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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.

Dispatches from the FT Global Healthcare and Biotech Conference

EMA: New pathways and Ebola vaccines can help expedite approvals

20-Nov-2014 - The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.

Dispatches from AAPS

Pfizer Director: Need for regulatory commitments clarity in NDAs, and US FDA concurs

05-Nov-2014 - A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.

Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

04-Nov-2014 - Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.

GSK £1bn savings plan to hit manufacture towards 2017, but UK likely immune

23-Oct-2014 - GlaxoSmithKline plans to cut manufacturing, sales and R&D as part of a three year plan to save £1bn ($1.6bn) annually. 

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

News from EDQM 50th anniversary conference

Drug complexity will change how Big Pharma uses Ph. Eur. says Pfizer expert

13-Oct-2014 - Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook. ...

Generics competition: change patent law over FAST Act, says expert

06-Oct-2014 - As US Congress considers the FAST (Fair Access for Safe and Timely Generics) bill to tackle “smokescreens” preventing competition, an expert tells in-Pharmatechnologist.com the problems behind marketing exclusivity run deeper...

Telormedix granted 'most important patent ' for TLR agonist bladder cancer drug

22-Sep-2014 - Telormedix has been granted a European patent for increasing the solubility of its lead bladder cancer toll-like receptors (TLR) treatment Vesimune.

Indian drugmakers to bring cheap HCV drug Sovaldi to developing world

16-Sep-2014 - Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.

Mannkind looks to Sanofi for secondary supply of inhalable insulin API

16-Sep-2014 - Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza following its commercialisation partnership last month.

Sanofi in $150m deal to commercialise Mannkind's inhaled insulin

11-Aug-2014 - Mannkind has partnered Sanofi for the marketing and commercialisation of its inhaled insulin drug Afrezza, recently approved by the US FDA.

GSK's declining Advair sales to be propped by respiratory portfolio

24-Jul-2014 - GlaxoSmithKline has issued upbeat guidance despite a 12% fall in sales of its blockbuster asthma and COPD drug Advair, as new products enter the respiratory drug market.

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up

23-Jul-2014 - Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose plant in Indiana.

Pfizer: Unexpected hike in volumes of post-patent drugs saves Irish jobs

11-Jul-2014 - Pfizer says 100 workers at an Irish facility will now keep their jobs due to an unpredicted increase in production volumes of off-patent drugs.

Mannkind preps Afrezza plant ahead of anticipated approval

16-Jun-2014 - Two billion cartridges of inhaled insulin drug Afrezza will be manufactured annually by Mannkind, the firm says as it awaits final approval next month.

PK/PD principles could tackle antibiotic resistance with single injection

09-Jun-2014 - A single-dose of an investigational MRSA drug could be equivalent to a ten-day course of antibiotics due to the application of PK-PD principles in its design and optimization, The Medicines...

Capsugel: New bioavailability enhancing capacity to fufill non-GMP demand

05-Jun-2014 - Capsugel has installed a commercial-scale dryer in its recently acquired Bend Research R&D facility, citing a rise in demand for non-GMP spray dried dispersion (SDD) services.

Colorcon expands Indian excipients site to capture generics market

30-Apr-2014 - Colorcon today opened an expanded facility in Goa, India to scale up production of tablet coatings and excipients for pharmaceutical manufacturers in South Asia.

Emerging excipient markets to outpace Western markets, report says

30-Apr-2014 - Experts have predicted emerging Indian and Chinese markets will outpace Western markets as the $2.3bn oral solid dosage form (OSDF) excipients global market grows at a sustainable rate.

'No longer simply a capsule provider' - Capsugel wins oral peptide contract

29-Apr-2014 - Capsugel is no longer a simple capsule provider but a differentiated player in the CDMO industry, the firm says as it wins a scale-up manufacturing contract for Chiasma and Roche’s...

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.

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