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Headlines > August 2014

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Merck KGaA biopharma division to make small molecule drugs in China

29-Aug-2014 - Biopharmaceutical firm Merck Serono will make small molecule drugs at the new plant it is building in China according to a company spokeswoman, who told us the firm will supply...

CFDA approves BTG bead delivery device for liver cancer

29-Aug-2014 - BTG has received approval from the China FDA for a liver cancer treatment which uses its hydrogel product DC Beads.

Novo Nordisk snaps up Olympus plant and rehires laid off NH workers

29-Aug-2014 - Novo Nordisk has bought a biomanufacturing facility earmarked for closure by Olympus Biotech and begun rehiring staff in order to support its haemophilia product pipeline.

GSK and Immunovaccine: delivery techs promise to deliver Ebola vaccine

29-Aug-2014 - A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a preclinical study.

Baxter donates IVs to aid groups fighting Ebola in Africa

29-Aug-2014 - Baxter International has donated intravenous fluids to aid organisations treating Ebola infected patients in Liberia and Sierra Leone.

GSK: GM yeast breakthrough won't kill off poppy-based opium

28-Aug-2014 - Poppies will continue to be the main source of industrial opiates long-term according to GSK, despite a recent breakthrough in efforts to produce it in GM yeast.

INFOGRAPHIC

Is Pfizer now eyeing up Actavis three months after failed AZ bid?

28-Aug-2014 - Pfizer is rumoured to be eyeing up Actavis three months after failing to woo AstraZeneca in a $120bn megamerger, but what would such a deal bring to the Pharma Giant?...

US claims Dr Reddy’s broke safety packaging rules for 4 years

28-Aug-2014 - Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.

Reinspection lands Alexion with 483 for Soliris plant

26-Aug-2014 - A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

EMD Millipore to supply Samsung's Yervoy plant in 10-year deal

26-Aug-2014 - EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

DEA approves manufacture of GHB at Patheon Cincinnati plant

26-Aug-2014 - Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

USP joins campaign against illegal online pharmacies

26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Argentina to allow Indian drug imports after inspecting five plants

25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

People on the Move

People on the Move at GSK, Allergan, Novartis

25-Aug-2014 - Our weekly round-up of the bright young things and big cheeses in pharmaceuticals.

EFPIA, EGA take issue with EMA’s guidance on stability data for APIs

25-Aug-2014 - EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes....

Correction

GE Healthcare: plans to move New Jersey ops to new Massachusetts HQ

22-Aug-2014 - GE Healthcare has said it plans to relocate operations in New Jersey to its new Massachusetts life sciences headquarters.

GSK welcomes US OK for Arnuity in light of declining Advair sales

21-Aug-2014 - US FDA approval of the inhaled corticosteroid (ICS) asthma drug Arnuity will help offset declining sales of the off-patent bestseller Advair, says GlaxoSmithKline.

Claris gets MHRA OK for injectables plant

21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.

Ben Venue site has no place in injectables network, says new owner Hikma

21-Aug-2014 - Ben Venue Laboratories will remain inactive says new owner Hikma as it looks to optimise its injectables manufacturing network.

Macfarlan Smith fined $12,000 after accident at API plant

21-Aug-2014 - Opiate API manufacturer Macfarlan Smith has been fined £12,000 for failing to ensure the safety of an employee injured at its plant in Scotland in 2011.

UK drug exporters shipping outside the EEA must seek MHRA approval

20-Aug-2014 - 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.

Eisai sues FDA for ‘losing one year’ of marketing to generics rivals

20-Aug-2014 - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.

India changes course, calls for bar codes for mono cartons in April

20-Aug-2014 - 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...

Frogs, fungus and falsified data - Indian firm falls foul of US FDA

20-Aug-2014 - 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...

Novartis invests $35m in stem cell tech company with option to acquire

20-Aug-2014 - Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.

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