FDA
Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.
To expand the population for the anti-amyloid Alzheimer’s drugs, Lilly and Biogen are testing presymptomatic patients. Will doctors be open to this paradigm-shifting change?
In this episode presented by Element Materials Technology, BioSpace’s head of insights discusses how China, historically focused on manufacturing, is increasingly becoming an innovation leader, particularly in pharmaceuticals, with guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney. Ultimately, balanced strategies involve domestic capacity investments coupled with global collaboration.
Mounjaro and Zepbound contributed more than $10 billion to the $11.98 billion in sales Lilly recorded for key products in the third quarter, despite price decreases for the GLP-1 medicines.
The investment, which will expand Eli Lilly’s existing campus in Puerto Rico, is slated to create 100 new jobs, on top of around 1,000 construction-related roles.
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
The clinical hold comes days after Intellia voluntarily paused enrollment and dosing in the same two studies.
FEATURED STORIES
Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”
Big Pharmas like Eli Lilly, Sanofi and Novartis headed back to the dealmakers table multiple times, with 32 total deals counted across the industry for the first half.
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month.
In the race to make the most tolerable obesity drug, there seems to be no clear winner—at least not according to analysts parsing the data presented at the American Diabetes Association annual meeting this week.
Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval of Novavax’s COVID-19 vaccine could indicate a politicization of the drug approval processes that could ‘imperil public health.’
FROM BIOSPACE INSIGHTS
BioSpace’s 2022 Salary Report explores the average salaries and salary trends of life sciences professionals. Though movement in the labor market slowed during the pandemic, recovery has been swift and employers are once again having to cope with a highly competitive talent market.
UPCOMING EVENTS
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh speculate on the impending Trump administration, discuss current challenges faced by CEOs and weigh investment in GLP-1s.
The Novo-Catalent deal now moving ahead highlights unprecedented investment in manufacturing, while also standing out as an exception to the unspoken rule of keeping M&As to less than $5 billion this year.
GSK, Gilead and Arcellx, Vertex and more present new data at the American Society of Hematology annual meeting just as sickle cell therapies Casgevy and Lyfgenia have a new outcomes-based payment model; Eli Lilly and Novo Nordisk pump new funds into manufacturing; and AbbVie makes a Cerevel comeback while uniQure clears a path toward accelerated approval in Huntington’s disease.
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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
  1. 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.
  2. Five years ago, Gilead signed a massive deal with Galapagos. After a restructuring, the pharma is still hunting for the potential it saw at the original signing.
  3. Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval.
  4. Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.
  5. While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation.
WEIGHT LOSS
  1. Compounded versions could make up as much as 40% of the semaglutide market, said Novo Nordisk CEO Lars Fruergaard Jorgensen on Thursday, but the company hopes to win patients over.
  2. Lexicon’s LX9851 targets ACSL5, a liver enzyme involved in fat metabolism that helps moderate fat accumulation and slow down gastric emptying.
  3. Deloitte urged pharma executives to “be bold” in a new report tracking the top 20 pharmaceutical companies’ R&D performance.
  4. Eli Lilly and Novo Nordisk are in a global battle for dominance in the weight loss space. BioSpace takes a look at the territory covered and what’s to come.
  5. With crucial lessons learned from the manufacturing shortages of injectable GLP-1s, experts say securing adequate supply of the upcoming oral options will be the sector’s next great challenge.
POLICY
  1. The new version of the bill will still need to go through the entire House and Senate.
  2. Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug developers from targeting the U.S. market, potentially benefiting domestic producers of biosimilars.
  3. FDA
    The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
  4. District Judge William Young, a nominee of Republican President Ronald Reagan, blasted the Trump administration’s NIH cuts as discriminatory and “bearing down on people of color because of their color.”
  5. CDC
    HHS Secretary Robert F. Kennedy Jr.’s actions in recent months have raised concerns that he is taking a heavy-handed and unilateral approach to vaccine policy in the U.S.
CAREER HUB
Instead of going through pharma job search websites, you should create a powerful LinkedIn profile. Check out Biospace to find out the benefits of having a strong LinkedIn Profile.
To help you in your job search, here are just a few of the remote job options in the life science industry, along with the qualifications and skills necessary to be successful in each role.
When vetting the qualities of potential candidates at a career fair, listen to and take interest in the unique lived experiences of each job seeker you meet, as well as their skills and qualifications.
Job descriptions are the candidate’s first impression of a company. And if that introduction includes exclusionary language, they’re less likely to apply even if they are the perfect fit for the job.
Known as the Lone Star Bio Hotbed, Texas is home to multiple major players in the biopharma and biotech space and is currently a fast-growing hub for the life science industry.
You know it’s important to nail the interview with a potential employer, but it’s what you do after an interview that might really influence your chances of getting the job. Find out how in our guide.
Being laid off from a job is stressful. Fortunately, there are steps you can take to curb some of that stress, relieve financial worries and make finding your next position as smooth a process as possible.
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
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
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
  1. Analysts at BMO Capital Markets expect Summit and Akeso’s HARMONi-6 readout to put some pressure on Merck and its blockbuster biologic Keytruda.
  2. Combining Trodelvy with Keytruda and pushing it into the frontline setting could “potentially double” the ADC’s market in metastatic triple-negative breast cancer, according to analysts at Truist Securities.
  3. Analysts at Leerink Partners said in a Monday note that DESTINY-Breast09’s findings “could support an approval” for Enhertu in first-line HER2+ metastatic breast cancer.
  4. 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.
  5. AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
NEUROSCIENCE
  1. The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of potentially fatal brain swelling and bleeding.
  2. WVE-N531, an oligonucleotide, elicited significant functional benefit and reversal of muscle damage in the Phase II FORWARD-53 trial. Wave plans to file for accelerated approval of the candidate in 2026.
  3. Eisai’s new fiscal 2027 forecast for Leqembi is roughly 50% lower than its projections a year ago.
  4. President Donald Trump continues to warn of tariffs on the pharmaceutical industry; Susan Monarez replaces Dave Weldon as CDC director nominee; Novo Nordisk joins the triple-G race; Alnylam wins approval for Amvuttra in ATTR-CM; and Cassava Sciences ends development of simufilam in Alzheimer’s.
  5. After years of controversy and allegations of doctored data, Cassava is moving on from Alzheimer’s.
CELL AND GENE THERAPY
  1. The companies were two years into a four-year, $400 million agreement aimed at developing and marketing gene therapies together.
  2. As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
  3. At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.
  4. The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
  5. The proposed acquisition by global investment firms Carlyle and SK Capital Partners could net shareholders $3 per share plus potential CVR dollars and provide bluebird bio with primary capital to expand the commercial reach of its gene therapies.