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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.
FDA Grants Approval of Treatment for Hepatitis C
FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).
FDA Grants Approval of Treatment for cGVHD
FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.
Horizon Discovery Releases CHO Genome Sequence for Bioproduction
Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.
EMA Looks at Drug Development for Senior Population
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
ISPE Bio Event Examines Approaches for Optimizing Operational Agility and Time-to-Launch Readiness
The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.
EMA Unveils Brexit Plan
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
FDA Accepts Application for Teva’s Herceptin Biosimilar
FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Predictions from CPhI Annual Reports—How Accurate Were They?
The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.
FDA advances biosimilars progress with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Janssen, Bavarian Nordic Partner on Hep B and HIV Vaccines
Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.
ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.
Manufacturers Struggle to Track Controversial 340B Drug Discounts
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
AstraZeneca, Merck & Co. in $8.5-Billion Oncology Collaboration
Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.
Cesca Receives Cellular Processing Patent for CAR-T Manufacturing
New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.
