Industry news

FDA quality focus will definitely mean winners and losers, report says

Eric Palmer / FeircePharmaManufacturing

The FDA intends to change the way it handles plant inspections, using metrics to suggest which plants may be having issues and making more frequent trips to those that appear at risk. While those companies committed to quality may be rewarded for their efforts, a new report warns that those that are already struggling with quality can expect to be more under the thumb of regulators. Those on tight margins may find it more than they can handle.

Big Pharma's new PCSK9, heart failure meds stuck in the slow lane. What gives?

Tracy Staton / Fierce Pharma Marketing

In noting Q4 sales of Sanofi ($SNY) and Regeneron's ($REGN) brand-new PCSK9 med Praluent--€5 million, a far cry from analyst estimates of €41 million or more--Bernstein analyst Tim Anderson said the big shortfall "is likely to bring scrutiny, as yet another example of slow uptake of a new medicine."

Are the big M&A players in biopharma waiting out the bear market?

John Carroll / FierceBiotech

One of the market themes that emerged in 2015 was that a marquee biotech player like Celgene ($CELG) could get a boost out of a high-profile acquisition--just as Big Pharmas like Roche ($RHHBY) and Eli Lilly ($LLY) remained aloof to the ever-rising, jaw-dropping price tags tied to drug pipelines after a three-year bull market.

FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality

FDA

The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget – an eight percent increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the Vice President.

World Cancer Day: Reflecting on progress and hope for the future in cancer treatment

Nicole Longo / PhRMA

More than 1.7 million new cancer cases are expected to be diagnosed in the United States this year. Although that number is daunting, World Cancer Day reminds us that tremendous progress in the prevention and treatment of cancer has been made over the years, and researchers around the globe are working together to advance cancer care for patients.

Canada’s chance to reform its approach to innovation

Jay Taylor / PhRMA

Intellectual property drives and sustains research, development and delivery of valuable new treatments and cures for patients who need them around the world. America’s world-leading research-based biopharmaceutical industry supports 3.4 million good-paying jobs in all 50 states. With this in mind, PhRMA takes the annual opportunity to submit our comments to the Office of the U.S. Trade Representative’s (USTR) Special 301 Report– a regular review of trade barriers that exist with U.S. trading partners.

09 February 2016

Tobira Therapeutics Completes Patient Recruitment for ORION Phase 2a Study of Cenicriviroc in Obese Patients with Suspected Fatty Liver Disease

Tobira Therapeutics, Inc.  ( NASDAQ : TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, announced that it has completed recruitment for the Phase 2a ORION study.

VC Snapshot: January

PitchBook Blog

Three of the biggest concerns for today's IPO investor

Nizar Tarhuni / Pitchbook Blog

We all know what the recent environment has been like in the Silicon Valley muddy fish bowl. LPs and non-traditional investors have funneled tons of money into the venture capital asset class and valuations have subsequently moved to record levels. Today, we’re at a crossroad. Many companies are staying private at a point in their lifecycle where traditionally we'd expect to start seeing them move to the public side, yet the sense is that the current environment isn't conducive to that.

Study: Smart contact lens offers continuous monitoring of glaucoma progression

Stacy Lawrence / Fierce Medical Devices

Researchers from Columbia University Medical Center have found that smart contact lenses that emit patterns of electrical signals can be used to detect the rate of glaucoma. The smart contact lens system, known as Triggerfish, is from Swiss startup Sensimed and is designed as a diagnostic. It offers an automated, continuous recording of ocular dimensional changes when worn over a 24-hour period.