News

India's quality lapses sparking turmoil throughout the generic drug industry

India is a crucial player in the global drug supply chain. But there is a growing perception among doctors that Indian-made meds fall short on quality, leading some drugmakers to cry conspiracy and others to wonder how best to respond.

New incontinence data could give Ipsen's Dysport a path to lucrative urology use

Ipsen announced "positive results" in a Phase II trial of Dysport in patients with urinary incontinence. That could put Ipsen's drug in line for more head-to-head competition with Allergan's Botox, which has successfully expanded into several medical uses.

Why is ThromboGenics' strategic review urgent? Just look at recent Jetrea sales

ThromboGenics admitted last month that slow U.S. sales of its lead drug had put it into a quandary. What could it do to turn the tide? Explore strategic options. Now, the company says sales lagged further for the second half of 2013.

Novo Nordisk taps bankers for potential IT unit spinoff

Novo Nordisk has stepped closer to a spinoff. The Danish drugmaker wants to hive off its information technology business, NNIT, and it has chosen Morgan Stanley and Danske Bank to advise it on the potential deal.

Pfizer sues India's Torrent in latest bid to fend off generic Viagra

With Lipitor already over the patent cliff, Pfizer has been working hard to hang onto exclusivity for its famed erectile dysfunction drug, Viagra. In its latest bid to block generic competition, Pfizer has sued Indian drugmaker Torrent Pharmaceuticals for patent infringement.

Intercept's lead drug boasts success in PhIII after worrisome side-effects disclosure

Intercept Pharmaceuticals delivered a bad news-good news punch over the weekend about its lead drug.

Italian prosecutors home in on Roche, Novartis execs in eye-drug collusion probe

Itlaian prosecutors have zeroed in on four executives at Roche and Novartis in their probe of potential fraud in the companies' eye-drug sales, Reuters reports, citing sources. The four executives weren't identified.

Shire recalls Gaucher drug but says it has plenty of supply in reserve

Shire is voluntarily recalling three lots of its Gaucher drug Vpriv but emphasized that it does not expect any supply interruption from the recall. Shire has promoted its drug's availability as an indirect selling point against a rival product from Genzyme that ran into supply issues 5 years--a problem the company has long since remedied.

In latest marketing-reform move, GSK recruits in-house doctors to speak for products

GlaxoSmithKline may be phasing out speaking fees for doctors, but that doesn't mean doctors won't be speaking about its products. As Bloomberg reports, the company plans to add physicians to its in-house marketing staff.

Bristol-Myers' Eliquis gets new FDA nod for use after ortho surgery

When Bristol-Myers Squibb and Pfizer launched their new anticoagulant, Eliquis, early last year, Wall Street analysts predicted it would be a $3-billion-a-year blockbuster. After more than a year of struggling to reach that goal, the companies got some good news late Friday, when the FDA approved the drug to reduce the risk of blood clots in the legs and lungs following hip or knee replacement surgery.

Tokyo hospital exec says Novartis employees deeply involved in leukemia-drug trial

Novartis employees were more involved in a Japanese drug study than previously suspected. The University of Tokyo Hospital said doctors not only let Novartis employees collect patient data from various trial sites but also allowed the Swiss drugmaker into its records on all 255 trial participants.

Statins and muscle aches are unrelated

So is Lipitor or Crestor causing you to have muscle aches? The answer is no, according to a new meta-analysis of the side effects of the cholesterol-lowering drugs.

GSK touts Anoro results as it preps for generic attacks on $8B-seller Advair

With aging top dog Advair losing ground to generic and branded competitors alike, GlaxoSmithKline is grooming a lineup of respiratory up-and-comers to step in with their own blockbuster sales. And new study results comparing Advair with not-yet-launched Anoro Ellipta could help the fledgling COPD treatment do just that.

FDA cites compounder for making tainted version of KV's Makena

After the FDA approved KV Pharmaceutical's Makena in 2011, the drugmaker asked the agency to stop compounding pharmacies from making their much cheaper versions of the drug. KV filed for bankruptcy reorganization after the agency turned its back on the request, but the FDA may now be coming around.

Celgene's superstar Revlimid again dissed by U.K. cost watchdog

Celgene is working to expand its portfolio of drugs, but for now its growth is primarily driven by extending the uses of its megablockbuster Revlimid. As successful as the myeloma drug has been, the U.K.'s NICE is again questioning its cost vs. benefit for certain patients.

Gilead's hot-selling Sovaldi draws more patent attacks

Gilead Sciences' Sovaldi portends to be a megablockbuster by the end of this year--and possibly the biggest-selling drug of all time a few years down the road. So it's no surprise that others are after a piece of the drug--Idenix Pharmaceuticals included.

Under fire, FDA chief Hamburg defends approval of pain pill Zohydro

As pharmacies began dispensing Zogenix's powerful new painkiller Zohydro this week, FDA Commissioner Margaret Hamburg found herself under increasing pressure to revoke her agency's approval of the drug and yank it off the market. But she's not about to cave in to the pressure, she told the U.S. Senate's Health, Education, Labor and Pensions Committee during a hearing on Thursday, according to Reuters.

Sun Pharma plant feels the heat of FDA import ban

A Sun Pharma plant has joined the growing ranks of Indian operations banned by the FDA for manufacturing issues. Unlike Ranbaxy Laboratories and Wockhardt, two other Indian generics players that have recently felt the sting of import alerts, the Sun Pharma plant is not key to its financial success.

Another Glaxo respiratory drug sees regulatory filings in its future

The British pharma giant says it's nailed the primary endpoint in a Phase III study of its injectable candidate mepolizumab, which will help set the severe eosinophilic asthma treatment up for its first regulatory filings.

Analysts see $1.5B boost for Pfizer on 'better than expected' Prevnar 13 data

Pfizer's Prevnar 13 vaccine slashed the number of pneumonia cases in older adults, according to details from a new study that could add up to $1 billion to its global sales.