News

The companies will collaborate on mRNA-based cancer vaccine development.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

The certification follows a successful inspection by the MHRA, with no critical or major observations. The site is now ready to start production.

The company sees a demand for customized individual packaging solutions as the pharmaceutical manufacturing industry moves towards smaller lot sizes that require aspects of individualization.

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

Walmsley will succeed Andrew Witty as CEO of the British drug maker.

CPhI announced the finalists in all 12 categories for the 2016 excellence in pharma awards.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

Adaptimmune entered into a manufacturing agreement with PCT for the manufacture of its SPEAR T-cell therapies.

The autoinjector is based on core technology licensed from Bespak.

The company will debut its multi-dosage weight checker at the October show.

CPhI outlines trends from the conference in Seoul.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

The agency has recommended marketing authorization for Ibrance in the European Union.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Bayer will acquire the agricultural company for $66 billion in an all cash transaction.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling batches of hyoscyamine sulfate (0.125mg).

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.

Allergan will acquire Vitae pharmaceuticals for $639 million.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

The Gx RTF ClearJect syringe is made of cyclic olefin copolymer and is tungsten- and adhesive-free.

The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.

Catalent will acquire Pharmatek, a San Diego-based manufacturer of oral, injectable, and topical products.