After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its COVID-19 shot, CEO John Jacobs said on the company’s Q1 earnings call: “When we have it, we’ll have it. Until then, we don’t have it.”
The cell engineering company, co-founded by oncologist and writer Siddhartha Mukherjee, does not see a path forward for its pipeline of early-stage cell therapies for two different types of cancer.
The biopharma job market likely won’t turn around until 2026, according to two industry experts. Both cited a need for more investment and noted the impact of uncertainty on the industry.
Takeda’s Julie Kim argues that Trump’s idea to match drug prices to that of other countries could cost the industry up to $1 trillion over the next 10 years.
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision to declare the end of the shortage of Novo Nordisk’s semaglutide, Judge Mark Pittman agreed that Eli Lilly’s tirzepatide is in sufficient supply, meaning compounding pharmacies can no longer sell the lucrative weight loss drugs.
FEATURED STORIES
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
A handful of billion-dollar deals in the rare disease space highlights the uptick in Big Pharma’s investment, but it’s still extremely low compared to the money flowing to more common indications.
While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.
A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.
Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
Follow News Editor Greg Slabodkin and Managing Editor Jef Akst as they travel with some 8,000 others for discussions of cell and gene therapy advances, challenges, regulations and more.
J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees.
In the second episode of our series on women’s health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories.
Job Trends
Novartis presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta® at the late-breaking clinical trials session of the European Renal Association Congress.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S. -
Cartesian Therapeutics’ mRNA CAR-T therapy met its primary endpoint in a mid-stage trial for the chronic autoimmune disorder and expects to raise $130 million via private placement equity financing. -
In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
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In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs. -
Alumis is debuting in an initial public offering Friday on the Nasdaq, though the $250 million IPO is less than its initial targeted raise of $274 million just days ago.
WEIGHT LOSS
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Novo Nordisk’s blockbuster type 2 diabetes medication is a sure bet for the list of the next 15 drugs whose Medicare prices will be negotiated in 2025 and go into effect in 2027, according to analysts and academics. -
Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects. -
In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively. -
Novo Nodrisk’s cannabinoid receptor–targeting obesity pill was picked up in the $1.1 billion acquisition of Inversago Pharmaceuticals last year. -
With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
POLICY
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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. -
AbbVie’s blockbuster Humira held 105 patents, shielding the anti-inflammatory drug from biosimilar competition for more than 20 years. Proposed reforms could help prevent companies from extending exclusivity with such patent thickets. -
Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days. -
A week after dining with Trump and his team at Mar-a-Lago, leaders at Pfizer and Eli Lilly have publicly stated that they intend to collaborate with the incoming administration on key issues affecting the pharma industry. -
Former president and CEO of CytoDyn Nader Pourhassan along with Kazem Kazempour, former CEO of the CRO running CytoDyn’s trials, are awaiting sentencing but could face up to 20 years in prison for each count of securities and wire fraud and insider trading.
We sat down with Associate Director of Talent Acquisition Jennifer Metivier and Chief People Officer Jennifer Peterson of Obsidian Therapeutics to discuss what type of candidates they prefer.
If you’re considering a career change from pharma to biotech, you’ll be happy to hear that according to industry experts, the transition is more common than you might think.
Keep reading to take a look at some of the best pharma jobs for travelers. These jobs will allow you to see different parts of the world while working in an exciting and fast-paced industry.
Thinking about starting a career in biotech? We’ve put together a guide to help you decide where to go within the biotech field and what steps you should take to get there.
The search for a biopharma job can be daunting, but it doesn’t have to be. Here is a complete guide to the biopharma job hunt, from researching job openings to writing resumes and cover letters.
Even if you aren’t looking for a new role in biopharma, nurturing relationships will only benefit you in the long run. To help, here is a complete guide to networking in the life science industry.
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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The overall survival edge over J&J’s Darzalex will help GSK strengthen its case as it plots the market comeback of Blenrep, which was pulled after a failed confirmatory study. -
Anito-cel has shown no signs of delayed neurotoxicity at around 9 months of follow-up, hinting at a safety profile that could set it apart from J&J and Legend’s Carvykti. -
According to Jake Van Naarden, president of Lilly Oncology, the excess deaths could be due to the high rate of crossover in BRUIN CLL-321. -
Analysts called the data “very competitive” but raised questions about safety. Merck gained ownership of the ADC when it acquired VelosBio in November 2020 for $2.75 billion. -
The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.
NEUROSCIENCE
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Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials. -
Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later. -
Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year. -
With Monday’s data from SAPPHIRE, Scholar Rock is building toward regulatory submissions for apitegromab in spinal muscular atrophy in the first quarter of 2025. -
Bristol Myers Squibb wins approval for the first novel schizophrenia drug in decades; Pfizer pulls Oxbryta from the market; new IVF and abortion laws could derail women’s health research; Roche touts CDK inhibitor deal and obesity pipeline and BioSpace heads to Meeting on the Mesa.
CELL AND GENE THERAPY
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The advantages of using circular RNAs—including increased durability, enhanced protein expression and substantially lower manufacturing costs compared to linear mRNAs—have driven a spate of investment in this technology. -
Fatalities are an unfortunate reality of clinical trials. How can companies best protect themselves? -
After more than a decade devoid of therapeutic advancements, a first-in-class T cell receptor therapy could be on the immediate horizon for synovial sarcoma patients. -
The company’s candidate, giroctocogene fitelparvovec, met its primary and key secondary objectives of superiority compared to the standard treatment of regular Factor VIII infusions. -
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.
