Industry News

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.

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.

The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites.

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, the highest number of approvals since 1996 and second-highest ever.

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

SCORR Marketing and Applied Clinical Trials release the results of EU clinical trials survey.

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

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

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

Baxter voluntarily recalls two lots of intravenous solutions due to particulates.

Jones Packaging and ThinFilm will collaborate on NFC OpenSense technology for pharmaceutical packaging.

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.

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

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

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.

Martin Shkreli, former 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.According to a press release from the Eastern District of New York State Attorney’s Office, a seven-count indictment was unsealed on Dec. 17, 2015 in federal court in Brooklyn charging Shkreli with securities fraud, securities fraud conspiracy, and wire fraud conspiracy.

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

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.

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.