| 11.06.23 | BMS continues ADC frenzy with $100M Orum deal; BioNTech inks 2 deals in BD spree

Laden...

1 jaar geleden

Html
Tekst

Regulatory Considerations for Radiotherapeutics and Radiodiagnostics

Scientific innovation in ligand targeting has spurred the development of many different types of radiopharmaceuticals (RPs) with a wide range of clinical uses. As those uses have grown, developers of RP products are faced with a regulatory environment that can be a challenge to navigate. We have a roadmap – read our guide for the details. Learn more.

Premier Research. Built for Biotech℠

Today’s Big News

Nov 6, 2023

BMS snags another ADC with modest $100M Orum deal

BioNTech adds bispecific candidate, mRNA delivery startup as cancer work takes center stage

SNAP, CAR-M and BiTE: New immunotherapy approaches previewed at SITC

Kodiak resurrects failed eye drug after phase 3 data rejuvenate approval prospects

UPDATE: MoonLake hopes another phase 2 win helps IL-17 drug shine brighter in inflammatory race

Celldex laces up next to Big Pharma players as drug reduces severity of chronic hives

Researchers cover bases with two different gene editing modalities to treat rare disease


A message from 35 North

Featured

BMS snags another ADC with modest $100M Orum deal

By Annalee Armstrong

Another day, another antibody-drug conjugate deal. This time it’s Bristol Myers Squibb snapping up Orum Therapeutics’ phase 1 blood cancer med for $100 million upfront.

BioNTech adds bispecific candidate, mRNA delivery startup as cancer work takes center stage

By Max Bayer

BioNTech is spending more of its COVID cash, betting over $1 billion on a licensing deal for a phase 2 bispecific antibody, just days after closing the acquisition of a lipid nanoparticle startup.

SNAP, CAR-M and BiTE: New immunotherapy approaches previewed at SITC

By Helen Floersh

Academics and industry folks from around the cancer world convened in sunny San Diego Nov. 1-5 at the Society for Immunotherapy of Cancer’s annual conference. Here are a few preclinical highlights.

How digital twins help improve biomanufacturing quality and security

Kodiak resurrects failed eye drug after phase 3 data rejuvenate approval prospects

By James Waldron

Kodiak Sciences gave up on tarcocimab tedromer earlier this year after a pair of phase 3 trials ended in failure. But a fresh batch of late-stage data has now given the anti-VEGF drug another shot at approval.

UPDATE: MoonLake hopes another phase 2 win helps IL-17 drug shine brighter in inflammatory race

By James Waldron

MoonLake Immunotherapeutics has maintained its position as a key player in the race to get an IL-17 inhibitor to market for inflammatory skin conditions courtesy of another successful phase 2 readout.

Celldex laces up next to Big Pharma players as drug reduces severity of chronic hives

By Annalee Armstrong

Celldex Therapeutics has some huge competition in immunology, but new phase 2 data from its monoclonal antibody showing a reduction in the severity of a chronic form of hives is helping put the biotech in the game.

Researchers cover bases with two different gene editing modalities to treat rare disease

By Helen Floersh

Two new studies offer more validation that prime editing and base editing have potential efficacy against the rare disease phenylketonuria.

Astellas touts 2-year results for $4.9B GA drug Izervay as it amps up Apellis rivalry

By Eric Sagonowsky

Astellas is counting on Izervay to deliver gains in a heated GA market clash against rival Apellis. Now, 2-year data show the drug's effects increase over time.

BD taps new FDA clearance for its 'one-stick' hospital blood draw system

By Conor Hale

BD is building on its goal of providing patients with a “one-stick hospital stay,” with a new FDA clearance for painless blood collection hardware that works through already placed IV lines.

House lawmakers launch probe into FDA's response to nationwide drug shortages

By Fraiser Kansteiner

As shortages of drugs like amoxicillin, penicillin, Adderall and certain chemotherapies continue to confound doctors and patients in the U.S., two high-ranking Republican lawmakers are pressing the FDA for answers.

FDA clears Neurovalens' neurostim headset to treat chronic insomnia

By Andrea Park

People suffering from chronic insomnia now have a new, drug-free option to treat the condition in the U.S.

Amid concerns about claims denials, Democrats seek greater oversight of Medicare Advantage plans' use of AI

By Noah Tong

Medicare Advantage prior authorization denials are in the crosshairs of House Democrats. They say evidence points toward insurers willingly allowing algorithms to wrongfully deny service to patients.

Fierce podcasts

Don’t miss an episode

Exploring the promise of earlier Alzheimer's treatment

While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident. In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky talks with the study lead, Reisa Sperling, M.D., to learn more.

'Podnosis': A look at Blue Shield of California's new pharmacy benefits model

'Podnosis': Cultivating cultural competency in the healthcare workforce


A message from Fierce Diversity, Equity, and Inclusion Forum

Resources

Whitepaper

Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.

Sponsored by: Thermo Fisher Scientific Production Chemicals and Services

Whitepaper

Plasmid DNA Design Considerations for Cell and Gene Therapy

Download our whitepaper to learn about plasmid DNA design considerations for cell and gene therapy applications.

Sponsored by: Aldevron, a GMP manufacturing CDMO of DNA, RNA, and Proteins

Whitepaper

Artificial Intelligence in Healthcare & Medical Affairs

This paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders.

Presented by Blue Matter, strategic consultants in the life sciences

eBook