Topic:

Regulatory

Latest Headlines

Latest Headlines

Beef producers lash out at USDA's choice of Humane Society vet for advisory panel

On July 21, when Agriculture Secretary Tom Vilsack announced the 19 members of the USDA Advisory Committee on Animal Health, a quick look at the names didn't seem like the list would raise any red flags. But now some agricultural groups are speaking out against one of Vilsack's picks: Michael J. Blackwell, a veterinarian and director of veterinary policy for the Humane Society of the United States.

UPDATED: FDA official encourages makers of Low T drugs to work together on a single risks trial

While data on the heart and stroke risks of testosterone enhancers have been mixed, the FDA has held firm on its position that "Low T" drugs should be used only for medical conditions not as a lifestyle drugs. Now the FDA says drugmakers need to provide new data on the heart and stroke risks of using them to boost testosterone in aging men. But, to save everybody a lot of time, effort and cost, it would be great if the drugmakers would do the clinical trial work together.

Drugs just don't get rejected much anymore, report says

Picking apart biopharma's protracted boom, analysts tend to focus on investors' ongoing appetite for risk, readily available early-stage funding and the vibe that getting drugs approved is simply much easier than it once was.  Forbes, with the help of BioMedTracker, has run the numbers on that last point, finding that the FDA has been green-lighting new drugs at an escalating rate for the past few years.

Italian court ruling clears way for Sorin's previously disputed merger with Cyberonics

Italy's Sorin Group fended off an objection to its planned merger with Cyberonics brought by the State's Attorney of Milan. Its stock is up almost 6% on the Milan Stock Exchange, as investors celebrate the news that the planned holding company, LivaNova PLC, is on track to be formed in the U.K. as planned thanks to a favorable court ruling.

Mylan expands recalls from plants spanked in FDA warning letter

Just days after the FDA hammered Mylan sterile injectable plants in India in a warning letter, the drugmaker has said it is expanding a recall of injected cancer meds it manufactures there for Pfizer.

Mylan sees three Indian plants under FDA scanner on quality

Three of Mylan-run drug manufacturing operations in India have been cited in a U.S. FDA warning letter for quality violations that included a failure to set procedures aimed at preventing microbiological contamination and on the use of torn gloves..

SK Chemicals ready to sell home-grown influenza vaccine as season gets underway

SK Chemicals said it has released for sale in the domestic market a cell-culture influenza vaccine, SKYCellflu, which received a nod South Korea's Ministry of Food and Drug Safety in March to ramp up production after receiving marketing authorization in December last year.

Australia's TGA registers Hospira's Inflectra

Australia's Therapeutic Good Administration has registered mAb biosimilar Inflectra (infliximab) from Hospira, the company said in a press release, noting it sets the stage for reimbursement under the country's Pharmaceutical Benefits Scheme.

E-cigs take center stage as U.K. advises use as a stop-smoking aid

The regulatory territory around e-cigarettes is murky. It's clouded by scientific issues around the potential and relative harm they cause, as well as governmental concerns around its oversight as a tobacco or a smoking cessation product.

Chinese regulators easing multi-region clinical trial hurdles

China's move to spur drug approvals is seen as a breakthrough on accepting multi-region clinical trial processes as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market, according to a briefing by the country's State Council, or cabinet.