In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.
GlycoEra’s lead candidate targets IgG4 autoantibodies, potentially addressing autoimmune diseases such as muscle-specific kinase myasthenia gravis and pemphigus.
Acute systemic infection caused the patient to develop fatal capillary leak syndrome, highlighting the unpredictability of gene therapies and potentially challenging investment in the space, analysts say.
With $90 million to start, Syndeio has a lead asset in Phase II clinical trials for major depressive disorder, with plans to soon launch a biomarker trial in Alzheimer’s disease.
According to President Trump, CMS Administrator Mehmet Oz is a “tough hombre” who can bring down drug costs “like a rock.”
Prothena has already discontinued the development of birtamimab, and anticipates further spending cuts, including workforce reduction.
FEATURED STORIES
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
As the pharma industry awaits congressional action on the bill, gaping holes in the domestic drug manufacturing ecosystem have never been clearer.
Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
The recent invalidation of an AAV gene therapy patent overlooks the complexity of innovation in biotechnology and could put a broad swath of intellectual property at risk.
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
Job Trends
Novartis announced new data demonstrating the early addition of twice-yearly* Leqvio® to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease, including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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The blank check company Thursday filed with the SEC for the initial public offering. While a specific business for Helix Acquisition Corp. II has not yet been identified, the fund will target biotech. -
Nearly two decades in the making, the companies expect to close the deal in the first half of 2024, after which Taro Pharmaceutical will become a privately held entity and will no longer trade on the New York Stock Exchange. -
The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024. -
Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time. -
Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year.
WEIGHT LOSS
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While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData. -
A Senate health committee report published Wednesday forecasts spending on prescription drugs to hit $1 trillion a year in 2031, unless the prices of GLP-1 medicines such as Novo Nordisk’s Wegovy are cut. -
Roche’s $2.7 billion acquisition of Carmot Therapeutics in December 2023 appears to be paying off as its investigational GLP-1/GIP receptor agonist induced strong weight loss in a Phase Ib study. -
The weight-loss drug bonanza continued in the first quarter of 2024 for Novo Nordisk and Eli Lilly, as Amgen also posted strong results, while Biogen and BMS struggled early in the financial year. -
While the FTC continues to review its $16.5 billion buy of Catalent, Novo Holdings announced Wednesday it has acquired a majority stake in Single Use Support, an Austrian life sciences tools company.
POLICY
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The chair of the House Committee on Oversight and Accountability wants the CEOs of CVS Caremark, Express Scripts and Optum Rx to fix statements they made in a hearing last month that contradicted the committee’s and Federal Trade Commission’s findings. -
Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition. -
Well-financed startup Tome is winding down operations just as two new companies, Borealis Biosciences and GondolaBio, are launching. Meanwhile, in the midst of already tense relations with China, House lawmakers raise the alarm about U.S. companies working with the country’s military on trials. -
The number of patients who will be eligible for Novo Nordisk’s blockbuster GLP-1 under new Medicare Part D plan guidelines will vary depending on how cardiovascular disease is defined, according to researchers. -
Johnson & Johnson’s proposed changes to the hospital drug discount program are inconsistent with the federal statute, according to the Health Resources and Services Administration.
While it’s only a few hundred words, writing a good follow-up email accomplishes a few important things. Here’s how you can write an impressive interview follow up email.
Often times, you can fall into a trap of seeing a particular title, skimming a listing, and firing off an application.
Are you interested in the practical application of life sciences research? If so, an understanding of translational research is useful to see the vast opportunities to help patients and cure diseases.
The life science industry produces a complex, high-stress and intricate work environment, so it’s no surprise that workaholics pop up in this industry all the time.
Whether your controlling coworker wants to hold onto the data for their own use or refuses to compromise with you. Whatever, it is, it can lead to various problems.
Are you willing to relocate internationally to further your career? It can be a difficult decision with much to consider including language, cultural and industry differences.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker. -
Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention. -
The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment. -
Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates. -
NuCana’s chemotherapy replacement has failed to improve progression-free survival in a Phase II test, sending the biotech’s shares down by 50%.
NEUROSCIENCE
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With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens. -
Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques. -
With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis. -
While Teva missed Wall Street expectations in the first quarter of 2024, it reported Wednesday a 5% increase in Q1 revenues while reporting that the company’s schizophrenia candidate scored a late-stage trial victory -
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.
CELL AND GENE THERAPY
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To help support the launch of Lyfgenia, bluebird bio on Monday entered into a five-year term loan deal with Hercules Capital that will extend the biotech’s cash runway through the first quarter of 2026. -
Orchard Therapeutics on Monday secured the FDA’s first approval for an autologous gene therapy to treat the rare metabolic disease metachromatic leukodystrophy in children. -
By votes of 11-0 and 8-3, respectively, an FDA advisory committee Friday deemed the risks of early death for both Johnson & Johnson’s Carvykti and Bristol Myers Squibb’s Abecma acceptable. -
Asgard Therapeutics, a Swedish gene therapy biotech, has closed a $32 million Series A round with help from prominent pharma players as it prepares for a 2026 IND. -
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
