
FDA approves the orphan drug Myalept for the treatment of leptin deficiency.

PTSM: Pharmaceutical Technology Sourcing and Management
Almac has added new blistering technology at their US packaging facility in Audubon, PA, as a solution to ease the transition between clinical and commercial launch of blister products.

Fluid Imaging Technologies calls for submissions for its Life Sciences & Materials Research Grant.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Nuevolution enters a license agreement with a subsidiary of Merck for small molecule compounds.

PTSM: Pharmaceutical Technology Sourcing and Management
Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.

FDA and EMA set up regular meetings to harmonize drug safety actions.

The combined company will create blockbuster product franchises in the central nervous system, gastroenterology, women's health, urology, and cardiovascular therapeutic categories.

PTSM: Pharmaceutical Technology Sourcing and Management
Metrics opens a new laboratory to support fast-track development of pharmaceutical products in North Carolina.

EMD Serono assigns operational changes.

FDA provides recommendations for submitting analytical procedures and methods validation data.

DIR Technologies will work with Pfizer to perform a three-month trial of the company's packaging integrity testing systems.

Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.

PTSM: Pharmaceutical Technology Sourcing and Management
Thirteen companies are accepted for participation in the supply chain program.

Ecolab's Shield Medicare division will now be called Ecolab Contamination Control.

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

PTSM: Pharmaceutical Technology Sourcing and Management
Cobra Biologics' GMP Compliance Certification has been extended to include QC testing.

NSF-IPEA now can provide excipient auditing and certification.

Mallinckrodt acquires Cadence Pharmaceuticals for $1.3 million.

EMA releases an update on its flu vaccine guidance.

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

The companies will pre-promote their auto-injection syringe inspection platform at ATX West.

Cytovance Biologics continues to work on the expansion of a manufacturing operations and GMP warehousing facility in Oklahoma.

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

Novartis is named among the 2014 Corporate Knights Global 100.

Sartorius appoints Michael Melingo to head marketing, sales, and services of the Lab Products & Services Division.

Shimadzu's new Solution Center features additional research space.

In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.

BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

Partners MPI Research, inviCRO, and 3D Imaging announce name of new facility for molecular imaging, autoradiography, and animal modeling.