All News

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen, disclosing that the NDA was not approved.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.

Patheon announced the appointment of Gilles Cottier as president of the company’s pharmaceutical development services.

Takeda Pharmaceutical Company and enGene have entered into a strategic alliance to develop novel therapies for specialty gastrointestinal diseases.

Adimab and Merck have entered into a definitive agreement to transfer Adimab’s antibody technology to Merck Research Laboratories.

Cell Therapy Catapult and Synpromics announced a collaboration to increase scale and efficiency of viral vector manufacturing.

Shire’s acquisition of Baxalta creates a leading company for rare disease drugs.

AstraZeneca and Moderna Therapeutics set to collaborate on mRNA therapeutic candidates for the treatment of cancer.

Novartis enters into alliance and licensing agreement with Surface Oncology.

A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.

Charles River Laboratories entered into a definitive agreement to acquire WIL Research.

FDA approved 45 novel new drugs in 2015, led by therapies for orphan diseases and and expedited approvals.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

Health Canada approved AbbVie’s Humira for the treatment of adults with hidradenitis suppurativa.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

More “me-betters” and more focused breakthroughs could enhance new drug development.

Merck KGaA, Pfizer, and Syndax enter into exclusive agreement to evaluate the use of avelumab and entinostat for ovarian cancer patients.

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.

Valeant announced its CEO, J. Michael Pearson, will be on medical leave of absence after being hospitalized for pneumonia.

Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.

GlaxoSmithKline acquires Bristol-Meyers Squibb’s late-stage HIV R&D assets.