Wed.May 22, 2024

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How to take advantage of the connected health opportunity in your next drug launch

Pharmaceutical Technology

When new medicines hit the market, sharing educational content with physicians, pharmacists, and patients is vital for ensuring safe and appropriate use.

Medicine 130
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Biogen, looking to diversify, acquires immune drugmaker HI-Bio for $1.15B

Bio Pharma Dive

The deal, only Biogen’s third since the start of 2018, is a sign the company is open to branching out beyond the neurological drugs that have long been its focus.

Drugs 189
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No nitrosamines: How parenteral packaging is evolving to meet today’s E&L challenges

Pharmaceutical Technology

As the nitrosamine scandal continues, we explore the advancements in parenteral packaging materials that are reducing the risk of this contaminant in modern injectables.

Packaging 243
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Scientists Warn Brain Diseases Are Getting Worse as Climate Change Intensifies

AuroBlog - Aurous Healthcare Clinical Trials blog

Climate change is making the symptoms of certain brain conditions worse, our new review has found. Conditions that can worsen as temperature and humidity rise include stroke, migraines, meningitis, epilepsy, multiple sclerosis, schizophrenia, Alzheimer’s disease and Parkinson’s.

Scientist 175
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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SixPeaks, a new obesity biotech, starts up with an option to sell to AstraZeneca

Bio Pharma Dive

AstraZeneca has an exclusive chance to buy the startup, which is developing a muscle-protecting weight loss medicine, within the next two years.

Medicine 189
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May 22, 2024: In TSOS Study, Clinical and Demographic Characteristics Predict Response to PTSD Interventions

Rethinking Clinical Trials

Dr. Doug Zatzick In a secondary analysis of data from the TSOS study pooled with data from 2 other comparative effectiveness trials, baseline patient clinical and demographic characteristics were associated with persistent symptoms of posttraumatic stress disorder (PTSD) symptoms and diminished treatment response. The report was published online ahead of print in Psychiatry.

More Trending

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CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

In-Vitro 157
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Regeneron faces new biosimilar threats; An AI biotech lays off staff

Bio Pharma Dive

Today’s rundown also includes news of an expanded partnership for Boehringer Ingelheim and updates to emerging medicines from GSK and Bristol Myers.

Medicine 169
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Genmab acquires biotechnology company ProfoundBio in $1.8bn deal

Pharmaceutical Technology

Genmab has concluded the acquisition of ProfoundBio, a clinical-stage biotechnology company, in an all-cash transaction valued at $1.8bn.

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Pfizer and Lilly are elbowing into the direct-to-consumer market. Will it work?

Bio Pharma Dive

Direct-to-consumer platforms can offer consumers an online path to sourcing popular medications, but some therapeutic areas may be better suited for the business model.

Marketing 152
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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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Pharmaceutical clean room manufacturing, flooring and design 

Pharmaceutical Technology

Discover the key factors and latest advancements in pharmaceutical clean room manufacturing, flooring, and design to ensure full regulatory compliance.

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Takeda Joins Hot Molecular Glue Market With $1.2B Deal

BioSpace

Riding the growing wave of interest in molecular glue degraders, Takeda has partnered with Chinese biotech Degron Therapeutics to develop novel therapies for oncology, neuroscience and inflammation.

Marketing 125
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Sanofi enters partnership to enhance drug development using AI

Pharmaceutical Technology

Sanofi has entered a collaboration with Formation Bio and OpenAI aimed at harnessing AI to expedite drug development.

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Pfizer Targets Another $1.5B in Cost Cuts By End of 2027

BioSpace

Amid its ongoing efforts to trim $4 billion in spending in 2024, Pfizer in an SEC filing on Wednesday said it is looking to save an additional $1.5 billion over the next several years.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Alvotech and Dr Reddy’s partner to commercialise AVT03

Pharmaceutical Technology

Alvotech has entered into a collaboration with Dr. Reddy's Laboratories for the commercialisation of AVT03 in the US, Europe and the UK.

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Pfizer, busy with $4B savings drive, plots even more cuts out to 2027

Fierce Pharma

Pfizer has made frequent headlines in recent months as it moves forward with a campaign to save $4 billion in annual costs by the end of this year. | Pfizer has made frequent headlines in recent months as it moves forward with a campaign to save $4 billion in annual costs by the end of this year. Now, the company has unveiled another savings drive that will run longer.

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Evotec shuts down gene therapy business in light of Q1 2024 loss 

Pharmaceutical Technology

Evotec will close an Austrian facility as it shuts down its gene therapy business Evotec GT, a move which will affect 40 employees.

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NICE and the controversy over a ‘clinically distinct disease’ designation

pharmaphorum

The debate rages on as NICE considers a 'clinically distinct disease' classification. Learn how this decision could reshape the STA process and patient treatment options.

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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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AltruBio secures $225m for immune checkpoint programme development

Pharmaceutical Technology

AltruBio has secured $225m in an oversubscribed Series B financing round to propel the clinical development of its ICE programme.

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FDA Flags Hypoglycemia Risk for Novo’s Once-Weekly Insulin Ahead of Adcomm

BioSpace

In advance of Friday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting, the FDA has raised concerns about hypoglycemia linked to Novo Nordisk’s insulin icodec, according to a briefing document.

Insulin 117
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AstraZeneca makes another obesity play funnelling $80m into SixPeaks Bio

Pharmaceutical Technology

AstraZeneca has the option to acquire SixPeaks in the next two years if the latter’s bispecific antibody proves successful.

Antibody 130
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Tony Blair Institute weighs in on use of NHS patient data

pharmaphorum

A think tank set up by former UK Prime Minister Tony Blair has called for the formation of a public-private trust that could oversee the sharing of anonymised patient data with trusted researchers.

Research 115
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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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Process automation and equipment

Pharmaceutical Technology

Download our list of leading pharmaceutical process automation technologies to make an informed purchasing decision.

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Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

Fierce Pharma

Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on m | Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on measures of agitation associated with dementia.

Trials 111
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NICE recommends Rhythm’s Imcivree for rare genetic obesity disorder

Pharmaceutical Technology

Rhythm expects Imcivree will be available on the NHS in England and Wales within the next three months.

Genetics 130
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GSK’s twice-yearly asthma drug clears two phase 3 trials

pharmaphorum

GSK’s follow-up to its severe asthma therapy Nucala has shown its value in a pair of phase 3 trials, reducing exacerbations compared to placebo with dosing once every six months. The company says new IL-5 inhibitor depemokimab (formerly GSK3511294) has the potential to become the first ultra-long-acting biologic for severe asthma with a six-monthly dosing schedule.

Trials 111
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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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New NIH findings on talc use and ovarian cancer pose challenge to J&J's high-stakes defense

Fierce Pharma

The more than 53,000 women in the U.S. | The more than 53,000 women in the U.S. who have filed injury lawsuits against Johnson & Johnson have added ammunition for their claims as new research indicates there is an association between long-term use of talcum-based powders and an increased risk of developing ovarian cancer.

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BioSpace x DIA: Navigating the Emergence of CGT Combination Products

BioSpace

BioSpace's Lori Ellis discusses the risks and challenges of cell and gene therapy combination products with DIA speakers James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.

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US senators accuse pharma firms of abusing patent system

pharmaphorum

Lawmakers across the political divide have accused the pharma industry of abusing the patent system to keep the prices of their products as high as possible.

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Orna Buys Competing RNA Biotech ReNAgade After Series A Financing

BioSpace

Orna Therapeutics announced Thursday it is acquiring ReNAgade Therapeutics, which launched in May 2023 with $300 million in Series A financing and is on BioSpace’s NextGen Class of 2024 startups to watch this year.

RNA 107
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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.