PharmExec Blog

EMA Responds Robustly to Conflict-of-Interest Claims

By Philip Ward, Applied Clinical Trials.

The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area. Read More »

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The Medical Technology Disconnect

By Doug Mowen.

The medical technology industry has a legacy of creating life-enhancing, life-extending products while rewarding its investors in the process. In fact, this connection between innovation and profitability has been a fundamental driver in the C-suites and boardrooms of many medical device, diagnostics and equipment companies.

But change is underway. Dominating external forces are disrupting the traditional strategies of medical technology leaders. Companies face greater economic pressures, a reformed healthcare system, new hospital and physician alignments, and new technological challenges. Read More »

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Industry Seeks Clearer Track-and-Trace Standards

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain, writes Jill Wechsler.

Beginning Jan. 1, 2015, manufacturers and distributors will need to have in place systems able to transmit information on prescription drug movement in the United States from plant, to packagers and various wholesalers and distributors, and ultimately to dispensers. FDA is charged by the Drug Supply Chain Security Act (DSCSA), a key component of the Drug Quality and Security Act (DQSA) of 2013, to issue guidance and rules for establishing such a process and is consulting with all stakeholders on viable approaches and policies (1).

FDA held a public workshop in May 2014 (2) to gain input from manufacturers and other supply-chain parties on developing standards for what eventually will be an interoperable tracking system for prescription drugs. FDA officials and industry leaders further reviewed DSCSA requirements, along with broader supply-chain security issues, at a June conference in Washington, D.C. sponsored by the Parenteral Drug Association (PDA). Read More »

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CMOs Take a Hit as Payers Refuse to Cover New Drugs

By Jim Miller.

The value of the customer relationship to a CMO is a function of two variables: unit volume and price per unit. Both variables are contentious issues: bio/pharmaceutical companies are putting enormous pressure on their CMOs for lower prices, while their inability to deliver forecasted volumes often means lost revenues for CMOs as reserved capacity goes unutilized. The resulting low margins depress CMO profitability and threaten their ability to raise capital and invest in replacement equipment and new facilities. Read More »

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Pharma Report Predicts Trillion Dollar Global Industry by 2020

By Colin McMahon.

EvalutePharma’s seventh edition of its World Preview documents that worldwide prescription drug sales forecast will exceed the one trillion dollar mark by 2020. The company bases this estimate on the growing compound annual growth rate (CAGR) that the pharmaceutical industry is currently enjoying. It predicts that CAGR will continue to grow through 2020, ultimately reaching a peak at 5.1%, up sharply from the increase from 3.8% to 4.4% over the past year.  Read More »

Posted in FDA, Gene therapy, Global, Guest Blog, R&D, Strategy | Tagged , , | Leave a comment
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