Papzimeos is the first immunotherapy approved for recurrent respiratory papillomatosis, a rare lung disorder involving the development of benign tumors in the airways.
The move comes after Robert F. Kennedy Jr. received pressure from the Children’s Health Defense, an anti-vaccine non-profit that he co-founded, which last month sued him over his failure to run the “statutorily required Task Force on childhood vaccine,” according to the lawsuit.
The Department of Health and Human Services’ mRNA pullback only applies to their use in upper respiratory disease, according to Secretary Robert F. Kennedy Jr.
As Trump has pressured drugmakers to lower the cost of medicines in the U.S., the pharma industry has coalesced behind a message of rebalancing what nations pay to better reflect the innovation and value of drugmaking.
The Boston-based AI/ML startup focuses on endocrine and cardiometabolic diseases and will use that expertise to generate new small molecule obesity medications for Lilly.
After two patients who received the investigational CDC7 blocker died, pushing forward with SGR-2921’s development would be “difficult,” according to Schrödinger, whose stock dropped 17.5% before the opening bell on Thursday.
FEATURED STORIES
Both Eli Lilly and the partnered companies Boehringer Ingelheim and Zealand Pharma have mid-stage data readouts this week, fueling the race in metabolic dysfunction-associated steatohepatitis.
There are multiple ways biopharmas create inclusive workplaces for LGBTQ+ employees, and they go beyond employee resource groups and benefits.
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.
While San Diego remains a top biotech hub behind Boston and San Francisco, the city—which hosts this week’s BIO International Convention—has seen employment drop amid economic headwinds.
Experts say approval of Lykos Therapeutics’ MDMA capsules for post-traumatic stress disorder would open the door to further research into psychedelic-assisted therapies.
AstraZeneca last week set another ambitious goal, this time with plans to nearly double its total revenue by the end of the decade. However, it’s easier said than done, according to analysts.
LATEST PODCASTS
In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO of Zymeworks and Josh Smiley, president and COO of Zai Lab, about how renewed confidence is driving biotech entering 2026.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
In this episode of Denatured presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, Mayo Clinic; Marilyn Geller, the Celiac Disease Foundation; and Dr. Paul Lizzul, AnaptysBio, about the challenges and opportunities facing celiac disease treatment.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
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.
DEALS
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There have already been several big biotech licensing deals in Q1. See inside for some of this quarter’s biggest licensing deals — from the surprising and pivotal to the lucrative and consequential. -
Jounce Therapeutics has received an unsolicited and non-binding acquisition proposal from Concentra Biosciences, looking to buy 100% of Jounce’s equity at a per-share price of $1.80 in cash. -
The SVB failure appears to have been caused by an underwritten public offering to raise $2.25 billion to cover security losses announced during SVB’s Q1 2023 mid-quarter update. -
Sanofi will acquire diabetes leader Provention Bio for $25 per share for a total of $2.9 billion, the companies announced Monday. -
Pfizer will acquire the Seattle-based antibody-drug conjugate leader in a $43 billion deal expected to close late in 2023 or early 2024.
WEIGHT LOSS
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This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more. -
The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity. -
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze. -
While Pfizer’s oral GLP-1 candidate met its primary endpoint in a Phase IIb obesity trial, twice-daily dosing of danuglipron resulted in high rates of adverse events including nausea, vomiting and diarrhea. -
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.
POLICY
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Merck on Monday secured the FDA’s green light for its 21-valent pneumococcal vaccine Capvaxive, which covers serotypes responsible for around 84% of invasive pneumococcal disease cases. -
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy. -
BioSpace’s Lori Ellis and Chantal Dresner bring live updates from the first day of #DIA2024 in San Diego. -
The hold on BioNTech and MediLink’s antibody-drug conjugate candidate BNT326/YL202 has halted enrollment in a Phase I U.S. trial in patients with non-small cell lung cancer or breast cancer, following multiple deaths. -
Novo Nordisk CEO Lars Jørgensen has agreed to appear before the Senate health committee in a hearing on the prices of its blockbuster drugs Ozempic and Wegovy.
Your employment or work history section of your resume is likely the single most important category in the entire document and, when done well, can make a powerful case to your potential employer about how and why you’re well qualified for their open position.
Going into a job interview, especially when you really want the job or don’t have much experience on the job market, can be a nerve-wracking few hours for many candidates.
If you’re considering a future in life science, there’s a good chance a lucrative salary isn’t the biggest draw. For many who choose science careers, the opportunity to satisfy an innate curiosity is more important than a stellar income.
Unlike the professional skills and experiences you gain through formal training or education, soft skills are those elusive interpersonal skills, personality traits, character attributes, or communication styles that will determine how you interact with your colleagues and the success or failure of the relationships you form in the workplace.
If you’re a seasoned employee and had the ability reach across the expanse of time and provide a fresh-out-of-college with some career advice, what would it be?
There are many reasons employees elect to remain at a given job: good salary and benefits, a strong sense of mission or duty, convenience, and so on. There are also many reasons that employees decide to leave a job – and one very common reason is management.
HOTBEDS
IN CASE YOU MISSED IT
As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.
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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Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards. -
Novocure’s stock spiked more than 15% Wednesday morning after the company announced its Tumor Treating Fields therapy met the primary endpoint in a late-stage trial. -
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials. -
AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers. -
At Thursday’s Pharma Media Day, Bayer touted Nubeqa as the fastest growing androgen receptor inhibitor in the U.S., which will achieve blockbuster status this year.
NEUROSCIENCE
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While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi. -
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter. -
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets. -
With data from the Phase III trial of donanemab expected in Q2, Eli Lilly presented the first clinical results from its next anti-amyloid antibody, remternetug, at AD/PD 2023. -
BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
CELL AND GENE THERAPY
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Addition joins a growing list of launches this year, following in the footsteps of startups like Crystalys Therapeutics and Ollin Biosciences. -
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy. -
These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down after another failed acquisition or, in the case of Pfizer and Novo, two heavyweights duking it out over a hot obesity biotech. -
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval. -
For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including already-approved CAR T products.
