Biopharma News

The facility located in Ware, UK, will be used to manufacture GSK’s Ellipta inhaler.

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

Linker technology and drug combinations play an important role in the efficacy of ADCs.

JW Biotechnology will focus on developing novel cell-based immunotherapies.

Sanofi says the program will vaccinate one million students from 6000 public schools in dengue-epidemic regions of the Philippines.

Inflectra is the second biosimilar to hit the market in the United States.

The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion.

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.

The new class of mAbs differs from approved anti-PD 1 mAbs because they do not block the PD-1-PD-L1 interaction.

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.

Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.

Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly ten 10 years in the position.

The companies say the acquisition will assist in expediting the clinical development of RhoNova, a potential treatment targeting rhodopsin-linked autosomal dominant retinitis pigmentosa.

GW Pharmaceuticals released Phase III trial results on Epidiolex, which was shown to decrease monthly convulsive seizures in children by 39%.

Clinical trials of Eli Lilly’s ixekizumab showed the drug displayed clinically meaningful improvements in patients with moderate-to-severe plaque psoriasis.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

Repligen reported a revenue increase of 45% at constant currency in the fourth quarter of 2015, which was driven primarily by strong growth in sales of its bioprocessing products, Jon K. Snodgrass, CFO of Repligen, noted during a fourth-quarter conference call. Specifically, the increased revenue came from the sales of its growth factors, ATF (alternating tangential flow) systems and consumables, and products from its chromatography group (e.g., OPUS columns, Protein A resins, and ELISA kits).

The collaboration is part of Innovate UK’s competition for the development of regenerative medicines.

Under the agreement, Caribou has granted IDT worldwide rights to commercialize CRISPR-Cas9 reagents under Caribou’s intellectual property.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.

FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.