Bio/Pharma News

The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Teligent is expanding its manufacturing and R&D complex in New Jersey.

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

Mayne entered into an agreement with Teva and Allergan to acquire 37 approved and 5 FDA-filed products.

The facility will be built in approximately 18 months using GE Healthcare’s KUBio modular facility solution.

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.

The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.

Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.

Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

Jazz will acquire Celator for approximately $1.5 billion.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.