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Novo Nordisk defiant despite $90,000 disclosure fine

An insulin model (Picture credit: Novo Nordisk).

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.

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News in brief

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.

For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.

WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.

Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.

Global Industry News

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

Elite opts to keep anti-abuse opioid manufacturing in-house from Outsourcing-Pharma.com

Elite Pharma has decided to manufacture its developmental anti-abuse pain drug in-house despite offers from several CMOs interested in the contract.

Physician groups call for separate names for biosimilars, reference biologics from BioPharma-Reporter.com

The American Academies of Clinical Endocrinologists, dermatologists and neurologists, as well as eight other physician groups and a number of individual physicians are calling for unique names for biosimilars to better track adverse events and ensure physicians understand what the biosimilar was approved for.

Miltenyi Biotec acquires lentiviral vector manufacturing business of Lentigen from BioPharma-Reporter.com

Miltenyi Biotec has acquired the lentiviral vector manufacturing business and related assets from Lentigen, a lentiviral technology provider for cell and gene therapy applications.

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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