Otsuka buys out of Akebia pact
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Editor's Note: Fierce Biotech will not publish on Monday, July 4, in celebration of U.S. Independence Day. We'll be back in your inboxes on Tuesday. Enjoy your holiday weekend!

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

VC biotech funding drops 46% in first quarter as firms guard against bear market

Just when biotechs could use cash the most, the well has dried up. Venture financing deal value for U.S.-based biotechs fell by 46% in the first quarter, compared to the same period a year ago, according to GlobalData.

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Top Stories

Déjà vu: FDA rejects NRx filing for emergency use in COVID-19

Aviptadil has gone 0 for 2 on emergency use authorization filings at the FDA. The new rejection is the latest in a series of blows to the COVID-19 candidate, driving NRx Pharmaceuticals to shift focus to its bipolar depression prospect. 

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Otsuka pays Akebia $55M to exit anemia pill pacts amid dispute and FDA rejection

Akebia Therapeutics has extracted one final payday from Otsuka Pharmaceutical. With Otsuka cutting its ties to oral anemia drug vadadustat in the wake of rejection by the FDA, Akebia has secured a $55 million settlement, sending its bargain basement share price up 50% in after-hours trading.

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Provention's embattled diabetes med delayed again by FDA to consider new info

Provention Bio thought the resubmission for its diabetes prevention drug teplizumab was in the clear. But now, the FDA needs more time for the application after getting a look at some new information.

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Hit with 'current market realities,' Heron axes more than a 3rd of 300-person workforce

Heron Therapeutics has joined the gaggle of biotechs laying off staff, cutting a third of its workforce as part of restructuring efforts that could bring an annual $43 million in savings.

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Fierce Next Gen: Eikon drops hints at early pipeline, plans for $660M-plus reservoir

After raising more than $660 million in less than a year, Eikon Therapeutics' future plans are coming into clearer view, with an oncology pipeline underway as the star-studded biotech looks to capitalize on—and expand—Nobel Prize-winning tech. 

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'The Top Line' podcast: FDA's coming COVID shot makeover, what's driving new M&A activity, plus this week's headlines

This week on "The Top Line," we discuss what FDA advisors want added to future COVID vaccine doses—and why. Also, experts predict an uptick in dealmaking, particularly for a few key companies.

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FDA recommends Pfizer, Moderna update their COVID boosters to target omicron subvariants

After the FDA's independent vaccine committee voted to update COVID-19 shots, the agency recommends that manufactures update their vaccines to target omicron subvariants BA.4 and BA.5.

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HHS issues guidance on patient privacy in wake of SCOTUS abortion ruling

Healthcare providers are not permitted to disclose patient health information unless faced with a court order, including information relating to abortion and other sexual and reproductive health care, HHS said Wednesday.

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MMS set for expansion under new private equity backer Lindsay Goldberg

Private equity firm Lindsay Goldberg has invested in Michigan-based contract research firm MMS as new therapeutic modalities drive growth in the drug development industry—particularly cell and gene therapies.

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Intuitive, Siemens score FDA nod to add 3D imaging to robotic lung biopsies

Too many cooks in the kitchen may spoil the broth, but medtech developers are betting that adding increasingly more tech tools to the operating room will only improve procedure success rates.

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Blueprint rounds up $1.25B to grow cancer portfolio through internal R&D and dealmaking

Blueprint Medicines is “converting future revenue to cash,” as CEO Kate Haviland put it. The company is selling royalties to its targeted cancer drugs Ayvakit and Roche-partnered Gavreto and securing additional money for future dealmaking.

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Chutes & Ladders—FDA fortifies executive team with 2 new hires, including a chief scientist

The FDA has shored up its executive team, naming both a chief scientist and chief medical officer. GSK has scooped up a couple of dealmakers from AstraZeneca. Biopharma veteran Huang joins upstart biotech backed by Novarits.

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Fierce Pharma Asia—Astellas' gene therapy setback and new partnerships; Fujifilm's $1.6B expansion

Astellas hit another gene therapy clinical hold, but the Japanese pharma signed two partnerships focused on novel antibody-drug conjugate technology and undruggable targets. Fujifilm is pouring $1.6 billion to bolster its cell culture manufacturing services. And more.

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Resources

Event: Cancer Progress 2022: Event Highlights & Session Recordings

Check out our 22 on-demand panels, featuring 100+ speakers. Tap into discussions of scientific progress in oncology around development, regulatory, clinical, commercial and investment perspectives.

Case Study: Roche cuts feasibility process by 36%

Explore how Cognizant SIP helped Roche streamline its global feasibility process.

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: 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.

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: 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