News

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).

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.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

UBM and Restec end Russia affiliation, with Restec to hold a separate IPhEB exhibition in Russia starting in 2018.

The merger enhances STA’s end-to-end capabilities as a full-service contract development and manufacturing organization.

The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.

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.

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).

The agency is asking public consultation on the concept paper.

Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

ipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.