New WHO Guidelines On Generics

Stephanie Sutton Pharm Tech EuropeThe World Health Organization (WHO) has released two new quality guidelines for generic pharmaceuticals concerning the preparation of dossiers in Common Technical Document (CTD) format and the data that should be provided.

It is hoped that both guidelines will support the objectives of the Prequalification Programme, a United Nations program managed by the WHO that aims to make priority medicines available to those who need them. The medicines should meet WHO-recommended norms and standards of acceptable quality. Read more »

No Generic Substitution In The UK

Stephanie Sutton Pharm Tech EuropeThe UK government has said it will not progress with plans for automatic generic substitution of medicines in primary care because “it is not clear whether the proposals would have provided substantial benefit to the NHS”, according to the UK Health Minister Lord Howe. Read more »

Protection from Patent Dependence

Erik Greb PharmTech editorIn the current economic slump, generic versions of branded drugs have become a bigger thorn in innovators’ sides than before. To safeguard their profits for just a bit longer, many companies have paid generic-drug manufacturers to delay the introduction of their products to the market. US and European authorities have called these arrangements anticompetitive, though, and events on Capitol Hill last week indicate that they might not be tolerated much longer. Read more »

sanofi aventis Unhappy About Generic Lovenox Approval

Alexis Brekke Pellek PharmTech editorThe US Food and Drug Administration approved the first generic version of the anticoagulant drug enoxaprin sodium injection on last Friday, July 23. Lovenox is the drug’s brand name, and it’s manufacturer, sanofi Aventis (Paris), was not happy about FDA’s decision. Read more »

AstraZeneca Versus the European Commission

Stephanie Sutton Pharm Tech EuropeCompanies always want the longest patent protection possible for their products — and with good reason considering the immense costs of R&D. However, some companies go a little too far in seeking patent protection to the point that they may even try to mislead the regulators in order to extend the life of patents. Read more »

Is Healthcare Reform Socialism?

Erik Greb PharmTech editorThe dust has partly settled since President Obama signed the “Health Care and Education Affordability Reconciliation Act of 2010.” By now, analysts have had a chance to examine the act’s details and get a sense of what practical effects the legislation will have. So what will healthcare reform mean for pharmaceutical manufacturers? Read more »

Patent expiries good news for healthcare providers

Stephanie Sutton Pharm Tech EuropePatent expiries and the imminent threat of competition from generics is the bane of many pharmaceutical companies’ lives and I’m frequently reading and writing about the doom and gloom pharma is facing because of these issues. This is of course a serious issue for the industry, but there are many beneficiaries, including healthcare providers. Read more »

Rodney Dangerfield and R&D

Erik Greb PharmTech editorThese days, research scientists, much like Rodney Dangerfield, can’t get any respect. The latest evidence of this arrived on Friday, when AstraZeneca (London) proposed to cut 3500 research and development (R&D) jobs by 2014. Read more »

EC scrutinizes patent settlements

Stephanie Sutton Pharm Tech EuropeThe European Commission has said it will be taking a close look at patent settlements where an originator has paid off a generic competitor in return for delayed market entry of a generic drug. Only yesterday, the EC released a statement saying that it has asked certain pharmaceutical companies to submit copies of their patent settlement agreements completed between originator and generic companies between July 2008 and Dec. 31, 2009. Read more »

Genzyme’s Friday the 13th

Erik Greb PharmTech editorFriday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

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