Industry news

Pharma groups to FDA: Stop that new off-label rule in its tracks

Tracy Staton / Fierce Pharma

Cheered by victories in off-label marketing lawsuits, pharma companies were expecting some loosening of the regulatory shackles when the FDA rolled out a new rule on the subject.

In Search of a Silver Lining: A Global Market Access Outlook

Neil Grubert / Pharmaceutical Executive

Just weeks into 2017, pharmaceutical pricing is making the headlines in countries all around the world and storm clouds are gathering for the life sciences industry. Neil Grubert asks, what are likely to be some of the key trends in market access this year and beyond, and what are the implications for the life sciences industry?

What digital spending slowdown? If WebMD sells, don't blame pharma, industry insiders say

Beth Snyder Bulik / FiercePharmaMarketing

With a collective head smack last week, pharma industry digital insiders read about WebMD’s decision to pursue a sale or merger after some reports blamed the move on slowing pharma spending on digital marketing.

Researchers show how to step up cancer therapy efficacy

Marchmont Innovation News

Researchers from Russia’s Moscow Lomonosov State University (MSU) and their Swedish colleagues have provided enough evidence to show that denying cancer cells access to nutrient substances could impact therapy both negatively and positively, depending on the type of an anti-tumor drug. 

WHO publishes list of bacteria for which new antibiotics are urgently needed

World Health Organization

WHO published its first ever list of antibiotic-resistant "priority pathogens" – a catalogue of 12 families of bacteria that pose the greatest threat to human health. The list was drawn up in a bid to guide and promote research and development (R&D) of new antibiotics, as part of WHO’s efforts to address growing global resistance to antimicrobial medicines.

Russia’s pharmaceutical market will almost double to $39 billion by 2021, says GlobalData

Global Data

The pharmaceutical market in Russia is one of the fastest growing globally and is set to rise from $20.91 billion in 2016 to $38.56 billion by 2021, representing a compound annual growth rate of 13%, according to research and consulting firm GlobalData.

28 February 2017

Clearside Biomedical, Inc. Receives Notice of Allowance for Ninth U.S. Patent

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Number 15/001,610 entitled, “Methods and Devices for the Treatment of Ocular Diseases in Human Subjects.”

27 February 2017

Clearside Biomedical, Inc. Redirects Pre-Clinical AMD Research Resources Toward Ongoing DME Clinical Development Program

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced that it has initiated a strategic realignment of its research and development resources from its pre-clinical development program for axitinib for the treatment of wet age-related macular degeneration (“wet AMD”) toward its ongoing clinical development program for the treatment of diabetic macular edema (“DME”) assessing ZuprataTM, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide.

FDA accepts Pfizer’s blood cancer candidate for speedy review

Ben Adams / Fierce Biotech

Pfizer said the FDA has given its experimental leukemia med inotuzumab ozogamicin a priority review as it gets to work on assessing the medication for approval, which could come as early as August.

China updates national drug list, adding some blockbuster Western meds

Angus Liu / Fierce Pharma

China has updated its list of medicines covered by national medical insurance, adding some new drugs with a focus on pediatrics and major illnesses such as cancer, hepatitis, and renal and cardiovascular diseases, including some from companies like GlaxoSmithKline and AstraZeneca.