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”
Category: Detroit
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”
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”
Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod
An Esperion Therapeutics drug that pairs two cholesterol-lowering medicines in a single pill has been approved by the FDA, the second regulatory nod for the company in less than a week. The reglator’s decision covers the combination of Esperion’s bempedoic acid (Nexletol) and ezetimibe, an older generic drug for reducing levels of the “bad” form … Continue reading “Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod”
Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected
As Esperion Therapeutics steered its cholesterol-lowering drug through clinical testing and regulatory review, CEO Tim Mayleben did something unusual for a pharmaceutical executive: he spoke openly about price. Specifically, he talked about how inexpensive the drug would be. As early as two years ago, Mayleben said an FDA-approved Esperion (NASDAQ: [[ticker:ESPR]]) drug would cost patients … Continue reading “Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected”
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”
Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug
Spruce Biosciences has raised $88 million to advance clinical testing of a drug for a rare inherited endocrine disorder that can lead to a potentially life-threatening hormonal imbalance. San Francisco-based Spruce aims to treat a form of congenital adrenal hyperplasia (CAH), an inherited condition that leads to a deficiency in enzymes needed to produce certain … Continue reading “Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug”
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”
Millendo Picks Poxel’s Arbet-Engels for Chief Medical Officer Post
Millendo Therapeutics (NASDAQ: [[ticker:MLND]]) has appointed Christophe Arbet-Engels to serve as its chief medical officer, the same position he held most recently at Poxel Pharmaceuticals. Arbet-Engels’s experience also includes positions at Biogen (NASDAQ: [[ticker:BIIB]]), Boehringer Ingelheim, Roche, Merck (NYSE: [[ticker:MRK]]), Aventis and Ligand Pharmaceuticals (NASDAQ: [[ticker:LGND]]). Millendo’s most advanced drug candidate, livoletide, is being developed … Continue reading “Millendo Picks Poxel’s Arbet-Engels for Chief Medical Officer Post”
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”
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”
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”
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”
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”
Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More
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”
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”
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”
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”
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”
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”
Stryker Adds to Trauma & Extremities Biz With $4B Wright Medical Deal
Medical device giant Stryker is strengthening its presence in trauma and extremities surgeries with a cash deal to acquire Wright Medical for $4 billion. According to deal terms announced Monday, Kalamazoo, MI-based Stryker (NYSE: [[ticker:SYK]]) will pay $30.75 per share, a nearly 40 percent premium compared to the Friday closing stock price of Wright Medical … Continue reading “Stryker Adds to Trauma & Extremities Biz With $4B Wright Medical Deal”
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”
Venture Investors Bets on Healthcare, and Milwaukee, With $75M Fund
Venture Investors is going all-in on healthcare with its latest venture fund. Launched in 1982, Venture Investors (VI) is the oldest venture firm in Wisconsin, and one of the older VCs in the US. Historically, early-stage life sciences and healthcare startups have made up the majority of its investments, but it has also backed young … Continue reading “Venture Investors Bets on Healthcare, and Milwaukee, With $75M Fund”
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”
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”