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News in brief

Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.

Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.

EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.

Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.

Global Industry News

Organovo: 3D printed liver tissue to challenge current toxicity models from Outsourcing-Pharma.com

A 3D printed human liver system could offer better informed risk-based decisions earlier in the drug development process than with current in vitro models, according to developers Organovo.

Cell line development set to get faster says Horizon Discovery from BioPharma-Reporter.com

CRISPR gene editing will make cell line development cheaper and faster according to Horizon Discovery, which says that new tech has application in both biomanufacturing and preclinical disease modelling.

G-CON's containment PODs launched in response to Ebola crisis from BioPharma-Reporter.com

G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.

Novartis invests $35m in stem cell tech company with option to acquire from BioPharma-Reporter.com

Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.

Former Cetero researcher hit with US FDA warning letter from Outsourcing-Pharma.com

A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.

Lonza not asked for back taxes following decision to close Hopkinton site from BioPharma-Reporter.com

Lonza has not been asked to pay back taxes after abandoning plans to expand its biologics plant in Hopkinton, Massachusetts last year.

What’s next for gene editing? After ‘knock-out’, time for ‘knock-in’ from Outsourcing-Pharma.com

Horizon Discovery says the gene editing tool CRISPR used to engineer its human cell lines is exploding the possibilities of screening for preclinical customers.

For single-use, 2,000 litres is Fujifilm's limit as it invests in US and UK from BioPharma-Reporter.com

Single-use bioreactors do not need to be bigger than 2,000L says Fujifilm Diosynth, which is investing in such technology at plants in the UK and US

Spotlight

Hikma buys Boehringer Ingeleheim CMO Ben Venue Labs

Ben Venue assets will bolster sterile injectables network, says Hikma

Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term,...

Is your drug name ok? Run a role-play, says FDA

Is your drug name ok? Run a role-play, says FDA

Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug...

Generics: change in pill shape makes patients 66% more likely to quit

Generics: change in pill shape makes patients 66% more likely to quit

Switching patients to generic pills of a different shape and colour increases the chances they will end...

Eli Lilly swaps dry powder for insulin in Indianapolis restructure

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

Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose...

Sterile injectables M&A could indicate return to in-house, says F&S
UPDATE

Sterile injectables M&A could indicate return to in-house production

Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says...

Glenmark to build first US manufacturing plant

Glenmark to build first US manufacturing plant

India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in...

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