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It’s the season for reevaluation as companies weed out programs that don’t offer much promise. At the head of the line is Sanofi SA’s once-potential myasthenia gravis blockbuster tolebrutinib. A partial clinical hold on the phase III study is part of the reasoning for stopping its development. But so is competition, the company said. Other companies eliminating development programs include Roche Holding AG, Gilead Sciences Inc., AB Science SA and Merck & Co. Inc.
It’s the season for reevaluation as companies weed out programs that don’t offer much promise. At the head of the line is Sanofi SA’s once-potential myasthenia gravis blockbuster tolebrutinib. A partial clinical hold on the phase III study is part of the reasoning for stopping its development. But so is competition, the company said. Other companies eliminating development programs include Roche Holding AG, Gilead Sciences Inc., AB Science SA and Merck & Co. Inc.
Starting out the year slow, biopharma financings are about 22% below where they were at the end of January last year, and they are well behind the first month of the previous two years as well, suggesting company executives may need to continue to prioritize costly programs as resources are depleted – at least for the near future.
Spinal muscular atrophy (SMA) has been surfacing more regularly in scientific journals lately, as drug developers – such names as Biohaven Inc., Roche Holding AG and Scholar Rock Inc. – continue to search for improved therapies directed at the condition, one that takes in a group of hereditary, motor neuron-destroying diseases.
Could long non-coding RNAs be the key to developing organ-specific antifibrotic drugs that only mediate their effects in disease-related contexts? That’s the intriguing hypothesis that Haya Therapeutics SA has set out to explore, and its lead program, in heart failure caused by non-obstructive hypertrophic cardiomyopathy, is now in IND-enabling studies. A first clinical trial is pencilled in for late 2024 or early 2025.
Turbine Ltd. began the new year with a partnership with Cancer Research Horizons, the innovation arm of Cancer Research UK, which will put its Simulatedcell computational biology platform to work on the vexed question of how best to position CDC7 inhibitors in cancer.
BioWorld Science Managing Editor Anette Breindl discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity.
While it made a sturdy effort as biopharma companies opted for licensing deals over M&As in 2022, the year did not surpass 2021 in deal values, falling about 3.5% short. Lackluster M&A values dropped to their lowest levels in five years and were down by 35.6% compared with 2021.
The $60.8 billion collected by biopharma companies throughout 2022 is a sharp drop from each of the two prior years, down by 48.6% from 2021 and 54.8% from 2020. Each were standout years by any measure and a direct result of the investment fervor for the industry brought on by the COVID-19...
In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.
For European biotechnology, 2022 was a year of contraction. Disclosed equity investments in European firms engaged in the discovery and development of therapeutics totaled $6.782 billion, down 55% on the previous year’s record-breaking tally of $15.193 billion. Last year’s tally is the worst...
It’s been a tough year for raising biotech money, according to the new U.K. Biotech Financing Report, but there are bright spots in an otherwise dark period. What happened last year in the U.K. basically mirrored what happened with global financings as IPOs are significantly down while venture...
Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. GLP-1R agonists, which are also called incretin mimetics and GLP-1 analogs, are likely to continue...
Researchers at Stanford University School of Medicine have developed a method to measure several thousand metabolites, including proteins, metabolites, inflammatory markers such as cytokines and, to a degree, lipids. “It’s like Theranos, except it works,” corresponding author Michael Snyder,...
A psychiatric disorder rarely comes alone. More than half of all individuals who meet the diagnostic criteria for any psychiatric disorder are diagnosed with more than one condition. That high degree of comorbidity is often viewed as a consequence of the heterogeneity of psychiatric disorders – and...
After raising an undisclosed sum in a series A round, French biotech company Adipopharma LLC aims to progress its make-or-break targeted insulin resistance peptide into a phase I trial in type 2 diabetes patients by the end of 2023.
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to...
Pulmobiotics Ltd., which was founded in 2019, is developing cell therapy for lung diseases, including lung cancer. But unlike other cell therapies for cancer, this one is based not on harnessing T cells but on engineering bacteria. The team has engineered Mycoplasma pneumoniae to deliver various...
Juvena Therapeutics Inc. co-founder and CEO Hanadie Yousef had the company’s name picked out several years before it was officially incorporated in 2017 to combine Yousef’s work in the mechanics of aging with an underutilized class of biologics and an advanced proteomics platform to tackle chronic...
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew...
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in...
Where European regulatory decisions were concerned, there was good news and bad news for pharma today as Sanofi SA and Regeneron Pharmaceuticals Inc. got the go-ahead for expanded approval of Dupixent (dupilumab) in pediatric atopic dermatitis patients whilst Ipsen SA’s ultra-rare bone disease drug...
In the absence of a European framework, industry is stepping up with an initiative to help EU patients cross borders to participate in clinical trials.
Abbvie Inc. and Eli Lilly and Co. Inc. have pulled out of the U.K.’s voluntary pricing scheme for branded drugs in protest at the 26.5% of their revenues they would be required to pay back to the government in 2023.
By next June or July, Swedish firm Atrogi AB expects to have data from a first-in-human phase Ia/Ib trial of its novel beta-2 adrenergic receptor agonist, ATR-258, which is in development for type 2 diabetes. The study has completed single...
Biophytis SA’s investigational treatment for hospitalized COVID-19 patients with severe disease, Sarconeos (BIO-101), reduced the risk of respiratory failure or early death by 44% compared to placebo, final data from a phase II/III COVA trial...
Sirnaomics Ltd. is gearing up to start a phase III clinical trial for its lead siRNA candidate, STP-705, for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ and basal cell carcinoma. STP-705 comprises two siRNA...
Taysha Gene Therapies Inc.’s stock (NASDAQ:TSHA) struggled Feb. 1 following the U.S. FDA’s recommendation that the company dose more patients in a double-blind, placebo-controlled study of TSHA-120 for the ultra-rare indication giant axonal...
Evelo Biosciences Inc.’s late-stage efforts with EDP-1815 are forging ahead despite unfavorable data in atopic dermatitis (AD), and talks so far with the U.S. FDA have proven encouraging, the company said. Cambridge, Mass.-based Evelo made public...
Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle.
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.