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After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays.

Europe’s Innovation Medicines Initiative (IMI) has appointed experts from Portugal and Finland to chair the IMI Scientific Committee.

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action.

Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules governing drug promotion to today’s world of internet communications and social messaging.

As expected, the Food and Drug Administration (FDA) approved only 27 new molecular entities (NMEs) in 2013.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process, writes Sean Milmo.

The headlines have moved on for the English Cancer Drugs Fund (CDF). Replacing the positive press releases such as “thousands of patients to benefit” in 2013 are headlines shouting out that “thousands face being denied life-extending medication”.

Two weeks in and the New Year already seems old. Yet members of our Pharm Exec Editorial Advisory Board are still eager to share their top of line predictions on trends that will shape the industry’s business and reputational assets.

Change has never been the word most associated with pharma. Irrespective of a record-breaking number of newly approved drugs over the last two years, a new report just out warns that continued growth is not sustainable unless R&D efficacies at drug companies are addressed and new paradigms adopted.

It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014.

Ten days in and the New Year already seems old. Yet members of our Pharm Exec Editorial Advisory Board are still eager to share their top of line predictions on trends that will shape the industry’s business and reputational assets.

Eli Lilly forecasts that its profit will fall by up to one-third this year, Reuters has reported. The drugmaker’s forecasted revenue for 2014 is now between $19.2 billion and $19.8 billion, with a net income of $3 billion and operating cash flow of $4 billion.

Trying to nail down the actual number of new drugs approvals in 2013 is like trying to swat a fly - it can be highly elusive.

Dominating the frontier of medicines discovery is a simple, endlessly challenging question: if not a drug, then what? Industry science has evolved from the chemical roots of the small molecule to the biologics synthesized from living organisms, but the delivery mechanism – pill or injectable – is basically the same.

For more than fifty years the basic European Union rules about medicines have been clear.

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency.

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.

PEGD 2014 Media kit

European Union (EU) regulators today reached agreement on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and places further safeguards on the safety of trial subjects.

The global Parkinson’s Disease market will decline from $3.4 billion in 2012 to $2.9 billion by 2019 (a negative Compound Annual Growth Rate of 2.3%), according to a new report by GBI Research (New York, NY).

FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan.

The number of drugs developed in Turku, Finland, and granted marketing authorizations this year now stands at three, with a fourth expected to follow.

In a bid to improve transparency in 2014, the European Medical Agency’s December Management Board Meeting cleared the way for the publication of the agendas and minutes of the Agency’s Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Advanced Therapies (CAT).

Amid the environment of a gradual economic recovery and continued consolidation of bio/pharmaceutical companies, scientists, technicians, and professionals involved in drug development expressed a mix of muted optimism and stagnant employment options.

GlaxoSmithKline (GSK) will invest £200 million ($327 million) to expand its manufacturing facilities in Ware, Hertfordshire and Worthing, Sussex in the United Kingdom and establish a new manufacturing innovation facility.

Collaboration seems to be ‘in’ thing and it’s set to continue in Europe with the European Medicines Agency (EMA) and EUnetHTA agreeing a three-year joint work plan.

I find December a fairly schizophrenic month. Half of your head is thinking back to what you’ve achieved, half of your head is focussing forward to what you will do in the New Year. Looking back on 2013, I re-read Should CEOs use Social Media?, a post I wrote back in February encouraging pharma CEOs to show their faces on the social networks. Looking forward, I wonder if CEOs will actually do it in 2014?

At a time when burst bubbles have created uncertainty for investors in the biomedical realm, it’s smart for a drug company to make use of new legislation and emerging trends in venture capital. This is particularly true in spurring confidence in that translational area of drug development many deem the “Valley of Death”.