Soleno’s Vykat XR is the first drug approved for the rare disease that directly targets its hallmark symptom.
The latest data from Johnson and Johnson’s Rybrevant and Lazcluze lung cancer combo was better than standard of care Tagrisso on overall survival. But analysts say the next step is getting a subcutaneous formula approved.
The German conglomerate announced a licensing agreement with Puhe BioPharma for a PRMT5 inhibitor used in a variety of cancers. Financial details of the deal were not disclosed.
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.
Donald Trump’s proposed tariffs on the EU would increase manufacturing costs for pharma companies and would stall medical innovation, according to the results of a recent survey by the Biotechnology Innovation Organization.
Eisai’s new fiscal 2027 forecast for Leqembi is roughly 50% lower than its projections a year ago.
FEATURED STORIES
New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.
Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
The vaginal microbiome plays a critical role in women’s health, from infection resistance to fertility, yet it continues to remain underexplored. With DNA Genotek™’s OMNIgene™•VAGINAL collection kit, researchers and innovators are empowered to collect stablized samples with precision to support women’s healthcare research and development of healthcare for women.
Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed.
As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy.
It can cure deadly diseases, save long-term healthcare costs and transform lives. But the U.S. insurance system still isn’t ready to pay for it.
FROM BIOSPACE INSIGHTS
The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.
LATEST PODCASTS
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
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.
Job Trends
23andMe Holding Co. announced a new, non-exclusive data license with GSK plc which extends their collaboration and enables GSK to conduct drug target discovery and other research using the 23andMe database, the world’s largest recontactable resource of genetic and phenotypic information from consented participants.
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SPECIAL EDITIONS
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
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.
DEALS
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Zilretta is the first treatment approved by the U.S. FDA for OA knee pain that uses extended-release microsphere technology. -
Cognition Therapeutics, Pyxis Oncology and IsoPlexis Corp. all announced IPO plans. -
Fresh out of the gates with $500 million in financing, Neumora Therapeutics forged a partnership with Amgen to develop and commercialize assets for neurodegenerative diseases. -
The deal, which includes an upfront payment of $1.75 billion, enables Boston Scientific to expand its electrophysiology and structural heart product portfolio. -
Newly appointed CEO Rob Davis must find a way to balance Merck’s portfolio before investors get (even more) antsy. And he is looking to be aggressive.
WEIGHT LOSS
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While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets. -
The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries. -
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news. -
Novo Nordisk’s Wegovy has been on a winning streak as of late, with a metabolic dysfunction-associated steatohepatitis approval last month and prime position in the oral obesity race. -
While Eli Lilly’s orforglipron is full speed ahead for a regulatory filing this year, the pharma is also pushing forward with one more Phase II study of naperiglipron, which uses the same scaffold as Pfizer’s failed obesity drugs danuglipron and lotiglipron.
POLICY
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Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.” -
Ascidian Therapeutics, a member of BioSpace’s NextGen Class of 2024, on Monday announced it received IND clearance from the FDA and was granted Fast Track designation for ACDN-01. -
The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors. -
The Centers for Medicare and Medicaid Services’ initial proposed drug price cuts, due to pharma companies by Thursday under the Inflation Reduction Act, could range from 25% to 60%, analysts told Reuters. -
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.
This article offers a template with examples of an effective cover letter for a research scientist job. Let’s explore some tips to help you write your own.
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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Ivonescimab elicited better overall survival in Asian patients with non-small cell lung cancer than in those from North America and European countries, in Western countries narrowly missing the statistical significance threshold the FDA is seeking. -
According to analysts, the new data could present a path to accelerated approval for ifinatamab deruxtecan, a product of Merck and Daiichi Sankyo’s troubled ADC partnership. -
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.
NEUROSCIENCE
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Research conducted at Temple University is showing a potential new way to address the onset of Alzheimer’s disease through the use of pharmacological chaperones. -
Novo Nordisk specializes in the diabetes market. The company appears to be making an entry into the Alzheimer’s market, which isn’t as unusual or unexpected as it initially sounds. -
Biogen is buying a novel CNS-penetrate inhibitor of casein kinase 1 (CK1) from Pfizer to develop for patients with behavioral and neurological symptoms in various psychiatric and neurologic diseases. -
As Biogen stays in the hunt for an Alzheimer’s treatment with the recent presentation of data about aducanumab made at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) conference on December 5, it’s expanding its pipeline. -
In an effort to understand aging, researchers from Stanford University and colleagues around the world analyzed almost 3,000 proteins in the blood of more than 4,000 people ages 18 to 94.
CELL AND GENE THERAPY
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Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy. -
Appia Bio’s shutdown continues an unfortunate trend this year that has seen biotech closures nearly every month. -
In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue. -
The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset. -
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.
