Entrada is paring back its research staff even as it gears up to hire employees to support a planned clinical trial for a Duchenne muscular dystrophy candidate.
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.
At the heart of the acquisition is Regulus’ farabursen, an miRNA-targeting oligonucleotide in early-stage development for rare autosomal dominant polycystic kidney disease.
GSK’s dealmaking will be “cautious and disciplined” under the current trade war, but the pharma will focus on looking for “opportunities created” amid these tensions, according to CEO Emma Walmsley. The company also reported a 4% earnings bump for the quarter.
It’s been a fraught road for the proposed merger between Acelyrin and Alumis, with Tang Capital’s Concentra Biosciences in February threatening to upend the deal with a proposed $3-per-share acquisition of Acelyrin.
The drug, a small molecule protein inhibitor, brought in $132 million in the first quarter, missing consensus estimates by 17%.
FEATURED STORIES
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.
Building and scaling biopharma workforces can go beyond recruiting permanent employees to include fractional workers and consultants. A Slone Partners executive discusses how these blended workforces operate, highlighting the strategic benefits.
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.”
After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.
A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
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.
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
Job Trends
Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for LITFULO™ (ritlecitinib).
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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GlaxoSmithKline unveiled plans for its new spinout in the consumer health division, Haleon. It is expected to be in place by mid-2022. -
HOOKIPA Pharma Inc.’s shares have soared after stating it amended and restated a collaboration and license agreement with Gilead Sciences to develop immunotherapies against HIV. -
Shares of ImmunoGen are climbing this morning after the company announced an antibody drug conjugate (ADCs) collaboration with Eli Lilly valued at up to $1.7 billion. -
Stoughton, Mass.-based Collegium Pharmaceutical is expanding its pain-treating portfolio with a $604 million buyout of Raleigh’s BioDelivery Sciences International (BDSI). -
New York-based Ovid Therapeutics and Healx have entered a strategic partnership to investigate the compound gaboxadol to treat Fragile X Syndrome (FXS).
WEIGHT LOSS
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The acquisition of breakout obesity star Metsera should pump new life into Pfizer’s portfolio, which over the last two years has suffered from three discontinued assets. -
In letters to Eli Lilly and Novo Nordisk, the FDA accused the companies of downplaying the risks of their GLP-1 weight loss drugs during a prime time special with Oprah Winfrey. -
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. -
The over-representation of males and Hispanic patients in Eli Lilly’s Phase III ATTAIN-1 study could explain why orforglipron “underperformed” expectations in a previous readout, according to analysts at BMO Capital Markets. -
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
POLICY
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With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science. -
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder. -
The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty. -
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials. -
The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.
This cover letter checklist can help you write impressive cover letters that describe your personality in the perfect way to employers. Follow the checklist and up your game.
Home to many of the world’s leading life science companies, the Genetown hotbed is a hub of activity. To help you in your job search, here are 10 Massachusetts biopharma companies hiring now.
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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For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent protections expiring in 2028. -
Moving forward, Innate will focus on the clinical development of its antibody-drug conjugate IPH4502, the lymphoma candidate lacutamab and the AstraZeneca-partnered monalizumab. -
On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda. -
Cullinan Therapeutics and Taiho Oncology’s zipalertinib elicited promising response rates in two mid-stage studies of non-small cell lung cancer patients with typical and uncommon EGFR mutations. -
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
NEUROSCIENCE
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Eisai and Biogen announced positive updates on the Phase IIB 201 and open-label extension studies they are conducting on the use of lecanemab to treat early Alzheimer’s Disease. -
AC Immune’s Phase II Lauriet study of investigational anti-Tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease (AD), only met one endpoint. -
The company is investigating the death of a 75-year-old woman who died of ARIA while receiving Aduhelm. -
Sungho Han, Ph.D., founder and CEO of Genuv Inc. in Seoul, South Korea, has built her career and her company by thinking outside the box. -
Research into Alzheimer’s disease is shifting from amyloid plaque and tau protein to neuroinflammation, white matter changes and insulin resistance.
CELL AND GENE THERAPY
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Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing. -
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.
