Industry News

Five million doses have been secured to address potential H5N1 influenza outbreaks.

The facility will focus on expanding end-to-end insulin production, aiming to address the needs of China’s growing diabetic population.

The biotech transitions to fee-for-service biologics manufacturing to support immunotherapy development.

The facility is capable of manufacturing up to four vaccines or biopharmaceuticals simultaneously

PTC could earn up to $1.9 billion through development, regulatory, and sales milestones

The PRV was awarded to PTC Therapeutics on November 13, 2024, alongside the approval of Kebilidi for AADC deficiency.

This marks Shorla’s fourth FDA approval.

The acquisition strengthens Roche’s portfolio in allogeneic CAR-T therapies and genetic medicines.

Company shifts focus to other programs after Alzheimer’s trial failure.

The nomination signals a focus on reducing bureaucracy and prioritizing healthcare reforms

The approval also triggers a $500 million milestone payment to BridgeBio under its royalty funding agreement.

The company cites Evotec's unwillingness to engage in discussions as the deciding factor.

FDA allows trial to continue at reduced dose following rare immune response.

Further expansions include the operational launch of Bio Campus II’s Plant 5 in April 2025.

Settlement delays generic entry until at least 2037, securing market exclusivity.

Chris Boshoff appointed R&D chief as Roger Dansey and Johanna Bendell take key oncology roles

Founding investors include Mission BioCapital, Mayo Clinic, and others such as Alexandria Venture Investments and Cedars-Sinai.

A Biologics License Application submission is planned for 2026

Of the investment, $26.4 million will be allocated to transplant antibodies and $15.8 million in diabetes treatments.

A severe immune response halted high-dose testing, with the trial continuing at a lower dose under FDA approval

Novartis will handle development and commercialization, with Ratio focusing on discovery and preclinical research

If authorized, individual Member States will determine pricing and reimbursement policies.

The nod marks the first U.S. approval for a gene therapy directly administered to the brain.

LaNova will receive $588 million upfront, with up to $2.7 billion in potential milestones.

The decision was prompted by safety concerns in phase 1/2 trials.

This investment includes $2 billion for new projects, which will create over 1,000 high-skilled jobs.

The deal follows a 2023 license agreement with Biotheus that granted BioNTech rights to develop and commercialize BNT327/PM8002 outside of Greater China.

This collaboration will combine Flare’s expertise in proteomics and mass spectrometry with Roche’s global reach and resources in oncology.

Initially placed on October 16, the hold followed reports of motor neuropathy in a patient

If approved, Darzalex Faspro would be the first therapy available for this condition, providing an option to treat patients before progression to active multiple myeloma.