Spring cleaning starts early as Sanofi and others cut programs
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.

Spring cleaning starts early as Sanofi and others cut programs
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.
Biopharma financings hit $3.9B in January, down by 22% from last year
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.
Today's news in brief
BioWorld briefs for Feb. 3, 2023.
Myostatin approach gains ground in SMA; Biohaven, Roche, Scholar Rock in mix
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.
Haya targets lncRNA for tissue-specific fibrosis drugs
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’s cell simulation platform to probe unanswered questions in oncology
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.

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Analysis and data insight

Shy of the prior year, deals reach $206B in 2022; M&As fall behind by 36%
Deals and M&A
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.
Biopharma financings stall in 2022; four other years higher than $60.8B raised
Financings
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...
Though down, accelerated approvals not out in 2022
Regulatory
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.
The year of the squeeze: Europe equity funding drops 55% to $6.8B in 2022
Financings
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...

Financings

The 2022 UK Biotech Financing report: IPOs dropped but venture cap stood strong
IPO
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...

Science

As weight loss medicine advances, its relevance recedes
Endocrine/Metabolic
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...

Microsampling plus multiomics enables mail-order metabolism
Endocrine/Metabolic
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,...
Common network found across multiple psychiatric disorders
Neurology/Psychiatric
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...

Newco news

Clinical trial on horizon for company that restores the adipocyte
Diabetes
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 on the path to validating traditional medicine for the modern world
Cancer
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 is developing cell therapy for lung diseases, but with a twist
Cancer
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 looking to hESC-secreted proteins for treating age-related disease
Musculoskeletal
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...
Lusaris tackling treatment-resistant depression with neuroplastogen approach
Neurology/Psychiatric
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...

U.S.

Biden administration to allow pandemic-driven public health emergency to end
Coronavirus
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...

Europe

EMA says yes to Sanofi/Regeneron’s dermatitis drug, no to Ipsen’s bone disease contender
Regulatory
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...

EFPIA: Borders shouldn’t be barriers to EU clinical trials
Regulatory
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, Lilly withdraw from UK pricing scheme over ‘punishing’ 2023 rebate
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.

Clinical

Trial data on Atrogi’s new diabetes drug imminent
Diabetes
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...
Now COVA is over, Biophytis vies for a piece of the COVID-19 pie
Coronavirus
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 seeks FDA guidance for phase III skin cancer candidate
Cancer
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 ponders new study for ultra-rare disease as stock droops
Neurology/Psychiatric
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’s path in AD not EASI as placebo response garbles SINTAX of phase II effort
Dermatologic
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 starts patient dosing in phase III clinical trial for ecnoglutide
Diabetes
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.

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