Orphan C & GTs have approval advantage: study

Today’s Big News

Oct 12, 2023

BioNTech takes another leaf out of Daiichi playbook, paying $70M for HER3-directed ADC


PepGen gains a little pep in its step as FDA lifts hold on myotonic dystrophy trial


Orphan cell and gene therapies more likely to reach approval than larger drug pipeline: study


Almirall signs $210M deal to use EpimAb's platform to develop bispecifics for immunology


Astria scratches dealmaking itch, paying Ichnos $15M to join eczema race led by Amgen, Sanofi


IQVIA allies with CEPI to speed drug development for battling future disease outbreaks


UK regulator looks to halve time to approve low-risk clinical trials

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Featured

BioNTech takes another leaf out of Daiichi playbook, paying $70M for HER3-directed ADC

BioNTech is flattering Daiichi Sankyo through imitation. Six months after picking up an Enhertu rival, the German biotech has paid $70 million upfront for an antibody-drug conjugate (ADC) directed at a second receptor targeted by Daiichi.
 

Top Stories

PepGen gains a little pep in its step as FDA lifts hold on myotonic dystrophy trial

A phase 1 study for PepGen’s myotonic dystrophy therapy has been cleared for launch in the U.S. after a five-month FDA clinical hold.

Orphan cell and gene therapies more likely to reach approval than larger drug pipeline: study

There’s a lot of risk inherent in biotech investment, but a new report suggests that an increasingly safe bet is one of the hottest areas of drug development: cell and gene therapy.

Changing the Pharmaceutical Commercialization Landscape

In a dynamic landscape, three emerging trends have the power to reshape the complexities of pharmaceutical commercialization.

Almirall signs $210M deal to use EpimAb's platform to develop bispecifics for immunology

Almirall will have exclusive global rights to any resulting therapies from the collaboration in return for milestone payments totaling up to $210 million as well as a slice of the royalties.

Modeling patient insights to make the most of clinical trials

Greg Lever, Director within the IQVIA Applied Data Science Center, reveals how modeling technology is being used to unlock value and enhance the experience of trial participants.

Astria scratches dealmaking itch, paying Ichnos $15M to join eczema race led by Amgen, Sanofi

Ichnos Sciences has finally found a buyer for its OX40 eczema program. Astria Therapeutics has taken the other side of the deal, paying $15 million upfront to secure a spot at the back of a race led by Amgen and Sanofi.

AnaptysBio announces top-line data showing rapid clearance of generalized pustular psoriasis (GPP), a rare systemic skin disease

AnaptysBio announces top-line data showing rapid clearance of generalized pustular psoriasis (GPP), a rare systemic skin disease

IQVIA allies with CEPI to speed drug development for battling future disease outbreaks

IQVIA, a leading biopharma data provider, is teaming with the Coalition for Epidemic Preparedness Innovations to advance the “100 Days Mission” focused on streamlining global clinical research for vaccines and other treatments targeting emerging infectious diseases.

UK regulator looks to halve time to approve low-risk clinical trials

The U.K.’s Medicines and Healthcare products Regulatory Agency established new guidelines that will cut by half the time it takes to approve lower-risk clinical trials.

Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. Reata staffers who worked in roles that are already covered at Biogen are losing their jobs.

Labcorp launches tri-biomarker blood test to aid Alzheimer's diagnosis

A year after unveiling its first blood test aimed at spotting the signs of a range of neurodegenerative diseases, Labcorp is ramping up its offerings in that realm with the launch of a new, Alzheimer’s disease-specific test.

Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer

Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence.

Employers increasingly open to GLP-1 coverage, analysis reveals

Despite its costs, interest in covering GLP-1 drugs among employers in 2024 has nearly doubled, according to a new survey.
 
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Resources

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Biology Informatics Solutions Brochure

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Five ways to get the most from your lab and manufacturing facilities

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.

 

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