FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.

Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.

A combination of eye imaging techniques and adaptive optics has revealed key details of choroideremia.

Actylis combines Aceto and its 10 acquired specialists into a singular global brand.

The collaboration will use Octagon’s functional target discovery approach and novel chemistry strategy in disease areas in which Novo Nordisk has specific expertise.

The dedicated solid-state research and development suite is designed to promote discovery of novel polymorph, salt, and cocrystal forms.

Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.

EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

The Public-Private Partnership for Rare Neurodegenerative Diseases will work to enhance understanding and develop treatments for rare neurodegenerative diseases.

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.

Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.

CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.

Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.

Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.

Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence.

Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

Leistritz’s Twin Extrusion Workshop, hosted from Nov. 29 to Dec. 1 in Warren, NJ, will dovetail classroom training and twin screw demonstrations.

MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.

Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.