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December 23, 2019___

Editor’s note: Please enjoy our top 10 stories of the year issue, plus your normal news. We will now take a publishing break until Jan. 2.


Today's Rundown

Featured Story

FierceBiotech's top 10 stories of 2019—Gilead's failure, Biogen's phoenix, JPM venue fatigue and more

As we reach the end of the year, we look back on the most read stories of the last 12 months as we also look ahead not just to a new year, but a new decade. So, what were the most read stories that you, dear reader, sought to end the 2010s with?

Top Stories

Gilead rocked by phase 3 failure of selonsertib in NASH

A phase 3 trial of Gilead’s NASH prospect selonsertib has bombed. The ASK1 inhibitor was no better than placebo at improving fibrosis, wiping out hopes that selonsertib would spearhead Gilead’s push into a new market.

Biogen resurrects aducanumab, arguing expanded data set supports FDA filing in Alzheimer's 

Biogen is planning to file for FDA approval of its failed Alzheimer’s disease drug aducanumab. The drug flunked a futility analysis in March, but Biogen resurrected it after factoring in data generated after the cutoff for the interim assessment.

[Sponsored] Invitae’s Detect Programs Breakdown Barriers to Genetic Testing

Lack of access to genetic testing delays diagnosis and limits access to clinical trials and approved therapies. Sponsored testing programs can help.

Attendees fed up with venue, high prices call to move JPM out of San Francisco

While the high cost of living in San Francisco has famously grabbed headlines, the costs of simply meeting there, even for a few days, are becoming untenable for some.

Celgene posts pivotal CAR-T data ahead of FDA filing

Celgene has posted data from a pivotal trial of its CAR-T therapy. The data look competitive against Gilead’s Yescarta and Novartis’ Kymriah, leading analysts to predict Celgene will win FDA approval next year.

Roche's effort to stop cancer metastasis unexpectedly leads to a Merck drug

Researchers at Roche and the Paul Scherrer Institute have identified a way to prevent the spread of certain cancer cells. Then they discovered that Merck already has a drug in development that may accomplish that feat.

Eli Lilly to shutter neuroscience R&D center next year

Eli Lilly is closing down its U.K.-based Erl Wood neuroscience in Surrey, leading to cuts and relocations.

Novartis strikes $9.7B takeover of The Medicines Company

Novartis has agreed to a $9.7 billion (€8.8 billion) deal to buy The Medicines Company for inclisiran. The takeover represents a big bet that the near-approval cholesterol drug will perform better commercially than rival medicines sold by Amgen and Regeneron and Sanofi.

Gilead drops anti-BCMA CAR-T from Kite, takes $820M charge

Buried in among Gilead’s fourth-quarter results statement is a line revealing it has abandoned an anti-BCMA cell therapy for multiple myeloma, part of its $12 billion acquisition of Kite Pharma.

As Celgene becomes BMS, its I&I lead lands CEO job at Takeda spinoff

As Celgene gradually phases into parent company Bristol-Myers Squibb, this is leaving little room at the inn for some of the top execs.

Biogen hit by 'transformative failure' as it cans aducanumab tests

Biogen and partner Eisai are throwing in the towel on late-stage tests for their key Alzheimer’s drug as independent experts reveal that it just won't make the grade.

Roche to pay Sarepta $1B upfront for DMD gene therapy rights

Roche is paying more than $1 billion upfront for the ex-U.S. rights to Sarepta's Duchenne muscular dystrophy gene therapy SRP-9001. The deal comes days after Roche advanced its push into gene therapies by closing the takeover of Spark Therapeutics. 

News of Note—J&J buys up drug delivery biotech; AstraZeneca out licenses asset; NASH biotech cancels IPO

Our final roundup of biotech news for the year, and the decade.

Resources

[Whitepaper] Why Partner with CSP’s to Validate Mission Critical Apps in the Cloud?

Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud.

[Whitepaper] How to Protect your Supply Chain from Security and Compliance Threats Utilizing On-Dose Authentication Technologies

Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication.

[Whitepaper] The Unexpected Key to Building Value in Drug Discovery and Development

Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Whitepaper] Q2 2019 Life Sciences M&A notes and trends

Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead.

[Whitepaper] What You Need to Know to Avoid Costly Delays in Your API Scale-Up

Are you facing costly delays in your API scale-up?

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

[Whitepaper] Modernizing clinical trials with Amazon Web Services (AWS)

From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks

[Whitepaper] The Impact of Step-Therapy Policies on Patients

Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system.

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