Aphena Pharma Solutions

Breaking News | Cold Chain Management | Fill/Finish | Industry News | Vials

Aphena Adds Cold Chain Storage, Biologics Packaging and Distribution

Expansion includes 14,000 cold chain pallet spaces in new 500K-sq.-ft. facility.

Contract Pharma Staff 11.11.20

Breaking News | cGMP Manufacture | Industry News

Aphena Pharma Completes $7M Facility Expansion

Newly renovated, 30,000-sq.-ft. facility and three large blending suites support liquids, creams, gels and suspensions.

Cntract Pharma Staff 10.28.20

Breaking News | CRO News | Promotions & Moves

Parexel Adds Experts to Regulatory Consulting Group

Four new hires from U.S. FDA and MHRA will serve as technical vice presidents

12.10.19

Breaking News | Drug Development | Trials & Filings

SK Bio Gains FDA Approval for XCOPRI

Marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval

11.25.19

Biologics, Proteins, Vaccines | Biosimilars

Biopharma Over 20 Years

A look at the key trends that have impacted the biopharma industry over the years.

K. John Morrow, Jr. and Eric S. Langer, BioPlan Associates 11.20.19

Reader Showcase

Shimadzu Introduces Nexera Preparative SFC System

Next-gen prep SFC system designed to provide the pharma industry with reliable high-performance semi-prep purification

11.15.19

Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future

...

10.28.19

Drug Development | Information Technology

Will Artificial Intelligence Revolutionize Pharma?

Bloomberg Intelligence's Elizabeth Krutoholow discusses whether pharma is ready for an AI revolution

Clinical Trials | Serialization | Supply Chain

Anti-Counterfeiting in the Pharmaceutical Industry: An Evolution

Keeping up with counterfeitors in the pharmaceutical industry is no easy task, but patients’ lives depend on it.

Ben Locwin, Healthcare Science Advisors 10.04.19

Breaking News | Facilities | Industry News

NextPharma Completes Acquisition of Santen’s Tampere Manufacturing Facility

Bolsters position in the pharmaceutical industry in Finland

10.02.19

Breaking News | Industry News

Colorcon Launches $50M Venture Capital Fund

Pharmaceutical leader partners with Touchdown Ventures to fund promising startups

09.18.19

Contracting And Outsourcing Exhibitor List

...

09.17.19

Regulatory Affairs

Quality Metrics Feedback

A look at FDA’s Quality Metrics Initiative, a complicated issue for all of pharma stakeholders

Gil Roth, President, Pharma & Biopharma Outsourcing Association 09.16.19

Breaking News | Clinical Trials | Industry News | Inspections | QA/QC

FDA Extends CRADA with CluePoints

Aims to further explore a data-driven approach to quality oversight in clinical trials

09.11.19

Tergus Pharma

Tergus is a full-service topical pharmaceutical research, development, testing and commercial manufacturing company.

09.10.19

cGMP Manufacture | Collaborations & Alliances

NIIMBL, FDA to Advance Innovation in Bio Manufacturing

CRADA enables FDA and NIIMBL to support investments in regulatory science research, and training needed to foster advanced manufacturing innovations

08.01.19

Trials & Filings

FDA Accepts RedHill Biopharma’s NDA for Talicia

Commercial launch of H. pylori treatment is planned shortly following potential FDA approval

07.16.19

Extractables and Leachables | Laboratory Testing

The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?

Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standards

Kristin Brooks, Contract Pharma 07.11.19

Trials & Filings

Sierra’s Momelotinib Granted FDA Fast Track Designation

Underscores potential for momelotinib to address unmet needs of patients with Intermediate/High-Risk myelofibrosis who have previously received a JAK inhibitor

06.19.19

cGMP Manufacture | Fill/Finish | Industry News

Aphena Pharma Solutions Invests $7M for Expansion

Expansion areas include additional manufacturing space, custom blending suites, new liquid blending vessels and an additional high-speed bottling line

05.15.19