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The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.

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

The partnership aims to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

The ready-to-use assays are specifically designed for companies looking to characterize their biosimilar products in the pipeline.

The conference discussed key industry issues including serialization, innovation, and patient-centricity.

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 agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

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.

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.

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

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

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.

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

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.

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

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

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 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.

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.

Concerns that physicians are not prescribing the most cost-effective medications available have prompted the Centers for Medicare and Medicaid Services to propose a set of new potential reimbursement schemes for Part B drugs in Medicare. CMS says the new proposed rule will test new payment approaches to reward good patient outcomes and will inject value into the system.

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