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.
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.
In December 2024, Teva also secured FDA approval for the other liraglutide brand Victoza, indicated for type 2 diabetes.
Health Secretary Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Sept. 4, following the ouster of CDC Director Susan Monarez and tapping of HHS Deputy Secretary Jim O’Neill as her interim replacement.
Nipocalimab, approved as Imaavy for generalized myasthenia gravis earlier this year, failed to show significantly added benefit when used with an anti-TNFα therapy in patients with rheumatoid arthritis.
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.
FEATURED STORIES
Look for renewed investment driven by lower interest rates in the new year, and a continued focus on late-stage assets, oncology and reaping the benefits of AI.
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
Expanding volumes of data point to mechanisms beyond weight loss and blood sugar control that contribute to cardiovascular benefits in the world’s fastest-growing drug class.
Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
LATEST PODCASTS
Lori, Greg and Tyler discuss last week’s call for a class-wide box warning on all commercial CAR T therapies, while investigations are ongoing into cases of secondary malignancies. How do we approach this balancing act of treatment and side effects?
BioSpace’s Lori Ellis and Chantal Dresner discuss anticipated job market trends for 2024 including unemployment, anticipated job search activity and hiring trends.
This week, Lori, Greg and Tyler discuss the first surge of IPO activity this year plus gene therapy pricing,
Job Trends
Moderna, Inc. (NASDAQ:MRNA) and OpenAI today announced their ongoing collaboration to co-innovate with a shared vision of AI’s transformative potential in the future of business and healthcare.
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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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Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year. -
AbbVie’s $10.1 billion takeover of ImmunoGen paces the cancer sector in early 2024, as ADCs and radiopharmaceuticals remain hot. -
As the antibody-drug conjugate space continues to heat up, Merck has acquired preclinical startup Abceutics—spun out of the University at Buffalo—and its novel platform that aims to make ADC therapeutics safer. -
The FTC and the U.S. Department of Justice’s antitrust division will have another 30 days to examine Novo Nordisk Foundation’s acquisition of contract manufacturer Catalent, according to an SEC filing. -
Contineum Therapeutics priced its initial public offering Friday, scaling back its expectations for gross proceeds of $110 million for clinical trials of a challenger to Boehringer Ingelheim and Roche.
WEIGHT LOSS
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Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts. -
Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions. -
BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial. -
Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist. -
Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures.
POLICY
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The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage. -
Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar. -
President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program. -
Around 300 FDA staffers laid off last week are being asked to return. So far, the Trump administration has terminated some 1,000 employees from the agency. -
The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human Services, despite controversy regarding his anti-vaccine history.
While continued learning opportunities are easy to access and many are quite affordable, the real question is, can you list these courses on your resume? And if you do so, what will recruiters in the biotech field think of them?
Some semblance of a work-life balance is already a challenge to maintain, but doing so when you’re working and living in the same space takes effort and one (or more!) of these strategies.
While you’ve likely answered many of these before, it never hurts to brush up on solid answers and think of new or recent anecdotes to illustrate your point.
How productive are you on a daily basis? The truth is, you probably don’t get as much done as you possibly can due to distractions. But, these productivity methods can help you for sure.
If you’re contemplating changing careers in the midst of the COVID-19 pandemic, the reality is that if it’s time to make a change, there’s no time like the present.
Oh, the world of professional email communication. It can be hard to navigate with various expectations across industries, age groups and cultures.
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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Despite recent enthusiasm around the PD-1/VEGF space, BMO Capital Markets analyst Evan Seigerman noted that Merck’s pact with LaNova Medicines is more “conservativism” on the pharma’s part than confirmatory of recent data in the drug class. -
GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate. -
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025. -
The acquisition will give BioNTech full ownership of an investigational bispecific antibody targeting the PD-L1/VEGF-A pathways, a hot area in oncology that could potentially replace standard checkpoint inhibitors for cancer treatment. -
With the Phase III failure, Syros will discontinue the study of tamibarotene for myelodysplastic syndrome and will default on its loan from Oxford Finance LLC.
NEUROSCIENCE
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BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward. -
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline. -
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies. -
Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity. -
The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
CELL AND GENE THERAPY
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Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease. -
The groundwork being done in 2024 is building the foundation for global collaboration in the future. -
Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday.
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Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review. -
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
