Breaking News on Global Pharmaceutical Technology & Manufacturing

Top Headlines

Novartis scoops GSK’s oncology portfolio, trades away its vaccine division

Novartis has agreed to acquire GlaxoSmithKline’s oncology pipeline for $16bn, while GSK will acquire Novartis’ vaccine business, excluding the flu vaccines, for $7bn.

Related news

News in brief

The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.

Swiss-Israeli supplier Frutarom has beefed up its botanical extracts in response to changing European Union laws for herbal products and medicines.

With Pfizer rumoured to be on the brink of a mega-merger with AstraZeneca, in-Pharmatechnologist.com brings you an interactive view of what £60bn ($101bn) could get.

Hospira has announced US recalls for seven lots of its propofol injection and one lot of 1% Lidocaine HCI Injection due to a glass contamination.

Global Industry News

Epirus hopes to bring its infliximab biosimilar to EU in merger with Zalicus from BioPharma-Reporter.com

Epirus and Zalicus have agreed to merge in order to focus on the development and manufacture of biosimilars.

Merck & Co. contracts Catalent to make sublingual hayfever drugs from Outsourcing-Pharma.com

MSD has selected Catalent to manufacture two recently approved sublingual pollen extract drugs using its Zydis formulation platform.

US FDA offers guidance on when two mAbs should be considered the same from BioPharma-Reporter.com

As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.

FDA ‘breakthrough’ scheme approves GSK biologic, but is it faster? from BioPharma-Reporter.com

The US Food and Drug Administration (FDA) has approved a second “Breakthrough Therapy” biologic but it is still unclear whether the programme speeds drugs to market, says an expert.

Sanofi sells therapy cells: Aastrom buys products and plants from BioPharma-Reporter.com

Aastrom Biosciences will pay Sanofi $6.5m (EUR4.7m) for its cell therapy business in a deal that gives the cash strapped regenerative medicines developer three commercial products.

AbbVie inks Humira packaging deal as it launches in Saudi Arabia from BioPharma-Reporter.com

AbbVie has teamed up with Arabio for the secondary packaging of its blockbuster biologic Humira as part of a launch into Saudi Arabian market.

Quintiles selects OmniComm for Phase I software from Outsourcing-Pharma.com

CRO Quintiles has signed a five-year agreement to use OmniComm Systems' technology for Phase I clinic automation. 

Spotlight

EMA to rejig variations procedures and industry contact staff in April

EMA to rejig variations procedures and industry contact staff in April

Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation...

Janssen Button? Will GSK's F1 team up prompt other collaborations?

Janssen Button? Will GSK's F1 team up prompt other collaborations?

GSK has ‘smashed’ production targets at a UK inhaler plant by revving up manufacturing operations with knowhow...

Indian API maker slammed with US FDA Warning over data issues

Indian API maker slammed with US FDA Warning over data issues

Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter...

US FDA issues new bioavailability guidelines

US FDA issues new bioavailability guidelines

The US FDA has published guidance of how sponsors should best document the bioavailability of products for...

Bioavailability breakthrough key to new cancer drug OKed in Japan

Bioavailability breakthrough key to new cancer drug OKed in Japan

Japan has become the first country to approve a new cancer pill that treats disease by interfering...

Key Industry Events

 

Access all events listing

Our events, Events from partners...