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News headlines

China patent gives Provectus green light to find partner for melanoma candidate, PV-10

27-Jan-2015 - China has told Provectus Biopharmaceuticals it will grant a patent for the method used to make the API in its skin cancer drug candidate, PV-10.

Hospira 'committed to quality' as total recall count hits 40 since 2012

27-Jan-2015 - A human hair found in a vial of Sodium Chloride Injection has led to the fortieth recall in three years for Hospira.

US Senator proposes NIH to be funded through Big Pharma ‘swear jar’

26-Jan-2015 - Pharma firms that break the law could be fined one percent of their blockbuster drug revenues if proposed US legislation is introduced.

News in brief

30 months for smuggler of Roche cancer drugs which lacked API

26-Jan-2015 - A second man has received a prison sentence after counterfeit vials of a Roche cancer drug containing no API were seized in 2012.

FDA's wearables guidance could slow pharma adoption in short-term, says analyst

22-Jan-2015 - Draft guidance distinguishing wearable medical devices from ‘general wellness’ devices could slow pharma’s adoption of such data in the short-term, according to an analyst.

State of the Union: Obama’s fast-track trade plans divide pharma

22-Jan-2015 - President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.

EMA supply interuption rules need clarification says industry; NGO says high prices cause shortages

21-Jan-2015 - Rules governing when drugmakers should warn regulators about supply interruptions need to take mitigation plans into account according to European industry groups.

EMA expands generic assessment pilot globally in response to industry

21-Jan-2015 - The EMA has responded to feedback from generic drugmakers by broadening an assessment sharing pilot to regulators outside the EU.

Cost, not compliance, behind Clayton closure, says Hospira

19-Jan-2015 - Hospira has announced it will close its plant in Clayton, North Carolina that it no longer deems cost effective for drug production.  

Novartis to close Puerto Rico plant and outsource to Eli Lilly

19-Jan-2015 - Novartis will close an OTC plant in Puerto Rico by 2019 and transfer manufacturing and packaging actives to sites in the US and facilities operated by Eli Lilly and Virbac.

Fresenius Kabi NY aseptic plant upgraded by USFDA

15-Jan-2015 - A Fresenius Kabi plant in New York has been upgraded, and up to five new products could receive FDA approval, almost three years after receiving a warning letter.

update

US FDA rejects Pharmexcil claims it no longer lets Indian regulators know about inspections

14-Jan-2015 - The US FDA has rejected Pharmexcil claims it no longer informs Indian regulators of manufacturing plant inspections and said its policy is to invite host-country inspectors to attend visits.

Drug disposal not our problem, industry tells Supreme Court

14-Jan-2015 - Industry groups PhRMA, BIO and GPhA are petitioning the Supreme Court to overturn a local law that requires pharma companies to cough up payment for safe disposal of medicines which make their way to one county.

US solvent disposal definition will encourage recycling, says SOCMA

14-Jan-2015 - Critical solvents used by the pharmaceutical manufacturers have been excluded from the EPA's final ruling on waste disposal, in a move welcomed by a US industry group.

EMA orphan approval hike reflects biology advances and pharma economics says expert

12-Jan-2015 - The record number of orphan drugs approved in Europe last year reflects the pharma industry’s need to refill pipelines and scientific advances says Genetic Alliance UK

FDA blocks Australia site from importing tainted Cialis as Lilly claims innocence

12-Jan-2015 - The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra. 

Judge rules Mylan monopoly suit against Celgene can continue

12-Jan-2015 - Mylan lawsuit accusing Celgene of using REMS to block generic Revlimid and Thalomid should go to trial says US Court.

US FDA approves Impax’s Parkinson’s disease treatment following resolved manufacturing issues

12-Jan-2015 - Almost two years since it was first rejected , Impax Pharmaceuticals said late last week that the US FDA has approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease.

Illicit vendors using YouTube to advertise fake drugs, says MHRA

08-Jan-2015 - Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social media sites to advertise their products, according to the MHRA.

After Warning Letter, a recall for Hospira injectables

08-Jan-2015 - Hospira has recalled ten lots of injectable Mitoxantrone it says are subpotent and contain impurities.

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