Merck's Januvia hit with impurity concerns
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Today's Rundown

Featured Story

FDA declines to free MaaT's microbiome drug from clinical hold after a year

MaaT Pharma is not getting out from under an FDA clinical hold for its microbiome drug any time soon. MaaT013, in development for steroid-resistant acute graft-versus-host disease (aGvHD), was placed on hold a year ago, halting a phase 3 trial in the U.S.

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Top Stories

HCA Healthcare, J&J explore better outcomes, nurse training, early cancer detection in new partnership

The two major players will lean on HCA's wealth of patients and nurses as they seek to tackle multiple sore spots for the healthcare industry.

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FDA relaxes impurity limit on Merck's Januvia after testing flags possible carcinogen. Are recalls next?

The potential cancer agent Nitroso-STG-19, also known as NTTP, has surfaced in certain samples of Merck & Co.’s Type 2 diabetes blockbuster Januvia, the FDA said Tuesday. Januvia, also known as sitagliptin, generated $5.3 billion in 2021 and ranked as Merck’s third best-selling drug behind Keytruda and Gardasil.

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BD teams up with Labcorp to develop new companion diagnostic tests using flow cytometry

The collaboration will see the medtech giant and Labcorp’s drug development division partner up with Big Pharma companies, with the goal of offering an end-to-end solution that spans the development, approval and distribution of diagnostic tests.

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BMS bites at GentiBio’s next-gen regulatory T cells, betting $1.9B on 3 programs

Bristol Myers Squibb is sold on GentiBio's engineered T-cell therapy, betting $1.9 billion on up to three programs. The deal comes a year after GentiBio hauled in more than $150 million in series A funds.

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Bristol Myers, in close CAR-T race with J&J and Legend, touts Abecma win in earlier myeloma

Bristol Myers Squibb is trumpeting a first-in-class win as it tries to move Abecma up in the line of multiple myeloma treatment. But it may wind up one step behind Johnson & Johnson and Legend Biotech in terms of treatment order.

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Federal judge OKs Blues plans' nearly $2.7B antitrust settlement

The settlement agreement ends a decade-long legal battle that stems from a 2012 class action suit alleging Blues plans would split up geographic areas to avoid competing with one another directly.

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Boehringer’s digital rewards club boosts COPD medication adherence by 44%: study

The RespiPoints program initially launched in 2016 with support for Spiriva Respimat, one of Boehringer’s inhaler-based prescription treatments for symptoms of COPD.

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New CEO Maselli extends Catalent's expansion blitz with $475M buyout of CDMO Metrics

New Catalent CEO Alessandro Maselli has pulled off his first key acquisition, a $475 million buyout of Metrics Contract Services. The CDMO, a subsidiary of Australia-based Mayne Pharma Group, has a 333,000-square-foot plant in Greenville, N.C., with the capacity to produce more than 1 billion solid-dose pills annually.

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Disc inks Gemini merger, secures cash from starry VC syndicate to advance ex-AbbVie, Roche drugs

Disc Medicine has secured cash to advance hematology assets picked up from AbbVie and Roche, inking a merger with the floundering Gemini Therapeutics and tapping a starry syndicate of VCs to extend its runway into 2025.

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Reva Medical returns with $45M to bring its bioresorbable stent to the US

The California-based outfit went through Chapter 11 bankruptcy proceedings in early 2020 and re-emerged as a private enterprise after about a decade as a publicly traded company.

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Walmart has a new policy denying some telehealth prescriptions for controlled drugs. It's implicating patients in recovery

Walmart is not accepting prescriptions for controlled substances written via telehealth without an in-person visit in the preceding 24 months, implicating virtual addiction treatment. Corporate policies that limit telehealth prescriptions “are a threat to patient safety and recovery,” said Anna Legreid Dopp with the American Society of Health-System Pharmacists.

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Vyne to reevaluate pipeline after eczema trial fail uproots plans

Vyne Therapeutics’ lead asset has failed to improve the severity of mild-to-moderate atopic dermatitis, uprooting the biotech’s plans and sending the stock plummeting.

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Merck selects Saama to add machine learning tech to drug development process

Saama's Life Science Analytics Cloud is powered by cloud computing and machine learning artificial intelligence technologies, the latter of which was trained using more than 100 million clinical data points.

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Resources

Whitepaper: End-to-end support for your asset's commercialization

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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?

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.

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

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

Case Study: 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.

Article: 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?

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

Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry.

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?

On-Demand 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.