News

Expansion at GSK’s Hamilton, MT site is designed to boost vaccine production capacity.

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.

Seqirus has taken the decision to make its cell-based flu vaccine, FLUCELVAX TETRA, using a completely cell-based production process.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

Former US Senator Jeff Flake and Brandon Allgood, PhD, will be the keynote speakers at the 2019 installment of CPhI North America, in Chicago, IL.

The program and speakers for CPhI North America’s third Women in Leadership Forum have been announced, happening on Thursday, May 2 from 8:00am–11:00am in Chicago, IL.

The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

The partnership includes a $10,000 donation to fund Illinois Biotechnology Innovation Organization (iBIO) STEM programming for girls in grades three through eight.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.

Brexit has the potential to rumble on until Oct. 31, 2019 as the UK is granted a further six-month extension by European Union leaders.

Legacy Pharmaceuticals has entered into a collaboration with SCHOTT to solve a technical challenge of leaching that is occurring with an antiviral drug.

Shareholders have approved the issuance of Bristol-Myers Squibb common stock for the pending $74-billion merger with Celgene.

The companies will join forces on a research project to develop end-to-end workflows for the preparation, characterization, and monitoring of biotherapeutics using liquid chromatography-mass spectrometry.

The new service offers a flexible, customizable suite of products and services designed to accelerate the clinical and commercial development of gene and cell therapies.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.

Concerto HealthAI’s real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer’s investigational therapies and commercialized therapeutics.

Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

The company’s Quantum peristaltic pump uses a patented single-use cartridge technology and is applicable to downstream bioprocessing.