The FDA considers how safe and effective a new drug is before approving it. But for addictive opioid painkillers, which have triggered a massive public health crisis, should the agency also weigh the potential for the medication to be abused? That’s one of the questions that new FDA Commissioner Scott Gottlieb is posing as he … Continue reading “Gottlieb Says FDA’s “Regulatory Tools” Can Help Fight Opioid Abuse”
Author: Frank Vinluan
Xconomy Editor Frank Vinluan is a business journalist with experience covering technology and life sciences. Based in Raleigh, he was a staff writer at the Triangle Business Journal covering technology, biotechnology and energy before joining MedCityNews.com as North Carolina bureau chief. Prior to moving to North Carolina’s Research Triangle in 2007 he held business reporting positions at The Des Moines Register and The Seattle Times.
Novartis’ Martin Seidel Joins IFM Therapeutics as V.P. of R&D
Martin Seidel is joining IFM Therapeutics to become the Boston biotech’s executive vice president of research and development. Seidel comes to IFM from Novartis (NYSE: [[ticker:NVS]]), where he was most recently global head of strategic alliances for the Novartis Institutes for Biomedical Research (NBIR). Before that, he was head of NBIR’s Genomics Institute of the … Continue reading “Novartis’ Martin Seidel Joins IFM Therapeutics as V.P. of R&D”
American Robotics Scouts Out $1.1M to Bring A.I. to Farm Drones
Drones are opening up the skies to farmers who want better ways to monitor their crops. But even though flying a drone over a field is less labor-intensive than walking through one, Reese Mozer says that current drones still take too much time and effort for farmers to use. Mozer, founder and CEO of American … Continue reading “American Robotics Scouts Out $1.1M to Bring A.I. to Farm Drones”
Celgene’s Data Could Lead To New Option For Multiple Sclerosis Patients
Celgene reported Monday that an experimental pill for the main type of multiple sclerosis met its main goals in a two-year study. By the end of the year, the Summit, NJ, drugmaker will ask the FDA to consider the drug, ozanimod, for approval. The Celgene (NASDAQ: [[ticker:CELG]]) drug is being tested in patients with relapsing … Continue reading “Celgene’s Data Could Lead To New Option For Multiple Sclerosis Patients”
Cook Medical Gets FDA OK for Device to Treat Rare Birth Defect
In rare instances, a baby’s esophagus develops improperly during pregnancy, leaving a gap in this tube connecting the throat to the stomach. Babies born with this condition can’t eat by mouth, and they require surgery to repair the defect. Bloomington, IN-based Cook Medical recently received FDA approval for a new medical device that offers a … Continue reading “Cook Medical Gets FDA OK for Device to Treat Rare Birth Defect”
Medtech Firm Nativis Appoints Ferguson Chief Scientific Officer
Nativis, a medical device company aiming to use ultra-low radio frequency energy to treat disease, has appointed Kenneth Ferguson chief scientific officer. Seattle-based Nativis is currently in clinical trials testing its medical device, Nativis Voyager, as a treatment for recurrent glioblastoma, a form of brain cancer. Before joining Nativis, Ferguson was chief development officer for … Continue reading “Medtech Firm Nativis Appoints Ferguson Chief Scientific Officer”
Ex-Sarepta CEO Garabedian Returns to Run Bio Accelerator Xontogeny
Chris Garabedian, a veteran biotech executive who helped turn Sarepeta Therapeutics around before his controversial exit in 2015, has returned to the life sciences scene—this time with a new venture to form some biotech startups and help others find their footing. Garabedian is the chairman and CEO of a new Boston-based life sciences accelerator called … Continue reading “Ex-Sarepta CEO Garabedian Returns to Run Bio Accelerator Xontogeny”
PrairieChar’s Manure-Processing Tech Takes Prize at Agtech Showcase
[Updated 5/18/17, 4:01 pm. See below.] Manure is an inescapable part of farming, and it can be an expensive and messy one at that. Large animal farms produce so much waste that it must be stored in tall piles or deep lagoons. If storms spill that waste or it somehow seeps into the groundwater, farmers … Continue reading “PrairieChar’s Manure-Processing Tech Takes Prize at Agtech Showcase”
AstraZeneca’s Yong Ben Joins BioAlta as Chief Medical Officer
BioAlta has named Yong Ben its chief medical officer. Ben comes to San Diego-based BioAlta from AstraZeneca (NYSE: [[ticker:AZN]]), where he most recently served as global clinical lead in immune-oncology. BioAlta is developing conditionally active biologic proteins (CABs), which deliver a therapeutic payload or spark an immune response in specific areas of the body.
Audentes Therapeutics Promotes John Gray to Chief Scientific Officer
Gene therapy developer Audentes Therapeutics (NASDAQ: [[ticker:BOLD]]) has promoted John Gray to senior vice president and chief scientific officer. Gray previously served as vice president of research and development for the San Francisco biotech. Before joining Audentes in 2014, Gray was assistant director of the Harvard Gene Therapy Initiative. Last year, Audentes raised $75 million in … Continue reading “Audentes Therapeutics Promotes John Gray to Chief Scientific Officer”
Eli Lilly Migraine Drug Hits Study Goals, Paves Way for FDA Filing
An Eli Lilly drug developed to stop migraine headaches before they can start hit its main goals in a late-stage clinical trial, the company said Friday. With those results now in hand, the Indianapolis-based drugmaker plans to file for FDA approval of the drug later this year. Eli Lilly (NYSE: [[ticker:LLY]]) tested its drug galcanezumab … Continue reading “Eli Lilly Migraine Drug Hits Study Goals, Paves Way for FDA Filing”
Merck Immunotherapy Drug Notches Another FDA Win in Lung Cancer
The FDA has approved use of a Merck drug in combination with chemotherapy as a first-line treatment for the most common type of lung cancer. The FDA approval for (NYSE: [[ticker:MRK]]) pembrozlizumab (Keytruda) to treat metastatic nonsquamous non-small cell lung cancer widens the use of the immunotherapy. Last year, the FDA approved it for lung … Continue reading “Merck Immunotherapy Drug Notches Another FDA Win in Lung Cancer”
Genentech Drug Fails to Beat Chemo in Treating Advanced Bladder Cancer
Genentech’s hopes to expand applications of a cancer immunotherapy treatment to more cancers were dealt a blow with the failure of that drug in a late-stage clinical trial. South San Francisco, CA-based Genentech, a division of Swiss pharmaceutical giant Roche, announced Wednesday that its drug atezolizumab (Tecentriq), failed a Phase 3 clinical trial testing the … Continue reading “Genentech Drug Fails to Beat Chemo in Treating Advanced Bladder Cancer”
Senate Vote Confirms Scott Gottlieb for FDA Commissioner
Scott Gottlieb will be the new FDA commissioner. The U.S. Senate voted 57 to 42 on Tuesday to confirm Gottlieb, a physician and venture capitalist, to lead the regulatory agency. He succeeds former FDA commissioner Robert Califf, who stepped down in January after President Donald Trump took office. Gottlieb is already familiar with the agency … Continue reading “Senate Vote Confirms Scott Gottlieb for FDA Commissioner”
Analysts Expect Payer Pushback as PTC Sets $35K Price For Duchenne Drug
[Updated, 5/9/17, 9:11 am. See below.] When Marathon Pharmaceuticals priced deflazacort (Emflaza), a steroid for Duchenne muscular dystrophy, at $89,000 per year, the prohibitive cost sparked such outrage that Marathon never launched the drug, but instead sold its rights to PTC Therapeutics. Since that time, South Plainfield, NJ-based PTC (NASDAQ: [[ticker:PTCT]]) has been planning its … Continue reading “Analysts Expect Payer Pushback as PTC Sets $35K Price For Duchenne Drug”
Novartis’ Owen Wallace Joins Fulcrum Tx as Chief Scientific Officer
Owen Wallace is leaving Novartis (NYSE: [[ticker:NVS]]) to become chief scientific officer of Cambridge, MA-based Fulcrum Therapeutics. At Novartis, Wallace was head of the company’s global discovery chemistry division. His experience also includes positions at Eli Lilly (NYSE: [[ticker:LLY]]) and Bristol-Myers Squibb (NYSE: [[ticker:BMY]]). Fulcrum aims to treat treat genetic conditions by developing drugs that … Continue reading “Novartis’ Owen Wallace Joins Fulcrum Tx as Chief Scientific Officer”
Accera Appoints Judith Walker Chief Medical Officer
Accera, a clinical-stage biotech developing treatments for central nervous system disorders, has appointed Judith Walker to its chief medical officer position. Before joining Boulder, CO-based Accera, Walker was vice president of product development at QuintilesIMS (NYSE: [[ticker:Q]]), where her responsibilities included neurology and pain drugs. Walker’s experience also includes posts at Teva Pharmaceutical (NYSE: [[ticker:TEVA]]) … Continue reading “Accera Appoints Judith Walker Chief Medical Officer”
VenBio Settles Immunomedics Litigation, SeaGen Nixes Cancer Drug Deal
A venBio campaign against a drug licensing deal between Immunomedics and Seattle Genetics has unwound the pact altogether. Three months after dealing for rights to an experimental breast cancer therapy from Immunomedics, SeaGen is now walking away due to delays and litigation that venBio, a biotech investment firm, brought against both parties. Meanwhile, Immunomedics (NASDAQ: … Continue reading “VenBio Settles Immunomedics Litigation, SeaGen Nixes Cancer Drug Deal”
Keeping Focus on Cancer, Karyopharm Licenses Antiviral to Anivive
A compound that Karyopharm Therapeutics has tested as an antiviral for humans is getting a new home with Anivive Lifesciences, which plans to bring the drug to market as a cancer treatment for dogs. Anivive is paying $1 million up front to Newton, MA-based Karyopharm (NASDAQ: [[ticker:KPTI]]) for rights to the drug, verdinexor. If Anivive, … Continue reading “Keeping Focus on Cancer, Karyopharm Licenses Antiviral to Anivive”
Genentech’s Raphaël Rousseau Joins Gritstone as Chief Medical Officer
Raphaël Rousseau has been appointed chief medical officer of Gritstone Oncology. Rousseau joins Emery, CA-based Gritstone from Roche subsidiary Genentech, where he most recently served as global franchise head for pediatrics in the firm’s Product Development Oncology division. Rousseau’s hire follows Gritstone’s recent promotion of Roman Yelensky to chief technology officer. Gritstone is developing a … Continue reading “Genentech’s Raphaël Rousseau Joins Gritstone as Chief Medical Officer”
A.I.’s Role In Agriculture Comes Into Focus With Imaging Analysis
The imaging technologies scanning farms today trace their roots to the space race. In 1965, the U.S. Geological Survey proposed using satellites to observe the planet. Seven years later, NASA launched Landsat 1. Among that satellite’s accomplishments: an estimate of the corn and soybean acreage stretching from Iowa to Indiana. The eighth version of Landsat … Continue reading “A.I.’s Role In Agriculture Comes Into Focus With Imaging Analysis”
Shire Sets Sights on Dry Eye Disease with Deal for Parion Drug
Shire is paying $20 million up front to acquire rights to a drug that Parion Sciences has developed as a potential treatment for dry eye disease. The deal calls for Shire (NASDAQ: [[ticker:SHPG]]) to take the lead on further work on P-321, a compound that Durham, NC-based Parion has tested in early-stage clinical trials. If … Continue reading “Shire Sets Sights on Dry Eye Disease with Deal for Parion Drug”
John Tucker Named President and CEO of scPharmaceuticals
Biopharmaceuticals company scPharmaceuticals has appointed John Tucker to the position of president and CEO. He has also been elected to the board of directors of the privately held company. Lexington, MA-based scPharmaceuticals has developed a drug delivery device that can administer medication just below the skin. The company’s lead product candidate is a subcutaneous formulation … Continue reading “John Tucker Named President and CEO of scPharmaceuticals”
Zymeworks Bags $58M in IPO to Bankroll Cancer Drug Trials
Zymeworks is the latest biotech to go public, raising $58.5 million through a stock offering that the company says will finance early stage clinical trials for its two lead cancer drug candidates. Vancouver, BC-based Zymeworks sold 4.5 million shares at $13 apiece, coming in at the low end of the $13 to $16 per range … Continue reading “Zymeworks Bags $58M in IPO to Bankroll Cancer Drug Trials”
FDA Approves BioMarin Drug, A First for Rare Genetic Batten Disease
BioMarin Pharmaceuticals has won the first FDA approval for a treatment for Batten disease, a rare group of disorders that rob children of vision, cognitive abilities, and motor skills, and usually prove deadly before adulthood. The San Rafael, CA-based biotech’s cerliponase alfa (Brineura) must be administered directly into the brain through a stent. At $27,000 … Continue reading “FDA Approves BioMarin Drug, A First for Rare Genetic Batten Disease”
Gottlieb’s FDA Nomination Gets Committee Nod, Advances to Senate
Scott Gottlieb’s nomination to the top post of the FDA is on its way to the full U.S. Senate. The Senate Health, Education, Labor & Pensions Committee voted 14-9 on Thursday to approve Gottlieb’s nomination to become FDA commissioner. All of the Republicans on the committee voted for Gottlieb, along with two Democrats, Sen. Sheldon … Continue reading “Gottlieb’s FDA Nomination Gets Committee Nod, Advances to Senate”
Forge Therapeutics Raises $15M to Take on Drug-Resistant Superbugs
One reason that drug-resistant “superbugs” are a growing healthcare problem is the hardiness of gram-negative bacteria, a type of bacteria whose characteristics render many antibiotics ineffective. Forge Therapeutics says it has found a way to target an enzyme found only in these bacteria, and potentially take them out. Now, the biotech firm is preparing to … Continue reading “Forge Therapeutics Raises $15M to Take on Drug-Resistant Superbugs”
OncoMed Slashes Workforce After Two Clinical Trial Failures in Cancer
After seeing its two most advanced cancer therapies fail in clinical trials this month, OncoMed Pharmaceuticals is slashing its workforce by half and focusing on compounds in earlier stages of development, the company announced Monday. The layoffs will leave Redwood City, CA-based OncoMed with 64 full-time employees. The company says that the cuts will save … Continue reading “OncoMed Slashes Workforce After Two Clinical Trial Failures in Cancer”
Becton Dickinson Aims Beyond Diabetes with $24B Bard Deal
In a medical technology merger with implications for the healthcare sector in the United States and beyond, Becton Dickinson is acquiring C.R. Bard for $24 billion to tap into the growing markets for products used in treating vascular conditions and cancer. Under the deal announced Sunday, Franklin Lakes, NJ-based Becton Dickinson (NYSE: [[ticker:BD]]) will pay … Continue reading “Becton Dickinson Aims Beyond Diabetes with $24B Bard Deal”
Center for Infectious Disease Research Appoints Aitchison President
John Aitchison has been appointed president of the Center for Infectious Disease Research. Aitchison has held several roles at the Seattle-based institute since 2011, most recently serving as its chief science officer. The institute focuses solely on infectious disease research that could lead to new drugs, vaccines, and diagnostics.
Michael J. Fox Foundation Promotes Sohini Chowdhury to Deputy CEO
The Michael J. Fox Foundation for Parkinson’s Research has promoted Sohini Chowdhury to deputy chief executive officer. Chowdhury previously was senior vice president of research partnerships for the New York-based nonprofit organization. The foundation says that in her new role, Chowdhury will work with CEO Todd Sherer and co-founder and executive vice chairman Debi Brooks … Continue reading “Michael J. Fox Foundation Promotes Sohini Chowdhury to Deputy CEO”
Biotech Startups at UNC Showcase Target Urgent Medical Needs
A technology that delivers drugs across the blood-brain barrier. A medical device developed to diagnose sepsis. And a potential new treatment for radiation contamination during a disaster. These were some of the technologies on display Wednesday evening at the Innovation Showcase, an annual event that shines the spotlight on companies that have spun out of … Continue reading “Biotech Startups at UNC Showcase Target Urgent Medical Needs”
Juno Therapeutics Appoints Sunil Agarwal President of R&D
Sunil Agarwal has been appointed president of research and development for Seattle-based cancer immunotherapy company Juno Therapeutics (NASDAQ: [[ticker:JUNO]]), which has fallen behind its rivals in the race to produce the first commercial T cell therapy known as CAR-T. Before joining Juno, Agarwal was chief medical officer of Novato, CA-based Ultragenyx Pharmaceutical (NASDAQ: [[ticker:RARE]]). His … Continue reading “Juno Therapeutics Appoints Sunil Agarwal President of R&D”
Cancer Drugmaker G1 Therapeutics Makes IPO Pitch To Wall Street
Pharmaceutical giants Pfizer and Novartis were first to gain regulatory approval with drugs that block a pair of enzymes important to tumor growth in breast cancer. Clinical-stage biotech G1 Therapeutics has a different approach to those same enzymes and will ask investors in the public markets to get on board. Research Triangle Park, NC-based G1 … Continue reading “Cancer Drugmaker G1 Therapeutics Makes IPO Pitch To Wall Street”
FDA Nixes Lilly, Incyte RA Drug, Seeks More Dosing and Safety Data
[Updated 4/14/17, 2:51 pm. See below.] In a surprise decision, the FDA has declined to approve an experimental rheumatoid arthritis (RA) treatment from Eli Lilly and Incyte, dealing a setback to a drug that is already approved in Europe and was expected to pass muster with U.S. regulators. Eli Lilly (NYSE: [[ticker:LLY]]) and Incyte (NASDAQ: … Continue reading “FDA Nixes Lilly, Incyte RA Drug, Seeks More Dosing and Safety Data”
Zoetis Builds on Biologics Pipeline with $85M Nexvet Acquisition
Zoetis announced on Thursday that it is acquiring Ireland-based Nexvet Biopharma in an $85 million deal that will bring new biologic drug candidates to the global animal health company. Parsippany, NJ-based Zoetis (NYSE: [[ticker:ZTS]]) will pay $6.72 per share to acquire Nexvet (NASDAQ: [[ticker:NVET]]), a price that represents a 66 percent premium over Nexvet’s closing … Continue reading “Zoetis Builds on Biologics Pipeline with $85M Nexvet Acquisition”
Tocagen IPO Raises $85M to Test Gene Therapy in Brain Cancer Trials
Tocagen raised $85 million in its stock market debut today, and underwriters saw enough demand to increase the number of shares in the initial public offering. Tocagen has been developing a gene therapy treatment for a deadly type of brain cancer. San Diego-based Tocagen (NASDAQ: [[ticker:TOCA]]) priced its offering of 8.5 million shares at $10 … Continue reading “Tocagen IPO Raises $85M to Test Gene Therapy in Brain Cancer Trials”
Lyndra’s Long-Acting Drug Delivery Technology Lands $23M Investment
One of the challenges in drug development is making formulations that have a long-lasting therapeutic effect. Implantable products that release a drug slowly over time offer one way to deliver medication for longer than a day, but such long-acting effects have been more difficult to achieve with pills. Drug delivery startup Lyndra has developed technology … Continue reading “Lyndra’s Long-Acting Drug Delivery Technology Lands $23M Investment”
Full Harvest Raises $2M to Make Ugly Fruit and Veggies Valuable
Consumers take it for granted, but the fruits and vegetables they see in grocery stores are the best of the lot. Tons of perfectly edible produce doesn’t make it to stores and is instead thrown away each season simply because the items are unappealing to the eye. Agtech startup Full Harvest wants to cut down … Continue reading “Full Harvest Raises $2M to Make Ugly Fruit and Veggies Valuable”
Emulate’s “Organ-on-a-Chip” Tech Picked for FDA Research Partnership
[Updated 4/11/17, 9:44 a.m. See below.] Experimental drugs encounter their earliest tests in petri dishes and animals, but these tests can fall short of predicting what happens in humans. The life sciences industry has been pursuing what many hope is a better way: packing human cells into tiny chips developed as stand-ins for organs. This … Continue reading “Emulate’s “Organ-on-a-Chip” Tech Picked for FDA Research Partnership”
FDA OKs 23andMe’s Direct-to-Consumer Genetic Tests, With Caution
[Updated 4/6/17, 7:42 pm. See below.] Consumers who aren’t squeamish about spitting into a tube and sending it to a lab can now have 23andMe test those samples to assess their risk of developing Parkinson’s, Alzheimer’s, and eight other disorders. On Thursday, the FDA gave the Mountain View, CA-based genetic testing startup the green light … Continue reading “FDA OKs 23andMe’s Direct-to-Consumer Genetic Tests, With Caution”
Peloton Names Ex-Medivation Executive Hirmand Chief Medical Officer
Cancer drug developer Peloton Therapeutics has appointed Mohammad Hirmand to the position of chief medical officer. He will start his new role at the Dallas-based company on May 1. Hirmand most recently served as chief medical officer of San Francisco-based Medivation, which Pfizer (NYSE: [[ticker:PFE]]) acquired last year in a $14 billion deal.
Former Allergan Exec Rhatigan Joins Merz to Lead North American Unit
Bob Rhatigan has been named president and CEO of the North American operations of German skin care products company Merz Pharma. Rhatigan will be based at Merz North America’s headquarters in Raleigh, NC. He comes to Merz from Irvine, CA, healthcare products company Alphaeon, where he was president and chief operating officer. His experience also … Continue reading “Former Allergan Exec Rhatigan Joins Merz to Lead North American Unit”
Zavante Plans FDA Filing After Antibiotic Hits Clinical Trial Goals
As bacteria develop resistance to older antibiotics, doctors are clamoring for new options that work on these drug- resistant strains. Zavante Therapeutics has been researching one drug as a possible alternative and, with results from a key clinical trial now in hand, the company is preparing to file for FDA approval early next year. San … Continue reading “Zavante Plans FDA Filing After Antibiotic Hits Clinical Trial Goals”
Speaker Lineup Takes Shape for “What’s Hot in Cancer Immunotherapy 2017”
Three years ago, Xconomy assembled a lineup of experts to discuss the emerging treatments that use the immune system to fight cancer. Join us in Seattle this June as we take another look at cancer immunotherapy. We’ll review the progress made so far and highlight how new approaches to treatment could help patients. Confirmed speakers … Continue reading “Speaker Lineup Takes Shape for “What’s Hot in Cancer Immunotherapy 2017””
Sarepta Appoints Catherine Stehman-Breen Chief Medical Officer
Catherine Stehman-Breen is moving to Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) to become the Cambridge, MA, company’s chief medical officer. Stehman-Breen previously served as vice president of clinical development and regulatory affairs for Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]), a Tarrytown, NY, biotech. Before joining Regeneron in 2015, Stehman-Breen held several posts at Amgen (NASDAQ: [[ticker:AMGN]]).
William Polvino Named CEO of Bridge Medicines
Drug discovery firm Bridge Medicines has appointed William Polvino CEO. Polvino most recently served as president and CEO of Denmark-based Veloxis Pharmaceuticals (NASDAQ: [[ticker:VELO]]), and ran Helsinn Therapeutics before that. Bridge, based in New York, launched last October to extend the work of the non-profit Tri-Institutional Therapeutics Discovery Institute. With Polvino’s appointment, Bridge says interim … Continue reading “William Polvino Named CEO of Bridge Medicines”
MS Drug Patent Rulings Give Biogen Win, Acorda Loss in Separate Suits
Biogen has won a patent case concerning its top-selling multiple sclerosis drug, allowing the company to keep exclusive rights on the pill without paying royalties to a European biotech that made claims on the drug. But in a separate case also decided today, Acorda Therapeutics lost four patents covering its flagship drug, a potentially significant … Continue reading “MS Drug Patent Rulings Give Biogen Win, Acorda Loss in Separate Suits”
Boston Scientific to Acquire Heart Device Maker Symetis for $435M
[Updated 3/30/17, 2:12 pm. See below.] Boston Scientific is acquiring Swiss company Symetis, the latest move made by the medical device giant to strengthen its portfolio of minimally invasive heart valve replacement products. Marlborough, MA-based Boston Scientific (NYSE: [[ticker:BSX]]) will pay $435 million in upfront cash to Symetis. With the deal in place, Symetis has … Continue reading “Boston Scientific to Acquire Heart Device Maker Symetis for $435M”
Third Rock’s Tango Aims For Drugs That Turn Cancer Against Itself
As the understanding of cancer advances, scientists are discovering built-in features of the disease’s own biology that can be tapped to halt its growth. Biotech startup Tango Therapeutics believes it can build on this concept to develop new cancer drugs, and it is now unveiling its approach, backed by $55 million in financing. The Series … Continue reading “Third Rock’s Tango Aims For Drugs That Turn Cancer Against Itself”