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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

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11-Feb-2015 - The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.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.

EMA expands generic assessment pilot globally in response to industry

21-Jan-2015 - The EMA has responded to feedback from generic drugmakers by broadening an assessment sharing pilot to regulators outside the EU.

MannKind: Small step for delivery tech R&D after Afrezza's giant leap

19-Jan-2015 - MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.

Shire takes $5bn gamble on NPS' hormone replacement PDUFA decision

12-Jan-2015 - Shire says its $5.2bn (€4.4bn) acquisition of NPS Pharmaceuticals is a calculated risk, coming just days before the US FDA decides whther to approve the hormone replacement therapy Natpara.

FDA defiant on orphan exclusivity rules even after court judgement

07-Jan-2015 - The US FDA says it will stick to its policy on orphan drug exclusivity despite a conflicting court ruling.

US pharmacy deals could cut costs of AbbVie and Gilead's HCV treatments

06-Jan-2015 - Gilead and AbbVie’s exclusive deals with payers CVS and Express Scripts could help cut the cost of the new class of treatments for America’s three million Hepatitis C sufferers....

AstraZeneca API plant set to shut by 2017 as Patent Cliff strikes again

18-Dec-2014 - An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.

Axim to build Dutch facility for cannabinoid-based chewing gum drug

04-Dec-2014 - A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build a manufacturing facility in the Netherlands.

Happy Thanksgiving for GSK with FTC approval of Novartis vaccine biz

27-Nov-2014 - Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.

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.

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