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.
23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
12-Feb-2015 - Opioid addiction drug Suboxone lost market share in 2014 according to newly independent Indivior, whose management says it is not intimidated by increased competition.
11-Feb-2015 - The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.
10-Feb-2015 - Stripping Merck & Co.'s hep C pill of breakthrough status shows the US FDA is monitoring market developments in real-time warns one industry analyst.
10-Feb-2015 - Unilife Corporation has ramped up production of delivery devices as pharmas looks to differentiate injectable therapies from the competition.
04-Feb-2015 - Pfizer, Lilly and Novo Nordisk will not be revisiting inhaled insulin opportunities despite the US launch and expected success of Sanofi and MannKind’s Afrezza.
22-Jan-2015 - Big Pharma firms like AbbVie are partnering with delivery device makers to guard against biosimilar competition according to Unilife CEO, Alan Shortall.
21-Jan-2015 - The EMA has responded to feedback from generic drugmakers by broadening an assessment sharing pilot to regulators outside the EU.
19-Jan-2015 - MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.
12-Jan-2015 - Shire says its $5.2bn (€4.4bn) acquisition of NPS Pharmaceuticals is a calculated risk, coming just days before the US FDA decides whther to approve the hormone replacement therapy Natpara.
07-Jan-2015 - The US FDA says it will stick to its policy on orphan drug exclusivity despite a conflicting court ruling.
06-Jan-2015 - Gilead and AbbVie’s exclusive deals with payers CVS and Express Scripts could help cut the cost of the new class of treatments for America’s three million Hepatitis C sufferers....
18-Dec-2014 - An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.
04-Dec-2014 - A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build a manufacturing facility in the Netherlands.
27-Nov-2014 - Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.
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.