus exclusively on human health under the name of a subsidiary whose lead cell therapies are now in early-stage clinical testing in cancer. Germantown, MD-based Intrexon (NASDAQ: [[ticker:XON]]) announced … Continue reading “No More Fish or Fruit: Intrexon Turns SynBio Focus to Human Health”
Bio Roundup: Amarin’s Approval, FTC v. Illumina, a $120M Deal & More
As national politics dominates the news in the final days of the decade, we at Xconomy are wrapping up the year with some big moves by the FDA, including an approval of the first drug OK’d reduce heart risk in patients with high triglycerides who are already taking statins. Holidays don’t provide immunity to bad … Continue reading “Bio Roundup: Amarin’s Approval, FTC v. Illumina, a $120M Deal & More”
Zafgen’s Path Forward Is Reverse Merger With Chondrial Therapeutics
Zafgen stumbled in clinical trials testing its experimental therapies for metabolic diseases. Going forward, it will have a new name, new management, and a mitochondrial disorder drug from another company. Boston-based Zafgen (NASDAQ: [[ticker:ZFGN]]) has entered a merger agreement with Chondrial Therapeutics, a rare disease drug developer just entering the clinic. Chondrial shareholders will own … Continue reading “Zafgen’s Path Forward Is Reverse Merger With Chondrial Therapeutics”