Industry News

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

The European Medicines Agency has issued a vacancy notice for the position of executive director.

FDA is examining and updating its programs for overseeing global operations and international affairs.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.

EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.

It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States

The UK government announced during the ABPI’s recent conference that it is making improvements to the Accelerated Access Collaborative.

AbCellera, Niaid Vaccine Research Center, and Ichor Medical Systems have formed a partnership to develop an end-to-end platform capable of developing field-ready, nucleic acid-based countermeasures against a pandemic strain of influenza.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.

MilliporeSigma event scheduled to recognize biotech challenges and support development potential.

The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

Biocatalysts, a global biotechnology company, has announced it has been named as one of the winners of the Queen’s Awards for Enterprise in Innovation.

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.

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

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.

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.

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