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Headlines > August 2016

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Out-of-spec assay drove Teva to recall antibiotic from Canadian plant

31-Aug-2016 - An out-of-specification assay result resulted in Teva recalling over 50,000 bottles of the antibiotic amoxicillin made at a facility in Canada.

Flexible molecules could be better drugs - for some targets

31-Aug-2016 - For drug molecules, having a flexible rather than a rigid structure can sometimes make you a better medicine, say scientists in California.

Impax recalls tablets due to incorrect labeling

30-Aug-2016 - Impax Laboratories has issued a voluntary recall for one lot of its Lamotrigine Orally Disintegrating Tablet due to incorrect labeling of its blister packs.

Mylan price hikes: Congress calls on FDA for generic EpiPen submission info

30-Aug-2016 - Congress has asked the US FDA for information on EpiPen generic submissions and processes in light of a series of price hikes by drugmaker Mylan.

RenovaCare looks to use skin as ‘natural bioreactor’ to treat burns

30-Aug-2016 - A device that isolates and sprays a patient’s own stem cells onto serious burns could have significant implications in the organ regeneration industry, says developer RenovaCare.

Catalent Q4 results

Catalent to add two 2,000L bioreactors in $34m WI biologics plant expansion

30-Aug-2016 - Catalent has more than doubled its biologics business since it went public in 2014, but the sector still represents less than 5% of the CDMO’s revenues.

Quality issues at ex-Sun Pharma plant land Frontida with US FDA warning

29-Aug-2016 - The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.

News in brief

Agilent helps launch carbohydrate analysis lab

29-Aug-2016 - The University of Adelaide and Agilent Technologies Australia Pty have partnered on the analysis of complex carbohydrates (‘glycans’).

Hikma continues beefing up US and European manufacturing capabilities

29-Aug-2016 - Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.

Grunenthal says anti-crush tech Endo uses for Opana ER helps prevent abuse

25-Aug-2016 - Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."

API firm Unimark Remedies warned by US FDA about Indian plants

25-Aug-2016 - The US FDA has warned API manufacturer Unimark Remedies about unsanitary conditions at its facility in Vapi and Bavla in India.

CPhI South Korea

Korea positioned to be global biopharma powerhouse, says industry association

25-Aug-2016 - Stem cells and biosimilars are driving the Korean pharma market, according to the country’s Biomedicine Industry Association KoBIA.

update - Hospira regrets non-compliance

Pfizer unit Hospira and Napp broke APBI code during Remsima push

24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.

CMO contracts will transfer to Pfizer

Pfizer to buy AstraZeneca's antibiotic business in deal worth up to $1.5bn

24-Aug-2016 - Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next...

Pharma pollution an 'ignored' cause of antibiotic resistance

24-Aug-2016 - Pollution in pharma supply chains is contributing to the spread of antimicrobial resistance (AMR), says a new report.

New synthesis promises to cut cost of making amine drugs

24-Aug-2016 - Scientists in Switzerland have developed a simple and cheap way to synthesise amines - compounds that form the backbone of many active pharmaceutical ingredients.

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.

Phyton has developed a cell-based thapsigargin production method for Inspyr

23-Aug-2016 - Phyton Biotech has developed a cell based way of making thapsigargin, a cytotoxic plant extract that is being developed for the treatment of cancer by Inspyr Therapeutics.

Cost pressures turning pharma towards automation tech, says Zenith

23-Aug-2016 - Increased cost pressures and a shift to biologics manufacturing are driving demand for automation technologies, says Zenith which is opening two offices in the US.

BASF API biz boosts Siegfried in H1, but IT integration costs hit profits

22-Aug-2016 - Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.

Actavis pulls Patheon-made diabetes pills after out-of-spec tests

22-Aug-2016 - Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.

Fast-tracked Factor Xa inhibitor is being made for Portola by CMC Biologics and Lonza

Portola 'surprised' with CMC concerns in FDA rejection of anticoagulant candidate

22-Aug-2016 - Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.

EMA says biologics developers need to be extra vigilant

19-Aug-2016 - Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.

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