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Gasket and Braided Hose Range for Fluid Path Validation
Watson-Marlow Fluid Technology Group added platinum-cured silicone gaskets and platinum-cured silicone braided hoses for fluid path validation to its BioPure range.
Samsung Bioepis Partners with Takeda to Develop Novel Biologics
The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.
Shire Announces Director and Senior Management Changes
Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.
CDER, CBER, and CDRH Directors Praise FDARA Reauthorization
The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
ISPE European Conference Announces Pharma 4.0
The International Society for Pharmaceutical Engineering (ISPE) announced its Europe Pharma 4.0 Conference, taking place November 23 – 24, 2017 in Verona, Italy.
Pfizer Gets FDA Approval for New Leukemia Drug
FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.
FDA Releases Supply Chain Guidance
The agency published guidance on identifying trading partners under DSCSA.
Biocon Withdraws Breast Cancer Biosimilar Filings in Europe
The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.
Amneal Pharmaceuticals Recalls Lorazepam Oral Concentrate
The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.
GSK Opens $57-Million Vaccines Facility in UK
GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.
Aslan Pharma Partners with Taiwan for Cancer Drug
A research collaboration joins Aslan with an academic research institute for studying small-molecule cancer drug candidates.
Cancer Genetics to Acquire Australian CRO
The $12-million acquisition will strengthen Cancer Genetics Inc.’s (CGI) capabilities in drug discovery, drug development, and early phase clinical trial testing in the field of oncology.
Alexion Gains Patent Protection Extension for Rare-Disease Drug
The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.
Regeneron Halts Development of RSV Biologic
The antibody therapeutic failed to meet its primary endpoint in a Phase III study.
SGS Expands Bioanalytics Capacity
The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.
ICH Announces Training Program
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Canadian Manufacturer Receives FDA Warning Letter
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Drug Supply Chain Tracking Challenges FDA and Manufacturers
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
China Joins ICH Global Harmonization Efforts
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
Avara Buys Sterile Manufacturing Facility from Pfizer
The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.
Pfizer Plans Gene Therapy Manufacturing Investment in North Carolina
Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.
FDA Extends Dynavax’s Hep B Vaccine Review
FDA requests more detailed information on a post-marketing study for Dynavax’s hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.
Merck KGaA and Baylor Partner on Vaccines for Neglected Diseases
Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.
Galena Biopharma, SELLAS to Merge
Upon merging, the combined company will be named SELLAS Life Science Group and will focus on cancer treatments with a late-stage pipeline featuring immunotherapies targeting hematology and solid tumors.
Congress Meets Deadline for Reauthorizing FDA User Fees
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
BMS Acquires Biotech Company in Billion-Dollar Deal
On August 3, 2017, Bristol-Myers Squibb (BMS) announced that it has agreed to acquire biotech firm, IFM Therapeutics, in a deal worth over $1 billion to develop BMS’ oncology pipeline.
Lonza Boosts Micronization Capacity with Acquisition
Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.
Seattle Genetics Acquires Pharma Manufacturing Facility from BMS
The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.
Congress Passes FDA User-Fee Reauthorization Bill
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
