After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.
Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts.
In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped patients lose the same amount of weight as patients on tirzepatide alone while preserving more muscle mass.
The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.
Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.
The new version of the bill will still need to go through the entire House and Senate.
FEATURED STORIES
With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
Pfizer CEO Albert Bourla is in a tough spot as activist investor Starboard Value continues to call for a change in the company’s leadership. However, analysts are supportive of the embattled executive.
The group of like-named companies that include Novo Holdings and Novo Nordisk—the two tied to a multibillion-dollar buyout of Catalent currently under FTC review—ultimately send proceeds to the Novo Nordisk Foundation, one of the world’s largest charitable foundations.
Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state.
In the wake of Pfizer’s voluntary market withdrawal of the popular sickle cell disease therapy, BioSpace looks at five investigational drugs currently making their way through the pipeline.
Pharmaceutical companies are combining antibodies with radioisotopes in a bid to more precisely deliver radiation to cancers and tumors.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
LATEST PODCASTS
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from JPM2024.
BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation discuss alternative financing strategies to consider for 2024. Listen now.
Greg Slabodkin, Heather McKenzie and Tyler Patchen discuss BioSpace’s tenth annual NextGen list of the hottest new life sciences companies.
Job Trends
Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
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.
DEALS
-
The contract manufacturer plans to expand its U.S. footprint with a former Roche facility in Vacaville, California, which Lonza contends is one of the largest biologics manufacturing facilities in the world by volume. -
Following in the footsteps of Bristol Myers Squibb and Eli Lilly, AstraZeneca on Tuesday jumped into the radiopharmaceuticals space by acquiring Fusion Pharmaceuticals in a deal worth $2.4 billion. -
Contineum Therapeutics joined the 2024 initial public offering class on Friday with an SEC filing. The biotech will use the IPO proceeds to complete a Phase II trial for its most mature candidate targeting multiple sclerosis. -
At the center of the deal is Amolyt Pharma’s late-stage candidate eneboparatide for the rare disease hypoparathyroidism. AstraZeneca also gains ownership of AZP-3813, which is being assessed for acromegaly in a Phase I trial. -
IFM Therapeutics announced Wednesday its subsidiary IFM Due has been acquired by Novartis. The acquisition provides the Swiss pharma with full rights to IFM Due’s portfolio of STING antagonists targeting inflammation-driven diseases.
WEIGHT LOSS
-
Encouraged by the potential of the weight-loss candidates acquired from Carmot Therapeutics, Roche will speed up the development of its obesity programs, seeking to differentiate itself in the market. -
With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday. -
Despite early 2024 optimism, BioSpace’s Job Market Trends report outlines a still sluggish situation in the biopharma industry, Novartis and J&J announce Q2 earnings, GLP-1 market leaders expand into China and the Cassava Sciences saga continues. -
Eli Lilly’s tirzepatide, which has previously been approved in China for diabetes, can now also be used for chronic weight management in the world’s second most populated country. -
With GLP-1 receptor agonists expected to dominate the weight loss market in the near term, several young companies are building on this mechanism, while others are taking a completely different approach.
POLICY
-
The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA. -
In the U.S., the chorus of opposition against the proposed buyout continues to grow and now includes the CEOs of Roche and Lilly, a broad coalition of unions and consumer groups and at least one senator. -
Iskra Reic will continue to serve as the pharma’s senior vice president for Vaccines and Immune Therapies as she steps in for Leon Wang, who was detained by Chinese authorities in November. -
Novartis is seeking to prevent the entry of generics for its blockbuster heart failure drug Entresto, its top-selling asset that brought in more than $6 billion in net global sales last year.
-
The payment scheme will tie gene therapy payments to improvements in health outcomes—and could potentially boost the uptake of these sickle cell disease treatments.
We interviewed Krissy Fuller, a human resources consultant, to learn more about the issue of mandated vaccines from an HR perspective and shared her predictions on what changes she thinks will last after the pandemic.
Learn some essential tips on how to build a resume or how to enhance your resume during COVID-19. These tips can increase the chances of getting you to the interview stage.
If you’re setting new career goals, try including these tips to shape a path forward.
After you’ve been in a role for a decent amount of time it can feel like you have learned all that there is to learn. But that’s not to say that you’ve learned all you can from the company and the people that work there.
Why are adaptive leaders so useful? And is adaptive leadership a quality that will benefit your life sciences career? Let’s explore this concept and find out.
Regardless of the field that you work in, mentioning top skills in your resume is a crucial step. Here are some tips to prepare the best leadership skills resume.
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
-
Bank of America analysts said prior to Thursday’s readout that Tyra Biosciences’ TYRA-300 could rival Johnson & Johnson’s kinase inhibitor Balversa, which has suffered from safety concerns and poor tolerability. -
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas. -
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year. -
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis. -
Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine.
NEUROSCIENCE
-
Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing. -
Sangamo and Pfizer’s hemophilia A gene therapy candidate scored a Phase III victory last week. However, with the genomic medicine company soon to run out of cash, Sangamo’s short-term prospects look bleak but not unsalvageable, analysts say.
-
Cognitive function in the liraglutide cohort declined 18% slower than in the placebo arm over one year of treatment, researchers announced Tuesday at the Alzheimer’s Association International Conference. -
The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment. -
Biogen and Sage Therapeutics’ investigational neuroactive steroid did not significantly improve upper limb tremors in patients with essential tremor, the companies announced Wednesday.
CELL AND GENE THERAPY
-
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use. -
With 15 patients started across its three gene therapies, bluebird bio claims a 138% year-over-year revenue growth and aims to initiate up to around 100 new patients in the current year. -
At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases. -
An autologous and personalized regulatory T cell therapy is safe in patients with type 1 diabetes, but does not help preserve β-cell function. -
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.
