The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
Azafaros will use the Series B haul to push lead asset nizubaglustat into late-stage studies for Niemann-Pick disease Type C and GM1/GM2 gangliosidoses later this year.
While industry groups decried the Trump administration’s new drug pricing order, analysts say it lacked details and the teeth to make a major impact without an act of Congress.
Lexeo wants to more quickly move investigational gene therapy LX2006 into a registrational study and hopes for a potential efficacy readout in 2027.
The package revives President Donald Trump’s much-maligned Most Favored Nation rule but goes further into the private markets and beyond, leveraging the patent system, drug importation and more.
In addition to eliciting greater weight loss than Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound does not come at the expense of safety, according to newly released comprehensive tolerability data—findings that Leerink analysts say confirm the GLP-1 drug’s edge in the closely watched market race.
FEATURED STORIES
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
Beam Therapeutics and Verve Therapeutics have each built their lead candidates on a technique billed as a safer alternative to conventional CRISPR. Clinical results have so far been promising.
As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
FROM BIOSPACE INSIGHTS
Jay Ferro, EVP, CIO, CPO & CTO at Clario discusses safety, trust and what keeps him up at night.
LATEST PODCASTS
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express concern about the FDA’s future; Pfizer’s obesity setback could be Viking’s gain; and BioSpace reveals the highest paid pharma CEOs.
In this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at Q1 job market performance, layoffs and administration decisions impacting the workforce.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses the underrepresentation of women in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
Job Trends
Health and Human Services employees aren’t the only ones out of work. Thousands of private-sector biopharma professionals lost their jobs in the first quarter.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
On election day, Tuesday, November 5, Americans will choose between former President Donald Trump and current Vice President Kamala Harris for their next president. The election will also see the rearrangement of Congress.
In the battle over drug prices, one sector of the healthcare industry has risen above all the players as the boogeyman: pharmacy benefit managers. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the lens now focused on PBMs’ business practices.
DEALS
-
The deal is a blast from the not-too-distant past, when special purpose acquisition companies were an easy way for companies to list on the public market with a bundle of cash to operate on. -
Roche’s Genentech is betting on the Flagship Pioneering–founded company’s discovery platform called DECODE to find new targets for an undisclosed autoimmune disorder. -
Alis Biosciences’ plan is a familiar tactic in the private equity world, but the firm will instead be listed on the public markets “in due course.” -
Despite making an unsolicited bid for gene therapy maker bluebird bio, Ayrmid failed to deliver a binding offer after weeks of due diligence. Bluebird’s board recommended that it go with Carlyle and SK Capital Partner’s original offer to take the company private for $30 million. -
Merck has not disclosed which of its peptide therapies it plans to develop oral formulations for.
WEIGHT LOSS
-
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.? -
In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug. -
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
-
Novo Nordisk filed for approval of an oral, 25-mg formulation of its weight loss blockbuster “earlier this year,” according to a company spokesperson. -
President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless they reshore their manufacturing operations.
POLICY
-
Nevertheless, Albert Bourla has been lobbying the U.S. government—as high as President Donald Trump himself—to skip the pharmaceutical industry tariffs, which Trump has threatened, in part as a way to shore up U.S. national security. -
While Vaxart can proceed with its study, fellow COVID-19 vaccine developers GeoVax and Novavax continue to be hamstrung by various regulatory roadblocks. -
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment. -
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events. -
Merck, Bristol Myers Squibb, Sanofi and Roche had little clarity on the potential impact of President Donald Trump’s pharmaceutical tariffs but many companies are already preparing for what’s to come.
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
As market values increase for computational biology and data science, biopharma companies are looking to hire R&D professionals in those areas. A biotech talent acquisition expert shares his insights on these in-demand roles.
Gratitude, a key part of stoicism, can benefit those working in—and being served by—the pharmaceutical industry.
Businessman and entrepreneur Mark Cuban recently discussed leadership with Leadership Lab columnist Michael Pietrack. The three lessons that came out of that conversation start with one word: caring.
When hiring job candidates to work on cell and gene therapies, companies look for more than just technical skills. Talent acquisition executives from Bristol Myers Squibb and Intellia Therapeutics offer an inside look at what they want in an employee.
Learn how to leverage your end-of-year downtime to document achievements, update your professional presence and prepare for a successful 2025.
HOTBEDS
REPORTS
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%.
CANCER
-
The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of patients with non-muscle-invasive bladder cancer. -
The FDA is currently reviewing Merck’s sBLA for Keytruda in head and neck cancer, with a target action date of June 23. -
The transaction is expected to close in the second half of 2025. With the deal, Merck KGaA is adding to its rare disease and oncology pipelines. -
With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the air. -
Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.
NEUROSCIENCE
-
Jefferies analysts predict Annexon’s tanruprubart could be approved by mid-2026. -
Jazz is being accused of anti-competitive practices regarding its narcolepsy drug, as generic competitors emerge on the market. -
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis. -
Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree. -
GSK is paying to access ABL Bio’s Grabody-B platform, which potentially enables therapies to cross the blood-brain barrier.
CELL AND GENE THERAPY
-
One day after the European Medicines Agency requested that three clinical trials of Elevidys be placed on hold after the death of a U.S. teenager, a data monitoring committee concluded that they should continue unchanged. -
Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in preclinical studies has shown the ability to cross the blood-brain barrier.
-
Already reeling from years of market chaos, the announced departure of CBER chief Peter Marks sent a ripple across biopharma markets. -
Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully. -
The layoffs will take place throughout 2025 and will mostly affect Tenaya’s research and manufacturing operations. The company is continuing to test its hypertrophic cardiomyopathy gene therapy.
