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.

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

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

EDCTP has granted EUR10 million to a collaboration of African and European antimalarial drug researchers to support late-stage clinical trials of a novel antimalarial combination.

Sandoz has signed an agreement with Shionogi for the commercialization rights of Rizmoic (naldemedine) within specific key European markets.

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.

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

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.

Hovione Technology has acquired global rights to a dry powder inhaler for pulmonary drug delivery, the Papillon DPI invented by Dr. Klaus-Dieter Beller.

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.

Catalent’s acquisition of Paragon Bioservices will provide expertise and in expanding gene and cell therapy markets.

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

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

Patient-centric drug development is becoming more important in the bio/pharma industry.

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.

NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.

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 acquisition of CiVentiChem’s facility in the United States is expected to enhance UK-based Sterling Pharma Solutions’ chemistry development capabilities.