Wed.Oct 09, 2024

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From Chaos to Clarity: Streamlining Your Generic Drug Portfolio

Drug Patent Watch

The pharmaceutical industry plays a crucial role in global healthcare, providing essential medications that improve and save lives. Within this industry, generic pharmaceuticals are particularly important due to their affordability and accessibility.

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Using de-identified lab data to find patients, target physicians and expedite treatment

Bio Pharma Dive

Many pharma companies are now using de-identified lab data to identify potential patients and their physicians in time to impact the patient’s treatment plan. In this Q&A, learn how lab data can be used to increase patient access.

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City Therapeutics launches with $135m Series A funding

Pharmaceutical Technology

City Therapeutics has announced its launch accompanied by a $135m Series A financing to lead advancements in RNAi-based medicine.

Medicine 245
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Lilly names Mount Sinai scientist as first chief AI officer

Bio Pharma Dive

Thomas Fuchs will lead artificial intelligence initiatives across Lilly, including in drug discovery, clinical trials and manufacturing.

Scientist 190
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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October 9, 2024: In This Week’s PCT Grand Rounds, Early Diagnosis and Treatment of COPD

Rethinking Clinical Trials

Dr. Shawn Aaron In this Friday’s PCT Grand Rounds, Shawn Aaron of the University of Ottawa will present “Early Diagnosis and Treatment of Asthma and COPD.” The Grand Rounds session will be held on Friday, October 11, 2024, at 1:00 pm eastern. Aaron is a professor of medicine at the University of Ottawa and the director of the Canadian Respiratory Research Network.

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AI startup Basecamp allies with the Broad to dream up ‘programmable’ genetic medicines

Bio Pharma Dive

The company, which is building a database of biological interactions found in nature, revealed $60 million in funding and a collaboration with David Liu’s lab.

Genetics 167

More Trending

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Lilly partners with AI specialist Insitro to develop metabolic medicines

Bio Pharma Dive

The latest deal in AI drug discovery is a twist on the usual big pharma-startup collaboration model, with Insitro licensing technology and Lilly eligible for royalties.

Medicine 157
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Anima Biotech’s machine learning programme ‘reveals new mRNA drug targets’

Pharmaceutical Technology

The company employs machine learning to uncover disease mechanisms at the mRNA level and to identify therapeutic candidates.

Drugs 147
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Protein prediction wins chemistry Nobel; Alnylam submits an all-important drug application

Bio Pharma Dive

AlphaFold’s developers were awarded science’s top prize. Elsewhere, J&J is shuttering an intriguing cancer study and Alnylam is asking for approval of a drug that could rival a Pfizer blockbuster.

Protein 144
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FDA declines to approve Zealand Pharma’s hypoglycaemia therapy in infants

Pharmaceutical Technology

The US FDA has declined to approve Zealand Pharma's dasiglucagon for hypoglycaemia in infants with congenital hyperinsulinism (CHI).

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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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Purespring raises $105M to advance gene therapy for kidney disease

Bio Pharma Dive

The Series B round will fund a Phase 1/2 trial of the company’s experimental treatment for IgA nephropathy.

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MSD ventures into fibroblast therapies with $1.9bn deal with Mestag

Pharmaceutical Technology

The deal allows MSD to license one or more therapies against inflammatory diseases developed using the UK biotech’s fibroblast platform.

Licensing 130
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Grand Rounds October 4, 2024: Health Trends Across Communities – A Novel Health System-Public Health Data Partnership (Tyler Winkelman, MD, MSc; David Johnson, MPH)

Rethinking Clinical Trials

                      Speakers Tyler Winkelman, MD, MSc Division Director, General Internal Medicine Hennepin Healthcare Co-Director, Health, Homelessness, and Criminal Justice Lab HHRI David Johnson, MPH Health Informatics and Epidemiology Program Manager Hennepin County Slides Keywords Electronic Health Record; Data Sharing; Public Health; Health Systems; Partnerships Key Points Collaboration across public health and health care is essential to developing actionable data

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Purespring secures $105m to start Phase I/II trial of IgAN gene therapy 

Pharmaceutical Technology

Purespring Therapeutics has raised $105m in a Series B funding round which will help progress its lead candidate PS-002 to clinic.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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GSK will pony up $2.2B to resolve 80K Zantac cases

Fierce Pharma

GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by us | GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer. The agreement frees the British pharma giant from litigating 93% of the state court cases it faced in the U.S.

Drugs 101
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Emergent to donate 20,000 Narcan doses to fight opioid overdoses, CEO says

Pharmaceutical Technology

Emergent said it is separately working on increasing the availability of its overdose reverser on site for businesses.

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Biogen fills in some of the blanks on its trial of a high-dose version of Spinraza

Fierce Pharma

A trial of Biogen’s spinal muscular atrophy therapy Spinraza suggests that a higher dose provides benefits to a broad range of patients.

Trials 109
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Could preventative care save the future of the NHS?

Pharmaceutical Technology

As a major report highlights the challenges of a struggling NHS, the call for preventative care is growing in the UK.

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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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Pfizer CEO Bourla to meet with activist investor Starboard Value on turnaround pitch: FT

Fierce Pharma

With Pfizer’s revenue and share price slumping after the drugmaker skyrocketed to new heights during the pandemic, the company’s executives will reportedly hear out activist investor Starboard Valu | Activist investor Starboard Value recently picked up a $1 billion stake in the drugmaker and will now pitch a strategy shift to top executives, the Financial Times reported.

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Sage takes another hit as Alzheimer's drug is canned

pharmaphorum

Sage Therapeutics stops development of dalzanemdor in Alzheimer's, a few months after pulling the plug on the drug in Parkinson's

Drugs 103
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Leo Pharma unveils up to 250 layoffs and relocations amid CEO's revamp

Fierce Pharma

Amid a transformation effort under CEO Christophe Bourdon, Danish dermatology expert Leo Pharma is embarking on another round of layoffs and relocations. | Leo is closing and relocating up to 250 roles as part of the “next step” in the dermatology company’s evolving strategy, a company spokesperson told Fierce Pharma. Most jobs affected by the move are based in Leo’s home country of Denmark and span “all business areas.

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Five Crucial Trends Facing U.S. Drug Wholesalers in 2024 and Beyond

Drug Channels

As regular readers of Drug Channels know, U.S. distribution and dispensing channels for prescription drugs are undergoing significant evolution and consolidation as the changing economics of pharmaceuticals challenge conventional business models. During this period of volatility, the core business model of the Big Three public pharmaceutical distribution companies—Cardinal Health, Cencora, and McKesson—remains intact.

Drugs 87
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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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Ex-Pfizer leaders side with firm against activist investor

pharmaphorum

Ex-Pfizer CEO and finance chief withdraw support for Starboard Value campaign seeking a change in strategy at the pharma group.

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Zealand's hypoglycemia drug suffers another FDA rejection tied to CDMO inspection

Fierce Pharma

After third-party manufacturing issues led to a December rejection of Zealand Pharma’s pediatric congenital hyperinsulinism (CHI) candidate, the Danish pharma’s latest snub seems to come down to ti | Zealand’s glucagon receptor agonist dasiglucagon has been rebuffed by the FDA once again, scrambling the company's plan to launch the hypoglycemia treatment in kids with congenital hyperinsulinism.

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FDA knocks back Zealand's dasiglucagon once again

pharmaphorum

Zealand Pharma has suffered another setback in its bid to bring glucagon receptor agonist dasiglucagon for ultra-rare disease congenital hyperinsulinism (CHI) to the US market.For the second time in less than a year, the FDA has issued a complete response letter to the company citing the need for data on a third-party manufacturing site that had failed an earlier inspection by the agency.

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Clearside eye disease candidate aces exam in pursuit of Roche's Vabysmo and Regeneron, Bayer's Eylea

Fierce Pharma

A decade into reformulating Pfizer’s oral renal cell carcinoma drug Inlyta (axitinib) into a treatment that can be injected for a variety of common eye diseases, Clearside Biomedical is making sign | Clearside’s CLS-AX (axitinib injectable suspension) has aced a phase 2b trial, achieving its primary and secondary outcomes for patients with neovascular age-related macular degeneration (wet AMD).

Trials 68
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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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Lilly names Thomas Fuchs as its first chief AI officer

pharmaphorum

Lilly names Thomas Fuchs as its first chief AI officer Phil.

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Purespring Therapeutics secures £80 million in Series B funding

Pharma Times

New investment to advance gene therapies for kidney diseases

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Digital innovation and the Direct-To-Patient Model

pharmaphorum

Explore how GenAI is disrupting the healthcare industry with digital innovation and the Direct-To-Patient model. Learn how this innovative approach is transforming patient care and access to medical services.

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Sanofi launches high-dose flu vaccine in the UK

Pharma Times

New vaccine aims to protect older adults from severe flu complications

Vaccine 86
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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.