Despite not differentiating itself from placebo, the Texas-based company said it plans to push pilavapadin into Phase III trials before long.
AbbVie is joining the amylin arena, though the pharma is still far behind leaders Novo Nordisk and Eli Lilly.
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
Roche’s asthma drug Xolair appears to be safer and more effective than oral immunotherapy at treating adults and children with one or more food allergies.
The partners are building toward a regulatory submission for Tezspire in chronic rhinosinusitis with nasal polyps in the first half of 2025.
In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why.
FEATURED STORIES
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.
A depleter of pathogenic T cells, rosnilimab’s novel MOA generated a differentiated efficacy, tolerability and safety profile in recent Phase 2b study
From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today.
While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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
Regeneron Pharmaceuticals, Inc. announced that Kathryn Guarini, Ph.D., and David P. Schenkein, M.D., have joined Regeneron’s Board of Directors effective September 8, 2023.
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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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Illumina plans to continue to pursue its acquisition of Grail Inc. despite the objection of the U.S. Federal Trade Commission. -
This morning, Ikena Oncology, Design Therapeutics and Edgewise Therapeutics began trading on the exchange. -
Several new initial public offering (IPO) announcements have been made by international and U.S.-based biopharmaceutical and biotechnology companies in the past couple of days. -
This week, four companies set sights on listing their shares on the stock market in hopes of raising significant funds to support the development of their pipelines and businesses. -
It’s been another strong week of biopharma companies making their debut on a stock exchange. Over the past 48 hours, three companies, Finch Therapeutics, Connect Biopharma and Gain Therapeutics, all made their debut on the Nasdaq.
WEIGHT LOSS
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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 sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues. -
Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.
POLICY
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An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong. -
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported. -
Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis. -
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment. -
After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call.
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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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.
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Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.
NEUROSCIENCE
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VectorY Therapeutics will evaluate the use of SHP-DB1, a capsid developed by Shape Therapeutics, to deliver therapies to the brain, including VectorY’s developmental Huntington’s and Alzheimer’s disease treatments. -
LB Pharma landed on the Nasdaq Thursday, with 3 million additional shares sold than expected. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy. -
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety. -
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
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. -
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. -
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.
