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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.

Acura pays Pfizer $2m to buy back anti-abuse tech and relaunch Oxecta drug

15-Apr-2014 - Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.

News in brief

Hikma's NJ plant given the all clear from the US FDA

02-Apr-2014 - Hikma has received a close-out letter for its oral manufacturing facility in New Jersey, two years after the US FDA issued a warning.

EU updates GMP principles on qualification and validation

11-Feb-2014 - European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP...

500 jobs to go as Novartis plans to shutter NY Diovan facility

22-Jan-2014 - Novartis says it intends to shutter a New York manufacturing site due to reduced demand following the loss of exclusivity on its one-time topseller Diovan.

Complex generics will boost speciality biz, Teva says

16-Jan-2014 - Complex generics will represent over 50% of Teva’s generic market by 2017, the firm says, but investments in delivery technology will have positive implications across the full business.

B-I's manufacturing network prepped as Actavis rolls out Micardis generic

09-Jan-2014 - Boehringer Ingelheim says it was well-prepared for the expiration of its blockbuster drug Micardis (telmisartan) with staff and capacity transfers as Actavis prepares to launch a generic version.

Lilly: Jobs to shift to insulin production in wake of Cymbalta expiration

16-Dec-2013 - Eli Lilly is scaling back manufacturing of Cymbalta but says there will be no major loss of production jobs as a number of firms begin producing generic versions.

Novo Nordisk and Roche' insulin pump collaboration gets EU thumbs up

26-Nov-2013 - Novo Nordisk has teamed up with Roche to launch a prefilled cartridge for insulin pump users and says the system offers advantages over injections.

Dispatches from AAPS

Non-oral FDCs are beneficial for patients and industry, say experts

13-Nov-2013 - Drug delivery experts say fixed dose combination (FDC) products for non-oral forms can benefit both the manufacturer and the patient.

News from CPhI

Second generation HPMC excipient can cut costs by 60%, says Dow

05-Nov-2013 - A new tableting excipient eliminates the need for wet granulation and saves up to 60% on overall manufacturing costs according to developer Dow.

Capsugel and Bend: 'Marriage made in heaven' as first tech transferred

31-Oct-2013 - The acquisition of Bend Research by Capsugel may be “a marriage made in heaven” for customers, the firms say, as the first drug delivery tech is transferred.

UPDATE - Dispatches from CPhI

Capsugel's purchase of Bend will strengthen partnership, says Dow

28-Oct-2013 - Dow says the acquisition of partner Bend Research is “good news” and will strengthen its developments in solving solubility and bioavailability issues in drug formulation.

DISPATCHES FROM CPhI

Catalent launches softgel products at CPhI: one vegetarian, one anti-abuse

23-Oct-2013 - Catalent has announced two new softgel solutions as it adds greater versatility to its Advanced Technologies Business Unit.

Almac and Novozymes team to offer pharmacokinetic improvements

22-Oct-2013 - Linking peptide and small molecule drugs to albumin will improve pharmacokinetics, says Almac as it partners its manufacturing capabilities with Novozymes’ half-life extension platform.

Cirrus studies formulation effects on MDI performance for US FDA

17-Oct-2013 - Cirrus Pharmaceuticals has received a grant to investigate the effect of excipient concentration and API molecule size on metered dose inhaler (MDI) formulations.

Giant Leap for Mannkind: Positive data from Ph III Afrezza trial

19-Aug-2013 - Mannkind says it is looking for partners to market its inhaled insulin drug Afrezza following positive data results in Phase III clinical trials.

Benefit Analysis Reqs Are More Work but Revised PSURs Are Better says EFPIA

09-Apr-2013 - Recent changes to EU drug risk-benefit reporting rules mean more work for multinational Pharmas but are still an improvement on ‘old-style’ PSURs says EFPIA.

EC says Drugmakers Have Time to Mark Risky Drugs with Black Triangle

11-Mar-2013 - The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.

DSM says generics-focused partnering will drive pharma growth

20-Feb-2013 - Royal DSM expects its pharma unit to perform better in 2013 driven by a generics and end-of-lifecycle drug-focused partnership strategy. 

AMRI Deal a Catalyst for Pharma Growth says Codexis

14-Feb-2013 - AMRI has teamed up with biocatalysis firm Codexis to develop cheaper, faster and greener ways of manufacturing APIs.

Update

Teva to Sell Californian Plant as Part of Cost-Cutting Initiative

11-Feb-2013 - Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.

Pfizer wants manufacturing 'efficiencies' in 2013

30-Jan-2013 - Pfizer's CEO has raised the possibility of more cost cutting in manufacturing operations in 2013 to offset the impact of patent loss for key products.

Lilly’s in-house trend continues with $140m insulin investment

05-Nov-2012 - Eli Lilly plans to boost its in-house insulin production capabilities will a $140m investment for its Indianapolis site.

Disptaches from AAPS

Eliminate scale up by using R&D equipment for commercial production: GSK

18-Oct-2012 - Using the same equipment from R&D to scale up will cut costs, time and improve efficiency, according to GSK.

Regulatory staff wages going up despite cost cutting pharma biz, says RAPS

21-Aug-2012 - Regulatory professionals’ pay packets are going up despite a general industry preference for cost cutting, according to a new report by RAPS.

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