Expect more ESG reporting from biotechs
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Editor’s Note: Fierce Biotech will not publish on Monday in observance of Presidents Day, but we'll be back in your inbox on Tuesday, Feb. 22. Have a great weekend!

Today's Rundown

Featured Story

GSK, in close race with Pfizer, slams brakes on phase 3 maternal RSV vaccine program over safety signal

GlaxoSmithKline has slammed the brakes on its pivotal maternal respiratory syncytial virus (RSV) vaccine program after a safety assessment, potentially handing an advantage to Pfizer in a close race to market.

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Top Stories

FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data

BioMarin Pharmaceutical faces a long clinical hold on its phenylketonuria (PKU) gene therapy trial. After stopping the trial over tumors in mice, the FDA has asked BioMarin to run additional nonclinical studies that are expected to take “several quarters” to assess the risk of BMN 307.

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'Early stage': Majority of biotechs don't disclose ESG practices, but most plan to in near term

The biotech industry has not caught the ESG bug that has swept across C-suites in recent years as part of the broad push for corporate social responsibility, according to a survey and review from life sciences law firm Fenwick.

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Sponsored: A New Way to Access Scientific Papers?

For researchers unaffiliated with an academic library, finding scientific papers can be time-consuming and expensive—and organizing or sharing them can be even harder. Can a new tool address this gap?

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Ligand to spin off J&J-partnered antibody unit with $70M in funding

Ligand Pharmaceuticals will spin off its Johnson & Johnson-partnered antibody platform business OmniAb and capitalize the company with $70 million.

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Ribon taps former Novartis VP, Flagship partner Raman as CEO

Cellular stress-focused biotech Ribon Therapeutics has hired former Novartis VP and Flagship Pioneering Senior Partner Prakash Raman, Ph.D., as its new CEO.

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Bayer hikes Nubeqa's peak sales to more than €3B on prostate cancer data, teeing up new 3-way battle against Pfizer-Astellas, J&J

Bayer has spelled out an even more bullish estimate for Nubeqa's blockbuster potential, thanks to a trial win in a new prostate cancer frontier for the androgen receptor inhibitor. But the German drugmaker still faces an uphill fight against two formidable incumbent players.

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Agios' first-in-class PK activator Pyrukynd scores FDA approval to treat rare blood disorder

More than a decade after its founding, Agios Pharmaceuticals has its first FDA green light. With the approval for Pyrukynd to treat hemolytic anemia in adults with pyruvate kinase deficiency, the company is off and running in the commercial arena.

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FDA hands down Class I rating to Vyaire Medical's ventilator recall

So far, no deaths have been reported in connection with the software flaw, but the FDA has received 18 complaints and reports of seven injuries linked to the issue.

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FTC deadlocked on whether to study PBM contracting practices such as DIR fees

The FTC deadlocked on whether to initiate a study into contracting practices of the PBM industry, despite fervent lobbying from pharmacists.

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Curebase adds real-world data, AI experts to board in decentralized trial push

Curebase has added real-world data and artificial intelligence experts to its advisory board in a bid to capture a greater share of the decentralized trials market.

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Is there a case for more medical emoji? Study looks at how clinicians use them on the job

Communications software company PerfectServe wondered whether it could identify evidence of burnout or frustration among clinicians expressed through emoji. But the company discovered just the opposite – emoji were overwhelmingly used to convey politeness and positive intent. Some researchers and physicians have made a case for a comprehensive set of medical emoji.

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Fierce Pharma Asia—Lilly, Innovent's I-O implications; Novartis' India job cuts; Moderna's Asia expansion

The FDA's negative opinion toward Eli Lilly and Innovent Biologics' PD-1 application has broad implications for Chinese biopharmas eyeing the U.S. market and future PD-1/L1 programs. Novartis India plans to cut 400 jobs after a sales pact with Dr. Reddy's. Moderna will build four new commercial subsidiaries in Asia. And more.

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Chutes & Ladders—Califf returns to FDA after narrow Senate confirmation

Robert Califf, M.D., will once again helm the top spot at the FDA after a narrow confirmation by the Senate. The NIH's Vaccine Research Center Director John Mascola, M.D., will depart at the end of March after nearly 22 years at the center, including eight in the top spot. 2seventy bio poached Steven Bernstein, M.D., from Turnstone Biologics to fill the chief medical officer post.

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Resources

Infographic: Providing comprehensive solutions for the most critical shipments

The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now.

Whitepaper: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Whitepaper: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

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: The CNS Market: 2021 Year in Review & Outlook for 2022

What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more.

Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper: 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.

Events