Biopharma News

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

FDA said in briefing documents ahead of a July 13, 2016 meeting that Sandoz’s biosimilar GP2015 has “no clinically meaningful differences” with the US-licensed and EU-licensed versions of Enbrel (etanercept) in terms of safety, purity, and potency.

Cancer cell lines could provide viable pathways to determining how tumors respond to specific anti-cancer drugs.

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

Biosimilar makers may have to wait an additional 180 days after receiving FDA approval before they can bring their drugs to market, according to a United States Federal Circuit Court ruling. On July 5, 2016 the court ruled in Amgen v. Apotex that after a biosimilar receives FDA approval, companies must notify reference product sponsors and wait 180 days before bringing the drug to market, a requirement in the Biologics Price Competition and Innovation Act.

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

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

Califf appointed Richard Pazdur as acting director of the Oncology Center of Excellence under the Cancer Moonshot Initiative.

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

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

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

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.

J&J’s Darzalex, in combination with two older drugs, was found to significantly extend progression-free survival in patients with relapsed refractory multiple myeloma.