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Hot Topics > Lifecycle management

Lifecycle management

Lifecycle management

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.

Novo Nordisk and Sanofi diabetes combo drugs receive US recommendation

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.

Use of a comparability protocol will aid post-approval CMC changes, US FDA

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.

MannKind waves 'au revoir' to Sanofi as it regains Afrezza rights

06-Apr-2016 - The rights to inhaled insulin drug Afrezza have returned to Mannkind Corporation, three months after Sanofi terminated its commercialisation deal.

Sanofi goes to High Court over Indian ban on fixed dose combo diabetes drug

24-Mar-2016 - Sanofi has challenged an Indian Government decision banning the manufacture and sale of its fixed dose combination diabetes drug, Amaryl MP.

Sanofi abandoning Auvi-Q after dosage problems led to total recall

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.

Momenta: Sandoz capable of countering Teva’s Copaxone protection strategy

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.

Janssen averse to extrapolation as FDA sits to review Remicade biosimilar

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.

Sandoz teams with delivery tech firm MedinCell to get under the skin of cancer

04-Feb-2016 - Novartis subsidiary Sandoz will commercialise small and large molecule injectables using French delivery tech firm MedinCell’s subcutaneous controlled release platform.

$4m grant not to be sniffed at as Mucosis looks to advance intranasal RSV vaccine

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.

‘Unshackled’ from Sanofi, MannKind turns to Technosphere and Twitter

14-Jan-2016 - MannKind says its Technosphere delivery platform could yield short-term cash and drive long-term growth.

AstraZeneca's purple reign? Dr Reddy's relaunches Nexium generic in blue

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.

Down but not out: MannKind sees positive in Sanofi’s Afrezza exit

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.

Biologic makers looking to delivery devices to gain competitive edge, Bespak

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.

Pfizer-Allergan merger

‘Over 90%’ of industry thinks Pfizer will sell generics biz

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...

Antibiotics: urgent calls for global payment pot

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....

Roche to exit four EU and US sites in small molecule network shake-up

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.

Immune cell binding nanoparticle could lead to new sepsis treatment

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.  

Biogen axing 11% of workforce in plan to save $250m annually

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.

US FTC: 'Product-hopping' illegally impedes generic entry

07-Oct-2015 - The US Government is becoming increasingly critical of industry attempts to ward off competition through ‘product-hopping,’ an IP lawyer says.

Latest job cuts leave MannKind a third smaller than in 2014, says CFO

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.

Pfizer hiring 40 at its Lipitor and Viagra API plants in Ireland

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.

Unilife cuts workforce by 17% as it shifts from R&D to commercialisation

15-Sep-2015 - Unilife has axed about 50 R&D jobs as part of a plan to reduce its operating expenses.

Progress seen In addressing US drug shortages, but challenges remain

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...

FDA offers draft guidance on quality metrics used to assess drug manufacturing

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...

Novo Nordisk exits transdermal deal with Zosana for type 2 diabetes candidate

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.

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