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.

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

The agency cited Emcure Pharmaceuticals with CGMP violations.

The merger creates a provider of sample prep, synthesis, and bioanalytical tools for biotherapeutics discovery, development, and manufacturing.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.

ANGUS reveals ANGUS Life Sciences as a new company division that will serve pharmaceutical, biotechnology, and agriculture markets.

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.

With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.

CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

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

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

The EC approved the merger on March 10, 2016 on the condition that Teva and Allergan divest certain assets in Europe.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.

The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.

The company will showcase workflow solutions for sample prep and data analysis.

The investment includes facility upgrades and expansion of development capabilities.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

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

The inspection confirmed that the facility was compliant with GMP guidelines.