
Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Bormioli Rocco Pharma offers new packaging solutions for powdered oral drugs, parenteral drugs, pediatric syrups, and protein-based drugs.

PTSM: Pharmaceutical Technology Sourcing and Management
The company has completed a small-scale capacity expansion at its site in Charles City, IA.

The company has appointed Albert Bourla, PhD, as its new COO.

PTSM: Pharmaceutical Technology Sourcing and Management
Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

PTSM: Pharmaceutical Technology Sourcing and Management
Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

Two of the medicines recommended for approval are orphan drugs.

PTSM: Pharmaceutical Technology Sourcing and Management
QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.

PTSM: Pharmaceutical Technology Sourcing and Management
The company has officially opened a local brand office in South Korean to support its existing business in the region.

PTSM: Pharmaceutical Technology Sourcing and Management
The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

The voluntary recall is due to blister packages containing the incorrect product.

The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.

Supply Chain Wizard has developed a set of integrated digital solutions to improve supply chain functions.

The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

Industry experts were honored for business, scientific, and social contributions.