The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.
Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.
Ivonescimab’s progression-free survival data in non-small cell lung cancer bode well for an upcoming overall survival readout, according to Truist analysts, who noted that “OS is likely to be statistically significant” in favor of the PD-1/VEGF bispecific.
Several sources are speculating that the potential buyer could be Eli Lilly, despite the breakdown of the pharma’s partnership with Nektar over atopic dermatitis therapy rezpeg.
Rybelsus can now be used as a primary or secondary prevention pill to lower the risk of major adverse cardiovascular events in at-risk patients with type 2 diabetes.
Glaukos’ Epioxa allows cross-linking therapy for keratoconus without requiring an incision. The biotech expects to launch the drug early next year.
FEATURED STORIES
From more than 30 target action dates in the last three months of the year, BioSpace has narrowed the list to six regulatory decisions that could have far-reaching implications for biopharma and patients.
While last week’s recommended changes by CDC advisors to the MMRV vaccine schedule are unlikely to have a tangible effect on Merck’s business, the company said the removal of choice for healthcare providers is “concerning.”
Small and large drugmakers alike have made big, proactive moves to secure the production capacity that will be vital to serving the weight loss market.
The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients.
With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval.
A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
LATEST PODCASTS
A draft copy of an upcoming MAHA report reveals a strategy in lockstep with recent HHS actions such as reviving the Task Force on Safer Childhood Vaccines; Viking Therapeutics reports robust efficacy from mid-stage oral obesity candidate but is tripped up by tolerability concerns; Novo Nordisk wins approval for Wegovy in MASH; and Lilly takes a pricing stand.
In this episode of Denatured, BioSpace’s head of insights Lori Ellis discusses the ‘enormous implications’ of patent policy changes with Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck.
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
Job Trends
A BioSpace survey found that 56% of employed and 81% of unemployed respondents are considering jobs outside biopharma. Some are also seriously thinking about leaving the U.S. to find employment in the field.
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SPECIAL EDITIONS
In this deep dive BioSpace analyzes the neuropsychedelic therapeutics pipeline, which grabbed headlines in February when the FDA accepted the New Drug Application for Lykos Therapeutics’ MDMA capsules for PTSD.
In this deep dive, BioSpace takes a closer look at the drug price crisis in the U.S. As President Joe Biden and former President Donald Trump gear up for a rematch in the 2024 election, we explore how federal reforms to lower costs could be leveraged on the campaign trail.
The job response rate has risen year over year, according to BioSpace data, indicating competition for roles posted on our website has increased.
DEALS
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Out-licensing drugs to multinational corporations is a natural step for Chinese biotechs, but the recent rise in deals is only scratching at the surface of partnership-ready biotechs in the region. -
The German giant is looking to develop new drugs for undisclosed eye diseases using Re-Vana’s extended-release injectable platform to supply drugs to the eye for months at a time. -
The star of GSK’s Hengrui partnership is the COPD candidate HRS-9821, which will complement the pharma’s respiratory pipeline that’s anchored by the anti-asthma drug Nucala. -
The collaboration focuses on ‘molecular gates,’ a class of molecules that the startup company Gate Bioscience says can stop pathogenic proteins from leaving the cell. -
The partnership with Matchpoint Therapeutics gets Novartis global rights on all molecules for several unannounced inflammatory diseases identified through the biotech’s discovery platform.
WEIGHT LOSS
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Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development. -
While Truist Securities analysts said the results from the ATTAIN-2 trial leave “room for competition,” they also pointed to a manufacturing advantage that could unlock a “double-digit billion dollar opportunity” for Eli Lilly. -
Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.
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The mad rush for safe and effective obesity drugs has winners—including Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy—and losers. Here are five molecules that never made it to the market. -
While it’s impossible to make apples-to-apples comparisons of the many obesity candidates with so many differences across clinical trials, we at BioSpace are giving it our best shot.
POLICY
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President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines. -
A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms. -
New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain. -
Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17. -
In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.
Check out five New York companies hiring biopharma professionals like you, including 2025 Best Places to Work winners.
Plus, communication errors that cost job offers and how to craft a LinkedIn “About” section
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
At Johns Hopkins University, the biomedical engineering program’s Design Team offering lets undergraduates dive deep into clinical projects that can help them land industry jobs, get provisional patents or even start companies.
Not everyone who completes a life sciences Ph.D. wants to continue working in a laboratory or in research. If this is the case for you, here are 12 careers for Ph.D. life scientists outside of the lab.
Candidates looking to enter biotech should focus on cultivating key skills, thoughtfully crafting their resumes and putting their best, most authentic foot forward in interviews. An internship, co-op or fellowship won’t hurt, either.
HOTBEDS
IN CASE YOU MISSED IT
Seven in 10 U.S. hiring managers say their company usually considers employing overqualified applicants, according to a survey from Express Employment Professionals and The Harris Poll. However, 75% of employers believe such hires struggle to stay motivated in lower-level roles.
REPORTS
This labor market report examines Q3 life science job market trends and the recruitment outlook for Q4 and beyond.
BioSpace surveyed life sciences employers to understand attitudes and current trends on AI usage in recruiting. This report explores the benefits of using AI tools in recruitment and provides practical recommendations for HR and talent acquisition professionals to leverage AI effectively. Concurrently, this report highlights the challenges and risks of using these tools without critical thought and intention.
As competition for life sciences talent peaks, BioSpace has undertaken research to determine what employers can do to ensure they don’t lose out on talent they actually want to hire and retain.
CANCER
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Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market. -
The French giant is gaining access to darovasertib, a small molecule protein kinase C inhibitor already in Phase II/III trials, with rights for the whole world besides the U.S. -
Exelixis is looking at the possibility of relocating some of the eliminated Pennsylvania roles to its headquarters in Alameda, California, according to a company spokesperson. -
Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate. -
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.
NEUROSCIENCE
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Novartis is licensing ARO-SNCA, a preclinical siRNA therapy for synucleinopathies, a group of neurodegenerative disorders including Parkinson’s disease. -
While the approval of Leqembi Iqlik bodes well for Biogen and Eisai’s planned application for a subcutaneous induction regimen next year, its financial impact remains “uncertain,” as potentially higher revenues from the injection could be offset by steeper costs of production, according to Jefferies. -
After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases. -
In another blow to Prothena’s neurodegenerative disease portfolio, anti-amyloid candidate PRX012 has run into the same problem that larger peers Biogen and Eli Lilly have battled: high rates of swelling in the brain. -
AMX0035—approved as Relyvrio in 2022 for amyotrophic lateral sclerosis but voluntarily pulled from the market last year—was unable to distinguish itself from placebo in a mid-to-late-stage trial of progressive supranuclear palsy.
CELL AND GENE THERAPY
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The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
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A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record. -
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy. -
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
