While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
Ivonescimab elicited better overall survival in Asian patients with non-small cell lung cancer than in those from North America and European countries, in Western countries narrowly missing the statistical significance threshold the FDA is seeking.
KER-0193 is a modulator of ion channels connected to autism spectrum disorder. The FDA bestowed orphan drug and rare pediatric drug designations on the candidate earlier this year.
According to analysts, the new data could present a path to accelerated approval for ifinatamab deruxtecan, a product of Merck and Daiichi Sankyo’s troubled ADC partnership.
The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries.
FEATURED STORIES
Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.
Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and more aim to deliver the next wave of progress with near-term data and regulatory milestones.
Achondroplasia, which affects around one in 20,000 babies, has just one approved treatment: BioMarin’s Voxzogo. However, new investigational treatments are vying to compete in the area.
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this month the company has secured an approval for AstraZeneca-partnered Dato-DXd, to be marketed as Datroway.
LATEST PODCASTS
The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United States. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, politics and a fragmented payer system contribute to the increasingly high costs to patients.
Bayer cut its C-suite nearly in half amid a massive restructuring. Meanwhile, the U.S. government says it will pay for Wegovy for patients with heart disease.
This week, we’re talking money! Following the release of BioSpace’s 2024 Salary Report, we discuss salary trends and how they are impacting the biopharma workforce.
Job Trends
Editas Medicine, Inc. today announced a two-year extension to the collaboration with Bristol Myers Squibb (NYSE: BMY) under which the parties may research, develop, and commercialize autologous and allogeneic alpha-beta T cell medicines for the treatment of cancer and autoimmune diseases.
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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
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Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products. -
Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq. -
Analysts predict a booming year for mergers and acquisitions, powered by obesity drug sales and pressure from upcoming patent expirations. -
As evidenced by this week’s buyouts by J&J and Merck, Big Pharma appears to have found a sweet spot favoring smaller deals over megabillion-dollar acquisitions. -
Merck on Wednesday announced a deal worth $3 billion to buy EyeBio and its first-in-class trispecific antibody Restoret, marking the pharma’s return to the ophthalmology space after nearly a decade.
WEIGHT LOSS
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Venture Capital firms Atlas Venture, Bain Capital Life Sciences and RTW Investments have led a $400 million Series A for Kailera Therapeutics, the latest obesity biotech to hit the scene. -
A week after it released positive early-stage data, Metsera has partnered with Amneal Pharmaceuticals in an effort to secure the development and supply of its investigational weight loss therapy MET-097. -
The acquisition was featured Monday in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs. -
Sen. Bernie Sanders’ aggressive targeting of Danish drugmaker Novo Nordisk’s Ozempic and Wegovy pricing, and not Eli Lilly’s rival drugs, is not fair. -
In a Tuesday Senate hearing on Novo Nordisk’s drug pricing, CEO Lars Fruergaard Jørgensen said he would be willing to sit down with the three largest pharmacy benefit managers who committed that they would expand coverage of Ozempic and Wegovy if Novo lowers its list prices for the blockbuster drugs.
POLICY
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After withdrawing its nomination for Dave Weldon last week, the Trump administration is now reportedly considering Texas Republican Michael Burgess to head the Centers for Disease Control and Prevention. -
A group of medical experts expressed concern about growing “disinformation” and “misinformation,” calling for adherence to recommended vaccine schedules. -
Democratic senators from Georgia, Oregon, Maryland and New Mexico called the Trump administration’s decision to terminate hundreds of CDC staffers reckless and unfair. -
The CDC budget cuts could pose headwinds for HIV drugmakers like Gilead and Merck but are unlikely to severely cripple their HIV divisions, according to analysts. -
The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.
We interviewed Krissy Fuller, a human resources consultant, to learn more about the issue of mandated vaccines from an HR perspective and shared her predictions on what changes she thinks will last after the pandemic.
Learn some essential tips on how to build a resume or how to enhance your resume during COVID-19. These tips can increase the chances of getting you to the interview stage.
If you’re setting new career goals, try including these tips to shape a path forward.
After you’ve been in a role for a decent amount of time it can feel like you have learned all that there is to learn. But that’s not to say that you’ve learned all you can from the company and the people that work there.
Why are adaptive leaders so useful? And is adaptive leadership a quality that will benefit your life sciences career? Let’s explore this concept and find out.
Regardless of the field that you work in, mentioning top skills in your resume is a crucial step. Here are some tips to prepare the best leadership skills resume.
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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With nearly 90% of patients showing no detectable cancer cells after treatment, J&J and Legend’s Carvykti could stave off competition from emerging CAR T therapies such as Gilead and Arcellx’s anito-cel. -
BNT327, now in early-phase trials, is part of a class of drugs that could one day challenge Keytruda’s dominance. BioNTech obtained the candidate when it bought Biotheus last month in an acquisition deal that could reach up to $950 million. -
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. -
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.
NEUROSCIENCE
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Wave Life Sciences in a Tuesday filing with the SEC said Takeda has elected to terminate its option to continue work on Wave’s WVE-003 clinical-stage Huntington’s disease program—a potential $5 billion commercial opportunity, according to the biotech. -
Johnson & Johnson is cutting several programs—most of which are in neurology and psychiatry—as the company also pulls back from the infectious diseases market. -
Under the deal, the Danish pharma will gain access to Longboard’s 5-HT2C receptor superagonist that is currently in late-stage development for seizures in various developmental and epileptic encephalopathies, including Dravet syndrome. -
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.
CELL AND GENE THERAPY
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Patients in the U.K. with transfusion-dependent beta-thalassemia will have access to Vertex Pharmaceuticals’ gene editing therapy Casgevy, thanks to an agreement with the National Health Service on the price. -
Experts say the time is now to develop and provide widespread access to genetic medicines for the rarest diseases. What’s more, they say it is a moral imperative. -
BioMarin Pharmaceuticals on Monday said it is restricting sales of its hemophilia A gene therapy to three countries in an effort to reduce costs and help the treatment become profitable by 2025. -
Longeveron and Lexeo Therapeutics are working on CGT therapies to treat Alzheimer’s disease, but it’s not clear whether they have a better chance of success than traditional approaches. -
Ultracompact CRISPR systems, which are in some cases one-third the size of Cas9, are being designed to be more specific and enable in vivo gene editing in difficult to reach tissues.
