Tue.Jun 04, 2024

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Climate change may aggravate multiple sclerosis

Pharmaceutical Technology

A June 2024 literature review has revealed that climate change has the potential to intensify MS symptoms, as well as the incidence, prevalence, and severity of other major neurological disorders.

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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

Bio Pharma Dive

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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GSK shares fall 9% in wake of Zantac court ruling

Pharmaceutical Technology

Monday saw a 9% drop in GlaxoSmithKline’s (GSK) share price on the London Stock Exchange (LSE) following a Delaware judge’s ruling on 31 May that over 72,000 lawsuits over discontinued heartburn drug Zantac, known generically as ranitidine, could go ahead.

Drugs 243
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Reversible Molecular Changes Can Cause Cancer, Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

Though one in two people will develop some form of cancer in their lifetime, there’s still much we don’t know about this disease. But thanks to continued research efforts, we keep learning more about the biology of cancer. One of these recent discoveries could even transform our understanding of how cancers develop.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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NIH AI tool predicts cancer patients’ immunotherapy outcomes

Pharmaceutical Technology

Scientists at the NIH have introduced an AI tool to predict the response to immune checkpoint inhibitors for cancer patients.

Scientist 281
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BridgeBio data show sustained benefit for achondroplasia drug

Bio Pharma Dive

Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.

Genetics 164

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Viking says biopsy data confirm MASH drug’s benefit

Bio Pharma Dive

The company may look to license the experimental liver disease drug as it focuses on an obesity treatment that's shown early promise.

Licensing 164
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FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex

Pharmaceutical Technology

EryDex is being evaluated in the Phase III NEAT study which will enrol over 100 patients with rare disease ataxia-telangiectasia.

Drugs 244
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Gujarat FDCA’s online WHO-GMP certificate verification to boost exports: Dr H G Koshia

AuroBlog - Aurous Healthcare Clinical Trials blog

With the effective implementation of its flagship e-governance programme, Gujarat Food and Drug Control Administration (FDCA)’s online WHO-GMP certificate verification is all poised to boost pharma exports, informs Gujarat FDCA commissioner Dr H G Koshia. Good Manufacturing Practice (GMP) is a critical concept in the pharmaceutical industry.

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ASCO 2024: Sanofi’s Sarclisa looks to gain an edge in multiple myeloma

Pharmaceutical Technology

Sarclisa is looking to make a dent in the anti-CD38 multiple myeloma treatment market dominated by J&J’s Darzalex.

Marketing 246
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Illumina board approves Grail spinoff

Bio Pharma Dive

One analyst said Grail, with a cash burn of $532 million in 2023, is likely to remain “a cautionary tale in diagnostics for years to come.

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BIOSECURE Act could impact US biopharma drugs with half in clinical-stage development

Pharmaceutical Technology

The BIOSECURE Act could impact more than 120 US biopharmaceutical drugs in development by companies partnered with Chinese contract development and manufacturing organisations (CDMOs) and biotechnology companies.

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Lilly wins NICE endorsement for tirzepatide in obesity—with a catch

Fierce Pharma

A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has retu | A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has returned with an endorsement in obesity.

Drugs 123
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Pharmaceutical waste containers and closure system 

Pharmaceutical Technology

Discover key considerations for selecting pharmaceutical waist containers. Find out about the latest technology used in pharmaceutical closure systems.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech's ties to China

Fierce Pharma

For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party (CCP) has continued to gain steam. | For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party has continued to gain steam. Now, several new names could be feeling the heat.

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Aurigene Pharmaceutical opens biologics facility in Hyderabad, India

Pharmaceutical Technology

Aurigene Pharmaceutical, a Dr Reddy's Laboratories unit, has opened a biologics facility at Genome Valley in the Indian city of Hyderabad.

Genome 130
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Key takeaways from ViVE: AI, security concerns, and industry transactions take centre stage

pharmaphorum

ViVE conference highlights the key takeaways on artificial intelligence, cybersecurity concerns, and industry transactions. Stay updated on the latest trends and partnerships shaping these fields.

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EMA CHMP recommends AstraZeneca’s Tagrisso for lung cancer

Pharmaceutical Technology

The EMA CHMP has recommended approval for AstraZeneca's Tagrisso for the first-line treatment of non-small cell lung cancer (NSCLC).

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The New Age of Decentralized Clinical Trials

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.

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Bayer taps Samsung wearables for menopause sleep study

pharmaphorum

Sleep disturbances are one of the most common and disruptive symptoms in menopausal women, but not enough is known about the causes, and current sleep aids are often ineffective. To plug that gap, Germany’s Bayer has joined forces with electronics group Samsung to carry out an observational study on sleep disturbances during menopause (SDM), tapping into the South Korean company’s position as one of the world's largest producers of consumer electronics.

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ASCO 2024: Moderna’s mRNA-4157 is poised to transform melanoma field

Pharmaceutical Technology

At the ASCO conference, investigators highlighted the potential of Moderna’s cancer vaccine combination based on Phase II data.

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Abbott’s OTC glucose monitor ‘will grow the market’

pharmaphorum

Just a few weeks after Dexcom’s Stelo became the first over-the-counter continuous glucose monitor (CGM) to be approved by the FDA, Abbott has got the green light for its Lingo device - and analysts think uptake by patients is now poised to take off.

Marketing 102
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Philogen and Sun Pharma seek EMA approval for melanoma therapy

Pharmaceutical Technology

Philogen and Sun Pharma have sought EMA approval for Nidlegy to treat locally advanced, fully resectable melanoma.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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ASCO 2024 - Mohit Manrao

pharmaphorum

Get insights into the exclusive interview with Mohit Manrao, AstraZeneca SVP and Head of Oncology. Explore the highlights of the conversation and ASCO 2024 here.

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ASCO 2024: Merus charges ahead with positive HNSCC results

Pharmaceutical Technology

Merus’ petosemtamab Keytruda combination therapy demonstrates a significant improvement on the HNSCC standard of care.

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Pharmacist Salaries and Employment in 2023: The Grass Keeps Getting Greener in Hospitals

Drug Channels

It’s time for the annual update to Drug Channels Institute’s (DCI) analysis of pharmacist salaries and employment. 2023 was another tough year for pharmacists working in retail settings. While average salaries grew, they did not keep pace with overall inflation. Pharmacist employment at drug stores shrank but grew at supermarkets and mass merchants.

Drugs 98
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Exclusive interview: Diane Lacroix talks innovations in clinical data management

Outsourcing Pharma

In celebration of Clinical Trials Day last month, OSP sat down with Diane Lacroix, vice president of clinical data management at eClinical Solutions, to delve into the latest advancements and future directions in clinical trials.

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How Machine Learning Drives Clinical Trial Efficiency

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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ASCO: Moderna may file melanoma vaccine on phase 2b data

pharmaphorum

New data from a phase 2b trial of Moderna and MSD’s neoantigen melanoma vaccine may be strong enough to consider filing for accelerated approval before a phase 3 programme.

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Mirum’s Livmarli gets thumbs up from CHMP for treating PFIC in young patients

Outsourcing Pharma

Mirum Pharmaceuticals just got a major boost as the European Committee for Medicinal Products for Human Use (CHMP) gave a positive nod to Livmarli (maralixibat) oral solution for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged three months and up.

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Advancing innovation in life sciences R&D and Quality: Towards a single source of truth

pharmaphorum

Discover the latest advancements in life sciences R&D and quality at the Veeva R&D Quality Summit at the Marriott Auditorium Hotel in Madrid. Join industry leaders as they discuss the importance of a single source of truth.

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Amarin's CEO resigns, leaving former interim chief to take over struggling drugmaker

Fierce Pharma

After Amarin's tussle with investor group Sarissa Capital led to a restructuring and a board shuffle, the struggling drugmaker is undergoing its third CEO shake-up in just over a year.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.