Pharmaguy's Insights Into Drug Industry News
185.9K views | +33 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

AstraZeneca Scrapes the Bottom of the Rejected Drug Barrel for "New Drugs" - Innovation Redefined

AstraZeneca Scrapes the Bottom of the Rejected Drug Barrel for "New Drugs" - Innovation Redefined | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AstraZeneca is working with outside researchers to look for untapped potential in drugs that the company has shelved, part of a broader move to improve its research-and-development output.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

AstraZeneca Sponsors Survey to Assess Patient Knowledge of Science Behind New Cancer Therapies

AstraZeneca Sponsors Survey to Assess Patient Knowledge of Science Behind New Cancer Therapies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Today sees the release of the results of a May 2016 survey of patient/carer groups about patient-focused scientific information on cancer, sponsored by AstraZeneca. 

 

KEY FINDINGS FROM THE SURVEY INCLUDE:

 

  • 99% of respondent patient/carer organisations “Agree” or “Somewhat agree” that people living with cancer want to know how their cancer treatments work.
  • Over 90% of respondent patient/carer organisations “Agree” or “Somewhat agree” that patients must understand scientific concepts about cancer if they are to better manage their cancer.
  • 57% of respondents indicate that increasing the awareness of cancer treatment options among patients and the public is a top priority of their organisation.
  • 61% of respondents say that the public is unfamiliar with basic scientific concepts about cancer.
  • 83% of patient/carer organisations have been asked by patients/carers about immuno-oncology. However, only 48.2 % of those same organisations are themselves familiar with the topic of immunotherapies in oncology.
  • 67% of patient/carer organisations have been asked by patients/carers about gene mutations associated with cancer and biomarkers. Again, though, only 52 % of the organisations themselves claim familiarity with the concepts of genetic testing and precision medicine.
Pharma Guy's insight:

Immunotherapy may offer new hope to cancer patients, but is also creating new challenges by complicating clinical trial designsXconomy reports. Researchers worry patients who want access to a treatment in the headlines will sign up for a clinical trial but drop out if they are assigned to the control group. Patients in cancer drug trials often know whether they receiving an experimental drug or the control treatment, and blinding many studies is futile.

 

Tremelimumab has been one of AstraZeneca's top drug prospects and is a leading example of the kind of cancer programs the pharma giant hopes to use to generate billions of dollars in new sales. A setback here will raise fresh questions for AstraZeneca as it attempts to play catch-up to the market leaders in checkpoint inhibitors.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Excuses, Excuses! Lions Health Grand Prix Still Smells Fishy to Me!

Excuses, Excuses! Lions Health Grand Prix Still Smells Fishy to Me! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When a pair of animated fish cracking jokes about triglyceride levels won the first pharma Grand Prix last year at the Cannes Lions International Festival of Creativity, the campaign was initially lauded for its smart, silly, irreverent tone. And then the backlash hit, and it was criticized for that same reason.

 

AstraZeneca had worked with DigitasLBi to develop the unbranded campaign, which kicked off in 2014 when the drugmaker received FDA approval to market Epanova, a prescription fish-oil pill that helps lower triglyceride levels.

 

Was this campaign emblematic of the good work the industry does? Did it matter that the campaign was unbranded, and not product-specific? Those are some of the questions agency leaders asked among themselves.

 

“I thought it was a very charming and disarming way to make people care about a subject matter that is quite mundane, which is triglycerides,” said Alexandra von Plato, this year's pharma jury president and group president of North America for the Publicis Healthcare Communications Group.

 

The use of humor, though, didn't deter criticism of the campaign, which stemmed from a deeper concern within the industry, she said. “In the scheme of how important this industry is and the importance of the work it does, [the campaign] felt a little trivial,” von Plato said. “That campaign for fish oil was good, but the sense was that it wasn't Grand Prix-worthy.”

 

Despite the success of Take It From a Fish, AstraZeneca at some point this year took down all of the campaign's online creative, including the website, Twitter feed, and YouTube videos.

 

Still, agency leaders say that the creation of Lions Health — this will be the specialty event's third year — is pushing agency creatives and their clients to do better work. “Even when people are complaining, it's probably good for the business because they are saying: Why aren't we winning more?” noted von Plato. “We certainly should be winning.”

 

Still, agency leaders say that the need for creativity in the pharmaceutical industry has more to do with addressing criticism about drug prices and the business case for direct-to-consumer advertising — which are two significant issues at play in the U.S. this year — than with winning the top prize at Cannes.

 

“The whole issue of pharma pricing and direct-to-consumer advertising has become a public and public health issue,” said Josh Prince, chief marketing officer at Omnicom Health Group and this year's jury president for the health and wellness category. “Because [the U.S. is] not a single-payer marketplace, a lot of things are third-party funded. [Since] consumers are now having to take on the cost burden of pharma, all of these issues are conspiring to make clients more conservative with their communications.”

 

But pulling back on risk-taking in marketing isn't expected to improve the dialogue between drugmakers and the patients, insurers, doctors, lawmakers, and investors who make up their audience.

 

“Conservatism is not going to help them,” Prince said. “It's really going to take inventiveness and inspiration and ambition and creativity. When it's done and it's done well, ideas can really cut through, even against all of the issues.”

Pharma Guy's insight:

Fish or no fish, this year's Grand Prix Award may be just as bad as last year's. For more on that, read: "Will New Cannes Lions Health Pharma Ad Prizes Be as Smelly as Last Year's Fish?"; http://sco.lt/5bGCZ7 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Like 3-Day Old Fish, AZ's Take it From a Fish Campaign Had Bad Taste

Like 3-Day Old Fish, AZ's Take it From a Fish Campaign Had Bad Taste | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AstraZeneca has suspended its Take it From a Fish campaign, taking down the online creative for a campaign that won the top prize at the 2015 Lions Health festival in Cannes, France.

The campaign website, TakeiItfromafish.com, the YouTube videos, and the Twitter feed and TakeItFromAFish.com website are all now inactive.

The unbranded campaign featured two dead talking fish, Sal and Marty, who discussed lowering their triglyceride levels amid jokes about their relationships, eating habits, and big-screen star quality.

“The Take It From A Fish campaign was an innovative pre-launch and non-branded marketing effort that has recently been discontinued,” an AstraZeneca spokesperson said in an email.

Take It from a Fish was the first campaign to win a Pharma Grand Prix at the Lions Health, the healthcare segment of the 2015 Cannes Lions International Festival of Creativity, held each June. Rob Rogers, co-CEO of the Americas for Sudler & Hennessey and the 2015 jury president, last year described the campaign as “an example of a traditionally conservative client doing something really groundbreaking.”

By most industry standards, the campaign was successful. Within three months, there was an 11% increase in searches for high triglycerides and the Twitter feed had the fourth highest follower count among pharmaceutical brands, DigitasLBi claimed.

At the same time, industry executives say it's relatively uncommon for companies to take creative work offline even if it was designed to support an unbranded marketing campaign. Drugmakers traditionally launch unbranded campaigns before moving forward with branded efforts.

There are a handful of reasons why a drugmaker might choose to remove creative content for an unbranded program. One unnamed executive wondered if the removal of the Take It From a Fish creative was more a question of corporate concern about “taste and tone” or if the outcomes of additional clinical trials for other indications were not as promising as initially hoped. Another said that certain pre-launch communications must be amended to promote a product in a branded environment.

Pharma Guy's insight:

Personally, I never saw what was creative about Abbott and Costello channeled as dead fish.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

AZ's OIC Super Bowl Ad Gets a Below Average Effectiveness Rating

AZ's OIC Super Bowl Ad Gets a Below Average Effectiveness Rating | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Advertising for the 2016 Super Bowl was disappointing, to say the least.  Of 61 TV spots evaluated by ABX:
  • Only 22 (36%) were equal to, or above, the “average” ABX Index for TV ads
  • Only eight (13%) were “excellent” based on ABX benchmarks


The ABX Index is an overall measure of ad effectiveness that has been shown to correlate to brand performance.  It is comprised of Awareness, Messaging, Reputation and Call-to-Action.  An ABX Index of 100 is average for all benchmarked ads, whereas an ABX Index of 109 is the average for TV spots.


The waterfall chart above, shows the ABX advertising effectiveness Index for each of 61 ads. Only a few exceed an Index of 120, which is the threshold for excellence.


AZ's Opioid-Induced Constipation ad, which has drawn a lot of criticism (http://bit.ly/OIC-Adcriticism), scored way below average (80) although it seems to have generated a lot of interest via social media (http://sco.lt/83HgyP). 


Keep in mind that the "popular" press ad ratings for Super Bowl are really only "Likeability" ratings.  While Likeability can contribute to the success of an ad, it is not predictive of success. For example, among these Super Bowl ads, Likeability has a very poor correlation with Purchase Intent.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

AstraZeneca Psychiatrist KOLs Forced to Resign from Texas State Hospital for Promoting Seroquel

AstraZeneca Psychiatrist KOLs Forced to Resign from Texas State Hospital for Promoting Seroquel | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Two psychiatrists at a Texas state hospital have resigned after being told they would face disciplinary actions for accepting hundreds of thousands of dollars in speaking and consulting fees from AstraZeneca while also promoting one of its drugs to state officials.


The psychiatrists allegedly violated various department rules as a result of their relationship to the drug maker, which involved efforts to ensure the Seroquel XR antipsychotic would be placed on the state formularyand prescribed by state physicians, according to letters sent to the physicians by the department. A formulary is a list of preferred drugs for which insurance coverage is made.


Texas officials say that one psychiatrist, Lisa Perdue, was paid more than $615,000 by the drug maker between 2005 and 2013, and allegedly approached members of the state’s Executive Formulary Committee, although did not disclose she did work for AstraZeneca, according to department documents. And Anthony Claxton received more than $231,000 between 2005 and 2012, according to department documents.

Pharma Guy's insight:


This illustrates the "toxicity" of Key Opinion Leaders (KOLs). For more on that read "A KOL by Any Other Name".


Meanwhile, the biggest pharma funder of the National Alliance on Mental Illness (NAMI) in 2009 was AstraZenca (AZ), which donated $1,255,000.00. Recall that AZ is forced to pay about 400X that amount ($520 million) to resolve allegations that it illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (see HHS press release here).

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

AstraZeneca paid $465K in kickbacks to mental health officials, committed fraud in Seroquel marketing, says TX AG

AstraZeneca paid $465K in kickbacks to mental health officials, committed fraud in Seroquel marketing, says TX AG | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AstraZeneca's battle over Seroquel marketing missteps drags on. Texas Attorney General Greg Abbott has sued the company for fraud, saying that AstraZeneca sales reps misled doctors and state Medicaid officials about Seroquel's side effects, paid kickbacks to two influential state decision-makers, and promoted the powerful antipsychotic for off-label uses.


AstraZeneca targeted Texas Medicaid for Seroquel sales, the suit claims, deeming the program "low hanging fruit" and "an ABSOLUTE MUST WIN" for the drug's brand team. Off-label promotion was "encouraged and rewarded," the suit says. The Medicaid program was so essential to Seroquel marketing, the AG's suit claims, that the company shelled out $465,000 to two top mental health officials to help boost scripts.

Pharma Guy's insight:


AZ seems to be a serial fraudster when it comes to off-label Seroquel promotion. Back in April 2010,  AstraZeneca was fined $520 million by U.S. DOJ to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation. For more on that and other pharma settlements, read The DOJ v Pharma Settlement Planetary System

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Four Approaches to Lung Cancer Disease Awareness Marketing

Four Approaches to Lung Cancer Disease Awareness Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Lung cancer sure seems to receive short shrift within oncology. It claims more lives every year than breast, prostate, and colon cancer combined, yet somehow isn't perceived as life-threatening or “bad” as those other diseases.

 

As witnessed by the very existence of the following campaigns, that's in the process of changing. Each of the approaches is valid and more ambitious than a great majority of the campaigns that preceded them. Here's why they work — and why they matter.

 

#1: Merck: Focuses on the science in Test. Talk. Take Action. The awareness campaign is designed to call attention to treatment options for non-small cell lung cancer.

 

#2: Novartis: Novartis provides the easiest to comprehend immuno-oncology primer to date in Harnessing the Science of Immuno-oncology at Novartis. No, this explainer video isn't specific to lung cancer, but it approaches its mission by employing the widest of wide-tent tactics — cartoons and euphonic narration.

 

#3: Free to Breathe (many pharma corporate partners): Flip to Breathe comes across a bit too similar to the Ice Bucket Challenge, plus the how-to video isn't as clever as its creators might think.

 

#4: Astrazeneca: Tell some stories. The stories land with more impact when they're told by people with skin in the game. [Meanwhile, “Merck’s New Keytruda DTC Ad is a ‘TRU Story’ Told by a Fake Patient (Actor)”; http://sco.lt/6nURcH

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

CDC Says AZ's FluMist is Ineffective Compared to Flu Shots; i.e., 3% v. 63%!

CDC Says AZ's FluMist is Ineffective Compared to Flu Shots; i.e., 3% v. 63%! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Dealing a blow to AstraZeneca in its largest FluMist Quadrivalent market, a CDC committee has recommended against any use of the nasal vaccine for the upcoming season. It’s a setback that AZ says it’s still working “to better understand” as the pharma navigates a changing flu vaccine landscape.

 The U.S. accounted for more than two-thirds of FluMist Quadrivalent's revenue last year, with $206 million of its $290 million in global sales. 

In issuing its recommendation, the CDC’s Advisory Committee on Immunization Practices weighed "data showing poor or relatively lower effectiveness" from three previous flu seasons. In late May, the body received data showing that FluMist was just 3% effective in children aged 2 to 17 during the 2015-2016 flu season, compared with an estimated 63% effectiveness for flu shots. ACIP said "no protective benefit could be measured" from the nasal vaccine.

AstraZeneca said some of the CDC data doesn't jibe with its own or with findings from studies by independent health authorities in the U.K. and Finland. The company said its vaccine was 46% to 58% effective overall last season.

What's odd, as Reuters reports, is that the CDC back in 2014 recommended FluMist over injectable competitors due to its superior efficacy at the time. Children are often given the nasal vaccine to avoid injections.

AstraZeneca said it’s communicating with the agency to learn more.

 

[Also read "Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggest"']

Pharma Guy's insight:

Keep in mind that CDC's definition of "effective" - whether for mist or shot - is not very impressive. For more on that, read Does the Flu Vaccine Work? What 62% "Effective" Really Means

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Will New Cannes Lions Health Pharma Ad Prizes Be as Smelly as Last Year's Fish? 

Will New Cannes Lions Health Pharma Ad Prizes Be as Smelly as Last Year's Fish?  | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Pharma and healthcare marketers from around the world will descend on the South of France this weekend for the third annual Cannes Lions Health creative awards and confab. And this year, pharma marketers will have more opportunities to win a prize.

New this year is the splitting of Pharma Lions into three categories: black box, branded communications and unbranded communications. There are also additional categories in both the Pharma and Health & Wellness Lions including digital craft and branded content. The two-day health event prefaces the larger 6-day global advertising creative colloquium that draws more than 11,000 marketing industry players every year with speakers ranging from actors Mindy Kaling, Gwyneth Paltrow, Will Smith and Channing Tatum to CBS chief Les Moonves and Hulu CEO Mike Hopkins.

While the Health Lions haven’t reached the paparazzi-worthy status of the entertainment Lions, the juxtaposition of the two events--along with changing and raised expectations for creative in healthcare and pharma marketing--lends heft to the health awards.

“The closer the Health Lions can be to the Lions, the better off we all are,” said Dave Sonderman, chief creative officer at InVentiv Health’s GSW. “… Generally speaking in the pharma space, the idea of celebrating life-changing creativity is a fantastic way to think about what it is we’re all trying to do.”

One yet-unanswered question is if will there be a Grand Prix winner for pharma? While AstraZeneca’s “Take it From a Fish” campaign took the best in show for pharma last year, the judges declined to award a grand prize for pharma in the show’s first year, 2014. Finalists, or short listed entries, won’t be announced until Friday, with awards handed out at a gala on Saturday night.

Around the awards are dozens of sessions and talks about creativity in pharma and healthcare marketing, including ones about the power of truth featuring Good Morning America anchor Robin Roberts; using creativity to inspire brand love hosted by Johnson & Johnson and BBDO; and “Badass Science Seeks Advertising to Match” sponsored by Grey.

GSW’s Sonderman is moderating a panel discussion about the science and art of empathy, including Harvard research work and the role virtual reality is beginning to play. GSW associate director of innovation Travis Rooke, meanwhile, will participate in a first-ever on-site workshops with other global agency creatives to tackle air pollution and come up with creative and collaborative solutions.
Pharma Guy's insight:

AstraZeneca has suspended its Take it From a Fish campaign, taking down the online creative for a campaign that won the top prize at the 2015 Lions Health festival in Cannes, France. For more on that, see here: http://sco.lt/7SNIcz 

 

Is Better Ad Creative on the #Pharma Horizon? Geez! I Hope So! http://sco.lt/6c0aJd 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Is Vermont Governor Shumlin Misguided? Yes Says #Pharma: OIC Ad Will Stay on Air

Is Vermont Governor Shumlin  Misguided? Yes Says #Pharma: OIC Ad Will Stay on Air | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Two drug makers are ignoring a demand from Vermont Governor Peter Shumlin to yank a television ad that he believes is a “shameful attempt” to exploit the opioid crisis.


The dispute arose last week when Shumlin released an open letter to Daiichi Sankyo and AstraZeneca after they ran an ad during the Super Bowl. The ad promoted awareness of opioid-induced constipation, a condition that can occur when someone is taking opioid painkillers.


Shumlin noted that a one-minute Super Bowl ad cost a reported $10 million — or more precisely, $5 million for each 30-second spot — and wants the drug makers to, instead, divert some of their promotional dollars toward prevention and treatment programs.


So what will the drug makers do?


A Daiichi Sankyo spokeswoman said in a statement that the drug maker acknowledges that opioid abuse is a “very serious public health” issue in the United States, but did not mention the possibility of pulling the ad. Instead, she wrote us that the company — along with AstraZeneca and five advocacy groups that also sponsored the ad — is “committed to raising awareness” about the condition.


In a letter to Shumlin, AstraZeneca wrote that “we believe our message encourages a clinically important conversation about OIC between patients and their doctors, which may also facilitate a broader discussion about safe and appropriate opioid use. While these discussions are separate and distinct, both are important for patients and their families.”


Their responses, however, did not mention pulling the ads or using advertising funds as Shumlin suggested.


“He’s way off base,” Richard Meyer, an industry consultant who writes The World of DTC Marketing blog, told us. “If he is so concerned about addiction, he needs to tighten the prescribing parameters and make it tougher for patients to become addicted.”


But another marketing expert disagreed.


“I suppose he, like many other state governors, is faced with increasing Medicaid costs and other expenditures related to opioid addiction,” said John Mack, who publishes Pharma Marketing News. “So, I don’t think he is the misguided one.”

Pharma Guy's insight:

My full reply to Silverman's inquiry ("Is Shumlin misguided?"): 


I suppose he, like many other state governors, is faced with increasing Medicaid costs and other expenditures related to opioid addiction. So, I don’t think he is the misguided one. The one who is REALLY misguided is Massachusetts Governor Charles Baker who eliminated $500,000 in funding for a program designed to curb the inappropriate prescribing of opioid drugs by physicians. Especially when police in his state (e.g., Gloucester; http://sco.lt/90L66j) are fighting drug addiction and specifically citing pharma companies as part of the problem.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

AZ's OIC Ad Wins Super Bowl #Pharma Ad Competition, But Hurts Industry

AZ's OIC Ad Wins Super Bowl #Pharma Ad Competition, But Hurts Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Two pharma brands debuted on TV's biggest stage in 2016, sparking a host of unfortunate bowel jokes I'm sure you've already heard.

One of the spots, by Valeant's Xifaxan, introduced much of America to “gut guy”—the latest DTC character to either charm or disgust audiences in the service of patient empowerment. The other spot, from AstraZeneca and Daiichi Sankyo, got Americans talking about constipation and opioid use.


Give credit to AstraZeneca, which certainly got people talking about opioid induced constipation. Unfortunately, most of the generated dialogue wasn't good.


Then, unexpectedly, opioid addiction became a major campaign issue during the New Hampshire Primary—held two days after the big game. As the pols might say it, AstraZeneca's optics were bad.


***************UPDATE*************

On Thursday, Vermont Governor Peter Shumlin called for the ad to be pulled, writing a letter to the two pharma CEOs saying, "In the midst of America's opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies' profits."

"For those of us in the community of addiction treatment professionals, the AstraZeneca ad's underlying message was as obvious as a blinking neon sign that read 'Use More Opioids!,'" wrote a professor and author of an addiction book in a Time web column. "It almost feels like the drug companies want to keep their flagship product (opioids) going full steam ahead by countering a major side effect with another drug. It's certainly in the best interest of the pharmaceutical companies to keep their clients satisfied enough to continue using their products."

The Washington Post headlined its coverage of the ad: "This Super Bowl ad proved just how much America loves its opioid painkillers."

Meanwhile, Pushed perhaps by the additional media coverage, so far the ad has been mentioned more than 38,000 times on social media, mostly on Twitter and Facebook, in the past few days, according to real-time TV tracker iSpot.tv. It also had a 50% positive Tweet rating and has been viewed more than 2 million times online, according to iSpot.

Read: "AstraZeneca and Daiichi Sankyo field backlash over Super Bowl OIC awareness ad"; http://bit.ly/1WhV1WI 


Pharma Guy's insight:

Related: "White House Critical of Opioid Constipation Drug Advertising"; http://sco.lt/9MRv6n 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA NexiumGate: Agency Delays Approval of Generic Version & Issuance of Stronger Warnings Of Brand

FDA NexiumGate: Agency Delays Approval of Generic Version & Issuance of Stronger Warnings Of Brand | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Will an FDA error mean that U.S. consumers will have to wait still longer to buy a generic version of the widely used Nexium heartburn pill?


Ranbaxy, you may recall, was the first generic drug maker to win the right to market a copycat version in the U.S., which would have allowed the company to do so for six months without any competition. The arrangement is designed to reward patent challenges to brand-name drugs and lower health-care costs.


But there has been a snag. The FDA banned imports of Ranbaxy products from four different facilities in India due to a raft of regulatory violations. And until manufacturing begins, the six-month market exclusivity remains in place, which means Ranbaxy rivals cannot make their own generic versions.


Last month, however, Ranbaxy executives confidently stated that they expected to be able to proceed with plans to sell generic versions of Nexium, which is marketed by AstraZeneca, and the Valcyte antiviral sold by Roche. Now, though, the FDA has rescinded the tentative approval, although the marketing applications remains under consideration, according to an agency spokeswoman.

What happened?

Pharma Guy's insight:


Not only did FDA's "mistake" cause a delay in a generic version of Nexium reaching the market, but the Agency also delayed issuing news safety warnings about the drug (see here). The result? All this helped AstraZeneca (AZ) post a healthy rise in third-quarter revenues as sales of the drug managed a small rise to $922m instead of a loss that would have occurred due to competition and bad safety news from the FDA (read Nexium windfall lifts AZ in third quarter).

more...
No comment yet.