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.
29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes...
07-Jul-2015 - Novo Nordisk has ended a development partnership using Zosana Pharma’s microneedle patch system with its GLP-1 analogue semaglutide, currently being investigated in an oral formulation.
08-Jun-2015 - GlaxoSmithKline is unconcerned about losing its position in the respiratory market as Mylan launches the first generic version of blockbuster asthma product Seretide in the UK.
04-Jun-2015 - MannKind’s CFO has no doubt Afrezza will be a blockbuster despite a slow start since launch and is adjusting its manufacturing network in preparation.
27-May-2015 - Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.
12-May-2015 - Sanofi's inhaled insulin drug Affrezza has generated lower than expected revenue due to marketing delays rather than low demand according to MannKind CFO, Matthew Pfeffer.
07-May-2015 - Vaccines being developed using Catalent's oral Zydis platform would increase compliance and cut costs but Big Pharma is slow to get on board, the firm says.
04-May-2015 - A liquid-gel which solidifies in the stomach could offer drugmakers an effective modified-release delivery option, according to the lead scientist behind the project.
21-Apr-2015 - A merger with Mylan would “transform the global generics space” says Teva, which has entered a $40bn bid as an alternative to the recently proposed Mylan-Perrigo deal.
21-Apr-2015 - An anti-fungal drug shows potential to treat a range of cancers, according to research from the Repurposing Drugs in Oncology (ReDO) project, but the drugmakers will need a financial incentive...
09-Apr-2015 - Mylan has bid $29bn (€27bn) to buy Perrigo in what the firm says will create a company with “unrivalled” manufacturing and supply chain capabilities across OTCs, generics and APIs.
02-Apr-2015 - Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence...
31-Mar-2015 - Columbia Laboratories has licensed a technology for delivering peptides using an intra-vaginal ring developed by MIT scientist Robert Langer.
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....