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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.

Aralez buys rights to AZ heart drug; encouraged by generic quality issues

10-Oct-2016 - AstraZeneca will supply Toprol-XL to Aralez Pharmaceuticals Trading for at least 10 years after selling the US rights to the off-patent beta blocker for $175m.

GDUFA II negotiations: CMOs to pay one third of facility fees

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).

Opinion

Brand biosimilar: does Amjevita give away Amgen's biologics strategy?

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?

Sarepta looks to scale up production on back of its DMD drug success

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.

Court rules in favour of Zydus' copy of Shire's controlled-release UC 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).

US FDA slams Elite Pharma for adverse reaction monitoring failures

05-Sep-2016 - Elite Pharmaceuticals has received a US FDA warning letter for failing to adequately monitor adverse drug experiences (ADEs).

Mylan price hikes: Congress calls on FDA for generic EpiPen submission info

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.

West: Amgen mAb approval helps validate drug delivery tech

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.

Amgen begins to see results from manufacturing efficiency drive

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.

Roche getting under the skin of biosimilar competition

25-Jul-2016 - Subcutaneous versions of its biologic blockbusters - including Mabthera and Herceptin - will help protect against biosimilar competition, says Roche.

BIO 2016

Califf: New FDA guidance to ensure all drug info is available to patients

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.

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...

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