Astellas seeks cancer knockout with Sutro deal
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Editor's Note: The June 28, 2022, edition of the Fierce Biotech Research newsletter was mistakenly sent earlier this morning to our Fierce Biotech readers. We apologize for the error, and hope you enjoy our usual daily line up of biotech stories. 

Today's Rundown

Catalent Trending Topic: Cell & Gene Therapy
Read on to understand how the industry is addressing gene therapy and cell therapy research and development.

Featured Story

Mystery solved: Roivant is Pfizer's TYK2 partner—and is cutting other programs to fund late-phase trials

Pfizer has revealed the new home of its TYK2 inhibitors. Months after disclosing a pact with a mystery startup, the Big Pharma has taken the wrapping off a deal with Priovant Therapeutics, a new Roivant unit that will seek to bring brepocitinib to market in dermatomyositis and lupus.

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Top Stories

'Welcome to scrutiny': BIO chair mounts defense against more rigorous accelerated approval process

As regulators and elected officials consider reforming the accelerated approval process, BIO chairman Paul Hastings is mounting a vigorous defense against proposals he says could threaten innovation.

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Astellas pays Sutro $90M to hit cancer with one-two punch from new ADC modality

Astellas has struck its second immuno-oncology deal of the month. The latest pact will see the Japanese drugmaker pay Sutro Biopharma $90 million, plus potentially upward of $1 billion in biobucks, for rights to three immunostimulatory antibody-drug conjugates, a modality designed to combine the best features of ADCs and personalized vaccine biology.

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Kezar's phase 2 lupus data spur hope for former pipeline-in-a-drug contender—and a share rally

Kezar’s hopes for zetomipzomib to become a catch-all drug for inflammatory disease having been stunted earlier in the year, new phase 2 data suggest the therapy is still in play to treat lupus nephritis.

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Data key to boosting trial diversity—and its time for CROs to act, says Phesi

Regulators' efforts to boost trial diversity are not enough, according to Phesi, which says data from unrepresentative studies should not be considered good quality. The artificial intelligence technology firm made the comments this week to coincide with a new analysis of clinical studies conducted over the past 15 years.

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Researchers look to the stars for new Alzheimer's target

To help crack Alzheimer's disease, researchers are looking to a North Star—or, more accurately, a star-shaped cell in the brain that could play a role in progression of the neurodegenerative disease. 

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Volume turns up on Decibel as hearing loss therapy protects patients in early-stage trial

A small data set but big improvement in the hearing loss brought on by chemotherapy was enough to send Decibel Therapeutics' shares soaring in premarket trading Tuesday.

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Conflicting state laws and 'unpredictable' enforcement await providers in post-Roe America

Single- and multistate provider organizations alike may find it difficult to keep their women's health services within the bounds of the law, attorneys say.

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DermBiont's topical gel hits goal in benign skin growth phase 2, clearing path for further development

DermBiont’s bet on SeylanMED has delivered a win in phase 2. Twenty months after acquiring the topical drug candidate SM-020, DermBiont has linked the prospect to improved outcomes in people with benign tumors, causing the phase 2 clinical trial to meet its primary and secondary endpoints.

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Cue Health to lay off 170 workers due to 'economic challenges,' COVID test funding cuts

After rocketing to medtech stardom amid the COVID-19 pandemic, Cue Health seems to be drifting back down to Earth.

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CMS rolls out new payment model on improving cancer treatments

CMS announced a new payment model aimed at improving care coordination and services for cancer treatments, including a new focus on improving health equity.

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Trial failure for Jazz’s cannabis-derived drug blunts goal to expand its use to US

Jazz Pharmaceuticals has revealed a setback, saying that its nabiximols oromucosal spray has flunked a phase 3 trial, coming up short in helping multiple sclerosis patients with lower-limb spasticity. Over a 21-day span, the spray—known as Sativex and on the market in Europe for 12 years—failed to improve muscle tone as measured by the Modified Ashworth Scale (MAS).

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Resources

eBook: 12 Pitfalls in Europe

For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Whitepaper: Medical Affairs Metamorphosis II: Medical Affairs’ Evolving Role as Insight Generator

Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve.

Article: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

White Paper: Jump Start for Biotech: New Lab Startup Guide

Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals.

eBook: Download the Cell Therapy Handbook

Explore the new cell therapy handbook from Thermo Fisher Scientific.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

Events