Reporting third quarter earnings on Tuesday, Johnson & Johnson CEO Joaquin Duato said the healthcare giant has not yet secured a drug pricing deal with the White House, but discussions are ongoing.
Kailera’s lead asset, KAI-9531, elicited an average weight loss of more than 17% in a Phase III study in China. The biotech expects to launch a global late-stage program for the drug this year.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q3 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.
Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.
Nabla and Takeda first joined hands in 2022, to push “the boundaries of next-generation biologics discovery,” according to the startup’s CEO Surge Biswas.
FEATURED STORIES
The ongoing conflicts between Ukraine and Russia, as well as Israel and Palestine, have sent ripples across various industries, including pharma. Medical science liaisons can help.
Mirador debuted last year with a massive $400 million and the goal of developing game-changing therapies for inflammatory and fibrotic diseases. The company aims to enter the clinic this year.
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth.
Johnson & Johnson has been fighting thousands of lawsuits over its now-discontinued talc products for 16 years. A pending judge’s ruling could finally put the issue to bed once and for all.
LATEST PODCASTS
Bayer joined BMS in announcing major overhaul; Takeda drops up to $2 billion for an anti-amyloid drug from AC Immune; and BioSpace reflects on last week’s ASGCT meeting—the good, the bad and the ugly.
On this episode of Denatured, Lori Ellis and guests discuss President Biden’s Executive Order on Advancing Women’s Health Research and Innovation and the outlook of investment in women’s health.
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
Job Trends
Agios Pharmaceuticals, Inc., a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, announced that the company is scheduled to present at the BofA Securities 2024 Health Care Conference on Thursday, May 16, 2024, at 11:40 a.m. ET.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline.
-
The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers.
-
Oral doses of SIGA Technologies’ antiviral drug Tpoxx will help the U.S. maintain its reserves of the vaccine in preparation for future potential outbreaks, according to the company.
-
After completing a buyout transaction with The Column Group to remove it from the stock exchange, NGM Bio has raised a $122M Series A to fund a registrational study for a rare liver disease drug and a Phase II trial in hyperemesis gravidarum.
-
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.
WEIGHT LOSS
-
While taldefgrobep alfa failed to show improved motor function in spinal muscular atrophy, treated patients saw a marked reduction in body fat. Biohaven plans to launch a Phase II trial in obesity by the end of the year.
-
Eli Lilly will provide the funding and expertise to advance Laekna’s LAE102, a first-in-class monoclonal antibody targeting the activin type IIA receptor to induce weight loss and boost muscle mass.
-
Wegovy is being made available to Chinese patients five months after its approval in the country. Novo will sell the medicine for about $193.27 for a one-month supply.
-
Despite crowding in the next-gen weight loss space, Metsera has raised over $500 million since its April launch, indicating a continued appetite for these drugs.
-
Cantor Fitzgerald analyst Olivia Brayer found supplementary bone mineral density data for Amgen’s obesity candidate MariTide that could point to a potentially greater fracture risk than previously revealed, but some other analysts view the findings as a nonissue.
POLICY
-
Jazz is being accused of anti-competitive practices regarding its narcolepsy drug, as generic competitors emerge on the market.
-
Billions in market cap are being shed as the markets reel over President Donald Trump’s escalating trade war. Eli Lilly’s value has dropped more than $95 billion in just one month.
-
Last week, The Trump administration reversed a Biden-era proposal for Medicare coverage of anti-obesity treatments. But on Monday, HHS suggested it is open to future policy considerations toward this end.
-
Senators Bill Cassidy and Bernie Sanders asked HHS Secretary Robert F. Kennedy, Jr. to make good on a pledge to appear before the committee regularly. It is not clear if or when the hearing, which was scheduled for Thursday, will take place.
-
Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage.
BioSpace recently interviewed Elizabeth Elting, founder and CEO of the Elizabeth Elting Foundation, to discuss her thoughts on how the pandemic has affected women in the workforce.
A well-designed career development program provides the right guidance and training for workers to improve their professional careers.
Do you know that growing emotional intelligence at workplace can be beneficial for career growth? If not, have a look at the article and learn some tips.
Controlling interruptions when working from home can be challenging, but a little planning and some established rules can help.
Are you an introvert who is worried about your performance? Well, do you know that these unique skills can make you an excellent leader? Let’s find out those skills.
If you’re struggling to find your dream job or unsure of what your next career move should be, career assessments might be the next right step. Here’s how to do it.
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
-
With an eye toward advancing a novel antibody-drug conjugate for gastrointestinal cancers, ArriVent is the latest biopharma player to ink a deal with a Chinese biotech.
-
Ascentage is looking to use the IPO proceeds to advance its Phase III candidates for chronic or small lymphocytic leukemia and for certain types of chronic myeloid leukemia.
-
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause.
-
Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
-
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024.
NEUROSCIENCE
-
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses.
-
Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor.
-
Despite the “unfortunate” failure, William Blair analysts do not believe that the utreloxastat readout will heavily affect PTC, instead postulating that the upcoming FDA decision on its phenylketonuria candidate sepiapterin will be a stronger driver of the biotech’s stock.
-
Alector is kicking off a resource realignment effort that will include a workforce reduction. The biotech expects its current cash position to last it through 2026.
-
Cassava Sciences has revealed the late-stage clinical failure of controversial Alzheimer’s drug simulfilam. The company had pledged to share the results whether “good, bad or ambiguous.”
CELL AND GENE THERAPY
-
In an effort to expand its cash runway beyond 12 months, Prime Medicine has signed a deal with Bristol Myers Squibb worth a potential $3.5 billion, while also streamlining its pipeline to trim costs.
-
Pfizer’s sudden market withdrawal of sickle cell therapy Oxbryta, which some analysts predicted would reach $750 million in sales by the end of the decade, has left patients and healthcare providers with few options, while investors question the pharma giant’s dealmaking prowess.
-
While the companies did not reveal the financial details of the deal, Novo Nordisk will provide funding for two Evotec sites in Germany and Italy to support the development of next-generation cell therapies.
-
4D Molecular Therapeutics reported its experimental gene therapy demonstrated a nearly 90% reduction in the need for annualized standard-of-care injections in patients with wet age-related macular degeneration.
-
Last month, Vertex said sickle cell patients had not yet received infusions of its gene therapy Casgevy. That’s now changed, as the company races with bluebird bio’s Lyfgenia.