| 04.03.23 | BioNTech pays $170M to enter ADC space; FDA slams brakes on Ascendis drug review

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IND-Enabling Studies: How to Meet Regulations and Avoid Clinical Holds

While relying solely on your nonclinical laboratory can be tempting when conducting IND-enabling studies, it’s important to provide significant input and oversight to ensure regulatory compliance. Watch our on-demand webinar to learn how to prepare so that your studies meet FDA guidelines.

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Today's Big News

Apr 3, 2023

BioNTech pays $170M to add would-be Enhertu rival to pipeline, expanding into ADCs in the process

Ascendis’ shares slump 38% as FDA unexpectedly halts hypoparathyroidism drug review

Vedere Bio II, unable to see past preclinical work, closes up shop

Pardes plans descent from COVID-19 antiviral flight path as lead candidate fails phase 2

Takeda opens 4th front in assault on celiac, tapping Innate to develop antibody-drug conjugates

Reeling from AstraZeneca's termination of pneumonia collab, Aridis lays off 20% of staff

David Liu’s lab shows new base editing SMA therapy could lead to a one-time therapy


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Featured

BioNTech pays $170M to add would-be Enhertu rival to pipeline, expanding into ADCs in the process

By Nick Paul Taylor

BioNTech is putting its COVID-19 vaccine dollars to work to add a new modality to its pipeline. Sitting on $15 billion, the German biotech has doled out $170 million upfront for the rights to two antibody-drug conjugates (ADC) in development at China’s Duality Biologics.

Ascendis’ shares slump 38% as FDA unexpectedly halts hypoparathyroidism drug review

By James Waldron

The FDA has thrown a curveball to Ascendis, bringing the company's hypoparathyroidism drug approval request to a screeching halt less than a month before a decision was due.

Vedere Bio II, unable to replicate past work that led to Novartis acquisition, closes up shop

By Max Bayer

Opthamology-focused gene therapy biotech Vedere Bio II, the successor to a Novartis-bought biotech that was scooped up in 2020, is closing up shop after failing to impress in preclinical studies.

Pardes plans descent from COVID-19 antiviral flight path as lead candidate fails phase 2

By Annalee Armstrong

Pardes Biosciences, launched in 2020 to find treatments in the height of the pandemic, will seek strategic alternatives after its antiviral for COVID-19 failed to clear the virus during a phase 2 trial.


A message from Digital Pharma East

Takeda opens 4th front in assault on celiac, tapping Innate to develop antibody-drug conjugates

By Nick Paul Taylor

Takeda really wants to land a hit on celiac disease. Not content with having just three pipeline prospects, the Japanese drugmaker has partnered with Innate Pharma to attack the disease with another modality: ADCs.

Reeling from AstraZeneca's termination of pneumonia collab, Aridis lays off 20% of staff

By James Waldron

Aridis has laid off a fifth of its workforce in the wake of AstraZeneca’s “surprise” move to terminate its pneumonia collaboration over a payment dispute.

David Liu's lab shows new base editing SMA therapy could lead to a one-time therapy

By Max Bayer

The lab of gene editing pioneer David Liu is out with new research touting the potential of base editing to bolster existing spinal muscular atrophy treatments. The researchers said that when combined with an FDA-approved treatment, therapeutic benefits were significantly extended.

Amid SVB storm, pharma's reputation bucks downward trend and scales up driven by insulin price drops

By Ben Adams

The pharmaceutical industry is making a comeback in the reputation stakes while every other industry around it is falling in Americans’ estimations as we edged toward a possible banking crisis in March.

Pixium Vision's bionic eye implant nets FDA breakthrough label in dry AMD

By Conor Hale

The Prima system aims to partially restore the ability to see at the center of a person’s visual field, the area most affected by the type of age-related macular degeneration known as dry AMD.

After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits

By Kevin Dunleavy

After Johnson & Johnson’s initial victory in its attempt to resolve talc lawsuits through a bankruptcy ploy, little has gone the way of the company. On Friday, J&J took another courtroom defeat as the Third Circuit rejected its bid to delay an order dismissing the bankruptcy.

CMS to raise Medicare Advantage pay rates by 3.3% in 2024; phase in risk adjustment changes

By Robert King

CMS finalized a 3.3% pay bump to Medicare Advantage plans for 2024 after proposing a 1% raise that some plans saw as a cut, and will phase in changes to risk adjustment over three years.

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