| 01.05.23 | Eisai rebuts repo rt that Alzheimer’s med contri buted to patient death; Amgen inks $2B ADC deal with Synaffix

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Today's Big News

Jan 5, 2023

Eisai rebuts NEJM report that Alzheimer's med contributed to patient's stroke death

Amgen piles $2 billion more into pharma’s ADC rush in Synaffix pact

Burned by FDA rejection, Y-mAbs drops 3rd of staff, cancer vaccine ambitions

Takeda troops rare disease drug to regulators after glimpse at phase 3 data

GSK pays WuXi $40M, bets $1.5B in biobucks for preclinical anti-cancer bispecific antibodies

Fierce Biotech Fundraising Tracker '23: HighTide washes up $107M; Metagenomi hauls in $100M

Moderna sprints toward RSV podium behind GSK, Pfizer, with eyes on combo vax

Renibus’ cardiac surgery drug aces phase 2 trial as biotech adds extra CEO

Roche further taps drug discovery spinout's Nimble tech in $1.1B biobucks deal

Biopharmas left Black and Latinx patients behind in oncology clinical trials, nonprofit says

Whitepaper: Biotech bill: impact for life sciences companies.

The National Biotechnology and Biomanufacturing Initiative, which channels more than $2 billion to America’s biotech sector, will have far-reaching implications not only for the domestic biotech space but industries at large, including life sciences. Where are the salient opportunities? What are the gravest risks? Read this in-depth white paper from Randstad for answers.

Featured

Eisai rebuts NEJM report that Alzheimer's med contributed to patient's stroke death

By Annalee Armstrong

Deaths in a clinical trial for Eisai’s Alzheimer’s drug lecanemab are once again being flagged, this time in a New England Journal of Medicine entry that highlights a potential risk for patients undergoing a certain type of emergency stroke treatment.

Amgen piles $2B more into pharma's ADC rush in Synaffix pact

By Annalee Armstrong

A day after buzzing Hummingbird Bioscience for an antibody-drug conjugate licensing pact, Synaffix is back with a substantially similar, yet bigger deal. The Singapore and U.S.-headquartered biotech will work with Amgen in a pact valued at up to $2 billion.

Burned by FDA rejection, Y-mAbs drops 3rd of staff, cancer vaccine ambitions

By James Waldron

In the wake of a bruising FDA rejection for its rare pediatric cancer drug, Y-mAbs Therapeutics has followed the increasingly common biotech trend of laying off staff and trimming back its remaining pipeline.

Takeda troops rare disease drug to regulators after glimpse at phase 3 data

By Nick Paul Taylor

Takeda has pressed go on plans to seek approval for its enzyme replacement therapy in an ultra-rare disease. Citing the “totality of the evidence” seen in phase 3, the Japanese drugmaker outlined its intent to head to regulators armed with data on the ADAMTS13 replacement therapy it acquired from Shire.

Whitepaper: Finding the Right Partner: Outsourcing Is Key to Growing Your Microbiome Testing Company

Download this whitepaper for guidance on how to Scale your Direct-to-Consumer Microbiome Testing Company and when it makes sense to outsource microbiome sequencing to a third-party provider.

GSK pays WuXi $40M, bets $1.5B in biobucks for preclinical anti-cancer bispecific antibodies

By Nick Paul Taylor

GSK is stepping up its interest in T-cell engaging antibodies, handing WuXi Biologics $40 million upfront for an exclusive license to one preclinical bispecific and options on three additional candidates.

Fierce Biotech Fundraising Tracker '23: HighTide washes up $107M; Metagenomi hauls in $100M

By Gabrielle Masson,Max Bayer,Annalee Armstrong

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

Moderna sprints toward RSV podium behind GSK, Pfizer, with eyes on combo vax

By Max Bayer

Moderna is eyeing a bronze medal in the RSV race behind Pfizer and GSK with plans to readout a phase 3 trial in the first quarter. And while CEO Stéphane Bancel is bullish on his shot's competitiveness, he believes a combo vaccine will likely be where the company stands out.

Renibus’ cardiac surgery drug aces phase 2 trial as biotech adds extra CEO

By James Waldron

Renibus Therapeutics’ lead candidate for patients undergoing cardiac surgery has sailed through a phase 2 trial, setting up the Texan biotech for a late-stage study in the coming months as it also unveiled a double-dose of CEOs.

Roche further taps drug discovery spinout's Nimble tech in $1.1B biobucks deal

By Annalee Armstrong

Roche is making sure its peptide discovery spinout Nimble Therapeutics stays close with a revision of the companies’ development partnership valued at up to $1.1 billion.

Biopharmas left Black and Latinx patients behind in oncology clinical trials, nonprofit says

By Helen Floersh

The new benchmark for oncology clinical trial diversity from the nonprofit behind the Good Pharma Scorecard gave one company a perfect score, but most others have work to do.

'Easy as 1, 2, Pee' — Withings' smart scanner puts a urology lab in your toilet bowl

By Conor Hale

To those who've always wanted to digitally monitor their bathroom health at home: you're in luck.

IQVIA tapped by Biostage to run its first clinical trial of esophageal implant

By Joseph Keenan

CRO giant IQVIA has signed on to conduct the first clinical trial of Biostage’s lab-grown esophageal implant.

Pfizer wins—again—in courtroom fight versus Astellas over Lexiscan patents

By Kevin Dunleavy

A federal appeals court has upheld a previous ruling that Pfizer’s Hospira did not infringe on patents in developing its generic version of Astellas' Lexiscan. The only option left for the Japanese company is an appeal with the U.S. Supreme Court.

Clinscience's owner takes majority stake in Florida-based CRO OncoBay

By Joseph Keenan

Poland-based Neuca Group, the parent company of CRO Clinscience, has taken a majority stake in Florida-based OncoBay to expand its reach in the U.S.

November's hospital margins up 12% monthly thanks to cooling expenses

By Dave Muoio

Shorter stays and modest labor relief helped contain costs, though hospitals' median margins still remain red for the year, per Kaufman Hall. The firm advised struggling hospitals to turn their eyes to outpatient services, which have enjoyed consistent revenue growth since last year and pre-pandemic.

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'Podnosis': Digital redlining in healthcare and breaking down barriers to care for gender-diverse populations

In this week's episode of "Podnosis," we talk about how telehealth exacerbates health inequities. We also discuss the impact of anti-trans legislation on healthcare and what providers can do to break down barriers to care for gender-diverse populations.

'The Top Line': The medtech industry’s highest paid CEOs, plus this week's headlines

'Podnosis': 2022's digital health unicorns and tapping population health for better care delivery

Webinar: Aligning for the Win - Best Practices for Building a Compelling Clinical Supply Strategy

Tuesday, January 24, 2023 | 11am ET / 8am PT

Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now.

Resources

Whitepaper

Medical Affairs Metamorphosis V: The (R)evolution in Medical Communications

This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series).

Sponsored by: Blue Matter, strategic consultants in the life sciences

On-Demand Webinar

Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Scale-Up Strategies for Late-Stage Cell Therapies

Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more.

Sponsored by: Catalent

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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?

Sponsored by: Catalent

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Linear Compression vs. Parallel Processing: Speeding Biologics Through Development and Into Clinical Trials

Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more.

Sponsored by: Catalent

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Intranasal Drug Product Development: Formulation to Manufacturing

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

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.

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.

Sponsored by: Catalent

Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.

Sponsored by: Catalent

Case Study

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

Sponsored by: Catalent