ObsEva’s US C-suite out the door

Today's Big News

Feb 24, 2023

Nektar's bitter pill: Phase 2 fail ends Lilly-partnered lupus program and prompts eczema rethink


Novartis punts Pliant-partnered NASH prospect amid pipeline prioritization pivot


ObsEva demolishes US C-suite in latest cost-cutting measures as Nasdaq delisting looms


Destiny seals C. diff therapy's phase 3 fate with Sebela


Fulcrum's clinical hold caps off tough week for sickle cell drug development


Sangamo shelves sickle cell therapy, joining rivals forced to rethink development plans


Chutes & Ladders—Roivant founder ditches board for White House bid

 

Featured

Nektar's bitter pill: Phase 2 fail ends Lilly-partnered lupus program and prompts eczema rethink

Nektar Therapeutics’ hopes of rebuilding its battered business around lupus lie in tatters. The key phase 2 clinical trial of rezpegaldesleukin missed its primary endpoint, prompting partner Eli Lilly to drop plans for further development in lupus and reassess its next steps in atopic dermatitis.
 

Top Stories

Novartis punts Pliant-partnered NASH prospect amid pipeline prioritization pivot

Novartis is nixing a nonalcoholic steatohepatitis candidate amid a narrowing of its therapeutic focus, walking away from a Pliant Therapeutics program it paid $50 million for back in 2019.

ObsEva demolishes US C-suite in latest cost-cutting measures as Nasdaq delisting looms

Having drastically reduced head count and sold off one of two remaining assets, ObsEva has now turned its sights on the company’s U.S.-based leadership as a way of clawing back some more savings.

Addressing the next wave of COVID-19 through a new approach to vaccines

Ocugen remains diligent in developing innovative COVID-19 vaccine options—including a non-mRNA injectable and next-gen inhaled vaccine—to meet the current need and prepare for an annual booster strategy.

Destiny seals C. diff therapy's phase 3 fate with Sebela

Destiny Pharma could be in line for $570 million thanks to a new co-development agreement with U.S.-based Sebela Pharmaceuticals for a C. difficile treatment.

Fulcrum's clinical hold caps off tough week for sickle cell drug development

Fulcrum Therapeutics’ sickle cell disease therapy has been placed on a clinical hold by the FDA, capping off a tough week for drug development for the condition that saw three separate treatments discontinued.

Sangamo shelves sickle cell therapy, joining rivals forced to rethink development plans

Sangamo has elected to shelve later-stage development of its sickle cell asset, saying that it would look to find a partner for future phase 3 development. The company joins two rivals that similarly announced scaling back sickle cell plans in the last day.

Medidata names Daloz CEO, Pray COO in leadership change

Medidata, a branch of Dassault Systèmes, made two big changes in its senior leadership ranks. The company named a new chief executive and a chief operating officer to lead the trial tech firm.

Bristol Myers Squibb, Boehringer Ingelheim and Roche most mature pharmas on social media (but still room for improvement): report

Bristol Myers Squibb, Boehringer Ingelheim and Roche are the most mature pharmas on social media, though there are still areas in which the companies can do better.

Spinal cord stimulation tech ventures beyond pain relief to restore arm mobility after stroke: study

Spinal cord stimulators were first approved to treat chronic pain in 1989, but in more recent years, researchers have begun studying the technology’s potential to address other conditions including those affecting movement.

'The Top Line': Could a SITC checklist maximize the value of immuno-oncology combo late-stage trials?

This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week.

Chutes & Ladders—Roivant founder ditches board for White House bid

Former Roivant Founder Vivek Ramaswamy announced a formal run this week for the White House, becoming the third Republican candidate to enter the field. As a part of the decision, Ramaswamy departed from Roivant’s board.

Fierce Pharma Asia—Eisai's Leqembi hurdle; AZ's cancer deal; and Mitsubishi's royalty win

Eisai's Alzheimer's disease drug Leqembi won't get any special Medicare coverage—for now. AstraZeneca signed a deal worth up to $1.1 billion for a Chinese antibody-drug conjugate. Plus more.
 
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'The Top Line': Could a SITC checklist maximize the value of immuno-oncology combo late-stage trials?

This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week.
 

Resources

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Strategizing for Clinical Trial Diversity

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The Power of Small & Safety: Nanoplasmid™️ Vector Platform

Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies.

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Commercializing Gene Therapies, Part 3 – Cost Drivers

This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years.
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Leveraging Archetypes for Effective Launch Strategy

Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches.
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Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

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Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?
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Step-wise strategy to address process characterization and late phase development

Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development.

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Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
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Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

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Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
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Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
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Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Research

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

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Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
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Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
Case Study

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

 

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