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-Apr-2016 - The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.
06-Apr-2016 - The rights to inhaled insulin drug Afrezza have returned to Mannkind Corporation, three months after Sanofi terminated its commercialisation deal.
24-Mar-2016 - Sanofi has challenged an Indian Government decision banning the manufacture and sale of its fixed dose combination diabetes drug, Amaryl MP.
23-Feb-2016 - Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product.
22-Feb-2016 - Teva has aggressively defended its market share for its blockbuster Copaxone says Momenta, six months after marketing partner Sandoz launched the first generic version in the US.
09-Feb-2016 - Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
04-Feb-2016 - Novartis subsidiary Sandoz will commercialise small and large molecule injectables using French delivery tech firm MedinCell’s subcutaneous controlled release platform.
21-Jan-2016 - Mucosis has been awarded a Wellcome Trust grant of €3.7m ($4m) to help develop a Respiratory Syncytial Virus (RSV) vaccine using its intranasal delivery platform.
14-Jan-2016 - MannKind says its Technosphere delivery platform could yield short-term cash and drive long-term growth.
06-Jan-2016 - Dr Reddy’s has changed the colour of its Nexium generic capsules from purple to blue in a bid to resume US sales, as litigation with AstraZeneca continues.
06-Jan-2016 - Sanofi has abandoned Afrezza less than a year after its launch, but the future of the inhaled insulin product is secure according to developer MannKind.
05-Jan-2016 - Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
30-Nov-2015 - Pfizer says it will decide in 2018 whether to split its generics and branded businesses but M&A experts are already predicting how the giant will get rid of its established...
17-Nov-2015 - As World Antibiotics Awareness Week draws attention to the threat of resistance, pharma companies large and small say a worldwide overhaul of payment models will make anti-infective R&D profitable again....
16-Nov-2015 - Specialised drugs made using flexible technologies are the future for Roche’s small molecule portfolio, the firm says as it restructures its production network.
26-Oct-2015 - A nanoparticle that binds to immune cells in the body has been shown to tune down inflammation and offer a potential first-of-a-kind treatment for sepsis.
22-Oct-2015 - Biogen will cut around 530 US jobs as part of a restructuring plan it hopes will save $250m (€221m) in operating costs annually.
07-Oct-2015 - The US Government is becoming increasingly critical of industry attempts to ward off competition through ‘product-hopping,’ an IP lawyer says.
07-Oct-2015 - MannKind has cut more jobs in efforts to streamline operations, leaving the inhalable insulin manufacturer around a third smaller than this time last year.
02-Oct-2015 - Over 40 new jobs will be created at Pfizer’s manufacturing sites in Cork, Ireland, including at a bulk Lipitor facility once earmarked for closure.
15-Sep-2015 - Unilife has axed about 50 R&D jobs as part of a plan to reduce its operating expenses.
31-Aug-2015 - New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US...
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.