On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

The American Association of Pharmaceutical Scientists (AAPS) announced the election of Dale Eric Wurster, PhD, FAAPS as president-elect of its board of directors.

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.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

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.

Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20

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 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.

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.

Charles River Labs has announced the acquisition of Brains On-Line (US), a contract research organization (CRO) that provides data on therapeutics for treating central nervous system (CNS) diseases.

The International Pharmaceutical Excipients Council (IPEC) has announced the winners of the 2017 award season.

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.

FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).

FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.

Sterigenics has increased gamma sterilization capacity in Fort Worth, Texas.

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.

FDA approves new targeted therapy for relapsed or refractory acute myeloid leukemia (AML).

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.