In another blow to Prothena’s neurodegenerative disease portfolio, anti-amyloid candidate PRX012 has run into the same problem that larger peers Biogen and Eli Lilly have battled: high rates of swelling in the brain.
Exelixis is looking at the possibility of relocating some of the eliminated Pennsylvania roles to its headquarters in Alameda, California, according to a company spokesperson.
The American Academy of Pediatrics called the decision to limit children’s access to COVID-19 vaccines “deeply troubling.”
Novo Nordisk has brought on other cardiometabolic collaborators this year, including United Laboratories International and Deep Apple Therapeutics.
The CDC director—the first to be confirmed by the Senate under new legislation—has been ousted after less than a month following internal unrest regarding new, more restrictive approvals for updated COVID-19 vaccines, according to multiple sources.
Looking for a biopharma job in San Francisco or South San Francisco? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
FEATURED STORIES
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.
While the last decade has brought considerable progress for patients with DMD, substantial unmet need remains. Several companies including Wave, Dyne and Avidity are looking to answer the call with investigational therapies targeting greater efficacy and broader reach.
Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.
At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry.
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.
There are currently no treatments available for celiac disease beyond a gluten-free diet. Several late-phase companies aim to change the paradigm and deliver hope and progress soon.
LATEST PODCASTS
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.
The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.
This episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients.
Job Trends
Merck, known as MSD outside of the United States and Canada, announced that the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival for the first-line treatment of patients with human epidermal growth factor receptor 2 -positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D. -
As we near the end of second quarter of 2024, the initial public offerings among biotechs have slowed, but the market is still going strong. -
Orna Therapeutics announced Thursday it is acquiring ReNAgade Therapeutics, which launched in May 2023 with $300 million in Series A financing and is on BioSpace’s NextGen Class of 2024 startups to watch this year. -
Days after backing out of two Ionis-partnered neuro programs, Biogen has inked a potential $1.8 billion buy of Human Immunology Biosciences and boosting its late-stage immunology pipeline. -
Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.
WEIGHT LOSS
-
The release of early-stage data on three oral weight loss drug candidates hints at which companies have the strongest hand, but the comparisons are rife with confounding variables, leaving analysts unsure about where to place their bets. -
In metabolic dysfunction-associated steatotic liver disease, a retrospective analysis shows that patients on GLP-1 receptor agonists are 14% less likely to progress to cirrhosis. -
When doses were increased rapidly in a Phase I study, patients on Roche’s investigational oral GLP-1 receptor agonist experienced nausea, vomiting, constipation, diarrhea, as well as abdominal distension. -
On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate. -
A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate.
POLICY
-
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. -
The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense. -
As Marty Makary and Jay Bhattacharya sail through the Senate health committee vote, Weldon’s confirmation hearing is canceled. Guggenheim Partners heralded the last-minute move to revoke Dave Weldon’s nomination as “a positive sign for reigning in vaccine criticism.” -
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
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
-
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. -
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.
NEUROSCIENCE
-
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
-
Sarepta has been hit with another patent infringement lawsuit, this time from Sanofi and its subsidiary Genzyme alleging that the biotech used protected technology related to AAV vectors.
-
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.
