On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.
The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.
Equipment and Processing Report
Understanding equipment design and product-contact surfaces enables strong cleaning action.
Equipment and Processing Report
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the January 2012 edition from ACS Valves and Terra Universal.
Equipment and Processing Report
The pharmaceutical industry has a history of developing innovative medicines and novel drug-delivery systems, but not all of its manufacturing processes use cutting-edge technologies. Demands to increase productivity in fill–finish lines are fueling the arguments of proponents of robotic automation to expedite manufacturing.
Equipment and Processing Report
I work in a quality control laboratory and use a pH meter with a single-junction reference probe to test samples taken from various pharmaceutical (drug) production lines. The probe I use has a six-month warranty. It slowly stops working after just a couple weeks. I am replacing it once a month. We make sure to store it correctly according to the manufacturer's specifications and even use probe cleaner at the end of each shift to ensure that it stays clean. What can I do to increase the lifespan to at least cover the warranty period?
Sanofi will co-invest in start-up biotech company Warp Drive Bio by providing financial funding and access to its strains library and expertise in natural products.
PTSM: Pharmaceutical Technology Sourcing and Management
The pharmaceutical majors advance vaccines for the developing world.
Xoma Restructures; AAIPharma Appoints Eric Evans as CFO; and More.
The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.
Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention. The recall follows consumer complaints of chipped or broken pills and inconsistent bottle packaging line clearance practices that could lead to stray tablets, capsules or caplets from other Novartis products.
Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion. The transaction will provide BMS with a potential candidate currently in Phase II development for the treatment of hepatitis C.
Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.
The National Institutes of Health has established the National Center for Advancing Translational Sciences, a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices.
Alexion Pharmaceuticals has signed an agreement to acquire all the capital stock of the biopharmaceutical company Enobia Pharma in a $610-million all-cash transaction.
USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.
AMRI Restructures; ISPE Appoints Nancy S. Berg as CEO; and More.
The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.
On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.
The benefits of harmonization may be on industry's wish list, but buying into change is another story.
Recent legal decisions have further divided generic and brand manufacturer cases.
As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.
Technology may expedite operations, but the absence of the human element could cost dearly.
To keep moving forward, the Pharmacopoeial Discussion Group needs industry participation.
The European Union market takes steps toward continuous processing and modular facilities.
Pharmaceutical Technology Europe
The next two years may see a shake up in the world's current top pharmaceutical companies, with Pfizer likely to be the only US firm to remain in the top five by sales.
PTSM: Pharmaceutical Technology Sourcing and Management
Pharmaceutical companies pledge donations of 14 billion treatments for the next decade to combat nine neglected tropical diseases.
Pfizer and GlaxoSmithKline have announced separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis, and is one of leading causes of death in children under the age of five in developing countries.
AstraZeneca Acquires Chinese Generic-Drug Company; Takeda Makes Management Changes; and More.
On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.