Plus, Vanda’s fiery response to FDA rejection

Today’s Big News

Sep 19, 2024

From 'science fiction to reality': New George Church-founded biotech raises $75M for cell therapy platform


Jury rules for Axonics in Medtronic’s long-running neuromodulation patent lawsuit


Vanda receives FDA rejection, issues fiery response against ‘conclusory’ refusal


Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection


Gavi, UK government tap Bavarian Nordic for 650,000 doses of mpox vaccine


Aligos' MASH prospect slashes liver fat in phase 2, but stock drops anyway

 

Featured

From 'science fiction to reality': New George Church-founded biotech raises $75M for cell therapy platform

GC Therapeutics has entered gameplay with the mission of unlocking a new generation of cell therapies, uploading with $75 million for its “plug-and-play” tech developed in the lab of—and with cells from—George Church, Ph.D.
 

Top Stories

Jury rules for Axonics in Medtronic’s long-running neuromodulation patent lawsuit

The case is one of several intellectual property disputes between the medtech giant and Axonics—which is currently waiting to become a subsidiary of Boston Scientific.

Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

Vanda receives FDA rejection, issues fiery response against ‘conclusory’ refusal

Vanda Pharmaceuticals has failed to persuade the FDA to approve its gastroparesis candidate on the strength of a phase 3 trial that missed its primary endpoint. The biotech came out swinging after the blow, accusing the FDA of sending a complete response letter that generally disregarded the evidence.

Gavi, UK government tap Bavarian Nordic for 650,000 doses of mpox vaccine

Gavi, the Vaccine Alliance and the U.K. government ordered a combined 650,000 doses of Bavarian Nordic’s Jynneos mpox vaccine just days after the Danish drugmaker announced it would focus its resources to produce as many as 2 million doses by the end of 2024.

Aligos' MASH prospect slashes liver fat in phase 2, but stock drops anyway

Aligos Therapeutics is heralding a midstage win in metabolic-dysfunction associated steatohepatitis after three different doses of its drug candidate significantly slashed liver fat at 12 weeks. Despite the company's enthusiasm, the results failed to impress investors.

Deerfield continues hiring spree with new marketing, comms appointments

The Deerfield life sciences agency has bolstered its comms and marketing team with two new senior hires.

Achilles drops cell therapy program, braces for layoffs after missing 'commercial viability' goals

Achilles Therapeutics has torn up its strategy. The British biotech is stopping work on its clinical-phase cell therapy, looking into deals with groups working on other modalities and preparing to lay off staff.

New migraine drugs less effective than previous generation of triptan meds: BMJ study

A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.

AscellaHealth launches podcast to address challenges in specialty pharma

In a bid to break down barriers facing both pharmas and payers in the life sciences industry, AscellaHealth has begun producing a new podcast that’ll talk through major issues in the space.
 
Fierce podcasts

Don’t miss an episode

The healthcare issues keeping employers up at night

In this week's episode of "Podnosis," we're diving into the healthcare topics employers are watching most closely.
 

Resources

Whitepaper

Unique Solutions for Drug Discovery and Development

Unique Solutions for Drug Discovery and Development
Whitepaper

Why Biotech Sponsors Need Outside Support: IRB, IBC, DMCs, and EACs

When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions.
Whitepaper

HPV-based cervical cancer screening: Gaining insights in sample preference and cost-effectiveness.

Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more.
Whitepaper

Overcoming drug development hurdles with phase-appropriate technology transfers

Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market.
Whitepaper

Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

Upcoming Fierce Events

17-19
Sep
Virtual Event
25-26
Sep
San Diego, CA
25-27
Sep
Philadelphia, PA
30-1
Sep-Oct
Boston, MA
30-1
Sep-Oct
Boston, MA

View all events