Exemptions to new export control policies have allowed companies to ship patients’ biological materials to foreign laboratories, including those in China and other adversarial nations, according to the FDA.
California’s life sciences jobs led the nation last year, according to a new California Life Sciences (CLS) report. However, employment growth slowed and could continue slowing. CLS President and CEO Mike Guerra discusses the critical factors influencing California’s success.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors.
After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.
The well-respected director of the FDA’s cell and gene therapy office was seen as a stabilizing and trustworthy voice inside the quickly reshaping FDA, especially since the late-March exit of CBER Director Peter Marks.
Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts.
FEATURED STORIES
Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.
Licensing deals have risen in prominence in a restrained market environment. Is it desperation, or an important part of the biotech ecosystem? Experts weigh in.
Look for renewed investment driven by lower interest rates in the new year, and a continued focus on late-stage assets, oncology and reaping the benefits of AI.
Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.
Expanding volumes of data point to mechanisms beyond weight loss and blood sugar control that contribute to cardiovascular benefits in the world’s fastest-growing drug class.
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.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
This week, an FDA adcomm unanimously voted for the approval of Eli Lilly’s anti-amyloid antibody as thousands of layoffs continue to rattle the industry.
How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology? Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.
The biggest conferences of the year dominated news this week: the American Society of Clinical Oncology annual meeting and the BIO International Convention.
Job Trends
Johnson & Johnson (NYSE: JNJ) announced today it has entered into a definitive agreement with Numab Therapeutics to acquire from Numab’s shareholders its wholly-owned subsidiary for the global rights to a novel, investigational first-in-class bispecific antibody, NM26, in an all-cash transaction of approximately $1.25 billion.
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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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The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers. -
Oral doses of SIGA Technologies’ antiviral drug Tpoxx will help the U.S. maintain its reserves of the vaccine in preparation for future potential outbreaks, according to the company. -
After completing a buyout transaction with The Column Group to remove it from the stock exchange, NGM Bio has raised a $122M Series A to fund a registrational study for a rare liver disease drug and a Phase II trial in hyperemesis gravidarum. -
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II. -
Akebia Therapeutics on Thursday said it regained full U.S. rights to its chronic kidney disease anemia drug Vafseo, which the biotech has priced at around $15,500 per year.
WEIGHT LOSS
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Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data. -
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents. -
After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile. -
Scaling GLP-1 manufacturing capacity remains a key priority for the pharma industry, to help supply catch up with the insatiable demand for weight loss drugs. -
BMO Capital Markets analyst Evan Seigerman called it “another positive indication” for Eli Lilly, whose top-selling diabetes and weight loss drugs are gaining market share as manufacturing continues to expand, while noting the drugmaker could start to benefit heading into third quarter earnings.
POLICY
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The back-to-back high-level disruptions in vaccine policy under Robert F. Kennedy Jr. comes as the U.S. records its first death from measles since 2015. -
While many industry players and observers have high hopes for the EPIC Act, some say budgetary headwinds could make it difficult for the current administration to make meaningful repeals or amendments to the IRA. -
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage. -
Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar. -
President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.
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.
To help alleviate some of the stress related to finding a new job, we’ve created a comprehensive guide detailing how to prepare for your biopharma job search.
Requesting disability accommodations is vital for your success in the workplace. You can find out everything about how to ask for accommodations in our guide.
Before searching for a job in the life sciences industry, it is essential to understand the differences between working as a contractor and a full-time employee.
HOTBEDS
IN CASE YOU MISSED IT
In advance of this week’s adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival.
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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In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum. -
Staff cuts will leave IGM Biosciences with 37 employees. The company is also halting development of two bispecific antibody T cell engagers for autoimmune diseases. -
If approved, Pfizer’s sasanlimab will distinguish itself from Merck’s blockbuster Keytruda as the first PD-1 inhibitor indicated in combination with BCG for high-risk non-muscle invasive bladder cancer patients who had not previously undergone BCG treatment. -
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. -
In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates.
NEUROSCIENCE
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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. -
Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone. -
With the failure of AbbVie’s emraclidine in two mid-stage trials, Bristol Myers Squibb’s Cobenfy is ‘sole muscarinic winner.’ -
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain. -
A slow launch for Alzheimer’s medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a few of the factors that have sent Biogen’s shares down this year.
CELL AND GENE THERAPY
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Last month, Vertex said sickle cell patients had not yet received infusions of its gene therapy Casgevy. That’s now changed, as the company races with bluebird bio’s Lyfgenia. -
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline. -
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general. -
BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting. -
Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.
