If you’re keeping track, FDA drug approvals have been on a tear in the past month with several decisions coming well ahead of their targeted dates. And then there’s Sarepta Therapeutics. Late Thursday, the FDA announced approval of the Cambridge, MA, biotech’s drug for Duchenne muscular dystrophy in patients who have a specific mutation. The … Continue reading “Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More”
Category: Raleigh-Durham
Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink
Iterum Therapeutics’ bid to bring patients a new antibiotic that’s safer than currently available drugs has fallen short of the main efficacy goal of a late-stage clinical trial. But the company is pinning its hopes on another Phase 3 study that will report data early next year. Iterum (NASDAQ: [[ticker:ITRM]]) reported preliminary Phase 3 data … Continue reading “Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink”
KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test
A KalVista Pharmaceuticals eye drug at the center of a research collaboration with Merck has failed a mid-stage clinical trial. KalVista (NASDAQ: [[ticker:KALV]]) developed its drug, KVD001, to treat diabetic macular edema (DME), a complication of diabetes that can lead to blindness. On Monday, Cambridge, MA-based KalVista said patients treated with the drug, given as … Continue reading “KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test”
Duke’s Jacob Jacobsen Joins Evecxia as Chief Scientific Officer
Evecxia co-founder Jacob Jacobsen has been appointed to serve as the biotech’s chief scientific officer. Jacobsen was most recently a scientist in the Duke University lab of Marc Caron, another co-founder of Research Triangle Park, NC-based Evecxia. His industry experience includes positions at Lundbeck and NeuroSearch. Evecxia’s lead therapeutic candidate, EVX-101, is in development as … Continue reading “Duke’s Jacob Jacobsen Joins Evecxia as Chief Scientific Officer”
Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More
It’s been a roller-coaster year for those hoping for new drugs to treat Alzheimer’s disease, a leading cause of death with rising treatment costs and no clear answer yet as to its cause. Clearing proteins, such as amyloid and tau, was once seen as the top contender for stopping or slowing neurodegeneration. Costly failures forced … Continue reading “Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More”
FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder
[Corrected 12:27 p.m. See below.] The FDA has rejected an experimental regenerative therapy that Enzyvant developed to restore immune system function in babies born with a rare disorder. The agency cited manufacturing issues, according to the company. Enzyvant received the notification, formally known as a complete response letter, on Wednesday, CEO Rachelle Jacques tells Xconomy. … Continue reading “FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder”
Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption
Editor’s note: This is Part 2 of a two-part post about innovation in digital health, co-authored by Rob Coppedge, CEO of Echo Health Ventures. Read Part 1 here. The Path Forward Between Echo Health Ventures and Blue Cross and Blue Shield of North Carolina, we work deeply on both sides of these partnerships and have perspective … Continue reading “Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption”
Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal
[Updated 12/4/19, 4:01 p.m. ET. See below.] Veracyte, a company whose tests help physicians make treatment decisions, is adding technology from NanoString to the fold to expand its diagnostic capabilities. South San Francisco-based Veracyte (NASDAQ: [[ticker:VCYT]]) announced Tuesday that it has reached a deal for global rights to develop and commercialize diagnostics based on the … Continue reading “Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal”
Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down
Editor’s note: This is Part 1 of a two-part piece on innovation in digital health, co-authored by Bryony Winn, chief strategy and innovation officer at Blue Cross and Blue Shield of North Carolina. Read Part 2 here. More than 6,500 people descended on HLTH in Las Vegas in late October to “solve the most pressing … Continue reading “Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down”
Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More
Bristol-Myers Squibb this week completed its acquisition of Celgene, a $74 billion deal that creates a pharmaceutical juggernaut. And all it took was the largest asset sale ever required by federal antitrust regulators. As the Federal Trade Commission reviewed Bristol’s (NYSE: [[ticker:BMS]]) deal to acquire Celgene, anti-inflammatory drug apremilast (Otezla) emerged as a sticking point. … Continue reading “Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More”
Biopharma Execs Remain Optimistic Despite Political Headwinds
Drug pricing debates and uncertainty associated with Brexit are the issues most likely to keep biopharmaceutical executives awake at night. Nevertheless, senior figures remain optimistic about the industry’s prospects in 2020. These are among the major findings of a survey of 500 industry leaders and investors conducted by investment bank Jefferies. “Nearly half of respondents … Continue reading “Biopharma Execs Remain Optimistic Despite Political Headwinds”
Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More
Lung injuries connected to the use of electronic cigarettes have topped 2,000 and killed 40 people, according to the Centers for Disease Control and Prevention. It’s still unclear whether the cases are tied to legally sold products or devices modified by e-cigarette users, but the CDC this week identified a “potential toxin of concern”—Vitamin E … Continue reading “Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More”
Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio
The list of activities our smartphones can control grows daily. Transfer money? It’s simple. Order groceries? That, too. Turn off the bedroom lights? Check. How about contraception? Advancing new forms of birth control is a central focus at Daré Bioscience (NASDAQ: [[ticker:DARE]]), a San Diego-based biopharma company that’s built a pipeline of experimental devices and … Continue reading “Daré to Add Microchip-Based Birth Control to Women’s Health Portfolio”
TransEnterix CEO Pope Steps Down, Fernando Appointed Successor
Todd Pope, president and CEO of TransEnterix (NYSE American: [[ticker:TRXC]]) since 2008, has stepped down. The Research Triangle Park, NC-based surgical robotics company promoted Anthony Fernando to take Pope’s place. Fernando had been TransEnterix’s chief operating officer and chief technology officer. Pope will continue to advise the company to help with the transition of his … Continue reading “TransEnterix CEO Pope Steps Down, Fernando Appointed Successor”
Neuroscience Is Taking the Spotlight at Xconomy’s Bay Area Xchange
These are heady times for neuroscience research. Startups developing new approaches to brain disorders are raising money to advance their discoveries toward clinical trials. One failed neuro drug is getting another shot. On Nov. 19 in San Francisco, we’ll hold the latest in our Xchange event series. What’s Next in Neuroscience Therapies will take a … Continue reading “Neuroscience Is Taking the Spotlight at Xconomy’s Bay Area Xchange”
Bio Roundup: Feds Sue Gilead, Biogen Eyes China, CRISPR’d Kidneys & More
During the state of the union address this year, President Trump pledged to end HIV transmission within the next decade. A key part of that plan is an HIV prevention drug made by Gilead Sciences. That drug has now become the center of a patent dispute between the Foster City, CA, drug maker and the … Continue reading “Bio Roundup: Feds Sue Gilead, Biogen Eyes China, CRISPR’d Kidneys & More”
3 Changes We Should Make to Address the Gender Pay Gap in Medicine
Women in medicine earn about 20 percent less than men. That is a problem for multiple reasons. It is, of course, not fair to the women who go through the same training and have the same skills as their male counterparts. Worse still, if well-qualified women are discouraged from entering the profession because of this … Continue reading “3 Changes We Should Make to Address the Gender Pay Gap in Medicine”
AstraZeneca Chooses China for R&D and AI Centers, $1B Biotech Fund
AstraZeneca says it will establish centers for drug research and artificial intelligence development in China. The pharmaceutical giant has also set up a $1 billion fund to foster biotech innovation in that country. The move—which was announced at the China International Import Expo this week—will see AstraZeneca found a global R&D center in Shanghai’s central … Continue reading “AstraZeneca Chooses China for R&D and AI Centers, $1B Biotech Fund”
GE Healthcare Opens Startup Labs at Former AstraZeneca UK R&D Site
The doors have opened at a GE Healthcare-supported open-access lab for startups at AstraZeneca’s former global center for oncology research and development at Alderley Park, the largest bioscience research campus in the UK. The AstraZeneca (NYSE: [[ticker:AZN]]) site in Macclesfield, UK, housed 3,500 staff and was instrumental in developing a number of its cancer drugs … Continue reading “GE Healthcare Opens Startup Labs at Former AstraZeneca UK R&D Site”
Aerie Names David Hollander Chief Research & Development Officer
David Hollander is joining Aerie Pharmaceuticals (NASDAQ: [[ticker:AERI]]) as chief research and development officer. Hollander most recently worked at Ora, where he was chief medical officer and senior vice president. His experience also includes more than a decade at Allergan (NYSE: [[ticker:AGN]]). Durham, NC-based Aerie has two FDA-approved glaucoma treatments: netarsudil (Rhopressa) and the netasudil … Continue reading “Aerie Names David Hollander Chief Research & Development Officer”
Biotech Roundup: Novartis on Hold, AMAG Vote, Neuro News & More
The brain has stymied many efforts to develop new neuroscience drugs, leading a number of big pharmaceutical companies to pull back on such R&D work. This week, Amgen joined them. Amgen (NASDAQ: [[ticker:AMGN]]) is ending its research and early development programs in neuroscience, the company announced during a conference call to discuss third-quarter financial results. … Continue reading “Biotech Roundup: Novartis on Hold, AMAG Vote, Neuro News & More”
FDA Halts Novartis Gene Therapy Study Amid Animal Safety Concerns
Novartis must stop enrollment of a clinical trial testing its gene therapy for a rare, muscular disorder after safety concerns surfaced in data from an animal study. The FDA put a partial clinical hold on a Phase 1/2 study testing the therapy, Zolgensma, Novartis (NYSE: [[ticker:NVS]]) announced Wednesday. The decision doesn’t halt the study entirely; … Continue reading “FDA Halts Novartis Gene Therapy Study Amid Animal Safety Concerns”
Bio Roundup: Biogen’s Reversal, FDA Moves Fast, a CF Cocktail & More
Earlier this year, it seemed that companies testing Alzheimer’s disease treatments based on a long-held hypothesis as to its cause—brain deposits of a protein called beta amyloid—were giving up the ghost. Biogen (NASDAQ: [[ticker:BIIB]]) was among them. The drug maker had stopped testing of a drug developed to target amyloid plaque after a Phase 3 … Continue reading “Bio Roundup: Biogen’s Reversal, FDA Moves Fast, a CF Cocktail & More”
Bio Roundup: Ichnos Emerges, Beyond CAR-T, BridgeBio Bails & More
New brand-name drugs typically grab the life science headlines. A venture capital firm will invest tens of millions to develop one and a pharmaceutical company hopes to recoup hundreds of millions by selling it. But a shortage of one particular chemotherapy is showing the crucial role generic drugs play in healthcare. This week, The New … Continue reading “Bio Roundup: Ichnos Emerges, Beyond CAR-T, BridgeBio Bails & More”
FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades
Eli Lilly won FDA approval for a migraine drug on Friday, giving the pharmaceutical giant a second medication that addresses the condition that causes millions of people to experience severe headaches and other debilitating symptoms. The FDA approved the drug, lasmiditan (Reyvow), as a treatment for acute migraine; it’s meant to be taken after the … Continue reading “FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades”
Bio Roundup: Nobel Prizes, Placebo Effect Rises, ICER’s Fire & More
Congrats to this year’s Nobel Prize winners in medicine… although, we have to ask: For the US researchers who are honored, isn’t there something crushing about a call in the middle of the night from Sweden, interrupting a dream about the perfect protein-protein interaction? Wouldn’t it be more logical for the committee to wait until … Continue reading “Bio Roundup: Nobel Prizes, Placebo Effect Rises, ICER’s Fire & More”
The Placebo Effect Is Hobbling New Psychiatric Drugs. What Can Stop It?
Sixteen years ago, Kim Witczak’s husband died by his own hand, turning her world upside down. He had just begun taking an antidepressant off-label for insomnia, and she believes an undisclosed side effect of the drug drove him to suicide. Compelled to act, she became an advocate for tougher safety standards. Witczak now sits on … Continue reading “The Placebo Effect Is Hobbling New Psychiatric Drugs. What Can Stop It?”
Five Years After Y Combinator First Admits Biotechs, They’re Dug In
Five years ago, the big tech incubator Y Combinator started to welcome life sciences companies into its sizable startup classes, which had previously nurtured entrepreneurs in information technology almost exclusively. That opening to biotech startups in 2014 was controversial at the time. Some observers simply wondered what kind of guidance a deeply tech-focused accelerator could … Continue reading “Five Years After Y Combinator First Admits Biotechs, They’re Dug In”
Nobel Prize in Medicine Goes to 3 Who Showed How Cells Sense Oxygen Levels
Oxygen’s importance in cellular processes has long been known. But the work to understand how cells sense and adapt to changes in oxygen levels has led to medical insights and potential treatments for anemia, cancer, and more—and today, it has turned into the 2019 Nobel Prize in Medicine. William Kaelin Jr., Sir Peter Ratcliffe, and … Continue reading “Nobel Prize in Medicine Goes to 3 Who Showed How Cells Sense Oxygen Levels”
Precision IBD Rebrands as Prometheus and Strikes R&D Deal With Takeda
This summer Nestlé Health Science sold Prometheus Laboratories, a gastrointestinal disease diagnostics unit it had acquired eight years prior, to a low-profile San Diego biotech called Precision IBD. About a month ago, Precision—a drug and diagnostic developer that’s focused, as its name suggests, on inflammatory bowel disease (IBD)—changed its name to Prometheus Biosciences and tapped … Continue reading “Precision IBD Rebrands as Prometheus and Strikes R&D Deal With Takeda”
Bio Roundup: PARP Progress, A New Commish, IPO-Palooza & More
It’s been a strange up and down ride for PARP inhibitors, a relatively new class of cancer drugs. Named for the tumor protein they target, PARPs rebounded after a big clinical setback in 2011 and have been at the center of many buyouts and big alliances—Pfizer and Medivation, GlaxoSmithKline and Tesaro, AstraZeneca and Merck. Four … Continue reading “Bio Roundup: PARP Progress, A New Commish, IPO-Palooza & More”
We’re Beginning to Realize the Cloud’s Full Potential at the Edge
Amazon Web Services (AWS), the first “public cloud” offering third-party data storage and compute services, launched in March 2006, and by 2012, there were multiple credible competitors. The hype was strong. Back then, cloud evangelists were predicting that essentially everything in the enterprise data center would migrate to one of just a few public clouds. … Continue reading “We’re Beginning to Realize the Cloud’s Full Potential at the Edge”
ESMO 2019: PARP and Prostate, SeaGen’s Win, KRAS Update & More
The European Society for Medical Oncology meeting has wrapped up in Barcelona, the last major clinical cancer conference until December’s annual ASH meeting for blood diseases. We’ve highlighted a few top stories for you. Amid all the fuss over cell, gene, and immunotherapies these days, an old-fashioned small-molecule class of drug called PARP inhibitors have … Continue reading “ESMO 2019: PARP and Prostate, SeaGen’s Win, KRAS Update & More”
Dova Pharmaceuticals Agrees to Sobi Acquisition, Shares Jump 38%
In the past three years, Dova Pharmaceuticals has completed a company launch, gone public, and won its first drug approval. Now the biotech is in line to be acquired by Swedish Orphan Biovitrum (Sobi). According to deal terms announced Monday, Dova (NASDAQ: [[ticker:DOVA]]) stockholders will receive $27.50 per share up front, a 36 percent premium … Continue reading “Dova Pharmaceuticals Agrees to Sobi Acquisition, Shares Jump 38%”
Biotech Roundup: Vaping Toll Rises, NASH News, Akcea Shakeup & More
Lung injuries linked to electronic cigarettes have topped 800 cases, including 12 deaths, according to the Centers for Disease Control and Prevention. Public health officials aren’t sure whether the injuries are from legally sold products made by companies such as Juul, or from black-market items such as those that allow users to “vape” the active … Continue reading “Biotech Roundup: Vaping Toll Rises, NASH News, Akcea Shakeup & More”
Drug Pricing: Innovation, Investment, and the Public Good
The US biotech and life sciences industry has a long and proud history of driving medical innovations that have improved healthcare outcomes across a wide range of diseases and the overall quality of life for people worldwide. For too long, however, the industry’s narrative has been dominated and defined by partisans with a specific agenda … Continue reading “Drug Pricing: Innovation, Investment, and the Public Good”
Enough with the Insanity. We Need to Fix Cybersecurity Now
The year 2019 has been another dreadful period for cyberattacks. The most notorious lowlights include: —More than 40 municipalities, including Baltimore, Albany and 22 cities in Texas alone, have seen their computer systems crippled by ransomware attackers demanding millions of dollars. —In one of the largest data breaches ever, a hacker broke into a Capital One server with a … Continue reading “Enough with the Insanity. We Need to Fix Cybersecurity Now”
Bio Roundup: Pelosi’s Reveal, Alder’s Deal, Biogen’s Fails & More
Boston, San Francisco, and a few other metro areas might dominate the US life sciences, but some weeks, all bio-related eyes are on the nation’s capital. Health concerns about vaping continue to mount, and the feds could get involved. Meanwhile, try to find someone in the federal government who isn’t involved in the drug-price debate. … Continue reading “Bio Roundup: Pelosi’s Reveal, Alder’s Deal, Biogen’s Fails & More”
Pelosi, Dems Unveil Price Plan: Are 25 Drugs Enough for Negotiation?
With the 2020 election just over a year away, House Speaker Nancy Pelosi (D-CA) has unveiled the Democratic Party’s answer to public discontent over high prescription drug prices. A preview of the plan was leaked last week. Today’s announcement doesn’t stray far. The new plan would have the U.S. Department of Health and Human Services … Continue reading “Pelosi, Dems Unveil Price Plan: Are 25 Drugs Enough for Negotiation?”
Bio Roundup: Award Winners, Lung Data, Dems on Drug Pricing & More
For decades, advanced lung cancer was a quick death sentence. That’s no longer a given, thanks in part to the arrival of immunotherapy. If a medical meeting in Barcelona this week was any indication, more help could be on the way. Targeted medicine isn’t new to lung cancer, but only a fraction of patients have … Continue reading “Bio Roundup: Award Winners, Lung Data, Dems on Drug Pricing & More”
After First Look at House Drug Plan, Stocks Rise Slightly
The first details of the long-awaited House Democrat plan to lower drug prices leaked out Monday night, with elements that have long been anathema to the biopharma industry and its supporters in Washington. While the world digested the details Tuesday, however, biopharma investors didn’t seem fazed. Some individual companies saw shares dip, but the biopharma … Continue reading “After First Look at House Drug Plan, Stocks Rise Slightly”
Herceptin Inventors, Immunology Pioneers Take Home 2019 Lasker Awards
This year’s Lasker Awards, the US’s most prestigious biomedical honor, are going to five scientists whose work led to a critical breast cancer treatment and significant basic research advances that have helped pave the way for immunotherapy. H. Michael Shepard, Dennis Slamon, and Axel Ullrich won the Lasker-DeBakey Clinical Medical Research Award for inventing trastuzumab … Continue reading “Herceptin Inventors, Immunology Pioneers Take Home 2019 Lasker Awards”
Your Car Is Hackable—Here Are Three Steps You Can Take
We’re used to protecting the information on our smartphones by keeping strong passwords and setting a lock screen. But fewer people know about the importance of protecting the information in their vehicles. Earlier this year, the automotive shopping website CarGurus asked 1,020 consumers questions about common security practices and the risks of connected cars. Here … Continue reading “Your Car Is Hackable—Here Are Three Steps You Can Take”
At Big Lung Cancer Meeting, Lights Shine on KRAS, Drug Combos & More
The treatment landscape for lung cancer has shifted significantly over the past few years, and more changes could be on the way. At the World Conference on Lung Cancer in Barcelona this weekend a number of drug makers trotted out some of their latest advances in immunotherapy, targeted pills, drug combinations, and more. Xconomy rounded … Continue reading “At Big Lung Cancer Meeting, Lights Shine on KRAS, Drug Combos & More”
Bio Roundup: MedCo’s Pricing Plan, Vertex’s Gamble, uBiome Undone
Being first to market with a new type of drug brings advantages. The first mover sets the bar for what physicians, payers, and patients can expect of that medicine and how much it costs. It grabs market share that followers have to steal away. But the first mover isn’t infallible if someone else has something … Continue reading “Bio Roundup: MedCo’s Pricing Plan, Vertex’s Gamble, uBiome Undone”
Robocalls Crowd Out Real Business Calls. This Startup Has an Answer.
The ways in which robocallers try to dupe us are becoming almost as plentiful as the frequency of the calls. An unknown phone number was once all scammers needed to trick the average person into picking up the call. Now, new hoaxes are making it increasingly difficult to avoid fraud, such as the “one ring” … Continue reading “Robocalls Crowd Out Real Business Calls. This Startup Has an Answer.”
Bio Roundup: Cholesterol Check, J&J’s Opioid Hit, AbbVie’s Flop & More
You might be camping, barbecuing, or sleeping on Monday. It’s Labor Day, after all. But in Paris, this cardiologist will be in a conference center, walking an audience through a slide deck packed with Phase 3 data for a new cholesterol-lowering drug, inclisiran. Inclisiran’s owner, the Medicines Co., jumped the presentation by a week, promising … Continue reading “Bio Roundup: Cholesterol Check, J&J’s Opioid Hit, AbbVie’s Flop & More”
New PCSK9 Cholesterol Drug Faces Tough Foe. (Hint: Not Cholesterol.)
[Updated 8/26/19, 10:30am. See below.] Remember when the new wave of expensive cholesterol-lowering drugs—known as PCSK9 inhibitors—was supposed to give the healthcare system a financial heart attack? Far from it. Four years after approval the two PCSK9 blockers on the market have yet to crack $1 billion in annual sales, combined, thanks to a gloves-off … Continue reading “New PCSK9 Cholesterol Drug Faces Tough Foe. (Hint: Not Cholesterol.)”
GSK’s Cancer Comeback Continues With Data for Multiple Myeloma Drug
An experimental GlaxoSmithKline treatment for multiple myeloma has achieved the main goal of a key study, and the drug maker plans to file for regulatory approval by the end of this year. GlaxoSmithKline (NYSE: [[ticker:GSK]]) said Friday that treatment with its drug, belantamab mafodotin, showed a “clinically meaningful overall response rate” in the study. The … Continue reading “GSK’s Cancer Comeback Continues With Data for Multiple Myeloma Drug”
Bio Roundup: Sarepta’s Stumble, Opioid Suits, Shkreli’s Legacy & More
Biotech news tends to slow down in August but the past seven days have been busy for regulatory decisions. Three drugs and two devices won FDA nods. Not all companies were as fortunate. Several biotechs reported failed clinical trials or unfavorable FDA decisions. The most notable one might be the rejection of a Sarepta Therapeutics … Continue reading “Bio Roundup: Sarepta’s Stumble, Opioid Suits, Shkreli’s Legacy & More”