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Teva faces EU antitrust probe over MS drug Copaxone

pharmaphorum

Teva’s Copaxone patent expired in Europe in 2015 and the Commission said it will investigate whether the company broke antitrust rules by defending the drug’s market position after the expiry. Now the European Commission has opened an investigation to see whether Teva acted illegally by blocking competition for Copaxone in the EU.

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Theranos founder Elizabeth Holmes guilty of fraud, says jury

pharmaphorum

They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

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Pharma 4.0™ Is Gaining Momentum and Driving Innovation

ISPE

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, and management communication strategy. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance?

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Please check your email to download the Report.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 2015: PhRMA won a lawsuit against HRSA regarding orphan drugs. 340B providers expressed significant concern.

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How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

In a 2015 systematic review of registered and published outcomes in randomised trials, researchers found that discrepancies between registered and published outcomes of clinical trials were common. Nevertheless, it is incumbent on trialists to communicate such changes. Later work simply re-affirmed this finding.

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DSCSA Postponement And What It Means For Independent Pharmacies

DiversifyRx

Most of the existing requirements have been in place since 2015 and require Pharmacies to have SOPs, Training, and data storage (or agreements with their ATPs in place) to maintain the required transaction data. The four requirements below are handled in various ways. Identifiers All products received must contain a product identifier.