Transcending the PTSD competition

Today’s Big News

Dec 6, 2023

Merck KGaA’s BTK drug flunks pivotal multiple sclerosis trials, sending shockwaves through the sector


As J&J outlines bullish pipeline goals, neuroscience pipeline takes a starring role


PTSD treatment is on the cusp of a paradigm shift. This biotech hopes to Transcend the competition


Pharvaris' oral hereditary angioedema med slashes attacks in turnaround post-FDA hold


IGM, with cash dipping below $390M, cuts headcount 22%, stops blood cancer work to stretch money


Syros’ stock up after sharing early, mid-stage AML data


Coya taps familiar friend Dr. Reddy’s to commercialize ALS med


Pfizer, Valneva overcome CRO issues to finish phase 3 recruitment for Lyme disease vaccine

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Featured

Merck KGaA’s BTK drug flunks pivotal multiple sclerosis trials, sending shockwaves through the sector

Merck KGaA just sent shockwaves through the BTK inhibitor space. Evobrutinib, the German drugmaker’s contender for a blockbuster opportunity, failed to beat Sanofi’s Aubagio in two phase 3 multiple sclerosis (MS) clinical trials, raising doubts about the prospects of a clutch of heavily backed rival candidates.
 

Top Stories

As J&J outlines bullish pipeline goals, neuroscience pipeline takes a starring role

Johnson & Johnson's neuroscience pipeline is taking center stage, now one of three therapeutic focus areas mentioned in the company's business review. Three neuroscience drugs are expected to rake in $1-5 billion in revenue by 2030.

PTSD treatment is on the cusp of a paradigm shift. This biotech hopes to Transcend the competition

As a flurry of recent developments underscores the coming wave of new psychiatric treatments, one biotech is looking to carve out relevance in the PTSD space, pointing to new phase 2 data as evidence.

Talking cancer immunotherapy with Cell Signaling Technology

CST fellow Amrik Singh outlines some of the key progress being made around CAR-T therapy and the impact that this highly specialized technique can have on cancer patients, even those who have been previously unresponsive to other forms of treatment.

Pharvaris' oral hereditary angioedema med slashes attacks in turnaround post-FDA hold

Patients taking Pharvaris’ preventative oral medicine for hereditary angioedema had an 84.5% reduction in monthly attacks during a phase 2 study. The results represent a turnaround for the medicine, which until June was on a clinical hold by the FDA.

Revolutionizing the clinical trial patient experience with IQVIA

IQVIA’s new technologies are changing clinical trials, reducing the administrative burden on staff and improving insights for sponsors.

IGM, with cash dipping below $390M, cuts headcount 22%, stops blood cancer work to stretch money

How much money does a biotech need to feel comfortable in today’s market? IGM Biosciences added to evidence that the number is big after the market closed Tuesday, when it revealed a 22% reduction in its headcount and prioritization of its pipeline to make the hundreds of millions in its bank go further.

Syros’ stock up after sharing early, mid-stage AML data

On the heels of a 35% workforce reduction and new CEO stepping in, Syros Pharmaceuticals is sharing an early snapshot of data from an AML trial that shows a 100% response rate among nine patients.

Coya taps familiar friend Dr. Reddy’s to commercialize ALS med

Coya and Dr. Reddy's are teaming up again on COYA 302, the former's ALS treatment nearing the clinic. The two were already collaborating on one of Dr. Reddy's biosimilars included as part of the asset's combo regimen.

Pfizer, Valneva overcome CRO issues to finish phase 3 recruitment for Lyme disease vaccine

Pfizer and Valneva have completed recruitment for a phase 3 trial of the Lyme disease vaccine VLA15 after work was halted earlier this year due to problems with one of the CROs at some of the trial sites.

SABCS: Seagen outlines Tukysa's value alongside Roche's ADC in breast cancer. But FDA path remains unclear

Seagen unveiled detailed data showing its Tukysa could offer additional tumor progression benefit on top of Roche’s ADC Kadcyla. But with a negative early trend in overall survival, Seagen seems not ready to knock on the FDA’s door.

Tough labor market holds Fitch's nonprofit hospital outlook at 'deteriorating'

Fitch Ratings' pessimistic 2024 outlook highlighted labor shortages, an uptick in union activity and potential second year of debt service covenant violations.

Rockley Photonics begins shopping around its health-tracking wearable

After wrapping up bankruptcy proceedings over the summer and, according to the company, emerging with all of its material customer contracts and tech development programs still in place, Rockley is ready to return to the process of finding buyers for its wrist-based biosensor.

UPDATED: As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

During an enterprise business review Tuesday, J&J laid out a range of expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast more than 10 drugs with peak sales potential of at least $5 billion, plus another 15-plus products with sales potential of at least $1 billion.
 
Fierce podcasts

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'The Top Line': Fiercest Women in Life Sciences, meet the Fierce 50

In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech.
 

Resources

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Executive Summary

Transitioning from using RUO to cGMP chemicals for clinical trials

By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially.
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The Potential of Predictive Algorithms for Pharma

Learn about the untapped power of AI-driven insights — where innovation meetings precision, effortlessly unlocking benefits for your organization.
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The Convergence of Consumer Wearables & Medical Devices

Medical devices & consumer wearables are starting to overlap, creating risks & opportunities for traditional medical device companies as well as consumer wearables manufacturers. This paper explores pros and cons from both perspectives.

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Fed-Batch Intensification To Increase Titer In Biologics Manufacturing

Improving efficiency and productivity in biologics manufacturing is a longstanding goal within today’s industry, especially now as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can help accelerate this pace of innovation through advanced process development techniques and high productivity manufacturing platforms.

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Effective Technology Transfers for Mammalian-Derived Biologics

As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. 

eBook

An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
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Overcome Challenges and Secure Successful Technology Transfers of Complex Biological Products in Sterile Manufacturing

A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer.
 

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