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In a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable.

Successfully commercializing a proprietary drug in China can be a Kafkaesque affair.

The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has awarded Northwest Biotherapeutics, Inc. (Bethesda, MD) the very first “Promising Innovative Medicine”, or PIM designation, for the company’s DCVax-L product.

This month’s ePatient Connections Summit in Philadelphia, PA, saw biopharmaceutical firms, medical device companies, and patient advocates discuss best practices for engaging patients online and in social media settings.

FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and “overcoming roadblocks”.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Canada’s Research-Based Pharmaceutical Companies (Rx&D) have welcome finalization of the text for the Comprehensive Economic and Trade Agreement (CETA).

Hemispherx Biopharma (Philadelphia, PA) has announced a set of research collaborations designed to develop “therapeutic cocktails against Ebola which may potentially overcome the emergence of drug resistance due to Ebola virus mutation”.

Value-based Pricing (VBP) was first discussed as far back as 2007 by the UK’s consumer authority, the now defunct Office of Fair Trading (OFT).

Scary tales of The-Next-Big-Social-Thing killing off the first digital marketing blockbuster have been building for years. McKinsey’s November 2013 iConsumer survey reported a 20 percent decline in email usage between 2008 and 2012, as the medium gave up ground to social networks and mobile messaging apps.

The European Medicines Agency (EMA) is reviewing available information on Ebola treatments currently under development to “facilitate evidence-based decision-making” by health authorities.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) reports that it has “strengthened its commitment in China”.

This week members of the Coalition for Healthcare Communication (CHC) met to discuss issues in healthcare communications and marketing like privacy and security, off-label advertising and the Sunshine Act along with an update on the overall DC environment.

The Non-Hodgkin Lymphoma (NHL) treatment market in the Asia-Pacific (APAC) countries of India, Australia, China and Japan will expand from $1.1 billion in 2013 to $1.7 billion by 2020, with Japan remaining the largest contributor to growth, according to GBI Research.

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions.

What can be gleaned about the direction that health policy will take for the next five years under the new European Commission, scheduled to take office at the beginning of November? Peter O’ Donnell address this question in his new Applied Clinical Trials column here.

It is estimated that applying big data strategies could potentially generate up to $100 billion in value annually across the US healthcare systems, specifically by optimizing innovation and improving the efficiency of research and clinical trials.

Merck KGaA has announced that it has agreed to buy Sigma-Aldrich for $140 per share in cash, or a total of $17 billion.

After almost two years of discussion and analysis, the Food and Drug Administration is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics

Although it is true that there are many legitimate ways to succeed, a host of these strategies appear to be diametrically opposite of one another: Diversified versus pure play, generic versus ethical, regional versus global, R&D versus limited R&D, organic development versus acquisitions, and so on.

A second payment has now been made under the UK’s Pharmaceutical Price Regulation Scheme (PPRS).

Up until a few months ago, there was little industry interest or public support for developing vaccines and treatments to combat the Ebola virus.

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan.

Biopharmaceutical manufacturing is following the general pharmaceutical market trend toward global expansion.

Merck’s Keytruda, recently approved in the US to treat patients with advanced melanoma that have stopped responding to other cancer therapies, will soon face strong competition from Bristol-Myers Squibb’s (BMS) Opdivo, an analyst from research and consulting firm GlobalData has reported.

The European Federation of Pharmaceutical Industries and Associations’ new medicines verification system will put an end to the re-sale of stolen and counterfeit drugs in the European supply chain, the organisation claims.

Early-stage and mid-size bio/pharmaceutical companies have enjoyed an embarrassment of riches over the past 18 months.

The Chinese market is attractive to foreign investors for many reasons. It is the world’s third largest market for pharmaceuticals with annual sale of US$71 billion.

The role of medical affairs is taking on greater importance, as relationships between life sciences companies and external stakeholders become more complicated.

Pharm Exec‘s 13th Industry Audit looks at how well a cross section of companies in big Pharma, mid-tier specialty and biotech are delivering against today’s hottest performance metric: shareholder value.

PEGD0814In this special Technology Issue of Pharm Exec Global Digest: Apple or Big Pharma: Who Will Lead in the Wearable Healthcare Device Space?; Google Glass - a Healthcare User’s Guide; UBISTART’s New Payout for Innovative Start-ups; and more… Click here to read the issue.