In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
Cycle’s second unsuccessful takeover bid comes on the heels of the FDA denying approval for Vanda’s tradipitant, which was being proposed for the treatment of gastroparesis.
Evonik’s latest layoffs are tied to discontinuing production of keto acids in Hanau, Germany, by the end of next year. Earlier this year, news broke the company is also cutting up to 2,000 employees globally by 2026.
Under the deal, the Danish pharma will gain access to Longboard’s 5-HT2C receptor superagonist that is currently in late-stage development for seizures in various developmental and epileptic encephalopathies, including Dravet syndrome.
European CDMO Ardena will buy Catalent’s oral solids manufacturing facility in Somerset, N.J.
While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
FEATURED STORIES
Analysts expect the partners’ first-mover advantage, clinical data and existing presence in lung disease to translate into significant sales, with GlobalData predicting Dupixent’s COPD revenues will top $6.5 billion within 10 years.
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
FROM BIOSPACE INSIGHTS
As technology continues to evolve, companies should have strategies that incorporate an understand of where they are now, where they want to be, and do they have the talent to get there.
LATEST PODCASTS
In the third episode of our mini series on artificial intelligence, Lori and guests continue their exploratory discussion on AI and the opportunity in patient lives.
Cell and gene therapy investment rebounds; WuXi Biologics and other companies named in BIOSECURE Act mull options; Bayer, J&J and Pfizer’s recent layoffs; updates from the weight loss space.
Bristol Myers Squibb wins approval for the first novel schizophrenia drug in decades; Pfizer pulls Oxbryta from the market; new IVF and abortion laws could derail women’s health research; Roche touts CDK inhibitor deal and obesity pipeline and BioSpace heads to Meeting on the Mesa.
TRACKERS
Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
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SPECIAL EDITIONS
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%.
The pace of mergers and acquisitions has accelerated. In this deep dive, BioSpace takes a closer look at the nature of recent deals and the players involved.
DEALS
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Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices. -
After four patient deaths, Kezar’s lupus trial is officially on hold, sparking investor Kevin Tang’s interest for acquisition. -
Big Pharma can’t seem to get enough radiopharmaceutical biotechs. With Lilly, Sanofi and BMS chasing Novartis into the complex space, all eyes are on these specialty biotechs. -
On the heels of Keytruda’s success in a Phase III perioperative trial for a disease where it had previously failed to improve event-free survival, Merck touts an I&I deal with UK biotech Mestag. -
As traditional fundraising methods falter for smaller firms, the rise of royalty deals is reshaping how companies access capital, offering an alternative that bypasses equity dilution and debt.
WEIGHT LOSS
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Cell and gene therapy investment rebounds; WuXi Biologics and other companies named in BIOSECURE Act mull options; Bayer, J&J and Pfizer’s recent layoffs; updates from the weight loss space. -
Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data. -
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents. -
After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile. -
Scaling GLP-1 manufacturing capacity remains a key priority for the pharma industry, to help supply catch up with the insatiable demand for weight loss drugs.
FDA
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The approval makes Pfizer’s Hympavzi the first once-weekly subcutaneous prophylactic injection for hemophilia B in the U.S., according to the company, which is currently embroiled in a row with activist investor Starboard Value. -
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease. -
Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor of Stealth BioTherapeutics’ Barth syndrome therapy elamipretide, citing the urgent unmet need. -
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue. -
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
In our comprehensive guide to salary negotiation, we’ll teach you what a market salary is, how to research a market value salary and, ultimately, how to negotiate your salary according to market value.
During the job application and interview process, candidates who lie to prospective employers and those who don’t properly highlight their accomplishments can find it difficult to land—or keep—their next role. We asked experts how to sell yourself positively and honestly.
Dealing with a toxic co-worker can be exhausting, and it can make your workplace more stressful. There are a few ways to make it easier, including developing healthy coping mechanisms and even talking it out with your colleague.
Job security is a hot topic among biopharma professionals. A career coach offers advice for how to evaluate and build it up and what to do if that evaluation leaves you worried.
Good company culture is a crucial aspect of professional life. Look at these 11 important indications of good workplace culture before accepting a job offer or use them to evaluate your new employer.
An appreciation for practicality, independent thinking and patient care can help disrupt the bureaucracy of Big Pharma.
HOTBEDS
REPORTS
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals.
CANCER
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The overall survival data from the late-stage trial will help Pfizer in its bid to expand the label for Talzenna and Xtandi, potentially covering all patients with metastatic castration-resistant prostate cancer regardless of biomarker status. -
The pediatric patients, with a rare neurodegenerative disease, were treated with bluebird bio’s Skysona to slow the progression of neurologic dysfunction. Six patients developed myelodysplastic syndrome and one patient developed acute myeloid leukemia. -
After several high-profile failures, including BMS’ $1.5B breakup with Agenus, anti-TIGIT therapies are generating cautious optimism. -
Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy. -
The acquisition was featured Monday in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs.
NEUROSCIENCE
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Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later. -
Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year. -
With Monday’s data from SAPPHIRE, Scholar Rock is building toward regulatory submissions for apitegromab in spinal muscular atrophy in the first quarter of 2025. -
Bristol Myers Squibb wins approval for the first novel schizophrenia drug in decades; Pfizer pulls Oxbryta from the market; new IVF and abortion laws could derail women’s health research; Roche touts CDK inhibitor deal and obesity pipeline and BioSpace heads to Meeting on the Mesa.
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From Eli Lilly to Karuna Therapeutics to current owner Bristol Myers Squibb, the newly approved schizophrenia drug had quite the journey to market. Former Karuna and Lilly executives discuss the “accidental” and “serendipitous” discovery.
CELL AND GENE THERAPY
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While ex vivo genome editing results in highly effective cell therapies, it can lead to off-target effects. Caribou Biosciences has come up with a novel approach for potentially more precise gene editing compared to all-RNA guides. -
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry. -
Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that investments reached $10.9 billion in the first half of this year—outpacing 2019’s $9.8 billion total—but far below the pandemic peak. -
The Financial Times reported Thursday that WuXi AppTec is looking to sell its cell and gene therapy manufacturing unit, with facilities in Philadelphia, while WuXi Biologics wants to offload some of its production sites in Europe. -
Stephen Majors from the Alliance for Regenerative Medicine, which hosts the conference, spoke with BioSpace about what the more than 2,000 attendees can expect to learn next week in Phoenix about the pressing issues confronting the industry.
