CytoDyn HIV program finally clears FDA hold

Today’s Big News

Feb 29, 2024

Novo Nordisk's new Boston-area campus reflects 'competitive' R&D growth, and not just for GLP-1s


After saving Yumanity's assets, Kineta faces shutdown as private placement fails to show up


CytoDyn finally clears FDA hold on HIV program after two years


With seeds from Turning Point, a new biotech blooms with $100M to take on small molecules


Ironwood seeing STARS as $1B bet hits in phase 3—and triggers 30% stock drop


Fierce Biotech Fundraising Tracker '24: BlossomHill brings in $100M series B; Kenai raises $82M

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

Novo Nordisk's new Boston-area campus reflects 'competitive' R&D growth, and not just for GLP-1s

Novo Nordisk executives unveiled the company's U.S. R&D hub on Wednesday, repurposing Dicerna's old headquarters as the new regional outpost. The event comes as Novo's R&D investments are skyrocketing, thanks to the revenue flooding in from the metabolic franchise.
 

Top Stories

After saving Yumanity's assets, Kineta faces shutdown as private placement fails to show up

In 2022, Kineta swooped in to rescue Yumanity’s immunotherapy from the scrapheap. Now, Kineta needs some rescuing itself. After a strategic review, the small oncology biotech is conducting a corporate restructuring and reducing its workforce by 64%.

CytoDyn finally clears FDA hold on HIV program after two years

After two years, CytoDyn’s HIV program is finally free of the FDA clinical hold. In a short update Thursday, CEO Jacob Lalezari, M.D., heralded the lifting of the hold as a “new chapter” for lead asset leronlimab.

Unlocking the Pathway Puzzle: How Biopharma Can Navigate the Clinical Pathways Landscape

The influence of oncology pathways is growing. Here are the challenges and opportunities for biopharma companies in the clinical pathways landscape.

With seeds from Turning Point, a new biotech blooms with $100M to take on small molecules

The first signs of spring are beginning to emerge and so too are the shoots of the next biotech from drug designer J. Jean Cui, Ph.D. BlossomHill Therapeutics has raised $100 million in a series B financing, bringing the company’s total fundraising to $173 million so far.

Autoantibodies: On Patrol for Cancer

Revolutionizing Cancer Detection: The Power of Autoantibodies

Ironwood seeing STARS as $1B bet hits in phase 3—and triggers 30% stock drop

Ironwood Pharmaceuticals’ $1 billion short bowel syndrome bet has delivered a phase 3 win—and wiped 30% off the company’s share price. While the study met its primary endpoint, the results failed to convince investors it can win out over Takeda’s Gattex, its potential generic copies and Zealand Pharma’s glepaglutide.

Biotech in 2024: Opportunities, Trends & Challenges

In this exclusive interview, ICON Biotech President Chris Smyth paints a picture of the operating environment facing biotechs in 2024.

Fierce Biotech Fundraising Tracker '24: BlossomHill brings in $100M series B; Kenai raises $82M

Welcome to Fierce Biotech's Fundraising Tracker, 2024's version.

In atypical Big Pharma-VC pact, Gilead secures $210M from Abingworth to fund Trodelvy trials

Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. But a new funding pact between Carlyle’s Abingworth and Gilead Sciences is somewhat unconventional.

SCRI and AstraZeneca strike deal for cancer clinical trials solutions

Oncology CRO Sarah Cannon Research Institute, or SCRI, has struck a deal with AstraZeneca to optimize the pharmaceutical giant’s cancer clinical trials in the U.S.

Belharra rides the sound waves, chronicling its short history in 'Birth of a Biotech Podcast'

Biotechs face a core communication challenge. How, in an industry that can spawn hundreds of startups every year, can you connect with the talent and investors who are integral to your prospects? Belharra Therapeutics has come up with an atypical answer to that question: podcasts.

FDA flagged animal testing issues at Neuralink lab last year: Reuters

Shortly after signing off on the first human trial of Neuralink’s brain-computer interface system last year, the FDA reportedly discovered a handful of quality control issues related to the Elon Musk-founded company’s animal experiments of the technology, according to Reuters.

Virta Health champions its nutrition therapy as an effective GLP-1 off-ramp. Here's why

A new study in Diabetes Therapy from Virta Health says the company's carbohydrate restricted nutrition therapy allows patients who no longer want a GLP-1 prescription to still keep the weight off.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Breaking down Eli Lilly’s ESG formula

This week on "The Top Line," we explore the impact of environmental, social, and governance measures, commonly known as ESG, on the pharmaceutical industry. Fierce Pharma's Fraiser Kansteiner engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights and discuss Lilly's specific ESG initiatives.
 

Resources

Whitepaper

The Oncology Market – 2023 Year in Review

This paper offers a detailed review of key events and developments in the oncology market during 2023.  It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more.

Whitepaper

Developing and Manufacturing Drugs with HPAPIs

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

 

Industry Events

 

Upcoming Fierce Events

11-12
Mar
San Francisco, CA
18-20
Mar
Savannah, GA
6-8
May
Jersey City, NJ
13-15
May
Newport Beach, CA
14-15
May
Newport Beach, CA

View all events