Industry news

FDA to pharma: Scrap that fine-print risk info in DTC ads

Tracy Staton, FeircePharma

Look for some big changes next time you run across a magazine ad for Crestor or Viagra or any of the brands on heavy rotation. The FDA has decided that its long-standing disclose-all policy on side effects was wrong. Way wrong.

How Device Makers Can Take Healthcare "Beyond the Pill"

Medical Devices and Diagnostic Industry

In the aftermath of the frenzy of JPMorgan Healthcare Conference that concluded mid January in San Francisco, the life sciences industry is taking stock of the themes emerging for 2015 and beyond.

FDA seeks budget boost for precision medicine IT infrastructure

Nick Paul Taylor / Fierce BiotechIT

The FDA has requested $2 million in President Obama's 2016 budget to build precision medicine-related IT infrastructure. The regulator highlighted cloud computing and data security as areas in which it needs to improve.

Apple's health tech takes early lead among top hospitals

Christina Farr / Reuter

Apple Inc's (AAPL.O) healthcare technology is spreading quickly among major U.S. hospitals, showing early promise as a way for doctors to monitor patients remotely and lower costs.

Low rates, M&A spur flood of pharma debt deals

Danielle Robinson / Reuter

Merck & Co's US$8bn jumbo bond is just the tip of the iceberg of debt supply from the healthcare sector in the months ahead with brand names like Novartis and Pfizer set to compete for investor cash.

Researchers develop low-cost smartphone device for quick HIV and syphilis screening

Emily Wasserman, FiercePharmaDevices

As devicemakers home in on cheap, rapid diagnostics for patients in developing nations, researchers are creating a low-cost smartphone device to quickly test for infectious diseases in poor countries.

Novo investing $750M in manufacturing this year

Eric Palmer, FeircePharmaManufactoring

Novo Nordisk ($NVO) has an insulin plant that will open soon in Russia and bought a plant from Olympus Biologics in the U.S. last year where it will make active pharmaceutical ingredients (APIs). These projects are part of efforts by the Denmark-based leader in insulin drugs to build its manufacturing capacity as it continues to grow.

Two new med tech incubators in the works--one with the AMA, the other Georgia Tech

Stacy Lawrence / Fierce Medical Devices

Early med tech innovation may get a bit of a boost with two new incubators. The American Medical Association is partnering with Chicago-based healthcare technology incubator Matter. The pair will create AMA Interaction Studio at Matter, a physical and virtual infrastructure for entrepreneurs and physicians to collaborate to develop new healthcare tech, services and products.

Precision Medicine Initiative focuses on genomics, data sharing, health IT

Mari Serebrov / BioWorld

Not nearly as expansive as the draft 21st Century Cures Initiative released earlier last week by a House committee, the president Friday unveiled his $215 million Precision Medicine Initiative focusing on collaborative efforts to leverage advances in genomics, data sharing and health information technology to accelerate biomedical discoveries.

FDA Encourages Supplements for Oncology Drug

Jill Wechsler, PharmExec.com

One way to reduce off-label prescribing of treatments for cancer and other conditions is for manufacturers to test additional indications and file supplemental applications to add those uses to approved labeling. The problem is that the testing and approval process for supplements takes a lot of time and money. And formal approval of new uses often is less critical in oncology where off-label prescribing is the norm.