Tue.May 14, 2024

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FogPharma, Artbio join forces to design a different radiopharma drug

Bio Pharma Dive

The biotechs aim to marry FogPharma’s polypeptide science with Artbio’s lead-based radiopharmaceutical technology in one of the industry’s hottest fields.

Drugs 204
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AbbVie makes psychedelic play with $2bn Gilgamesh collaboration

Pharmaceutical Technology

The two companies will develop neuroplastogens for psychiatric disorders as psychedelic market activity ramps up.

Marketing 243
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6 Principles of Our Rare Disease Methodology That Drive Success for Our Sponsors

Worldwide Clinical Trials

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.

Trials 204
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Sands Capital raises $555M fund amid upturn in biotech ‘crossover’ investing

Bio Pharma Dive

The firm, one of the sector’s more active crossover investors, closed the fund during a surge in the financings that bridge biotechs to the public markets.

Marketing 195
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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

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SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

AuroBlog - Aurous Healthcare Clinical Trials blog

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.

Vaccine 189
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Bayer details layoffs as company shake-up continues

Bio Pharma Dive

The reduction of 1,500 roles in the first quarter is part of CEO Bill Anderson’s plan to shrink Bayer’s bureaucracy and “radically realign” its culture.

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More Trending

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Study reveals heart failure device could monitor patients and prevent hospitalisation

Pharma Times

Heart failure is a cardiovascular disease that affects more than 64 million people worldwide

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Bayer reports drop in Q1 sales amidst patent litigation challenges

Pharmaceutical Technology

Bayer announced a fall in Q1 sales and predicted future challenges in the Xarelto market in its Q1 update.

Sales 147
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5 Principles of Our Rare Disease Methodology That Drive Success for Our Sponsors

Worldwide Clinical Trials

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.

Trials 130
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AI database to bolster research for GLP1-RAs as precision medicines

Pharmaceutical Technology

Dandelion Health’s database can be used as a tool for sponsors to decide which indications to next investigate GLP1-RAs in.

Medicine 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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With 4-year data, Novo bolsters star power of obesity blockbuster Wegovy

Fierce Pharma

With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.

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Cytokinetics looks to take on BMS’ Camzyos in hypertrophic cardiomyopathy

Pharmaceutical Technology

Cytokinetics plans to file for approval in both the US and Europe for its hypertrophic cardiomyopathy therapy by the end of the year.

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Bayer slashed 1,500 roles in Q1 as simpler organization takes shape

Fierce Pharma

When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.

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UK Government expands opioid overdose treatment access

Pharmaceutical Technology

The UK Government is set to revise legislation, allowing professionals to supply naloxone, an opioid overdose antidote, without prescription.

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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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After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi

Fierce Pharma

After suffering a setback with U.S. regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. | Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency.

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Sanofi to make €1bn biomanufacturing investment in France

Pharmaceutical Technology

Sanofi has announced a significant investment exceeding €1bn ($1.07bn) to expand biomanufacturing capacities at its sites in France.

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Another delay for Ascendis' hormone therapy as FDA extends review by 3 months

Fierce Pharma

It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.

Hormones 122
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NHS introduces Pfizer’s tafamidis for ATTR-CM treatment

Pharmaceutical Technology

The UK NHS has introduced Pfizer's tafamidis for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a rare heart condition.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UKHSA and ICL confirm variant which plays key role in global surge of Strep A infections

Pharma Times

More than 3,000 people in England were affected by Strep A between September 2022 and May 2023

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Pint Pharma announces Orladeyo approval in Mexico for HAE prevention

Pharmaceutical Technology

Pint Pharma has announced that COFEPRIS in Mexico has approved ORLADEYO (berotralstat) for the prophylaxis of hereditary angioedema.

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Lonza, busy with capacity upgrades and exec turnover, hints at CDMO industry rebound

Fierce Pharma

A tough biotech funding environment and a downturn in COVID-related contracts has weighed heavily on CDMOs of all stripes in recent years. | With a new CEO waiting in the wings, Swiss manufacturing juggernaut Lonza is attempting to reassure the market that a CDMO industry stabilization is playing out.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

Trials 119
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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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Unlike Regeneron, Bayer doesn't feel as much of a pinch from Roche's Vabysmo

Fierce Pharma

Roche’s Vabysmo has taken a chunk of the market from Regeneron and Bayer’s Eylea. But Bayer hasn’t taken quite the same hit as its U.S. partner.

Marketing 111
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Bayer cutbacks start to be felt with 1,500 jobs shed in Q1

pharmaphorum

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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Pharma Pulse 5/14/24: The Impact of Medicare Advantage Employer Group Waiver Plans, The Need for Stepped-Up Patient Support & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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In vitro gametogenesis: the science has to be right, and it has to be safe

pharmaphorum

Today’s podcast sees web editor Nicole Raleigh speak with Dr Mark Leondires, founder and medical director at Illume Fertility, who shares his own journey and insights on In vitro gametogenesis (IVG).

In-Vitro 113
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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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Obesity drug slashes risk of heart attack or stroke 'regardless of weight lost’

BioPharma Reporter

Anti-obesity jabs could reduce the risk of heart attacks, strokes or heart failure in obese people irrespective of the amount of weight they lose while using the medication, according to a new study.

Drugs 105
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12 Questions with Michael Stevinson

pharmaphorum

Get to know Michael Stevinson from IPG Health Medical Communications with these 12 insightful questions. Learn more about his background, experiences, and perspectives.

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Buyer Checklist for Security Assessment of eClinical Vendors

Cloudbyz

Clinical trials are the backbone of medical research, driving innovation and ensuring the safety and efficacy of new treatments. With the rise of eClinical systems, the management of clinical trials has become more efficient and data-driven. However, this shift also brings significant security challenges. Ensuring the protection of sensitive clinical data is paramount.

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Cytokinetics prepares to take on BMS’ Camzyos in HCM

pharmaphorum

Cytokinetics has revealed the results from a phase 3 trial of its hypertrophic cardiomyopathy (HCM) drug aficamten that it hopes will allow it to compete with Bristol-Myers Squibb’s first-to-market Camzyos.

Trials 105
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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.