Industry news

Breakthrough designation: Cornucopia or gold star?

Brian Orelli / BioWorld

Since the FDA's breakthrough therapy designation came into existence as part of the FDA Safety and Innovation Act in July 2012, the agency has granted the designation to 145 drugs. The Center for Drug Evaluation and Research (CEDR) has fairly consistently granted the designation to about a third of the applications, while companies applying to the Center for Biologics Evaluation and Research (CBER) haven't quite known what to expect with the designation granted to just 8 percent of the applications in the 2013 fiscal year, the first full year companies could apply, to a high of 40 percent granted in fiscal 2015.

Third approval flows from U.S. biosimilar pipeline

Mari Serebrov / BioWorld

The FDA approved its third biosimilar Tuesday: Sandoz Inc.'s Erelzi, a biosimilar to Amgen Inc.'s Etanercept. As it has with the first two biosimilars, the agency approved an extrapolated label, licensing Erelzi for all of Etanercept's indications – rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. The follow-on was tested in plaque psoriasis against the EU-licensed version of Enbrel, with a bridging study to the U.S. version.

Russia rises in global innovations ranking

Marchmont Innovation News

Russia ranked 48th in the  2016 Global Innovation Index (GII) , just ahead of Chile and Costa Rica and immediately after the United Arab Emirates and Turkey. In this year’s ranking Russia rose from the 56th place it occupied last year. Published annually by the Cornell University, the INSEAD Business School and the World Intellectual Property Organization in partnership with other institutions, the index ranks 128 nations by their capacity for, and success in, innovation. 

Can pharma use Twitter Stickers to make community connections that bond?

Beth Snyder Bulik / FiercePharmaMarketing

Ready to get sticky on Twitter, pharma? Twitter introduced stickers in June as a way for users to add fun visual expressions to their photos and connect back to the platform. Now it’s invited brands to the party.

CRO industry poised for steady growth as new work in China explodes

John Carroll / ENDPOINTS

The future looks good for the CRO industry. Not great or fantastic, but a lot better than it has been earlier in the decade. A new report out from KPMG notes that the industry appears headed for steady growth through 2019, with the largest organizations emerging from a major round of consolidation set to outperform the hundreds of smaller companies that still operate in biopharma. One of the big trends to look for here is a shift to China, where CRO work has been exploding. The CRO market was a modest $1.4 billion in 2007, but grew to $6.4 billion in ’14.

China drug exports to U.S. rise but companies struggle with quality

Eric Palmer / Fierce Pharma

Chinese companies now account for more than 50% of the global active pharmaceutical ingredient (API) market. It has more than 500 companies registered to sell in the U.S. and 10 times that many serving its own market. But many of those continue to struggle to meet international standards.

As cardio R&D shrinks in size, a new study highlights some serious pitfalls – and a positive shift

John Carroll / ENDPOINTS

In biotech circles, it’s become an article of faith that cancer offers some of the best prospects in new drug development. Cardiology, meanwhile, looks like a long, expensive and risky prospect. And a new study now underscores the impact that shift in attitude has had, while spotlighting a solidly upbeat migration to a new generation of therapies looking to carve out some novel results as me-too drugs are relegated to the sidelines. The authors, including Aaron Kesselheim at Brigham and Women’s, also call out developers for failing to publish the results of failed studies.

Fact Check: The truth about biopharmaceutical patents

Mark Grayson / PhRMA

Recent reports and news stories have alleged that government-protected monopolies have led to high drug prices for patients. The studies distort the proven IP system as monopolistic and ignore the very real challenges and obstacles that are inherent in the R&D process.

30 August 2016

Miramar Labs, Inc.® Appoints Patrick F. Williams To Board of Directors

Miramar Labs, Inc., (MRLB), a global aesthetic company, announced today the appointment of Patrick F. Williams to the Company’s Board of Directors. Mr. Williams will serve as Chairman of the Audit Committee, bringing nearly 20 years of financial management experience.

Innovators vs Exploiters: Drug Pricing And The Future Of Pharma

Life SCi VC

Pharmaceutical pricing got thrown onto the front page again last week, causing the expected anaphylactic reactions among politicians, practitioners, and parents. The root of this crisis: Epipen’s 600% price increase over the past eight years. The biannual upticks underlying that number finally caused a blowback as back-to-school buyers were faced with big out of pocket expenses this year that their insurers passed onto them.