Category: Medicine

Medicine

Using AI to Create New Parkinson’s Treatments: Q&A with Mattias Alder

Alder, CEO of Gain Therapeutics, discusses how the Magellan platform was used in the creation of GT-02287.

Medicine

Lene Oddershede Discusses Upcoming Projects from the Novo Nordisk Foundation

In an interview with Pharm Exec Associate Editor Don Tracy, Lene Oddershede, SVP, Natural & Technical Sciences, Novo Nordisk Foundation

Medicine

FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC

Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76%

Medicine

FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease

Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately

Medicine

Essential Pharma Acquires Reminyl, a Cholinesterase Inhibitor to Treat Mild to Moderately Severe Dementia from Janssen Pharmaceutica NV

Acquisition includes rights to marketing in the European Economic Area, Thailand, South Korea, and other regions for oral treatment of

Medicine

Texas Biomed Developing Potential Bird Flu Vaccine

While human infections of the virus are rare, a strain recently appeared in dairy cows before infecting a human in

Medicine

Will Synthetic, AI-Based Digital Humans Change Pharma and Life Sciences? Q&A with Abid Rahman, SVP Innovation, EVERSANA

Rahman discusses the new opportunities that digital twins present to researchers.

Medicine

Phase III SELECT-GCA Trial for Rinvoq Yields Promising Results in Treating Patients with Giant Cell Arteritis

According to results of the study, 46% of patients with giant cell arteritis administered Rinvoq achieved sustained remission from weeks

Medicine

Pharma Pulse 4/18/24: Is it Fair Certain Biotech Investors Get an Early Look? The Health and Healthcare of Millennials & more

The latest news for pharma industry insiders.

Medicine

Pharmaceutical Executive: April 2024 Issue (PDF)

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

Medicine

Pharma Pulse 4/17/24: AI has a Measurement Problem, How Advancements in Technology Are Transforming the Field & more

The latest news for pharma industry insiders.

Medicine

The IRA Impact: Navigating Its Evolving Complexities

Amid lingering questions and uncertainty, a look at ways pharma companies can prioritize incorporating the Inflation Reduction Act into their

Medicine

Pharma Pulse 4/16/24: Mitigating Drug Shortages, PBM Legislation in Washington & more

The latest news for pharma industry insiders.

Medicine

Fighting for Innovation

Damien Bailly, president of established markets at Astellas, discusses why partnerships and collaborations are a critical organizational—and wider ecosystem—imperative in

Medicine

Rare Disease Summit Recap

Greater Than One’s Chief Strategy Officer, Andrew Bast, shares his takeaways from 2024 Rare Disease Summit in Philadelphia, PA.

Medicine

Supply Shortages in Weight Loss Drugs

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses factors that are contributing to ongoing supply issues

Medicine

The Rapid Growth of Remote Patient Monitoring Solutions Can Accelerate Decentralized Clinical Trials

Pharma companies and RPM manufacturers must work together to find solutions to make DCT more commonly available.

Medicine

Aspiring for the C-Suite? Consider Being a Chief of Staff

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

Medicine

Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer

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

Medicine

FDA Approves AstraZeneca’s Fasenra as Add-On Maintenance Therapy for Children Aged 6 to 11 with Severe Asthma

Treatment was initially approved in 2017 for the same indication in children aged 12 and up.

Medicine

FDA Approves New Administration Methods for SK Life Science’s Xcorpi for Adults with Partial-Onset Seizures

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

Medicine

Philips Respironics Finalizes Consent Decree Regarding Business Operations in the US with Department of Justice, FDA

Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep and

Medicine

Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies

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

Medicine

Bristol Myers Squibb Reveals Promising Data for KarXT, a Potential Treatment for Schizophrenia

A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT

Medicine

Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

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

Medicine

FDA Issues Complete Response Letter to Supernus for SPN-830, a Potential Treatment for Motor Fluctuations in Parkinson Disease

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

Medicine

FDA Approves Expanded Indication for Dovato to Include Adolescent Patients with HIV

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

Medicine

Pharma Pulse 4/5/24: Patient with Pig Kidney Goes Home, Combining AI and Market Access & more

The latest news for pharma industry insiders.

Medicine

QuantalX Joins FDA’s Total Life Cycle Advisory Program

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

Medicine

FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy

Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease

Medicine

A Decade of Data Under the Belt

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have

Medicine

Amylyx Begins Process of Discontinuing Relyvrio/Albrioza for Treatment of ALS

Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial

Medicine

Johnson & Johnson Set to Acquire Shockwave Medical, Aiming to Strengthen Company’s MedTech Division

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

Medicine

Teva, mAbxience Strike Licensing Deal for Biosimilar Candidate Focused on Multiple Oncology Indications

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

Medicine

Moderna Releases Promising Data from Phase I/II Clinical Trial on mRNA-3927 for Propionic Acidemia

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

Medicine

Abbott Receives FDA Approval for TriClip, a Medical Device for Repairing Tricuspid Regurgitation

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

Medicine

FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder

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

Medicine

Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer

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

Medicine

FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside

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

Medicine

FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

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

Medicine

Mishe Announces Omnichannel Pharmacy Network

The network will work with DiRx and MakoRX.

Medicine

Pharma Pulse 3/29/24: Super Micro’s AI Boom Carries a Big Price Tag, Leveraging Digital Tools to Optimize Manufacturing & more

The latest news for pharma industry insiders.

Medicine

Fierce Females in the Life Science Space

In this week’s episode, in recognition of international women’s month, Editor Miranda Schmalfuhs has compiled audio clips from interviews with

Medicine

Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

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

Medicine

FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

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

Medicine

Researchers Present First Study Using Biomimetic AI Digital Twins

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

Medicine

Pfizer Makes Publicis New Global Creative Duties Partner

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

Medicine

FDA Approves Akebia’s Vafseo for Anemia in Adults with Chronic Kidney Disease on Dialysis

Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan

Medicine

FDA Grants 501(k) to Two Avicenna.AI Products

Both products are designed to help radiologists.

Medicine

FDA Approves Winrevair, Merck’s Novel Treatment for Pulmonary Arterial Hypertension

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

Medicine

FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors

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

Medicine

The Regulatory Consequences of the Mifepristone Case: Q&A with Meg Alexander, Chief Strategy Officer at Ovid Therapeutics

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

Medicine

Viking Therapeutics Reveals Positive Results from Oral Obesity Drug

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

Medicine

UCB's Women of Childbearing Age Program

In this Pharmaceutical Executive video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, talks about the

Medicine

FDA Approves AstraZeneca’s Ultomiris for Neuromyelitis Optica Spectrum Disorder

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are

Medicine

CDC Releases Health Alert and Pushes for Increase in Measles Vaccinations

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

Medicine

Pharma Pulse 3/22/24: Surgeons Transplant Pig Kidney into a Patient, Effective Ways to Engage Patients, Caregivers, and Advocacy Groups & more

The latest news for pharma industry insiders.

Medicine

FDA Approves Italfarmaco SpA’s Duvyzat for Duchenne Muscular Dystrophy

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation

Medicine

Addressing Unmet Needs in Schizophrenia, Pulmonary Arterial Hypertension & NASH

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses the three drugs featured in their Drug

Medicine

Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

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

Medicine

Medicare to Cover Wegovy for Certain Indications

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

Medicine

Emerging Trends at the Intersection of AI & Marketing

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

Medicine

Research Lab Unveils Tool to Improve Clinical Trial Participation

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

Medicine

FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension

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

Medicine

Pharmatizing AI

Using the 3 Rs to guide AI transformation in Pharma.

Medicine

AstraZeneca Announces Plans to Acquire Fusion

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

Medicine

FDA Grants Accelerated Approval to Takeda's Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

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

Medicine

AI’s Impact on CEO/Founder Sustainability

In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on

Medicine

FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma

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

Medicine

BeiGene and Leukemia & Lymphoma Society Sign Three Year Agreement

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

Medicine

Pharma Pulse 3/15/24:Pharma Dealt Loss Over Discount Program, Adopting New Manufacturing Technologies & more

The latest news for pharma industry insiders.

Medicine

FDA Approves First Treatment for Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

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

Medicine

FDA Grants Accelerated Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory CLL, SLL

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

Medicine

FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who

Medicine

Hurdles Hindering the Translation of AI-Powered Research into Tangible Clinical Benefits

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses why

Medicine

How AI Could Have Helped Past Challenges

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

Medicine

AstraZeneca Acquires Amolyt Pharma with the Aim of Developing Rare Endocrine Disease Treatments

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

Medicine

How’s Business?

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

Medicine

Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

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

Medicine

Putting Menopause Medication on the Main Stage

In this Pharmaceutical Executive interview, Jill Jaroch, Senior Director, Women’s Health & Urology Marketing at Astellas, discusses the decision to

Medicine

Positioning Medical Information as a Trust Driver for Your Brand

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

Medicine

Contributing Factors to the Growing Gap in Access Between the US and Europe

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses findings

Medicine

FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH

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

Medicine

Boehringer Ingelheim Unveils New Out-of-Pocket Cap Initiative for its Inhaler Product Portfolio

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

Medicine

FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments

Medicine

Approval of Eli Lilly's Alzheimer Drug Donanemab Delayed as FDA Seeks More Information

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding

Medicine

Relyvrio Falls Short of Primary Endpoint in Phase III PHOENIX Trial in Patients with ALS

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

Medicine

FDA Approves Expanded Indication for Wegovy to Lower Cardiovascular Risk in Adults with Heart Disease, Obesity

FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and

Medicine

How Data Integrity Landscape Will Evolve Over the Five Years

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape

Medicine

FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in

Medicine

Lilly Updates Open Letter Regarding the Use of Tirzepatide for Cosmetic Weight Loss

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

Medicine

Bayer Won’t Be Splitting Up

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

Medicine

Gilead, Merus Strike Deal to Develop Novel Trispecific T-Cell Antibodies for Cancer Treatment

Agreement to focus on research, option, and licensing for discovery of dual tumor-associated antigen-targeting antibodies.

Medicine

FDA Approves Pair of Interchangeable Denosumab Biosimilars

The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis,

Medicine

WebMD Ignite Announces Collaboration with FDB

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

Medicine

Amring Changes Name to Nordic Pharma, Inc. Amid Ownership Change

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

Medicine

How the Pandemic Changed the Way Pharma Looks at Data Integrity in 2024

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics, discusses data security threats from human

Medicine

FDA and Workflow Services Detail First 100 Days of Data Collection Partnership

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

Medicine

CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors

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

Medicine

The State of Obesity-Related Clinical Research: Q&A with Simon Bruce, Vice President, Internal Medicine, Drug Development Solutions, ICON

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

Medicine

Bristol Myers Squibb Reveals Promising Results from Trial of Zeposia for Multiple Sclerosis

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

Medicine

With the Rise of GLP-1 Agonists for Treating Obesity, Will Access Challenges Prevent Progress?

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

Medicine

CMS Signals Looming Sunshine Act Audits: How to Prepare

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

Medicine

Biosimilars Report Shows Challenges, Opportunities Across Disease States

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

Medicine

Do Direct-to-Consumer Pharmacies Present More Challenges for Patients?

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

Medicine

AbbVie, OSE Immunotherapeutics Strike Deal to Develop Monoclonal Antibody for Chronic Inflammation

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

Medicine

Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug

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.

Medicine

Allecra Therapeutics' Exblifep Approved by FDA for Complicated Urinary Tract Infections

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

Medicine

IQVIA Study Highlights the Importance of Adult Vaccination in the US

Results of the study determined that adult flu vaccination rates among Medicaid populations were significantly low, highlighting other health inequities.

Medicine

Asthma Medication Xolair May Reduce Peanut Allergies, New Study Finds

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

Medicine

Amgen Opens Its Most Advanced Manufacturing Facility in Ohio

The site will have a staff of 400 employees.

Medicine

IQVIA Executive Director Discusses Global Use of Medicines 2024 Report – Part 1

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of

Medicine

HLTH Inc. and GE Healthcare Reveal Healthcare-Themed Art Gallery

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

Medicine

FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease

The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of

Medicine

FDA Warns Against Using Smartwatches or Smart Rings to Measure Blood Glucose Levels

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

Medicine

NIH Study Estimates Pfizer’s Paxlovid Could Reduce COVID-19 Hospitalizations, Saving Billions in Healthcare Costs

Results of a study conducted by the National Institutes of Health indicate that the Paxlovid prevented a substantial number of

Medicine

Frontier Medicines Announces Series C Funding to Advance Development of Next Generation KRAS Blocker

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

Medicine

Study Finds Parkinson Disease Drug Nearly Matches Wegovy in Weight Loss Effects

Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while

Medicine

Senators Pen Letter to FDA Urging Stronger Enforcement on Deceptive Direct-to-Consumer Social Media Ads Promoting Prescription Drugs

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

Medicine

Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee

Medicine

Planning for the World: Q&A With Sandra Anderson, SVP of International Commercialization at Cencora

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

Medicine

WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy

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

Medicine

Servier’s Potential First-in-Class Targeted Therapy for IDH-Mutant Gliomas Granted FDA Priority Review

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

Medicine

AstraZeneca’s Tagrisso With Chemotherapy Gets FDA Approval for EGFR-Mutated Non-Small Cell Lung Cancer

The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or

Medicine

Copay Adjustment Programs: What’s Next for Manufacturers?

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

Medicine

Study Shows Potential of Artificial Intelligence in Predicting Responses to Treatment for Major Depressive Disorder

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

Medicine

Cultivating a Bespoke Recruitment Strategy for Your FSP Partnership

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

Medicine

Cancer & Work: Acting Together: An Interview With Raj Verma, Chief Diversity, Culture, and Experience Officer at Sanofi

In an interview with Pharm Exec Associate Editor Don Tracy, Raj Verma, Chief Diversity, Culture, and Experience Officer, Sanofi, discusses

Medicine

Digging Deeper Into Bayer’s ASCO GU Presentation

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

Medicine

Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods

Medicine

FDA Grants Traditional Approval to Tepmetko for Metastatic Non–Small Cell Lung Cancer

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

Medicine

GSK Completes Acquisition of Aiolos Bio

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

Medicine

Pharmaceutical Executive: February 2024 Issue (PDF)

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

Medicine

Aurlumyn Becomes First Severe Frostbite Medication to Receive FDA Approval

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

Medicine

FDA Approves Ipsen’s Onivyde Combination for Metastatic Pancreatic Adenocarcinoma

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

Medicine

Roche Ends Agreement With Repare Therapeutics to Develop ATR Inhibitor Camonsertib

Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment

Medicine

Building Resiliency: Essential Leadership Principles for 2024

Embracing business imperatives such as operational efficiency and a focus on a patient-centric approach can help pharma leaders provide a

Medicine

Using AI to Solve Drug Shortage Issues

In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses

Medicine

FDA Approves Takeda’s Eohilia, an Oral Treatment for Eosinophilic Esophagitis

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

Medicine

How to Stand Out in the Wellness Space as a Pharma Brand

Key steps in relationship-building beyond just treatment options.

Medicine

Takeda's TAK-861 Shows Promising Results in Phase IIb Trial for Narcolepsy Type 1

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

Medicine

Samgsung Biologics, LegoChem Biosciences Partner on Development of Antibody-Drug Conjugate

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

Medicine

The Promise and Peril of AI in the Physical World

The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between

Medicine

New Report Says Generic Drug Market Is Set to Grow Over $175 Billion by 2027

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

Medicine

BioNTech and Autolus Announce Strategic Alliance to Bolster CAR-T Cell Pipeline

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

Medicine

2024 Life Sciences Accounting & Reporting Congress

2024 Life Sciences Accounting & Reporting Congress

Medicine

Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities

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

Medicine

Gilead Discontinuing Development of Magrolimab in Hematologic Cancers Following Full Clinical Hold by FDA for Increased Risk of Death

Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of

Medicine

Novartis To Acquire MorphoSys AG

The agreement will strengthen Novartis’ oncology pipeline.

Medicine

Amgen's Novel Weight Loss Drug Shows Potential for Longer Lasting Effect With Less Frequent Dosing Than Wegovy, Zepbound

In a Phase I trial, data suggest that Amgen’s maridebart cafraglutide (MariTide) may allow patients to take lower and less

Medicine

FDA Grants Priority Review to Expand Indication of GSK's Arexvy for RSV Protection in Adults Aged 50-59 Years

The FDA assigned a Prescription Drug User Fee Act action date of June 7, 2024, to an application that would

Medicine

Synchron, Potential Competitor to Elon Musk’s Neuralink, Obtains Equity Interest in Acquandas to Accelerate Development of Brain-Computer Interface

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

Medicine

Novo Nordisk’s Parent Company to Acquire Catalent To Boost Supply of Wegovy

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

Medicine

Novartis Terminates Licensing Rights With Allarity for Cancer Drug Due to Missed Payments

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

Medicine

Novo Nordisk Increases Supply of Lower-Dose Wegovy to Meet Continued Demand

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

Medicine

FDA Issues Warning of Contaminated Copycat Eyedrops

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

Medicine

Sanofi Announces New Reservation Program to Mitigate Shortages of RSV Vaccine for Next Season

Beyfortus (nirsevimab-alip), a monoclonal antibody that protects against respiratory syncytial virus-associated lower respiratory tract disease, experienced higher than anticipated demand

Medicine

Shubh Goel, VP, Head of Immuno-Oncology and Gastrointestinal Tumors Franchise, US Oncology Business Unit, AstraZeneca, Discusses Positive Results From Phase III Trial In Patients With HCC

In an interview with Pharm Exec Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology

Medicine

CDC STI Surveillance Report Finds Over 2.5 Million Cases of Sexually Transmitted Infections, Skyrocketing Rates of Syphilis

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

Medicine

DELFI Diagnostics Launches Assay That May Improve Monitoring of Cancer Treatment Response

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

Medicine

Veracity Benefits, Levrx Technology Reveal New Digital Health Tech App

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

Medicine

Biogen Pulls Plug on Controversial Alzheimer Disease Drug Aduhelm

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

Medicine

New Lilly Marketing Campaign Highlights Patient Challenges in Road to Recovery

Eli Lilly advertisement emphasizes that advancements in in medicine can lead to improved population health.

Medicine

Bristol Myers Squibb's Breyanzi Granted FDA Priority Review for R/R Follicular Lymphoma, Mantle Cell Lymphoma

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to be evaluated in patients with relapsed or refractory follicular lymphoma and mantle cell

Medicine

FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy

This is Takeda’s second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against

Medicine

EMA Grants Bersiporocin Orphan Drug Designation

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

Medicine

FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo's Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma.

Medicine

Report: Three US Residents Suffering from Hypoglycemia Used Suspected Counterfeit Ozempic

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

Medicine

Combating the Opioid Crisis With Long-Acting Injectables

Substance use disorder is a complex condition that demands innovative solutions, one of which that has shown promise is the

Medicine

Recent Licensing Agreement Poised to Advance Company ADC

In an interview with PharmExec Associate Editor Don Tracy, Jingsong Wang discusses Nona Biosciences’ recent exclusive license agreement with Pfizer

Medicine

GLP-1 Agonists May Lower Cirrhosis, Liver Cancer Risk in Type 2 Diabetes Patients

Study finds that individuals who took GLP-1 agonists for a long duration had a lower risk of going on to

Medicine

Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products

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

Medicine

FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies

FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be

Medicine

FDA Approves Expanded Indication for Dupixent to Treat Eosinophilic Esophagitis in Pediatric Patients

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

Medicine

FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

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

Medicine

Reimagining Medical Education for the Digital Age

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

Medicine

FDA Grants Clearance to Clinical Trial for NK CellTech’s Non-Genetically Modified Natural Killer Cells

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

Medicine

Gilead's Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer

Medicine

Weeding Out Data Inconsistencies in CDL: Q&A With Roxy McCloskey, Thought Leader at SCIEX

McCloskey discusses the steps that drug developers can take to ensure better CLD outcomes in 2024.

Medicine

Opdivo Plus Yervoy Reduces the Risk of Colorectal Cancer Disease Progression or Death by 79% Versus Chemotherapy

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

Medicine

Has Pharma Given Up on Long-Term Adherence?

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

Medicine

The Evolving Role of PBMs: An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group

In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses the changing role of

Medicine

Novartis' Lutathera Shows Significant Survival Benefit as First-Line Treatment for GEP-NETs

Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive

Medicine

Making the Case for Early-Stage Commercial Analytics

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

Medicine

Pusan National University Announces Potential Breakthrough for Muscle Regeneration Using Nanotech

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

Medicine

FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose

Medicine

Navigating Success During a Rare Disease Product Launch

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

Medicine

Sun Pharma and Taro Reach Definitive Merger Agreement

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

Medicine

Poll Reveals Only a Small Number of Older Americans Have Used Online Direct-to-Consumer Health Services

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

Medicine

FDA Approves Takeda’s HyQvia for Maintenance of Chronic Inflammatory Demyelinating Polyneuropathy

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

Medicine

Phesi Releases Annual Analysis of Clinical Development for 2023

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

Medicine

Arcutis’ Zoryve Shows Progress for Individuals with Atopic, Seborrheic Dermatitis

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

Medicine

Report: Pharmaceutical Contract Manufacturing Market Expected to Hit $140 Billion by 2030

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

Medicine

FDA Clears AnX Robotica’s NaviCam SB for Expanded Indications

The device can produce AI-assisted readings.

Medicine

Department of Defense Awards Emergent BioSolutions With $235.8 Million Contract for Anthrax Vaccine

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

Medicine

Foundational Questions in Data Reporting, Analytics to Meet Reimbursement-Directed Marketing Goals

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

Medicine

Mucinex Survey Reveals Americans Only Feel Healthy For Half of Every Month

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

Medicine

RemeGen's Antibody-Drug Conjugate Gets FDA Fast Track Designation for Ovarian Cancer

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