Pfizer’s migraine nasal spay wins FDA nod

Today's Big News

Mar 10, 2023

SVB capital crunch sends biotechs on bank run


FDA finds at least 19 cases of skin cancer in breast implant data, including 3 deaths


Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret


DOJ charges former Stimwave CEO with fraud scheme that added a fake receiver to neurostim device


Gilead Sciences, after long battle against HIV drug fraudsters, scores $175.2M in judgements

 

Featured

SVB capital crunch sends biotechs on bank run

Silicon Valley Bank’s capital raise of $2 billion has sent shockwaves across the biotech industry and spurred a panic among some top venture capital firms that are urging their companies to withdraw deposits.
 

Top Stories

FDA finds at least 19 cases of skin cancer in breast implant data, including 3 deaths

Though the FDA has long been aware of the risk that some people with breast implants may develop a rare form of T-cell lymphoma—now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and tracked by the regulator since 2011—the agency has only recently begun warning about other cancer risks linked to the implants.

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

The key prize in Pfizer’s $11.6 billion acquisition of Biohaven Pharmaceuticals was blockbuster-to-be migraine pill Nurtec OTC. Now, five months after competing the purchase, Pfizer has taken a nasal spray version of the treatment across the FDA finish line. On Friday, the regulator signed off on Zavzpret (zavegepant) for both the treatment and prevention of migraine headaches in adults.

DOJ charges former Stimwave CEO with fraud scheme that added a fake receiver to neurostim device

Laura Perryman, the former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud insurers.

Gilead Sciences, after long battle against HIV drug fraudsters, scores $175.2M in judgements

After a long legal battle against a web of fraudsters who allegedly abused Gilead's free PrEP drug program, a Florida judge has issued default judgements against two groups of defendants.

Vyne swings behind BET inhibitors, seeks partner for failed eczema drug

Vyne Therapeutics is putting its mash-up of Pfizer’s Xeljanz and Novartis’ Gilenya on the back burner. After sifting through the data from a failed midphase eczema trial, the biotech has begun searching for a partner for the program to free up its own cash for development of its BET inhibitors.

Amid Novartis spinoff efforts, Sandoz pledges $400M for biosimilar manufacturing in Slovenia

Novartis may be in the process of spinning out its generics and biosimilar outfit, Sandoz, but that doesn't mean the latter company is pausing manufacturing investments. The generics and biosimilar player revealed plans for a $400 million plant in Slovenia.

FDA's first 'safer technologies' nod goes to Endolumik's glowing tube to guide weight-loss surgeries

The FDA’s nascent Safer Technologies Program, or STeP, is getting a major glow-up.

Fierce Biotech Layoff Tracker 2023: Neoleukin cuts 70% of staff, CEO; Olema lays off 25% staff

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.

'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines

This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines.
 
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'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines

This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines.
 

Resources

Executive Summary

Optimizing drug discovery in a fast-moving market

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Answering your specific questions about mRNA/saRNA manufacturing

Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here.
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Proven Pharmaceutical Go-To-Market Model

Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success.

Research

Strategizing for Clinical Trial Diversity

Like many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials.
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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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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.
On-Demand Webinar

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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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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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.

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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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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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.

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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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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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.
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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.
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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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