Latest Headlines

Latest Headlines

FDA widens review of Dr. Reddy's manufacturing ops

Dr Reddy's Laboratories has again come under the spotlight of the U.S. Food and Drug Administration which has ordered a third-party audit covering the entire manufacturing network of the company, according to a report by  Livemint.

GSK beats AstraZeneca to finish line, wins FDA approval of first anti-IL-5 injectable for asthma

GlaxoSmithKline secured FDA approval for Nucala, an injectable treatment for asthma, a therapeutic dominated by inhaled drugs. Still, the alternative form of drug delivery for respiratory conditions has the potential to reach sales of $7 billion a year, according to analysts.

Feds to scrutinize med tech Medicare reimbursement in fiscal 2016

The Office of the Inspector General promised to put med tech reimbursement under the microscope during fiscal year 2016, citing Medicare costs associated with defective medical devices, cardiac catheterizations, imaging services and clinical labs as some of the device-world arenas worthy of particular scrutiny. Another area of focus will be medical device cybersecurity, according to the internal government watchdog's FY 2016 work plan.

Collegium's pain drug wins a 'tentative' FDA approval with Purdue blocking the way

Collegium Pharmaceutical won FDA approval for its abuse-deterrent take on oxycodone, but an ongoing patent dispute with Purdue Pharma stands in the way of the drug's launch.

Teva's late-stage Huntington's drug scores 'breakthrough' bragging rights at FDA

Eight months after Teva scooped up the promising SD-809 (deutetrabenazine) to correct a severe movement disorder afflicting some 500,000 patients in the U.S., the company has scored bragging rights to the FDA's breakthrough drug designation.

Lilly, Merck join Valeant in DOJ spotlight with new inquiries on pricing

Big Pharma has been getting it from all sides lately over drug pricing, with companies such as Valeant taking most of the heat as lawmakers, presidential candidates and the public weigh in on the issue. But now Eli Lilly and Merck are joining Valeant in the hot seat as the U.S. Department of Justice probes the companies over how they report prices to government-funded drug programs.

China to restart mainland IPOs, with pharma ready to roll

Chinese officials said last week they will lift a ban on mainland initial public offerings (IPOs), clearing the way for 10 companies already approved to move ahead with their listings within two weeks and another 18 to list before the end of the year, according to a report in the Wall Street Journal.

Luye's schizophrenia drug gets nod to move ahead with NDA approval

Luye Pharma Group said its injectable risperidone schizophrenia drug was given the go-ahead for a new drug application (NDA) from the U.S. Food and Drug Administration with no additional clinical trials needed, according to a report by China Daily.

Gilead snags FDA green light for 4-in-1 HIV combo

Gilead is facing mounting competition in the HIV space from players including GlaxoSmithKline's ViiV Healthcare. But now, it has a new combo product to tout in Genvoya, which won an FDA go-ahead Thursday. 

Dr. Reddy's feels FDA heat, gets warning letter for three plants

A regulatory hammer has been hanging over Dr. Reddy's Laboratories since the FDA wrote up one of its plants for falling short of quality standards. That hammer has now fallen hard with the drugmaker becoming the latest large Indian drugmaker to be hit with a warning letter.