Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer.
The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.
With more than $1.5 billion on the line, Gilead looks to bolster its CAR T portfolio.
EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza.
During this webinar BioSpace sits down with former FDA Chief Information Officer Vid Desai to discuss the potential advantages and pitfalls of deregulation stemming from one of President Donald Trump’s first executive orders. Together, they uncover what this shift means for drugmakers, compliance and patient safety.
In this episode presented by PII, BioSpace’s head of insights discusses decentralized clinical studies and how connected technology can improve patient compliance with guests Oliver Eden and Travis Webb.
FEATURED STORIES
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.
Since 2016, the FDA has approved three disease-modifying treatments for spinal muscular atrophy, with several companies—including Novartis, Scholar Rock and Biogen—progressing novel candidates through clinical trials.
The FDA approval of Alnylam’s Amvuttra sets up a three-way race with Pfizer and BridgeBio, which both market transthyretin stabilizers for transthyretin amyloid cardiomyopathy.
With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff.
The explosion of GLP-1 weight loss drugs is reminiscent of the early days of PD-1 inhibitors, but key market differences suggest history may not repeat itself.
The ongoing conflicts between Ukraine and Russia, as well as Israel and Palestine, have sent ripples across various industries, including pharma. Medical science liaisons can help.
LATEST PODCASTS
In this second episode of our collaboration with DIA, we discuss the challenging, collaborative process of regulating advanced therapy product development with guests James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.
AstraZeneca targets $80 billion in revenue by 2030, layoffs at Bayer, BMS and Pfizer continue to generate attention across the biopharma industry, Takeda takes a deep dive into the molecular glue space and conference season is in full swing.
BioSpace’s Lori Ellis discusses the risks and challenges of cell and gene therapy combination products with DIA speakers James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.
Job Trends
Gilead Sciences, Inc. and Kite, a Gilead Company, will present 18 abstracts during the 2024 American Society of Clinical Oncology Annual Meeting.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
-
Sangamo Therapeutics announced Tuesday it secured an exclusive licensing agreement with Roche’s Genentech, which is paying $50 million in near-term upfront fees and milestone payments to develop novel genomic medicines for neurodegenerative diseases. -
Biotech entrepreneur Arie Belldegrun and former Roche CEO Franz Humer are part of the credit firm’s push to provide companies with another source of funding, Symbiotic Capital announced Tuesday. -
As part of a pipeline realignment, Bristol Myers Squibb is returning the rights to Agenus for its proprietary TIGIT bispecific antibody program and terminating their 2021 license, development and commercialization agreement. -
With an upfront $800 million payment and $325 million in potential milestones, Otsuka Pharmaceutical is acquiring Jnana Therapeutics’ drug discovery platform and rare disease candidate, the companies announced Thursday. -
A report from J.P. Morgan shows an increase in biopharma activity so far this year and where some improvement can be made.
WEIGHT LOSS
-
The EMA approved a kidney disease–related label expansion for the blockbuster GLP-1 drug after a study showed reduced risk of death by 20%. -
The discontinuation of STRIDES is a rare stumble for the next-generation obesity field and comes just weeks after Amgen announced underwhelming mid-stage data for MariTide. -
Eli Lilly is aggressively ramping up its manufacturing capacity for tirzepatide as compounding pharmacies continue to challenge an FDA decision to formally end the shortage of the obesity and diabetes drug. -
In recent months Novo Nordisk has invested several billions of dollars to boost its manufacturing capacity—including its highly contested $16.5 billion merger with CDMO giant Catalent. -
The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week.
POLICY
-
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president. -
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming. -
The Fourth Circuit’s ruling follows a Supreme Court verdict that also allowed the Trump administration to move forward with its mass layoffs at federal agencies. -
As the industry awaits official word from the administration on how the tariffs will hit, analysts go over the possibilities with one certainty: there will be increased costs for medicines. -
Analysts suggested that the tariffs will have little effect on reshoring manufacturing and will likely decrease patient drug access and increase costs.
Just like first impressions, the first 30 days at your new job can set the tone for a new position.
Providing interview feedback to the candidate after an interview is very crucial if you want to pick out only the best. This article will help you do that efficiently.
Are you feeling that your productivity is decreasing at work? Here are some beneficial time management strategies to be mindful of to get work done efficiently.
Here are some of the best remote companies to work for this year. These companies can provide you with the right kind of exposure that will help you professionally.
What are the benefits of becoming a remote worker? Let’s explore together.
If you’re considering preparing for your next interview, know that you need to learn the art of drafting a perfect cover letter to show that you’re a great match for the position.
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
-
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this month the company has secured an approval for AstraZeneca-partnered Dato-DXd, to be marketed as Datroway. -
The unsuccessful Phase III results are the latest to suggest that the blockbuster cancer drug is finally bumping up against its limits after racking up around 50 approvals since getting its first FDA nod in September 2014. -
Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year. -
With an eye toward advancing a novel antibody-drug conjugate for gastrointestinal cancers, ArriVent is the latest biopharma player to ink a deal with a Chinese biotech. -
Ascentage is looking to use the IPO proceeds to advance its Phase III candidates for chronic or small lymphocytic leukemia and for certain types of chronic myeloid leukemia.
NEUROSCIENCE
-
Some 90% of investigational drugs fail—and success rates are even more dire in the neuro space. Here, BioSpace looks at five clinical trial flops that stole headlines over the past 12 months. -
Even as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla slowly roll out onto the market, experts question the efficacy of these anti-amyloid antibodies and the amyloid hypothesis overall. -
GSK, Gilead and Arcellx, Vertex and more present new data at the American Society of Hematology annual meeting just as sickle cell therapies Casgevy and Lyfgenia have a new outcomes-based payment model; Eli Lilly and Novo Nordisk pump new funds into manufacturing; and AbbVie makes a Cerevel comeback while uniQure clears a path toward accelerated approval in Huntington’s disease. -
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130. -
Relmada Therapeutics will halt two Phase III trials of a major depressive disorder drug after a futility assessment and explore strategic alternatives including a potential sale to maximize shareholder value.
CELL AND GENE THERAPY
-
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. -
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.
