Industry news

EU and US Pledge to Recognize Each Other’s GMP Inspections

Randi Hernandez / BioPharm International

In a landmark decision, the United States FDA and the European Commission announced on March 2, 2017 that they will recognize each other’s inspection assessments at pharmaceutical manufacturing facilities. The Mutual Recognition Agreement amends the 1998 agreement on good manufacturing practices and comes three years after initial discussions began.

Where do drug names come from? According to Octavia Spencer's SNL character, the contacts in her cellphone

Tracy Staton / Fierce Pharma

Drugmakers spend big money crafting the names of their new products. Specialists draw on the “personalities” of each letter of the alphabet—which is why we get so many Z’s and X’s—brainstorm dozens of candidates and run their ideas by the FDA for its all-important approval.

Leveraging Cognitive Search and Search-Based Applications

Laurent Fanichet / Pharmaceutical Executive

Pharmaceutical companies accumulate enormous amounts of data over many years of working on drugs, from early research, via lab projects through years of clinical trials, approval processes, and ensuing pharmacovigilance. They are permanently confronted with the question of how to best leverage that data in different situations, whether presenting new drugs for FDA certification, putting together teams of experts for new projects or conducting clinical trials based sometimes on years of intense research.

Five ways collaboration can drive life science communication success

Marco Ricci / PharmaPhorum

Cross-agency collaboration seems a logical step for any life science communications company looking for success – but are there new means of achieving a successful partnership? Firm believers in this idea are European life sciences communications agency Healthware International and US-based Intouch Solutions, whose recent partnership has resulted in a new international life science marketing agency, Intouch Solutions International – a joint venture that Healthware CEO Roberto Ascione describes as unlike “a common network alliance”.

Flipping the patient? New WeGo Health platform offers quick access to patient experts

Beth Snyder Bulik / FiercePharmaMarketing

Not all pharma interactions with patients are deep dives. Sometimes pharma marketers just need quick patient insights or input. That’s the gap WeGo Health is hoping to fill with its just-launched WeGo Health Experts platform. Traditionally, WeGo has served large pharma companies on projects that are in-depth and service-heavy with a team of experts assigned to connect healthcare organizations with some of its 100,000 digital patient leaders. 

The tools of choice in person-centred care

Linda Banks / Deep Dive

NHS England’s chief executive, Simon Stevens, recently stated that focus must be put on care in the community and in the home to tackle the huge deficits facing NHS trusts. Here Sir Jonathan Asbridge, Clinical Director of Healthcare at Home and President of the European Society for Person Centred Healthcare, explains to pharmaphorum’s Linda Banks how such a shift to ‘person-centred’ care can help health services and pharma manage finite budgets and improve outcomes.   

GPP and GSP rules are coming into effect in Russia starting from March 1

GMP News

Starting from March 1, Orders of the Ministry of Health of Russian Federation approving Good Pharmacy Practice and Good Storage Practice are coming into effect in the Russian Federation.

Russian Ministry of Health might authorize selling medicinal drugs via Internet

GMP News

On February 27, 2017, Russian Ministry of Health published a draft resolution „About distance retail sales of medicinal products for human use and medicinal products for veterinary use (except for narcotic and psychoactive medicinal drugs).“

02 March 2017

Syndax Pharmaceuticals Reports Fourth Quarter and Year-end 2016 Financial Results and Provides Clinical and Business Update

Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the fourth quarter and year ended December 31, 2016. In addition, the Company provided a pipeline update as well as a review of upcoming milestones. As of December 31, 2016, Syndax had $105.3 million in cash, cash equivalents and short-term investments.

Under the pricing spotlight, pharma sticks to single-digit hikes in 2017

Eric Sagonowsky / FiercePharma

It's evidence to justify pharma's current fears. Amid all of the recent scrutiny on drug pricing—and after enjoying years of great pricing freedom in the U.S.—drugmakers have reined in their price hikes since the start of 2017. And that may threaten this year's revenue.