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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.

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.

Update

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.

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.

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