Industry news

FDA set to add inspectors to India, report says

Matthew Driskill / FiercePharmaAsia

As the U.S. Food and Drug Administration continues to crack down on manufacturers in China and India, the agency looks set to add at least 5 inspectors to the subcontinent to rein in cases of fake drugs and falsified tests that have already cost India millions of dollars in lost sales.

Listen up, pharma marketers--to patients' social media posts, that is

Carly Helfand / FiercePharmaMarketing

Pharma companies are coming around on social media, however slowly. But how many are actually listening to what their patients say on social media platforms--and doing something with the feedback they get?

UK Pharmaceutical Companies Collaborate on CAR-T Cell Immuno-oncology Therapies

BioPharm International

Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology announced on Jan. 6, 2016 the launch of a collaboration to develop a new immuno-oncology cellular therapy created modifying the genes of T-cells to target solid tumors.

Enhancing New Drug Development

Jill Wechsler / BioPharm International

FDA once again approved more innovative new drugs this past year, beating a near record set in 2014. Yet, John Jenkins, director of the Office of New Drugs (OND) in The Center for Drug Evaluation and Research (CDER), is concerned if this pace of development will continue.  

Biotechs launch an IPO blitz as Nasdaq stumbles out of the gate

John Carroll / FierceBiotech

Nasdaq started off 2016 by stumbling out of the gate on Monday, taking a nasty hit along with the other major stock indexes as jitters about the Chinese market rattled investors once again. But 6 different biotechs shrugged off the chill that has afflicted industry stocks for months and filed IPOs which are collectively looking to raise hundreds of millions of dollars in the new year.

The biggest winners--and losers--in the 2015 race for new drug approvals

John Carroll / FierceBiotech

In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs.

Japan's push on innovative drugs gets a budget boost

EJ Lane / FeircePharmaAsia

Japan's cabinet gave the nod to a draft of next year's budget in a Christmas Eve meeting that saw the Ministry of Health, Labor and Welfare (MHLW) get funds outlined in September to promote development of innovative drugs and medical devices--and paves the way for compassionate clinical trial approvals.

FDA sends fewer drug promotion action letters in 2015--but is that a good thing for pharma?

Beth Snyder Bulik / FiercePharmaMarketing

The downward trend continues for FDA action letters--but whether that's actually a good thing for the industry remains to be seen. In 2015, the OPDP issued just 9 letters, down from 10 the previous year. While the one-year drop is small, a further look back points to an ongoing decline since 2010, when there were 52 action letters sent. In the years between, there's been an annual decline in the number of letters. There were 31 sent in 2011; 28 in 2012 and 24 in 2013.

Hospitals respond to 'alarm fatigue' with patient monitoring innovation: WSJ

Emily Wasserman / FierceMedicalDevices

Back in 2013, nonprofit hospital accreditor the Joint Commission set alarm safety for patient monitoring as its safety goal, giving hospitals until January 2016 to set up new policies and procedures for related devices. With the first of the year come and gone, healthcare centers are rolling out new solutions to reduce unnecessary alarms and improve monitoring.

Precision medicine plan in China may be announced in March

Matthew Driskill / FiercePharmaAsia

The Chinese government is expected to announce a precision medicine initiative in March that could dwarf the $215 million U.S. plan announced last year.