Industry News

Amgen announces FDA will review the company’s BLA for ABP 501.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

The partnership will focus on the identification and analysis of host-cell proteins in biologics.

Novartis announced on Jan. 5, 2016 that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.

GS1 US announces the expansion of its advisory services program to address industry needs.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

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

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

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

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

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.

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

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.

This month marks the death of a pioneering, yet pragmatic, thinker whose work brought PAT and QbD to more pharmaceutical and biopharmaceutical companies around the world.

The National Institutes of Health released a strategic plan covering the fiscal years 2016-2020.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

The agency has launched a new web platform to foster scientific innovation.

Pharmaceutical CEO Martin Shkreli was arrested on Dec. 17, 2015 at his New York apartment and charged with securities fraud.Martin Shkreli, chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc., was arrested on Dec. 17, 2015 at his apartment in New York City for securities fraud.

AstraZeneca announced the completion of a tender offer for all of the outstanding ZS Pharma shares.

Sanofi enters into exclusive negotiations with Boehringer Ingelheim on a business asset swap.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.