FDA
The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were reportedly underway Tuesday, with CDER Office of New Drugs Director Peter Stein added to the list of casualties.
Future Pak—whose acquisition offer was rejected by Vanda Pharmaceuticals last summer—is offering to buy Theratechnologies for an unsolicited $255 million. The Canadian biotech is under an exclusivity agreement with another yet-to-be-disclosed potential purchaser.
Leerink analysts warned that Kennedy’s remarks to FDA staff would likely be a negative for the biotech industry.
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.
According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.
Novartis plans to build seven new facilities in the U.S., touting the creation of up to 1,000 new jobs at the company. The new facilities will include a biomedical research hub in California, two radioligand plants, and four manufacturing sites.
FDA
Analysts at William Blair expect drug developers will continue to perform “at least some animal testing” on their investigational products. Though the process to phase out animal testing will begin “immediately,” no specific timetable was given.
FEATURED STORIES
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
In the current legal and political landscape, it is all about survival for DEI initiatives.
More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO.
LATEST PODCASTS
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
In this episode, Lori and guests discuss the pursuit of adequate representation and how clinical trials are being shaped by the legal environment they operate within.
Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing.
Job Trends
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
Year-over-year BioSpace data show there were fewer job postings live on the website in the fourth quarter of 2024, and the decrease was higher than the third quarter’s drop.
The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
DEALS
  1. M&A activity surges and IPOs return as the biotech industry navigates a changing business landscape marked by strategic consolidation and renewed investor focus on innovation.
  2. The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.
  3. Armed with a combined $850 million in cash, the companies said Thursday the resulting biotech will have a pipeline that could deliver 10 clinical readouts over the next 18 months.
  4. The size of the global immunology market is projected to nearly double by 2032 to a quarter of a trillion dollars. Here are this year’s standout deals in the space.
  5. After dropping $4 billion on a deal with the Japanese company last year, Merck is getting back some of its investment as Daiichi Sankyo buys into a Phase I/II T-cell engager therapy acquired from Harpoon Therapeutics.
WEIGHT LOSS
  1. With Amgen’s MariTide results at the lower end of investors’ expectation of 20% to 25% weight loss, the much-anticipated readout sent the company’s shares tumbling.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
FDA
  1. Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
  2. With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval in the second half of 2025.
  3. FDA
    Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster.
  4. Other notable greenlights this year include Bristol Myers Squibb’s Cobenfy, the first novel therapeutic for schizophrenia in 35 years, and Madrigal Pharmaceuticals’ Rezdiffra, the first-ever treatment for MASH.
  5. The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion in 2023. It’s welcome good news for Vertex following last week’s subpar clinical results for its non-opioid analgesic.
CAREER HUB
Since 2020, the life sciences industry has worked to rebound from the COVID-19 pandemic. But one sector’s growth has far outpaced the others–the biotech industry.
Despite a government report showing that hiring slowed over the month of June, job postings on BioSpace’s life sciences-focused job board saw a marked increase.
Here are 10 career paths to consider that don’t include bench work, along with role descriptions and links to jobs available now on BioSpace’s job board.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
To be self-employed in the life sciences, you must have a strong network and background and experience in a relevant area.
While MBAs can reflect positively on job applicants, work experience can often be more valuable, depending on the area.
If management isn’t your strength, there are several upper-level positions that don’t require you to manage others. Here are five high-paying life science jobs that don’t include management.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
REPORTS
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals.
CANCER
  1. On Thursday, Boehringer Ingelheim announced a partnership with Synaffix to advance antibody-drug conjugates and exercised its fourth license option under a 2013 collaboration with Oxford BioTherapeutics.
  2. In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates.
  3. 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.
  4. 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.
  5. 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.
NEUROSCIENCE
  1. 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.
  2. 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.”
  3. Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability.
  4. After previously failing studies in Parkinson’s and Alzheimer’s, dalzanemdor’s latest stumble in Huntington’s disease has pushed Sage Therapeutics to pull the plug on the NMDA receptor modulator.
  5. Trump fingers Robert F. Kennedy Jr. to lead the HHS, lupus and ATTR-CM dominate headlines this week, bluebird bio has a cash gap to leap and RegenxBio eyes Sarepta in Duchenne muscular dystrophy.
CELL AND GENE THERAPY
  1. While ex vivo genome editing results in highly effective cell therapies, it can lead to off-target effects. Caribou Biosciences has come up with a novel approach for potentially more precise gene editing compared to all-RNA guides.
  2. The pediatric patients, with a rare neurodegenerative disease, were treated with bluebird bio’s Skysona to slow the progression of neurologic dysfunction. Six patients developed myelodysplastic syndrome and one patient developed acute myeloid leukemia.
  3. Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
  4. Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that investments reached $10.9 billion in the first half of this year—outpacing 2019’s $9.8 billion total—but far below the pandemic peak.
  5. The Financial Times reported Thursday that WuXi AppTec is looking to sell its cell and gene therapy manufacturing unit, with facilities in Philadelphia, while WuXi Biologics wants to offload some of its production sites in Europe.