J&J’s layoffs hit medtech group

This Week

Mar 10, 2023

Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing


Merck's cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2 


Johnson & Johnson layoffs hit medtech business, with more than 350 cuts in California


'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines


Practice-changing Polivy? FDA questions Roche data amid high-stakes lymphoma expansion bid


Big Pharma regained 'mojo' last year, but biotech valuations remain 'precarious': report

 

Featured

Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing

After scoring an accelerated approval for Alzheimer's disease drug Leqembi in January, Eisai and Biogen hope to turn that into a traditional approval by July 6. But an advisory committee will get a chance to vote on the drug first.
 

Top Stories

Merck's cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2

Merck & Co. has looked to its mid-to-late stage cardiovascular pipeline as a potential goldmine amid the race to replace Keytruda's revenue stream. And a handful of new readouts provide a glimpse into the promise the company is banking on.

Johnson & Johnson layoffs hit medtech business, with more than 350 cuts in California

Amid reports of layoffs within Johnson & Johnson's Janssen pharmaceutical division and outgoing consumer health group, the job cuts have now reached J&J’s medtech division.

'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines

This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines.

Practice-changing Polivy? FDA questions Roche data amid high-stakes lymphoma expansion bid

When Roche touted data for Polivy in previously untreated large B-cell lymphoma, the company billed the drug as the first potential new treatment standard in nearly two decades. But the FDA sees things differently.

Big Pharma regained 'mojo' last year, but biotech valuations remain 'precarious': report

Anyone looking for a road map out of the biotech bear market will take little comfort from Evaluate Vantage’s latest report. While Big Pharma valuations “regained their mojo” toward the end of last year, the outlook remains bleak for smaller-scaled drug developers.

Fierce Biotech Layoff Tracker 2023: Neoleukin cuts 70% of staff, CEO; CODA shuts down

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.

Amid major restructuring, Novartis CEO Vas Narasimhan's 2022 pay fell by more than a quarter

After handing Narasimhan $9 million in performance-based pay in 2021, Novartis' compensation committee slashed the CEO’s award in that category by a whopping 61% last year. The pay cut, spurred by turbulent performance between 2020 and 2022, contrasts sharply with Novartis’ execution during the first three-year stretch under Narasimhan’s lead. 

Chasing Moderna, Merck pays $50M to join race to develop cancer-preventing vaccine

Merck & Co. has joined the emerging race to develop an Epstein-Barr virus vaccine, paying ModeX Therapeutics $50 million upfront and dangling $872.5 million in biobucks for global rights to a preclinical challenger to shots in clinical development at Moderna and the NIH.

Right on Cue: Pfizer keeps up cadence of COVID-19 risk awareness pushes with another diagnostic pact

Pfizer is once again looking to a diagnostic developer to drum up interest in its COVID-19 drug. Having kicked off the strategy last year through deals with Lucira Health and Roche, the Big Pharma has now partnered with Cue Health to raise awareness of the risks of progressing to severe COVID-19.

After SK Capital buyout, Apotex yanks 6 batches of glaucoma med on sterility concerns

Apotex on Wednesday kicked off a recall of six lots of the glaucoma and ocular hypertension drug brimonidine tartrate ophthalmic solution. The company is acting “out of an abundance of caution” after it found cracks on the caps of certain brimonidine tartrate bottles. Those cracks could jeopardize the drug’s sterility, potentially paving the way for unwanted side effects, Apotex said.

Novartis ready to head for deep space with Voyager after a year 'kicking the tires'

It’s been a year since Novartis ventured into orbit with Voyager Therapeutics to find new central nervous system targets. Now, the Big Pharma is ready to go deeper into space with the AAV capsid discovery biotech.

Bernie Sanders urges Sanofi, Novo Nordisk to be like Eli Lilly in reducing insulin prices

In slashing the cost of its insulin earlier this week by some 70%, Eli Lilly responded quickly to President Joe Biden’s State of the Union appeal to producers of diabetes medicines. But Lilly’s initiative wasn’t enough for relentless pharma industry adversary Sen. Bernie Sanders. In separate letters to the world’s other two premier manufacturers of insulin, Sanofi and Novo Nordisk, Sanders has asked them to also reduce the “outrageous” price of insulin in the United States.

CZI in Chi: Chan Zuckerberg Initiative sets first location for $1B biohub expansion

CZ Biohub Chicago will focus specifically on developing new technologies equipped with sensors and probes that can draw out high-resolution biological information from human tissue at a molecular level.

FDA delays BioMarin's gene therapy approval decision by 3 months

After a long road to the FDA finish line for BioMarin, the agency just moved the goal post back by a few months. The new decision date for hemophilia A gene therapy Roctavian is June 30 versus the previous date of March 31.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Surprising multibillion-dollar medtech M&A deals

This week on "The Top Line," we discuss 2022's M&A trends in the medtech sector and the surprising multibillion-dollar megadeals. We also cover the top headlines from this week.

 

Resources

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Spotting Influences in the HCP-Patient Conversation

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Optimizing drug discovery in a fast-moving market

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Answering your specific questions about mRNA/saRNA manufacturing

Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here.

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Proven Pharmaceutical Go-To-Market Model

Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success.

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Strategizing for Clinical Trial Diversity

Like many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials.
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The Power of Small & Safety: Nanoplasmid™️ Vector Platform

Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies.

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Leveraging Archetypes for Effective Launch Strategy

Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches.

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.

eBook

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications.

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Step-wise strategy to address process characterization and late phase development

Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development.

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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.
Research

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.

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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.
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.

 

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