Why this role provides a critical ‘boot camp’ for future pharma leaders.

Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis.

This facility is the first of four facilities to be built in the area.

New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube.

Ellenor discusses key points from the recent SCOPE presentation.

Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts.

A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia.

Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis.

According to the letter, the FDA believes that the investigational apomorphine infusion device is not ready for approval in its current form.

Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1.

The latest news for pharma industry insiders.

FDA’s program will provide guidance to the development of the company’s Delphi-MD technology.

Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy.

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have to show after a 10 years in the weight loss/obesity space.

Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.

The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets.

Agreement comes as Teva aims to strengthen its biosimilar portfolio as part of its “Pivot to Growth” strategy.

Early results have demonstrated that mRNA-3927 has led to a 70% reduction in the relative risk for metabolic decompensation events in patients with propionic acidemia.

Approval comes amid positive results from TRILUMINATE trial, which demonstrated improvement in 90% of participants treated for a leaky tricuspid heart valve.

Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.

Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States.

The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.

Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.

The network will work with DiRx and MakoRX.

The latest news for pharma industry insiders.

In this week’s episode, in recognition of international women’s month, Editor Miranda Schmalfuhs has compiled audio clips from interviews with female KOLs that she’s been fortunate enough to speak with over this past month for content across a few of our brands.

Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies.

Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy.

The study used technology developed by a variety of companies, including RYLTI.

The news comes less than a year after Pfizer announced that IPG would handle this role.

Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.

Both products are designed to help radiologists.

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.

Action marks the first FDA-approved blood screening test for malaria.

Alexander discusses the broader implications the case could have on FDA’s ability to regulate the industry.

Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.

In this Pharmaceutical Executive video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, talks about the program’s creation and their most successful strategies for encouraging the inclusion of women of childbearing age in clinical trials.

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

The agency released guidelines for vaccinations guidelines for children as young as 6 months old.

The latest news for pharma industry insiders.

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses the three drugs featured in their Drug Pipeline Insights Report for 2024 and which unmet needs they address.

Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings.

The drug was recently cleared to treat cardiovascular risks, making it eligible for Medicare Part D.

In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, talks about what’s coming marketing with the use of AI.

Cold Spring Harbor Laboratory details how the new tool will help reduce common barriers to trial participation.

Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.

Using the 3 Rs to guide AI transformation in Pharma.

The acquisition will bolster AstraZeneca’s ability to develop radioconjugates for cancer treatments.

Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on thelong-term well-being of founders and CEOs.

In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

As part of the partnership, BeiGene will serve as a sponsor at LLS events.

The latest news for pharma industry insiders.

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.

Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses why no novel active substances have yet been brought to market through AI technology despite increasing investments in the space for drug discovery as shown in IQVIA’s Global Trends in R&D 2024 report.

In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses how AI could have helped address past challenges.

Acquisition is highlighted by eneboparatide, Amolyt’s Phase III peptide for hypoparathyroidism with a novel mechanism of action.

The voluntary recall was ordered due to potential silicon particulate exposure.

The new season could bring with it more possibilities for renewal in the biotech sector, as our coverage this month highlights.

In this Pharmaceutical Executive interview, Jill Jaroch, Senior Director, Women’s Health & Urology Marketing at Astellas, discusses the decision to continue VEOZAH’s presence during the big game, the inspiration and message behind the commercial, and if Taylor Swift played a factor in their decision making

Four steps to maximize the impact of medical information services as an engagement gateway.

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses findings from IQVIA’s Global Trends in R&D 2024 report that shows why the US continued to lead in new drug launches in 2023.

Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia.

Starting June 1, Boehringer Ingelheim plans to cap inhaler products for respiratory diseases at $35 per month for eligible patients.

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

Relyvrio did not significantly alter amyotrophic lateral sclerosis disease progression as measured by the ALSFRS-R total score at Week 48 compared to placebo.

FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists in the lab focused on data integrity.

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

Eli Lilly continues to emphasize the potential harm that could come with using GLP-1 receptor agonists for off-label purposes.

The company plans to spend the coming years strengthening its market position and pipeline while also clearing its issues with litigation and debt.

In this Pharmaceutical Executive interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics, dives into the greatest threats to the integrity of data in R&D and threats presented by hackers.

The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.

The partnership has the goal of improving patient education and treatment directions.

Rebranding aims to align company with its parent company and other subsidiaries.

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics, discusses data security threats from human error to AI tech and how COVID-19 impacted data integrity.

The agency teamed up with the software company to develop platforms and networks to collect de-identified data.

The agency updated its recommendations after a vote by the ACIP advisory committee.

Simon discusses a recent survey ICON conducted with professionals in obesity-related clinical research.

Phase III DAYBREAK study found consistent safety with Zeposia in patients with relapsing forms of multiple sclerosis.

JAMA commentary suggests that issues such as high costs, access, and equity will stop patients from obtaining GLP-1 agonists to treat obesity.

New guidance suggests that CMS may be ramping up Sunshine Act auditing activities, potentially resulting in monetary liability for noncompliant reporting entities.

Cardinal Health report highlights new biosimilar treatments, legislative developments, and multiple industry perspectives.

Commentary cites lower control over health plan costs and the potential bias for prescribing drugs through influence from drug manufacturers.

OSE-230 was developed to activate a unique mechanism for resolving chronic inflammation, focusing on modulation of macrophages and neutrophils.

NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer.

The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act.

Trial data support Tevimbra combined with chemotherapy as a potential first-line treatment option for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction cancer.

FDA has approved the medication in adults and children with allergies.

Collaboration aims to leverage Nhwa’s expertise in the country’s neuro-psychiatric health sector.

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of Medicines 2024 report as well as the significant projected growth in spending and growth in diabetes and global obesity

The gallery will be a part of the HLTH Europe event and will be open to all attendees.

The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.

The agency issued a statement reminding the public that it has not approved any such devices for this use.

Results of a study conducted by the National Institutes of Health indicate that the Paxlovid prevented a substantial number of hospitalizations associated with COVID-19.

Funds expected to advance multiple programs into clinical studies, including FMC-376, which targets KRASG12C cancers.

Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while also reducing inflammatory biomarkers linked to heart disease.

Letter emphasizes the need to protect children from potentially harmful medical advice spread on social media.

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

Anderson discusses the complexities of planning for a global launch and the common mistakes companies make that cause problems along the way.

Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.

The FDA has assigned a Prescription Drug User Fee Act action date of August 20, 2024, for Servier’s New Drug Application for vorasidenib.

The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.

Amid shifting healthcare cost strategies, how manufacturers can apply past lessons to best support patients and help boost drug adherence.

Investigators harness machine learning to evaluate response to sertraline treatment for major depressive disorder.

How a multipronged approach to staff recruitment can accelerate trial success.

In an interview with Pharm Exec Associate Editor Don Tracy, Raj Verma, Chief Diversity, Culture, and Experience Officer, Sanofi, discusses features of the company’s support program for patients diagnosed with cancer and other critical illnesses.

Iris Kuss, head of clinical development, and Jorge Ortiz, head of medical affairs, discuss the company’s recent presentation at ASCO GU.

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

The FDA previously granted accelerated approval to Tepmetko for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

This acquisition will add asthma treatment A1O-001 to GSK’s portfolio.

Click the title above for a link to open the Pharmaceutical Executive February 2024 issue in an interactive PDF format.

Treatment aims to reduce the risk of finger or toe amputation due to frostbite.

Pancreatic adenocarcinoma is the most common form of pancreatic cancer, with more than 60,000 diagnoses per year in the United States.

Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment when the first patient was dosed with the novel cancer drug.

Embracing business imperatives such as operational efficiency and a focus on a patient-centric approach can help pharma leaders provide a stable foundation amid lingering uncertainty.

In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.

Takeda expects Eohilia single-dose stick packs will be available by the end of February for patients aged 11 years and older with eosinophilic esophagitis.

Key steps in relationship-building beyond just treatment options.

Novel oral orexin receptor 2 agonist produced statistically significant and clinically meaningful improvements in wakefulness compared with placebo in patients with narcolepsy type 1.

Joint venture aims to submit an Investigational New Drug application to the FDA by early next year for treatment that targets solid tumors.

The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between AI’s potential and its full utilization in this space.

According to the study conducted by Technavio, North America will contribute to 37% of the expected growth.

BioNTech will invest $200 million and get access to Autolus’ manufacturing sites.

2024 Life Sciences Accounting & Reporting Congress

The three-year initiative comes with $15 million in funding.

Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of death in patients with acute myeloid leukemia.

The agreement will strengthen Novartis’ oncology pipeline.

In a Phase I trial, data suggest that Amgen’s maridebart cafraglutide (MariTide) may allow patients to take lower and less frequent doses over time while still maintaining significant weight loss.

The FDA assigned a Prescription Drug User Fee Act action date of June 7, 2024, to an application that would expand the indication of Arexvy to include adults 50-59 years with an increased risk of respiratory syncytial virus-related lower respiratory tract disease.

Synchron’s brain-computer interface device is being developed to allow patients with mobility challenges to operate certain technology with their mind.

The drugmaker will directly acquire three finish-fill sites as part of the deal.

Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.

The company has struggled to supply the drug to patients due to overwhelming popularity.

The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand.

Beyfortus (nirsevimab-alip), a monoclonal antibody that protects against respiratory syncytial virus-associated lower respiratory tract disease, experienced higher than anticipated demand that led to shortages during the 2023-2024 season.

In an interview with Pharm Exec Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology Business Unit, AstraZeneca, provides her thoughts on the success of the trial.

The US Department of Health and Human Services has initiated a comprehensive strategy to address the escalating syphilis rates, as a result.

DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.

App aims to leverage digital technology to significantly reduce pharmacy costs.

Aduhelm (aducanumab-avwa) was granted accelerated approval by the FDA in June 2021 despite misgivings from the agency’s Peripheral and Central Nervous System Drugs Advisory Committee.

Researchers noted the onset of symptoms in patients who were treated with contaminated HGH therapy.

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to be evaluated in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma following treatment with a Bruton tyrosine kinase inhibitor.

Portals are finally a viable channel as life sciences companies shift to modular to build their digital ecosystems, create and approve content, and deliver omnichannel experiences.

The agency recognized the medication as a significant advancement for the treatment of IPF.

A deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.

Report comes after the FDA seized thousands of counterfeit Ozempic units.

Substance use disorder is a complex condition that demands innovative solutions, one of which that has shown promise is the use of long-acting injectables.

In an interview with PharmExec Associate Editor Don Tracy, Jingsong Wang discusses Nona Biosciences’ recent exclusive license agreement with Pfizer Inc. for the development and commercialization of HBM9033.

Study finds that individuals who took GLP-1 agonists for a long duration had a lower risk of going on to develop more severe forms of liver disease, including cirrhosis and liver cancer.

Atypical antidepressant linked to severe adverse effects and death as a result of misuse.

FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.

The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.

New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products.

Embracing new digital-based tools is critical throughout the healthcare landscape to prepare for the rise of telemedicine as a permanent way of life.

NK010 is reportedly the first Chinese trial of its kind to be approved by the FDA.

The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.

Pharma marketing strategies that are both socially and ethically responsible can build long term success for the life sciences industry.

Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

Will the FDA ultimately step in and mandate a credible effort to eradicate the mindset that long-term adherence is not achievable?

In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses the changing role of PBMs and recent price structure overhauls.

Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.

Analytics capabilities are no longer a nice-to-have, but a necessity to build and maintain a successful business and competitive edge.

According to the university, new nanotech scaffolding can be used to support tissue growth.

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.

Webinar Date/Time: Thu, Feb 15, 2024 11:00 AM EST

Sun Pharmaceutical Industries will purchase Taro’s outstanding shares for $43 each, which will total $348 million.

Researchers believe low numbers in the use of direct-to-consumer healthcare services could rapidly trend up.

HyQvia is the only subcutaneous immune globulin infusion that can be administered once per month.

New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.

Company displayed findings at the 2024 Winter Clinical Dermatology Conference in Hawaii demonstrating significant improvements in atopic dermatitis and seborrheic dermatitis.

Roots Analysis report suggests increase can be attributed to the growing demand for advanced therapies and biologics.

The device can produce AI-assisted readings.

The BioThrax vaccine is indicated for active immunization to prevent anthrax disease caused by Bacillus anthracis in individuals aged 18 through 65 years.

Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.

The survey is part of the brand’s new marketing campaign.

RC88 is under evaluation for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Although medications such as Mounjaro and Zepbound have shown efficacy in helping individuals lose weight, there are not yet enough results to fully support these claims.

The company also announced that it has submitted its new glucose monitoring system to the FDA for approval.

While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies.

Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the best evidence for defense.

SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action […]

Both companies are now under the Norstella umbrella. Evaluate announced the acquisition of J+D Forecasting, a provider of forecasting solutions focused on the pharmaceutical and life sciences industry. The move will bring J+D under the Norstella umbrella, the parent company of Evaluate. The parent company also includes Citeline, MMIT, Panalgo, and The Dedham Group. Norstella […]

Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies. Both Merck and Johnson & Johnson have announced separate acquisitions of biopharmaceutical companies in moves that strengthen their respective oncology pipelines. Merck has acquired Harpoon […]

Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising. Following a review spanning November and December 2023, on December 29, 2023, the US District Court for the Southern District of New York granted the Federal Trade Commission’s (FTC) request for a preliminary block to prevent IQVIA from acquiring Propel Media.1 The FTC […]

Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions. Telix Pharmaceuticals has filed a biologics license application (BLA) to the FDA for the novel positron emission tomography (PET) imaging agent 89Zr-DFO-girentuximab (TLX250-CDx; Zircaix) for clear cell renal cell carcinoma (ccRCC).1 The BLA submission was based on […]

JAMA study investigates whether physical or behavioral healthcare needs are associated with the risk of underinsurance across household income levels. In a recently published study by the JAMA Network, researchers aimed to discover the prevalence of underinsurance among children with special health care needs (CSHCN) in the United States and assess variations based on the […]

Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus […]

Over the past 15 years, on average, racial and ethnic diversity in multiple US regions has increased by 1% to 5%. One concern that has been consistently raised in the healthcare professional community is whether or not the race, ethnicity, and sex diversity of students in US health professions programs is an accurate representation of […]

VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. Invivyd, Inc. has filed a request with the FDA for emergency use authorization (EUA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. The EUA submission […]

Merger agreement includes the Gracell FasTCAR platform, which could significantly improve the efficacy of CAR T-cell therapies. AstraZeneca had a busy holiday season as it reached a definitive agreement to acquire Gracell Biotechnologies Inc. in a deal that could potentially reach up to $1.2 billion. The acquisition of Gracell, a clinical-stage biopharmaceutical company, includes the […]

Practical recommendations for a path forward for both biopharma C-Suites and their employees. Kerry McKittrick is a co-director of the Harvard Project on Workforce, an interdisciplinary applied research project between the Harvard Kennedy School’s Malcolm Wiener Center for Social Policy, the Harvard Business School’s Managing the Future of Work Project, and the Harvard Graduate School […]

Artificial intelligence (AI) has enormous potential in healthcare, but all too often, it gets misunderstood. Especially with the proliferation of AI in other industries and chatGPT. And yet, AI offers more promise than that. With the right supporting infrastructure and context, intelligent tools stand to not only pump out data but also tangibly improve diagnostic […]

Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a […]

Drug companies face new hurdles in a rapidly changing marketplace. How do they finance new drug development amid the uncertainty? How much is a prescription medicine really worth? For patients suffering from cancer or other severe illnesses where the right drug is a matter of life or death, no price is too high. Someone with […]

Pivotal trial findings show favorable clinical safety and efficacy data for mRNA-1345 in lowering the incidence of respiratory syncytial virus-associated lower respiratory tract disease. The results of a pivotal Phase III trial show favorable clinical safety and efficacy data for Moderna’s investigational respiratory syncytial virus (RSV) vaccine mRNA-1345. In findings published in The New England […]