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August 02, 2019

Pfizer is merging the off-patent drugs franchise under its Upjohn brand with generics heavyweight Mylan—combining two under-pressure businesses into a new giant with projected 2020 revenues of $19 billion to $20 billion. It fulfills the dreams long-held by some Pfizer analysts and investors who’ve hoped for a generics hive-off, and brings new leadership to Mylan: CEO Heather Bresch plans to end her stint at the company—which spans 28 years and a series of controversies—after the deal is done in mid-2020. Those stories and more make up our top reads this week.

Featured Story

Pfizer's big split is finally here, thanks to a giant generics merger with Mylan

In a deal that would finally deliver on years of split-up talk, the pharma giant has agreed to merge its off-patent drugs business with Mylan. And in the process, Mylan investors will finally get what they want—new leadership.

Top Stories Of The Week

Lilly drops PD-L1/TIM-3 bispecific from clinical pipeline

Eli Lilly has dropped a PD-L1/TIM-3 bispecific antibody from its clinical pipeline. The asset moved into a phase 1 advanced solid tumor trial late last year but was culled from the pipeline before delivering final data.

Novartis' Entresto flops crucial heart failure trial, imperiling $5B sales goal

Entresto’s blockbuster turn in 2018 was a long time coming for Novartis, which held on to a $5 billion vision for the drug even as its launch lagged. Those dreams took another hit Monday when Entresto flopped a phase 3 trial.

Amgen's KRAS drug shows promise in 2 additional cancers: colorectal and appendiceal

Two months after posting the first clinical data for a KRAS inhibitor, Amgen is at it again. The Big Pharma reported in its second-quarter earnings presentation that AMG 510 shrank tumors in patients with colorectal and appendiceal cancers.

Red flag upgrade for Pfizer: FDA limits Xeljanz in colitis, slaps black box on label

For Pfizer’s blockbuster immunology drug Xeljanz, an FDA safety communication has now turned into a boxed warning. And forget the drug's approval as a first-line ulcerative colitis treatment, at least for now.

Mylan CEO Bresch set to exit after years of controversy—and one last big deal

During Mylan CEO Heather Bresch's 28-year stint at the company, it has utterly transformed into a generics giant—and courted controversy along the way. Now, Bresch says she's stepping aside to clear the way for an even bigger version of Mylan.

J&J's multiple sclerosis prospect beats Sanofi drug in phase 3

A phase 3 trial of Johnson & Johnson’s multiple sclerosis prospect ponesimod has met its primary endpoint. The readout sets J&J up to file for approval this year, boosting its prospects of getting a return on its $30 billion takeover of Actelion.

Editas, Allergan kick off long-awaited in vivo CRISPR trial

Though Editas and Allergan are not the first companies to test a CRISPR-based medicine in humans—that distinction goes to CRISPR Therapeutics and Vertex—their treatment is the first that edits DNA within the body.

Merck shuns big M&A, growth concerns as Keytruda keeps steamrolling

Merck in the past has faced investor criticism that it’s a one-trick pony with Keytruda. But with a trick that good, analysts say, why worry?

Preventing DNA damage in Parkinson's by replacing a key protein's function

New research reveals the protein alpha-synuclein, which has been implicated in some brain disorders, actually plays a vital role in preventing the death of neurons in Parkinson’s. The findings could inspire new treatments.

Merck to build Gardasil 9 plant and add 425 jobs, but will cut 150 elsewhere

Merck’s Gardasil is not just a moneymaker, it is a job creator. Just weeks after announcing a Virginia expansion that comes with 100 jobs, the drugmaker says it will build a new plant for Gardasil in North Carolina with 425 more. 

Exact Sciences to buy Genomic Health in $2.8B deal

Exact Sciences has moved to acquire Genomic Health, with plans to bring their cancer screening and diagnostic tests up through a combined commercial organization of about 1,000 employees, including sales, marketing and reimbursement staff.

Resources

[Whitepaper] Flow Chemistry: A Scale-up Solution for Modern API Development and Manufacturing

Patheon, part of Thermo Fisher Scientific, offers advanced API manufacturing technologies such as continuous processing and continuous analytics to deliver high-quality products with well-defined features to meet your timelines and volume requirements.

[Whitepaper] The Impact of Artificial Intelligence on Outcomes Based Contracting

Understanding the challenges for formulary decision makers and manufacturers.

[Whitepaper] How Vertex Cut Database Build Timelines by 50%

This white paper details how leveraging new reporting capabilities, live UAT feedback sessions, and an agile design approach to study builds will save them time and money.

[Whitepaper] The Truth about Physician Referrals and Clinical Trials

The Study Voices survey challenges the myth that physicians won’t refer patients to clinical trials, and it identifies opportunities to engage physicians as partners in the enrollment process.

[eBook] Small molecules 2.0: the bigger picture

The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…these are exciting times for our industry.

[Paid Marketplace] Faster Research. Smarter Bibliographies.

Cut your research time in half - with an easy-to-use app for scientists that combines full-featured reference management with integrated search and on-demand document delivery.

[Video] Almac Launches Almac Adapt™ - a New Patient-Centric Supply Solution

Innovative Just in Time Manufacturing solution enables sponsors full late stage customisation of clinical trial materials

[Video] PwC Webcast: Goodbye cost shifting, hello employer activism

How are employer activism strategies beginning to replace the cost-sharing of the past, and improve the health of the workforce?

[Report] NEW Report on 2019 e-Prescribing Regulations and Potential Impact

Patient demand for more information on their care is driving new e-prescribing regulations, and technology is evolving to help providers meet them. This report provides an overview of key areas where such regulation has emerged, and what it could mean for providers and healthcare IT companies.

[Whitepaper] IoT Technologies & Informatics Integration in Pharmaceuticals

Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies.

[Case Study] Clinical Supply Management

Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study.

[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

Download the eBook to explore a proactive approach for clinical supply management.