As R&D productivity declines and the age of blockbuster medicines reaches an end, the pharmaceutical industry is looking at ways to extend the profitable life of its products up to and beyond patent expiry.
20-Nov-2014 - The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.
05-Nov-2014 - A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.
04-Nov-2014 - Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.
23-Oct-2014 - GlaxoSmithKline plans to cut manufacturing, sales and R&D as part of a three year plan to save £1bn ($1.6bn) annually.
21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.
13-Oct-2014 - Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook. ...
06-Oct-2014 - As US Congress considers the FAST (Fair Access for Safe and Timely Generics) bill to tackle “smokescreens” preventing competition, an expert tells in-Pharmatechnologist.com the problems behind marketing exclusivity run deeper...
22-Sep-2014 - Telormedix has been granted a European patent for increasing the solubility of its lead bladder cancer toll-like receptors (TLR) treatment Vesimune.
16-Sep-2014 - Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.
16-Sep-2014 - Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza following its commercialisation partnership last month.
11-Aug-2014 - Mannkind has partnered Sanofi for the marketing and commercialisation of its inhaled insulin drug Afrezza, recently approved by the US FDA.
24-Jul-2014 - GlaxoSmithKline has issued upbeat guidance despite a 12% fall in sales of its blockbuster asthma and COPD drug Advair, as new products enter the respiratory drug market.
23-Jul-2014 - Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose plant in Indiana.
11-Jul-2014 - Pfizer says 100 workers at an Irish facility will now keep their jobs due to an unpredicted increase in production volumes of off-patent drugs.
16-Jun-2014 - Two billion cartridges of inhaled insulin drug Afrezza will be manufactured annually by Mannkind, the firm says as it awaits final approval next month.
09-Jun-2014 - A single-dose of an investigational MRSA drug could be equivalent to a ten-day course of antibiotics due to the application of PK-PD principles in its design and optimization, The Medicines...
05-Jun-2014 - Capsugel has installed a commercial-scale dryer in its recently acquired Bend Research R&D facility, citing a rise in demand for non-GMP spray dried dispersion (SDD) services.
30-Apr-2014 - Colorcon today opened an expanded facility in Goa, India to scale up production of tablet coatings and excipients for pharmaceutical manufacturers in South Asia.
30-Apr-2014 - Experts have predicted emerging Indian and Chinese markets will outpace Western markets as the $2.3bn oral solid dosage form (OSDF) excipients global market grows at a sustainable rate.
29-Apr-2014 - Capsugel is no longer a simple capsule provider but a differentiated player in the CDMO industry, the firm says as it wins a scale-up manufacturing contract for Chiasma and Roche’s...
15-Apr-2014 - Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.
02-Apr-2014 - Hikma has received a close-out letter for its oral manufacturing facility in New Jersey, two years after the US FDA issued a warning.
11-Feb-2014 - European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP...
22-Jan-2014 - Novartis says it intends to shutter a New York manufacturing site due to reduced demand following the loss of exclusivity on its one-time topseller Diovan.
16-Jan-2014 - Complex generics will represent over 50% of Teva’s generic market by 2017, the firm says, but investments in delivery technology will have positive implications across the full business.