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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.

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FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes...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.

GSK breathes freely as Mylan launches Seretide generic in UK

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.

MannKind: Social media buzz will propel Afrezza to blockbuster status

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.

Novartis to assess biologics with micro-sugar-needle delivery tech

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.

MannKind: Afrezza's slow start due to delays not demand for inhalable insulin

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.

Catalent's oral Zydis tech: a hard pill for injectable vaccine makers?

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.

Controlled-release tech turns liquid drugs solid in stomach

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.


Teva bids $40bn for Mylan in proposed generics megamerger

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.

Anti-fungal shows promise for cancer breakthrough in preclinical tests

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...

My oh Mylan! $29bn Perrigo deal would create 'unrivalled' manufacturing network

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.

Sanofi: 80% of population ignored as pharma targets lower-risk specialty R&D

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...

Columbia Labs adds intra-vaginal ring tech and drug delivery pioneers

31-Mar-2015 - Columbia Laboratories has licensed a technology for delivering peptides using an intra-vaginal ring developed by MIT scientist Robert Langer.

EMA calls for industry involvement in applying new ISO standards to drugs

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.

Suboxone sales down as opioid addiction drug market intensifies

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.

BMS follows Merck as glut of HCV drugs leads to loss of fast-track status

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.

Merck's loss of HCV Breakthrough status shows FDA's pragmatism, says analyst

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. 

Unilife upping device production as market opportunity offsets flat sales

10-Feb-2015 - Unilife Corporation has ramped up production of delivery devices as pharmas looks to differentiate injectable therapies from the competition.

Inhaled insulin: Sanofi alone as Big Pharma declines to revisit past

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.

Pharma turning to injectable systems to protect biologics, says Unilife

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.

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