Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use
Bio Pharma Dive
APRIL 5, 2024
The FDA’s clearance comes three weeks after a panel of advisers endorsed expanded use of Abecma despite safety concerns raised by the agency.
Fri.Apr 05, 2024
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MiNA and Nippon Shinyaku enter RNAa therapeutics deal
Pharmaceutical Technology
APRIL 5, 2024
MiNA Therapeutics has entered into an agreement with Nippon Shinyaku to develop RNAa therapeutics for rare neurodegenerative ailments.
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Boehringer Ingelheim to lay off staff amid biosimilar challenges
Bio Pharma Dive
APRIL 5, 2024
The German pharmaceutical company is “streamlining” its custom-facing teams behind Cyltezo, a copycat version of AbbVie’s immune disease drug Humira.
Key mechanism controlling bone marrow stem cells could lead to new therapies
Pharma Times
APRIL 5, 2024
Hoxa9 and b-catenin molecules are a rare population of self-renewing HSCs found in bone marrow
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
England’s MMR vaccinations up 23% following NHS initiative
Pharmaceutical Technology
APRIL 5, 2024
Recent campaigns have targeted children and young adults in low vaccine uptake areas amidst a rising number of measles cases.
High-flying Vertex hikes CEO Reshma Kewalramani's pay by 30% to $20.6M
Fierce Pharma
APRIL 5, 2024
Vertex CEO Reshma Kewalramani, M.D., made $20.6 million in 2023, which was an increase of 30% from her $15.9 million pay in 2022.
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A Reflection on Shared Moments of Strength and Progress in the Rare Disease Communities
Worldwide Clinical Trials
APRIL 5, 2024
For many people, February 29th is simply Leap Day, an extraordinary date that appears only once every four years. For others, this rare day is aptly the day we honor rare disease communities. Observed annually on the last day of February since 2008, Rare Disease Day has grown into a global movement for raising awareness, promoting research, and advocating for improved access to rare disease treatments and support services.
AstraZeneca reports positive Phase III results for Imfinzi in small cell lung cancer
Pharmaceutical Technology
APRIL 5, 2024
Despite a failed bid to expand Imfinzi’s treatment scope in NSCLC, the drug has proved effective in treating small cell lung cancer.
Advances in immunosuppression research may bring transplant patients closer to “one organ for life”
pharmaphorum
APRIL 5, 2024
Advances in immunosuppression research may bring transplant patients closer to “one organ for life” Mike.
GSK expands Asia-Pacific reach for Trelegy Ellipta with Singapore approval
Pharmaceutical Technology
APRIL 5, 2024
GSK’s Trelegy Ellipta has been approved as a maintenance therapy for both asthma and COPD in Singapore.
Inclusive Innovation: Key to the Future of Healthcare
Fierce Pharma
APRIL 5, 2024
Inclusive Innovation: Key to the Future of Healthcare jpiatt Fri, 04/05/2024 - 10:37
Amylyx axes ALS drug from market after Phase III failure
Pharmaceutical Technology
APRIL 5, 2024
Last month, Amylyx announced that the Phase III confirmatory trial of ALS drug Relyvrio failed to meet its primary and secondary endpoints.
J&J to acquire Shockwave Medical for $13.1B
Bio Pharma Dive
APRIL 5, 2024
The deal comes just over a week after The Wall Street Journal reported the companies were discussing a merger.
Acumen and Lonza to produce Alzheimer’s drug sabirnetug
Pharmaceutical Technology
APRIL 5, 2024
Acumen has entered a partnership with Lonza to further the development of sabirnetug, a potential treatment for Alzheimer's disease.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
As Humira biosim sales languish, Boehringer Ingelheim plots layoffs in pivot to hybrid sales model
Fierce Pharma
APRIL 5, 2024
Despite Boehringer Ingelheim’s 2021 Humira biosimilar approval being heralded by some analysts as a “landmark achievement” for the field, the drug—dubbed Cyltezo—has struggled to gain traction than | Facing lackluster Cyltezo sales, Boehringer Ingelheim will prune its ranks in the U.S. and adopt a different way of marketing its Humira biosimilar.
UK MHRA approves Advanz Pharma antibiotic for complex infections
Pharmaceutical Technology
APRIL 5, 2024
The UK MHRA has approved Advanz Pharma’s combined antibiotic, cefepime/enmetazobactam, to treat complicated infections.
Bristol Myers’ Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer
Fierce Pharma
APRIL 5, 2024
After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma. | After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers’ CAR-T therapy Abecma into the earlier treatment of multiple myeloma.
Caris and Merck KGaA link to develop ADCs for cancer treatment
Pharmaceutical Technology
APRIL 5, 2024
Caris Life Sciences has entered a collaboration with Merck KGaA for the development of antibody-drug conjugates (ADCs) for cancer.
AstraZeneca’s Imfinzi tackles another type of lung cancer with latest trial win
Fierce Pharma
APRIL 5, 2024
AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance in stage 3 non-small cell lung cancer and extensive | AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance in stage 3 non-small cell lung cancer and extensive-stage small cell lung cancer.
myTomorrows and brainstrust partner to support patients living with brain cancer
Pharma Times
APRIL 5, 2024
Affecting 80,000 people in England, 12% of brain tumour patients survive beyond five years of diagnosis
House committee to press FDA Commissioner Robert Califf on shortage oversight, other issues
Fierce Pharma
APRIL 5, 2024
Amid ongoing drug shortages and other headline-grabbing issues that fall under the FDA’s purview, the House Committee on Oversight and Accountability is putting the agency’s commissioner Robert Cal | The April 11 hearing could be contentious, as the committee wants to “hold the commissioner accountable" for the FDA's action on drug shortages, among other issues, according to a statement from Chairman James Comer, R-Kentucky.
ADRIATIC buoys Imfinzi’s prospects in early lung cancer
pharmaphorum
APRIL 5, 2024
ADRIATIC trial finds AstraZeneca's cancer immunotherapy Imfinzi improves survival in patients with limited-stage small cell lung cancer (SCLC)
The New Age of Decentralized Clinical Trials
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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.
AACR 2024: What Cancer Researchers Are Talking About
BioSpace
APRIL 5, 2024
The American Association for Cancer Research (AACR)’s annual conference runs April 5 through April 10. BioSpace will have all the key data and news out of San Diego.
Merck taps Caris’ AI expertise in ADC-focused alliance
pharmaphorum
APRIL 5, 2024
Germany's Merck partners Caris Discovery on artificial intelligence-powered discovery of antibody-drug conjugates in a $1.
Ed Schoonveld Discusses List Prices for Pharmaceuticals in the US Compared to Other Countries
Pharmaceutical Commerce
APRIL 5, 2024
In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.
CRUK gives £58m funding for clinician scientist training
pharmaphorum
APRIL 5, 2024
Cancer Research UK has announced a £58.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Overcoming EDC Implementation Challenges: Best Practices for Biotech Sponsors
Cloudbyz
APRIL 5, 2024
Implementing Electronic Data Capture (EDC) systems in clinical trials offers numerous benefits, including improved data accuracy, faster data availability, and streamlined processes. However, biotechnology sponsors face several practical challenges during its implementation. Here are ten of these challenges along with best practices to avoid or mitigate them: 1.
Aardvark said to be planning IPO, plus other bio financings
pharmaphorum
APRIL 5, 2024
Our regular round-up of financings in the biotech sector is headed by rumours of a $150 to $200 million initial public offering (IPO) for Aardvark Therapeutics, an emerging player in the weight-loss category, alongside a trio of big private rounds.
Pharma Pulse 4/5/24: Is 2024 the Year for Psychedelic Medicine? Barriers Impacting Enrollment in Lung Cancer Trials & more
Pharmaceutical Commerce
APRIL 5, 2024
The latest news for pharma industry insiders.
In refiling $16.5B Catalent buyout pitch, Novo gives FTC more time for review
Fierce Pharma
APRIL 5, 2024
After Novo Holdings set the stage for a $16.5 billion buyout of contract manufacturing giant Catalent earlier this year, its parent company is giving antitrust officials more time for their review | After Novo Holdings pitched a $16.5 billion buyout of Catalent in February, the companies have given the FTC extra time to review the deal.
How Machine Learning Drives Clinical Trial Efficiency
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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.
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