Ginkgo takes a Stride in gene therapy development

Today's Big News

Apr 5, 2023

'Like salmon swimming upstream': FDA’s Marks lays out plan to boost gene therapy approvals


Bayer's incoming CEO won't rule out consumer, agriculture spinoffs: report


Ginkgo, hunting for biotech platforms that 'collect dust,' scoops up AAV gene therapy capsid specialist


Philips’ latest ventilator recall linked to inaccurate high-pressure oxygen delivery


J&J proposes $8.9B talc settlement deal but some plaintiffs decry 'woefully inadequate' offer

 

Featured

'Like salmon swimming upstream': FDA's Peter Marks lays out plan to boost gene therapy approvals

The FDA has approved 12 gene therapies so far, and the agency's top drug regulator wants to see the road ahead illuminated with green lights.
 

Top Stories

Bayer's incoming CEO Anderson won't rule out consumer, agriculture spinoffs: report

For certain Bayer investors, the entry of a new CEO this summer could mean another shot at breaking up the German conglomerate. And for now, Roche veteran Bill Anderson, poised to take the throne from outgoing chief Werner Baumann in June, is keeping an “open mind.”

Ginkgo, hunting for biotech platforms that 'collect dust,' scoops up AAV gene therapy capsid specialist

Ginkgo Bioworks doesn’t want the biotech industry’s therapies. But it does want the platforms that create them, which is why the cell programming company is buying up StrideBio for its gene therapy platform.

Philips’ latest ventilator recall linked to inaccurate high-pressure oxygen delivery

Try as Philips might to forge a path out of its two-year-long saga of a slew of respiratory device recalls, the company is facing yet another—linked to more than 62,000 of its ventilators.

J&J proposes $8.9B talc settlement deal but some plaintiffs decry 'woefully inadequate' offer

After already spending billions to defend itself against claims its talc products cause cancer, J&J is moving to end the litigation altogether. But lawyers for some plaintiffs have said the offer is "woefully inadequate."

How much does a biotech pay? Community-generated data tool gives a peek at industry's salaries

A new community-generated data resource from Pillar VC, the Founder-led Biotech Summit and compensation analysis firm Pave seeks to take the guesswork out of the process by summarizing salary ranges from 90 companies.

Amid CE mark suspension, Getinge cardiac balloon pumps hit with 2nd Class I recall this year

The recall affects just over 8,900 of the Hybrid and Rescue models of Getinge's Cardiosave balloon pumps, more than half of which were distributed in the U.S.

In a refreshingly transparent disclosure, NGM Bio CEO reveals what led to 33% head count reduction

NGM Bio’s webpage declares "We're Hiring!" but a peek at the investor relations section of the biotech’s website tells a different—and sobering—story.

DOJ charges 3 former Magellan execs with fraud over faulty lead tests

Federal prosecutors are alleging that the trio of former leaders knew the tests provided incorrect results—and conspired to cover up those flaws—well before Magellan notified customers and regulators of the potential inaccuracies.

Proxygen, averaging a new collab every 10 months, sticks $2.5B molecular glue deal with Merck

Proxygen has inked a third licensing deal in less than 30 months, singing on agreement with Merck & Co. worth more than $2.5 billion. The Austrian biotech is not disclosing how many targets the deal is for.

COVID-19 tracker: Gilead touts early study win for oral antiviral

Gilead touted new findings on an oral antiviral. InflaRx's Gohibic won an authorization to treat critically ill COVID-19 patients. Plus more.
 
Fierce podcasts

Don't miss an episode

'The Top Line': The financial trends biotechs could face in 2023, plus this week's headlines

This week on "The Top Line," we discuss how 2023 is shaping up to be much the same as last year when it comes to financing trends for biotechs. We also cover Emergent's Narcan winning the first over-the-counter approval for an opioid-overdose drug and more of this week's top headlines.
 

Resources

Whitepaper

The Hematopoietic Colony Forming Cell (CFC) Assay for Drug Safety and Toxicity

The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process
Whitepaper

Accessing and Analyzing Relevant Content in Today’s Information Chaos – R&D Challenges and Opportunities

We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing?
Whitepaper

Blueprint for Commercializing Cell and Gene Therapies

How advanced medicines commercial readiness differs and the resources needed to maximize potential.
Whitepaper

Coming to America: Keys to Success for ex-US Digital Health Companies Entering the US Market

This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market.
Whitepaper

Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.
Whitepaper

Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
Whitepaper

Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
Whitepaper

Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

Whitepaper

Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
Whitepaper

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.
Whitepaper

Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
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.
 

Industry Events

 

Upcoming Fierce Events

1-3
May
May 1-3, 2023 | Jersey City, NJ
12-14
Jun
San Diego, CA
13
Jun
Free Virtual Event
20-22
Jun
Free Virtual Event
22
Jun
Free Virtual Event

View all events