Industry news

Feds come down in support of subsidizing copays in some clinical trials

Varun Saxena / FierceMedicalDevices

The feds recently said that device companies can subsidize copays in clinical trials, a move that was praised by food and drug attorneys at Hyman, Phelps & McNamara. An advisory opinion issued by the Office of Inspector General involved an incident in which subsidizing a copay was necessary in order to keep the trial's subjects blinded so that they would not know whether they were receiving the treatment or control procedure, known as a sham.

It is going to take a village to advance precision medicine

Mari Serebrov / BioWorld

Faced with more than 80 million genetic variants that may or may not affect a person's health or risk of disease, the FDA is realizing that it will take a village in the cloud to expand its current regulatory borders and deliver the promise of precision medicine.

Real-time data can put slow drug launches into the fast lane, researcher says

Beth Snyder Bulik / FiercePharmaMarketing

Ask any pharma company: Drug launches are tough. A thousand things can go right or wrong. But that's where data--especially quickly gathered, targeted data--can make the difference.

Patent challenger Bass shrugs off Celgene's attack on his short-selling motives

Tracy Staton / Fierce Pharma

Money makes the world go round--the patent world, that is. That's the word from hedge funder Kyle Bass, who has been targeting drug patents he calls "low quality," and shorting pharma stocks along the way.

What does Google's corporate shuffle mean for its biotech ambitions?

Damian Garde / Fierce Biotech

Google ($GOOG) is divvying up its composite parts, becoming, depending on whom you ask, the new Berkshire Hathaway, the next General Electric or something heretofore never seen. But the move could have mixed implications for Google's nascent but growing life sciences empire--including the high-profile, secretive biotech Calico --as shuffling things around could expose such moonshot projects to the pitchforks of profit-hungry investors.

13 August 2015

Neothetics Reports Second Quarter 2015 Financial Results

Neothetics, Inc.  (NASDAQ:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today reported financial results and business progress for the second quarter 2015.

Then and Now: How Prescription Drug Prices Fall Significantly Over Time

Holly Campbell / PhRMA

Prescription drug prices fall significantly over time because the marketplace is unlike any other part of the U.S. health care system.

How slow can Big Pharma go in emerging markets?

Carly Helfand / FiercePharma

Industry watchers have pointed to a slowdown in pharma's emerging markets growth as a worrying sign for companies that have been heavily targeting developing nations while the U.S. and European markets stagnate. But just how slow has the growth become?

FDA makes its first approval of a 3-D printed drug

Nick Paul Taylor / Fierce Biotech IT

For the first time, the FDA has approved a drug produced using a 3D printer. Aprecia Pharmaceuticals picked up the approval and distinction of being first past the post when the FDA gave the all-clear to its adjunctive therapy for the treatment of epilepsy.

The Future of Clinical Pathways

Guest Contributor / PhRMA

Utilization of clinical pathways, in which an individual’s treatment follows a defined protocol, can help ensure patients receive the best possible care based on the most recent scientific data. However, clinical pathways can institutionalize a “cookie cutter” approach instead of personalized medicine, as well as limit treatment options in order to cut costs. So, which of these will be the future for clinical pathways?