FDA sparks hope for Curis
To view this email as a web page, click here
Bridgebank

Thank you to Bridge Bank for sponsoring our editorial feature: FierceBiotech 15 Where Are They Now?

Featured Story

Jounce gets trounced as phase 2 data disappoint once again, prompting pipeline rethink

Jounce can't seem to find success atop its pipeline, reporting another phase 2 failure. As a result, the company says it's reevaluating one of its top monoclonal antibody programs in an attempt to gain some traction.

read more

Top Stories

Guess what’s SPAC? Ocean Biomedical resuscitates Wall Street play all but dead in 2022

After being left for dead in 2022, Ocean Biomedical is trying to revive the once-booming SPAC play that hit Wall Street. The new company, equipped with a preclinical assets plucked from research institutions, expects to be valued at nearly $350 million.

read more

FDA sparks hope for Curis, lets biotech resume enrollment for part of phase 1/2 leukemia study

Curis has received another spark of hope as the FDA lets the biotech resume enrollment for a part of its phase 1/2 study assessing emavusertib in patients with leukemia.

read more

After chat with FDA, ImmunoGen delays pivotal top-line data on blood cancer ADC to 2024

ImmunoGen is rethinking the pivotal program for blood cancer antibody-drug conjugate pivekimab sunirine. After talking to the FDA, the biotech is focusing its phase 2 trial on patients without prior or concomitant hematologic malignancy, causing the top-line data drop to slip from 2022 to 2024.

read more

Amgen's Lumakras triumphs in confirmatory trial, threatening Mirati's accelerated approval window

Amgen has bagged the first randomized clinical trial win in the KRAS inhibitor class of cancer medicines. Beyond just a temporary data disadvantage, the development could bode ill for potential runner-up Mirati Therapeutics.

read more

Seeking to accelerate R&D response, philanthropist puts up $171M to create pandemic antiviral center

COVID-19 largely caught the world off guard, leading to a mad scramble to repurpose and develop drugs to curb the impact of SARS-CoV-2. Geoffrey Cumming wants to ensure that next time is different—and is donating 250 million Australian dollars ($171 million) over the next 20 years to make it happen

read more

Pfizer and Moderna's updated COVID boosters are here, with swift rollout likely to follow

The public wait for another round of COVID-19 vaccine boosters is finally coming to an end. Wednesday morning, the FDA gave the all-clear to Omicron-targeted COVID-19 shots from Moderna and Pfizer-BioNTech.

read more

LumaBridge inks deal with PICI to expand immunotherapy development

LumaBridge, which was formerly Cancer Insight, signed a partnership with the Parker Institute for Cancer Immunotherapy to develop new immunotherapies.

read more

Bayer’s BlueRock inks cardiovascular cell therapy delivery deal

Bayer’s BlueRock Therapeutics has partnered with BioCardia on the delivery of cell therapies, paying a “sizable” upfront fee to access minimally invasive technology that could get its heart failure candidates to their targets.

read more

Theranica ropes in $45M for smartphone-connected migraine modulation armband

Fundraising can be a constant headache for many health tech startups—but not for Theranica. The company has managed to keep a steady stream of financing coming in and investors interested in its technology since its 2016 founding.

read more

Six years after initial pledge, Califf launches another FDA program to study the opioid crisis

In a blog post, FDA Commissioner Robert Califf said the agency has launched an Overdose Prevention Framework to combat the opioid crisis. The strategy targets unnecessary prescriptions, prolonged prescribing and counterfeit drugs, while promoting the development of treatments for substance use disorders and education programs for doctors.

read more

CMS: ACOs saved Medicare $1.6B overall in 2021 as big changes on the horizon

Accountable care organizations generated $1.6 billion in savings for Medicare last year, the fifth straight year the program has garnered savings.

read more

Resources

eBook: Make the most out of hybrid conferences

Improve your congress competitive intelligence and cut down costs by 50%

Whitepaper: Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules

Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success.

Whitepaper: The Hands-Free, Low-Volume, Microfluidic Elisa Alternative

Advanced research requires advanced tools. Our next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. Simply load, scan, and insert your cartridge and come back to fully analyzed results in 75 minutes. Rethink your ELISA, with Ella.

Whitepaper: Plan for scalable process liquid and buffer preparation

Set a solid foundation for successful scale-up of buffer preparation.

Event: Drug Development Boot Camp® 2022

The total immersion, transformative training will take place at the Harvard Club in Boston. VIRTUAL in real time is also available. Contingencies for COVID19 will apply. Register NOW for a large early bird discount www.drugstomarket.com/drugbootcamp.

Whitepaper: Genetic Insights for Biopharmaceuticals

See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Article: 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.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

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

Case Study: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Article: 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?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry.

On-Demand Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Events