Unlike other hemophilia therapies, Qfitlia is indicated for both hemophilia A and B, and can be given in patients regardless of the presence of neutralizing antibodies against clotting factor VIII or IX.
BMO Capital Markets analysts said the results potentially position lepodisiran as “one of the most durable assets in development to date” in the competitive Lp(a) space, where drugs are designed to lower the risk of cardiovascular events such as heart attack and stroke.
Ayrmid’s offer is 50% higher than bluebird’s previously announced deal with Carlyle and SK Capital Partners.
According to BMO Capital Markets, Rybelsus’ outcomes in SOUL were “inconsistent,” failing to significantly lower cardiovascular death and nonfatal stroke.
Werner held roles at Bristol Myers Squibb, AstraZeneca and Novartis before landing at Alltrna, where she works to develop tRNA-based treatments for a range of diseases.
In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.
FEATURED STORIES
As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases.
Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs.
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
Greg Slabodkin, Heather McKenzie and Tyler Patchen discuss BioSpace’s tenth annual NextGen list of the hottest new life sciences companies.
On this episode of the Weekly: Biden administration puts pressure on the biopharma industry; renewed interest in psychedelics after MindMed announces LSD-based candidate meets primary endpoint; bluebird changes its tune.
How can startup leaders support long-term sustainable growth and investment? BioSpace’s Lori Ellis speaks with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen for their advice and recommendations on how biopharma startups should approach funding.
Job Trends
One year since forming its Advisory Board, Lokavant, the clinical trial intelligence platform company, announces three new members, including Pfizer’s Head of Predictive Analytics Jonathan Crowther.
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SPECIAL EDITIONS
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.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
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The early-stage oncology startup filed for an initial public offering on Wednesday, seeking funds to help develop its novel cancer therapies targeting extrachromosomal DNA.
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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Companies inked 204 deals in the fourth quarter of 2023 with venture capital funding slipping to $6.3 billion from $7.8 billion in the third quarter last year, according to market data firm Pitchbook.
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After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year.
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Antibody-drug conjugates are a breakthrough in targeted cancer therapy and will continue to attract big pharma investment over the next few years, finds a new report from market intelligence firm Evaluate.
WEIGHT LOSS
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Pfizer selects its candidate for the oral GLP-1 race as Eli Lilly strives to overtake Novo Nordisk in the injectable weight-loss drug space. Meanwhile, pressure builds to reduce drug prices in the U.S.
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To help keep pace with the demand for GLP-1 therapies, CordenPharma has announced a sizeable $980 million investment in its U.S. and European sites.
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Some analysts say so, and a recent study suggested Lilly’s tirzepatide beat Novo’s semaglutide at inducing weight loss, but there are other factors in the market race.
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Despite recent concerns about suicidality and other neuropsychiatric issues, a recent study has found that Novo Nordisk’s Ozempic (semaglutide) is associated with lower risks of dementia, cognitive deficit and nicotine misuse.
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Pfizer said Thursday it is pushing ahead with a once-daily, modified-release formulation of its oral GLP-1 obesity therapy danuglipron, with dose optimization studies in the second half of 2024.
POLICY
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Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
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Amgen’s Enbrel, Bristol Myers Squibb’s Eliquis and Johnson & Johnson’s Stelara will account for 51.4% of the Inflation Reduction Act’s drug price negotiation savings in 2026, according to the Brookings Institution.
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In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.
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For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous.
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Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
Since almost every job market has become more competitive, you need to start improving your skills. Here are a few tips that can help you in skill development.
Before we look at the tips and tricks that can help you bag a job in pharma, we should look at the complications that you might face when getting the job.
Workplace issues can arise anytime so it is always better to be prepared to seek out the problems directly in a mannered way to avoid any kind of personal rivalry.
Let’s talk about some common mistakes job candidates make during interviews, so you can steer clear of them for your next interview! Here’s how to nail a job interview.
Here are some effective career development tips that can help you stay ahead and accomplish milestones. Don;t miss any of it if you want a successful career.
Project leadership is not an easy task to handle. You become responsible for every action. Therefore, learn some tips to perform your duty effectively.
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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The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
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High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures.
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The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
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Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.
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In an effort to build its commercial capacity, Moderna on Thursday announced it is lowering research and development spending, while pushing back its target for breaking even by two years to 2028.
NEUROSCIENCE
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The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.
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PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study.
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Psychedelic drug developers are homing in on the potential $16 billion depression treatment market, with a particular focus on treatment-resistant depression.
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Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein.
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A new observational study from the University of Iowa points to the potential of alpha-blocker drugs, commonly used to treat enlarged prostates, as a preventive therapeutic option for dementia with Lewy bodies.
CELL AND GENE THERAPY
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Adeno-associated viruses have long been go-to vectors for gene therapies. How AAVs are improving will be among the cell and gene therapy topics to be covered in Baltimore this week.
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Follow News Editor Greg Slabodkin and Managing Editor Jef Akst as they travel with some 8,000 others for discussions of cell and gene therapy advances, challenges, regulations and more.
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Ahead of the FDA’s June target action date for Sarepta’s Duchenne muscular dystrophy gene therapy, ICER Chief Medical Officer David Rind blasted the regulator’s accelerated pathway in a JAMA viewpoint article.
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Astellas Pharma and Poseida Therapeutics have entered into a second CAR-T contract to develop novel and flexible allogeneic cell therapies in oncology.
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Q&A: Development Scientist at AGC Biologics Sara Morlacchi analyzes the growth of the cell therapy industry and barriers for cost and accessibility.