Antidepressant prescriptions continue to steadily grow in England
Pharmaceutical Technology
JULY 7, 2023
As quarterly antidepressant prescriptions hit 22 million, the NHS looks to cut down patient reliance.
Fri.Jul 07, 2023
246 
Novo Nordisk brings new round of lawsuits against compounded versions of Ozempic and Wegovy
Fierce Pharma
JULY 7, 2023
As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. | In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. And now, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
AC-0676 by Accutar Biotechnology for Follicular Lymphoma: Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
AC-0676 is under clinical development by Accutar Biotechnology and currently in Phase I for Follicular Lymphoma.
Do Physician-Owned Hospitals Offer Lower Negotiated, Cash Prices?
XTalks
JULY 7, 2023
A recent study in JAMA Network Open analyzed the differences in commercial negotiated prices and cash prices between physician-owned hospitals (POHs) and non-POHs. Data on commercial negotiated prices and cash prices for eight specific services were analyzed from 156 POHs and 1,116 non-POHs in 78 hospital referral regions (HRRs). The eight services included spinal injection, therapeutic physical therapy exercise, magnetic resonance imaging (MRI) scan of the lower spinal canal, computed tomograph
Thermo Fisher agrees to acquire CorEvitas for $913m
Pharmaceutical Technology
JULY 7, 2023
Thermo Fisher Scientific has signed a definitive agreement for the acquisition of CorEvitas from Audax Private Equity for $912.5m in cash.
Pfizer’s Newly Approved Litfulo to Take on Eli Lilly’s Olumiant in Growing Alopecia Market
XTalks
JULY 7, 2023
Pfizer’s alopecia JAK inhibitor Litfulo (ritlecitinib) has become its fourth US Food and Drug Administration (FDA) approved product in the past several weeks. Litfulo is entering the alopecia market to rival Eli Lilly’s Olumiant (baricitinib), which was approved as the first drug for alopecia areata a year ago. While Olumiant only has approval for adults, Litfulo has a slight edge as it is indicated for both adults and adolescents 12 years of age and older — it’s the first drug approved for trea
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Breaking news: FDA grants approval for first Alzheimer's drug slowing disease progression
BioPharma Reporter
JULY 7, 2023
The first and only approved anti-amyloid Alzheimer's Disease (AD) treatment shown to reduce the rate of disease progression and slow cognitive impairment has been granted approval by the FDA.
AC-0676 by Accutar Biotechnology for Follicular Lymphoma: Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
AC-0676 is under clinical development by Accutar Biotechnology and currently in Phase I for Follicular Lymphoma.
Novavax COVID-19 vaccine produces immunity
Pharma Times
JULY 7, 2023
Second dose of treatment generates response among young people during Oxford University trial - News - PharmaTimes
Astellas gains FDA priority review for gastric cancer therapy BLA
Pharmaceutical Technology
JULY 7, 2023
The US FDA has awarded priority review for Astellas Pharma’s biologics licence application for zolbetuximab to treat gastric cancer.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Etripamil Nasal Spray Shows Promising Phase III Results for PSVT Treatment
XTalks
JULY 7, 2023
Milestone Pharmaceuticals Inc., a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). The trial results, published in The Lancet , demonstrated significant improvement in various PSVT symptoms among patients who received the nasal spray compared to those who received a placebo.
ABBV-101 by AbbVie for Relapsed Chronic Lymphocytic Leukemia (CLL): Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
ABBV-101 is under clinical development by AbbVie and currently in Phase I for Relapsed Chronic Lymphocytic Leukemia (CLL).
Psych Symposium 2023: Could psilocybin provide relief for anorexia sufferers?
Outsourcing Pharma
JULY 7, 2023
Anorexia nervosa is a notoriously difficult illness to treat. It has the highest mortality rate of any psychiatric disorder, yet there is currently no FDA approved therapy for the condition.
ABBV-101 by AbbVie for Relapsed Chronic Lymphocytic Leukemia (CLL): Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
ABBV-101 is under clinical development by AbbVie and currently in Phase I for Relapsed Chronic Lymphocytic Leukemia (CLL).
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
Advertisement
Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Marketing Food to Children: An Evolving Landscape Following WHO’s New Guidelines
XTalks
JULY 7, 2023
Earlier this week, the World Health Organization (WHO) released new guidelines that emphasized the critical role that marketers must play in safeguarding children’s health. The WHO underscored the need for tighter regulations to protect children from the adverse effects of food marketing. This directive of marketing food to children carries profound implications, demanding a significant shift in child-focused marketing strategies.
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy
Pharmaceutical Technology
JULY 7, 2023
The US FDA has granted traditional approval for Eisai and Biogen’s Leqembi to treat Alzheimer’s disease (AD) in adults.
Fierce Pharma Asia—AZ, Daiichi's ADC scare; Moderna's China investment; Takeda's F-Star deal
Fierce Pharma
JULY 7, 2023
AstraZeneca and Daiichi Sankyo's TROP2 antibody-drug conjugate returned a concerning safety message. Moderna reportedly plans to invest up to $1 billion in China. | AstraZeneca and Daiichi Sankyo delivered a concerning safety message for their TROP2 antibody-drug conjugate. Moderna reportedly plans to invest up to $1 billion in China. Takeda expanded its antibody partnership with F-Star Therapeutics with a new deal potentially worth $1 billion.
Shorla enters deal to license chemotherapy drug in US
Pharmaceutical Technology
JULY 7, 2023
Shorla Oncology has signed a licensing agreement with an undisclosed drug UK firm for a chemotherapy drug, PIP-101.
The New Age of Decentralized Clinical Trials
Advertisement
This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Incyte’s Opzelura gets MHRA authorisation
Pharma Times
JULY 7, 2023
Therapy involves the treatment of non-segmental vitiligo among adults and adolescents - News - PharmaTimes
EU grants full marketing authorisation for Novavax’s Covid-19 vaccine
Pharmaceutical Technology
JULY 7, 2023
The EMA has granted Novavax’s Covid-19 vaccine a full marketing authorisation, based on Phase III trial data.
Optimizing Access: Balancing Speed-to-Therapy and Gross-to-Net
Drug Channels
JULY 7, 2023
Today’s guest post comes from Sahil Naik, Chief of Staff to the CEO at Phil, Inc. Sahil discusses how manufacturers can balance patients’ access to therapy with gross-to-net (GTN) goals. Visit [link] to learn more about how Phil helps improve the patient experience while managing GTN. Read on for Sahil’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.
Pfizer invests in biopharma company Caribou Biosciences
Pharmaceutical Technology
JULY 7, 2023
Pfizer has invested $25m in clinical-stage CRISPR genome-editing biopharmaceutical firm Caribou Biosciences.
Roles and Responsibilities of Specialized Clinical Supply Experts
Advertisement
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
FDA slams Intas, Ipca over manufacturing shortfalls at 3 Indian plants
Fierce Pharma
JULY 7, 2023
After a pandemic-fueled lull the past few years, FDA inspections are back in full force. This week, a pair of Indian drugmakers have found themselves in the agency’s crosshairs. | The FDA has issued a trio of Form 483s after inspecting three Indian drug plants. One write-up went to Intas Pharmaceuticals while the other two were handed down to Ipca Laboratories.
Oncolytic Virus for Human Papillomavirus Associated Cancer, Human Papillomavirus Infections and Coronavirus Disease 2019 (COVID-19) by Blue Sky Immunotherapies for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
Oncolytic Virus for Human Papillomavirus Associated Cancer, Human Papillomavirus Infections and Coronavirus Disease 2019 (COVID-19) is under clinical development by Blue Sky Immunotherapies and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN).
RxPreferred to offer Humira biosimilar through Mark Cuban's online pharmacy
pharmaphorum
JULY 7, 2023
RxPreferred to offer Humira biosimilar through Mark Cuban's online pharmacy Eloise.
Oncolytic Virus for Human Papillomavirus Associated Cancer, Human Papillomavirus Infections and Coronavirus Disease 2019 (COVID-19) by Blue Sky Immunotherapies for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
Oncolytic Virus for Human Papillomavirus Associated Cancer, Human Papillomavirus Infections and Coronavirus Disease 2019 (COVID-19) is under clinical development by Blue Sky Immunotherapies and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN).
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Changing Faces: Pharma and biotech hires from May & June 2023
pharmaphorum
JULY 7, 2023
Changing Faces: Pharma and biotech hires from May & June 2023 Mike.
ORIN-1001 by Shanghai Fosun Pharmaceutical (Group) for Kidney Cancer (Renal Cell Cancer): Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
ORIN-1001 is under clinical development by Shanghai Fosun Pharmaceutical (Group) and currently in Phase II for Kidney Cancer (Renal Cell Cancer).
America’s mental health crisis: Why we need a Moonshot
pharmaphorum
JULY 7, 2023
America’s mental health crisis: Why we need a Moonshot Mike.
ORIN-1001 by Shanghai Fosun Pharmaceutical (Group) for Kidney Cancer (Renal Cell Cancer): Likelihood of Approval
Pharmaceutical Technology
JULY 7, 2023
ORIN-1001 is under clinical development by Shanghai Fosun Pharmaceutical (Group) and currently in Phase II for Kidney Cancer (Renal Cell Cancer).
Accelerating Clinical Supply Through Integrated Drug Development
Advertisement
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Let's personalize your content