Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.
With venture funding tightening in the post-COVID landscape, efficiency has become more critical than ever. In this interactive webinar industry experts explored actionable strategies for maintaining quality under financial pressure. Watch now.
The antibody anselamimab, which AstraZeneca picked up in its 2021 purchase of Caelum Biosciences, failed to improve survival and reduce hospitalizations, but the company sees promise in data from an unspecified patient subgroup.
Johnson & Johnson’s $23.7 billion in second-quarter earnings, driven by cancer and neuroscience drugs, exceeded analyst expectations, while CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030.
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.
Shanghai-based LaNova Medicines—which has captured the attention of some of the biggest Western pharmas—will be folded into fellow Chinese company Sino Biopharmaceutical in a deal worth up to $951 million.
FEATURED STORIES
On June 10, the FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for Lilly’s Alzheimer’s drug.
The Celularity CEO and founder tells BioSpace he believes that placenta-derived cells are the future of stem cell therapies to fight autoimmune disease, cancer, even aging.
In this deep dive, BioSpace takes a closer look at the drug price crisis in the U.S. As President Joe Biden and former President Donald Trump gear up for a rematch in the 2024 election, we explore how federal reforms to lower costs could be leveraged on the campaign trail.
In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
LATEST PODCASTS
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
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.
Job Trends
LAVA Therapeutics N.V. ( Nasdaq: LVTX ), today announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207.
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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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One day after revealing a restructuring initiative, Jounce Therapeutics announced it plans to merge its business in an all-stock deal with clinical-stage biotech Redx Pharma. -
Amid mounting pressure from investors and shareholders, Bayer’s supervisory board unanimously appointed outsider Bill Anderson as its new CEO. -
Karuna Therapeutics acquired exclusive rights to Goldfinch Bio’s investigational TRPC4/5 channel candidates in a deal potentially worth $520 million. -
Sen. Elizabeth Warren (D-MA) voiced concerns to the FTC regarding the prospective acquisitions of Horizon Pharmaceuticals and Opiant Pharmaceuticals by Amgen and Indivior. -
bluebird bio, Inc. is expecting gross proceeds of $120 million with its newly announced public offering of 20,000,000 shares.
WEIGHT LOSS
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After a bidding war erupted between Pfizer and Novo Nordisk over the fledgling obesity drugmaker, Metsera sided with its original suitor in a final agreement announced late Friday evening. -
During a press conference to announce a drug price deal for GLP-1s, President Donald Trump asked for more details about the ongoing bidding war between Novo Nordisk and Pfizer over obesity biotech Metsera. -
The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on. -
The agreement will also secure a $150 price for future weight loss pills from Novo Nordisk and Eli Lilly—at least initially. -
The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.
POLICY
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The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements. -
National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents. -
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others. -
Following two deaths due to presumed sepsis, the FDA has placed a partial clinical hold on three trials for Zentalis’ azenosertib including a Phase I in solid tumors, Phase II in platinum-resistant ovarian cancer and Phase II in uterine serous carcinoma. -
Merck on Monday secured the FDA’s green light for its 21-valent pneumococcal vaccine Capvaxive, which covers serotypes responsible for around 84% of invasive pneumococcal disease cases.
A new year calls for a renewed sense of focus, direction, and motivation in your career. It’s a time to let go of the bad habits that have been holding you back professionally, and replace them with newer, better strategies that will help you to have a year of growth and success in 2019.
California’s life science sector is a major player in the state’s job creation and economic development. In 2016, life science companies in California employed more than 360,000 professionals.
Holidays mean a lot of opportunity to socialize with people both within and outside of your field, and if you happen to be on the job market or considering making a career switch in 2019, it can also be a great opportunity to make organic connections with people who may end up helping you out in the future.
Here are 7 self reflection questions to ask yourself during the New Year to find out if you’re on the right path to achieving your career goals in the coming year.
Flexible hours. More vacation time. Work from home. Free gym memberships. Free snacks. Company-sponsored outings. Student loan payment assistance. These are some of the perks that companies dangle in order to attract top talent to their ranks.
Need help writing your career change cover letter? Here are some tips that will get you started on the right path by making you the best candidate for the job.
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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Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023. -
BeiGene’s Brukinsa becomes the first BTK inhibitor approved for follicular lymphoma, the most common type of low-grade non-Hodgkin lymphoma. -
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness. -
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene. -
Retaining the full rights to Trodelvy, Gilead now has access to $210 million in financing from venture capital firm Abingworth to help push the antibody-drug conjugate into non-small cell lung cancer studies.
NEUROSCIENCE
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2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications. -
TauRx Pharmaceuticals and Anavex Life Sciences presented positive results from their candidates at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco, CA. -
Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients. -
Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday. -
BioSpace sat down with Roche Global Head of Neurodegeneration Rachelle Doody, Ph.D. and Alzheimer’s Drug Discovery Foundation Co-founder Howard Fillit, M.D. to discuss the highlights.
CELL AND GENE THERAPY
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The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z. -
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study. -
The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy. -
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.
