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-Sep-2016 - The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
28-Sep-2016 - Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
20-Sep-2016 - Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
19-Sep-2016 - Shire says it will appeal a decision invalidating a patent surrounding the controlled-release composition of its ulcerative colitis drug Lialda (mesalazine).
05-Sep-2016 - Elite Pharmaceuticals has received a US FDA warning letter for failing to adequately monitor adverse drug experiences (ADEs).
30-Aug-2016 - Congress has asked the US FDA for information on EpiPen generic submissions and processes in light of a series of price hikes by drugmaker Mylan.
01-Aug-2016 - Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.
28-Jul-2016 - A restructuring programme which closed two US facilities and slashed hundreds of jobs has paid off says Amgen, attributing increased margins to better manufacturing efficiencies.
25-Jul-2016 - Subcutaneous versions of its biologic blockbusters - including Mabthera and Herceptin - will help protect against biosimilar competition, says Roche.
13-Jun-2016 - Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
26-May-2016 - The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.
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....