Topic:

Regulatory

Latest Headlines

Latest Headlines

Bristol-Myers and AbbVie speed toward FDA approval with a 'breakthrough' cancer drug

A new drug for blood cancer from Bristol-Myers Squibb and AbbVie is on the fast track to FDA approval, winning a priority review to treat multiple myeloma.

Alexion wins a pair of EU approvals to build out its rare disease ranks

Alexion Pharmaceuticals is no longer a one-product company, winning tandem European approvals for two rare disease drugs it hopes will mimic the success of Soliris, the world's most expensive treatment.

Services grow in Singapore with Asian clinical, manufacturing biologics boom

Singapore has gathered pace as a place for companies in Asia to source services related to biologic clinical and manufacturing with recent additions in the city-state highlighting niches in a growing market.

India's Maharashtra state asks blood banks to send plasma to Reliance Life Sciences in albumin shortage

Facing an acute shortage of human albumin, the medicines regulator in India's Maharashtra state has written to all blood banks instructing them to provide plasma to the company that produces the most of the product in the state, Reliance LIfe Sciences, in a step that along with imports may ease the situation.

Titan Pharma submits opioid addiction-fighting subdermal implant for FDA approval

Titan Pharmaceuticals announced that it has resubmitted its application for FDA approval of its subdermal implant for the delivery of buprenorphine/naloxone as a maintenance treatment for opioid addiction. The move follows a surprise rejection in 2013.

Social media spin mistress Kardashian mops up Duchesnay's marketing mess

Kim Kardashian knows a thing or two about cleaning up messes on social media. Amid the festivities at this past weekend's MTV Video Music Awards, the celebutante put out a corrected social media post for Canadian pharma Duchesnay's morning sickness med, Diclegis, weeks after the FDA came down on the company for violating its branding rules and demanded that it fix the problem.

How openFDA's 'crazy collision' of Silicon Valley and federal culture is reshaping the regulator

Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns from the congressional watchdog, the FDA is now garnering plaudits for its embrace of agile and open development. This new way of thinking is central to--and to an extent responsible for--the recently unveiled precisionFDA initiative.

Another recall by Indian drugmakers as U.S. FDA notes troubles

Two leading Indian drug firms once again face quality in manufacturing issues with the U.S. FDA, leading in this case to voluntary recalls even as both face extensive remedial actions to bring plants back into the good graces of the regulator.

Japan's MHLW gives nods for Remicade, VFend, Tracleer, INOflo new indications

Japan's Ministry of Health, Labor and Welfare last week gave the nod to several new drug indications, including Mitsubishi Tanabe's Remicade for intravenous use and indications of entero-Behcet, neuro-Behcet and vasculo-Behcet diseases when existing treatments are inadequate, a spokesman for the ministry said.

Insulet says troubled wearable insulin pump plant back on track, just as FDA issues recall notice

Insulet said its long-troubled Billerica, MA, manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.