Topic:

Regulatory

Latest Headlines

Latest Headlines

Ariosa Diagnostics scores CE mark for prenatal test software

Roche's Ariosa Diagnostics nabbed a CE mark for software for its noninvasive prenatal test, a win for the company months after it scored expanded coverage for the tool in the U.S.

FDA taps PatientsLikeMe to harness patient info for drug-safety monitoring

PatientsLikeMe has been on a roll as of late, inking deals with biopharma giants such as AstraZeneca, Genentech and Biogen to provide its patient-reported data for the companies' R&D initiatives. Now the company is shifting gears, planning to work with the FDA to see how its patient reports could improve drug safety.

NanoCarrier aims for PhI study on neck cancer in Japan for NC-6004

In something of a surprise move, Japan's NanoCarrier submitted a Phase I application to the Pharmaceuticals and Medical Devices Agency for oncology candidate NC-6004, Nanoplatin, on June 9.

Japan's PAFSC backs Lilly's dulaglutide, among others, in latest round

Eli Lilly Japan's once-weekly glucagon-like peptide-1 receptor agonist dulaglutide was recommended for approval by Japan's Pharmaceutical Affairs and Food Sanitation Council's (PAFSC's) First Committee on Drugs, an advisory panel to the health minister, following a June 5 meeting, an official said.

Video prescriptions, advice, on the cards for hard-pressed patients in Japan

Older patients and those who suffer from chronic diseases or live in far-flung locales in Japan may soon be allowed to get or renew prescription drugs through video calls,  Nikkei Asian Review  said, cracking open a door into online medicine so far largely shut by opposition from brick-and-mortar businesses.

Australia's Circadian gets FDA nod for PhI on AMD candidate

Australia's Circadian Technologies won Investigational New Drug approval from the U.S. FDA for Phase I clinical trials of OPT-302 for patients with wet age-related macular degeneration, the company said on Monday. 

Japan's MHLW sanctions Takeda on Blopress marketing

Takeda Pharmaceutical was sanctioned by Japan's Ministry of Health, Labor and Welfare for using exaggerated marketing materials to promote hypertension medicine Blopress and was issued a business improvement order with which it will comply, according to a June 12 press release from the company.

S. Korea moves to calm MERS fears as regional caution remains

On Monday, South Korea moved to reopen schools shut last week on concerns of a wider spread of Middle East respiratory syndrome (MERS) even as the health ministry reported 5 new cases and regional governments kept up precautions, according to Today newspaper.

Roche slashes hep C drug price 65% for government clinics in India

Certain government clinics in India will see prices for Roche hepatitis C drug Exxura cut by 65%, according to the Business Standard, citing a local company executive.

Oculus receives FDA clearance for novel, spray-based wound care formulation

Oculus Innovative Sciences announced that it has received FDA 510(k) clearance for its Alevicyn SG Antipruritic Spray Gel to treat dermatologic conditions like burning and itching skin, as well as skin irritation, lacerations, abrasions and minor burns.