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Headlines > July 2014

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Harvard develops new nanoparticle as drug delivery device

31-Jul-2014 - A group of researchers at Harvard Medical School has developed a strongly cationic nanoparticle that physically absorbs proteins to form a new type of drug-carrier complex in aqueous solution. 

Hospira's Rocky Mount 'returns to health' as reinspection cites no observations

31-Jul-2014 - Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.

UK says hidden drugs shortage ‘getting worse’ as generics supply slows

31-Jul-2014 - The UK All-Party Pharmacy Group (APPG) has warned Britain is suffering from a shortage of branded and generic drugs.

Impax preparing response to FDA Form 483 with 10 observations

30-Jul-2014 - Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.

Chinese firm imported misbranded API into US, says FDA warning letter

30-Jul-2014 - Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Amgen to slash 23% of its manufacturing footprint and 2,900 US jobs

30-Jul-2014 - Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.

Anti-addiction film resilient to generics, says Reckitt Benckiser

29-Jul-2014 - Reckitt Benckiser’ opioid addiction drug Suboxone delivered by sublingual film has shown a 'surprising' level of resilience against generic competition, the firm says as it plans to spin-out its pharmaceutical business....

Biocon: Political turmoil hits sales, but quality systems ensure future

29-Jul-2014 - Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.

Waters broadens mass spec offering with REIMS acquisition

29-Jul-2014 - Analytic science company Waters has acquired all of the assets of MediMass, which includes its Rapid Evaporative Ionization Mass Spectrometry (REIMS) technology, as well as patent applications, software, databases and REIMS...

Ben Venue assets will bolster sterile injectables network, says Hikma

28-Jul-2014 - Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term, despite the transfer of equipment across its sterile injectables network.

Who are pharma's movers and shakers?

28-Jul-2014 - The latest changes at Bayer, biopharma, and the winner of Professional Woman of the Year in this week's column.

First come, first served? FDA may allow reservation of drug names

28-Jul-2014 - The US Food and Drug Administration (FDA) is inviting public comment on plans to allow drug companies to reserve proprietary names for medicines as early as the end of Phase...

GSK's declining Advair sales to be propped by respiratory portfolio

24-Jul-2014 - GlaxoSmithKline has issued upbeat guidance despite a 12% fall in sales of its blockbuster asthma and COPD drug Advair, as new products enter the respiratory drug market.

UK Gov should seek licenses for off-patent drugs in new indications says MP

24-Jul-2014 - The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals...

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

24-Jul-2014 - Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.

Ipca halts API shipments to US following 483 at Indian plant

24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

Italy to look at drug pricing during EU presidency

24-Jul-2014 - Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

MonosolRx finds new licensee for oral film delivered ondansetron

23-Jul-2014 - MonosolRx has found a new US licensee for its oral film ondansetron product, Zuplenz, signing up Galena BioPharma nearly four years after previous partner Strativa handed the drug back.

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

23-Jul-2014 - Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

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

23-Jul-2014 - Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose plant in Indiana.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. ...

UPDATE

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

22-Jul-2014 - Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.

Feature

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

22-Jul-2014 - Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.

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