Manifold will use its tissue-targeting shuttle technology to help Roche develop new therapeutics for diseases of the central nervous system.
A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure.
Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk’s unsolicited bid to acquire obesity biotech Metsera.
Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.
Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone.
FEATURED STORIES
Market reaction to recent readouts from Compass Pathways and Beckley Psytech/atai in treatment-resistant depression speaks to the hurdles psychedelic therapies must clear to quell concerns about commercial viability.
Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach their full potential and ensure no eligible patient is overlooked.
Armed with the latest biological knowledge and cutting-edge computational techniques—and, of course, investor dollars—these six biotechs are playing in the largely underappreciated longevity space, developing therapies that may improve the quality of aging.
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
The industry sector focused on aging is only about 10 years old, but acting on what scientists already know, a new crop of biotechs, backed by investors, are taking a disease-centric approach to extending the human lifespan.
TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and shuttered businesses. Here are five biopharma players staying alive with differentiated candidates against the once promising immuno-oncology target.
LATEST PODCASTS
In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.
BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
Job Trends
AstraZeneca’s supplemental New Drug Application for TAGRISSO® has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated non-small cell lung cancer after chemoradiotherapy.
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
-
Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year. -
The deal follows a $1.06 billion U.S. contract in July 2024 and a $1.24 billion agreement with an Asia-based pharma a few months later. -
On the company’s Q4 earnings call where an eyepopping $88.8 billion in full-year sales were revealed, leaders shifted focus away from enormous takeovers to single-digit billion buy outs. -
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. -
Five years ago, Gilead signed a massive deal with Galapagos. After a restructuring, the pharma is still hunting for the potential it saw at the original signing.
WEIGHT LOSS
-
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis. -
Long considered resistant to economic downturns, the pharmaceutical industry may face a greater challenge this time around as GLP-1s dominate and the population grows older. -
Last week, The Trump administration reversed a Biden-era proposal for Medicare coverage of anti-obesity treatments. But on Monday, HHS suggested it is open to future policy considerations toward this end. -
Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree. -
Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage.
POLICY
-
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space. -
In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership. -
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors. -
Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency. -
The new version of the bill will still need to go through the entire House and Senate.
Becoming a chemist in the biopharma industry takes hard work, dedication and a willingness to continuously learn. Here’s what you need to know to become a biochemist.
As automation ramps up in the coming years, many jobs will be lost to machines. Here are a few life science sectors that are expected to maintain steady growth in the coming years.
Landing your first internship can be a major milestone in your career journey. Here’s what you can do to set yourself up for success and make the most of your life science internship.
The best thing a professional can do when considering a position at the FDA is weigh the pros and cons. To help, we’ve created a guide to working at the FDA, with benefits, challenges and tips.
The life science field offers a wealth of opportunities, even for those working outside of the field. Here are six life science jobs that don’t require industry experience.
With so many differences in research and regulation, it’s more important now than ever for job seekers considering moving outside of the U.S. to educate themselves before they make the leap.
HOTBEDS
IN CASE YOU MISSED IT
Perfecting microbial manufacturing processes means taming its greatest asset: speed. This rapid process for creating biologics also means a race against time, where success hinges on conquering three key challenges: designing a robust microbial strain, optimizing fermentation for industrial scale, and ensuring consistent high-yield product yield.
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 American Association for Cancer Research’s annual conference featured updates from several companies on key candidates and assets, including Merck’s Keytruda and GSK’s Jemperli. -
The drug, a small molecule protein inhibitor, brought in $132 million in the first quarter, missing consensus estimates by 17%. -
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.? -
Pfizer’s sasanlimab, when used with standard of care, reduced the likelihood of disease recurrence or progression, death due to any cause or persistence of cancer cells by 32% in patients with high-risk non-muscle invasive bladder cancer. -
The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of patients with non-muscle-invasive bladder cancer.
NEUROSCIENCE
-
Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in preclinical studies has shown the ability to cross the blood-brain barrier.
-
After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, which today began a rolling BLA for accelerated approval. -
Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
-
The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of potentially fatal brain swelling and bleeding. -
WVE-N531, an oligonucleotide, elicited significant functional benefit and reversal of muscle damage in the Phase II FORWARD-53 trial. Wave plans to file for accelerated approval of the candidate in 2026.
CELL AND GENE THERAPY
-
Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth. -
Roche acquired Spark Therapeutics in 2019 for $4.8 billion. -
Abecma made $406 million in 2024, of which BMS paid $43 million to 2seventy bio as part of their profit-sharing agreement. -
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space. -
On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
