Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.

Star Group merges with Vox Medica, Calcium NYC

Star Group merges with Vox Medica, Calcium NYC

The newly formed group will be known as Calcium with Steve Michaelson, formerly of Rosetta Wishbone, at the helm.

Survey finds pay doesn't make doctors happy

Survey finds pay doesn't make doctors happy

Medscape's survey of over 24,000 physicians found that a paycheck is not necessarily linked to a physician's professional satisfaction.

CDC sees declines in some diabetes complications

CDC sees declines in some diabetes complications

Centers for Disease Control data shows that diabetes complications including heart attack and amputation fell in the twenty years between 1990 and 2010. The bad news: the number of diagnosed diabetes patients tripled during that same time period.

BI rethinks hepatitis business, posts 2013 results

BI rethinks hepatitis business, posts 2013 results

Boehringer Ingelheim says it is no longer pursuing an interferon-free combination of faldaprevir and deleobuvir.

Roche wraps quarter with two fewer pipeline medications

Roche wraps quarter with two fewer pipeline medications

Roche also announced first-quarter sales shrank 1%.

2013 favored specialists, specialty Rx

2013 favored specialists, specialty Rx

The latest IMS Institute for Healthcare Informatics assessment of 2013's prescription drug use shows that 2.3% of prescriptions account for 30% of a patient's out-of-pocket prescription costs.

Gilead and AbbVie HCV meds face off in hard-to-treat

Gilead and AbbVie HCV meds face off in hard-to-treat

New data from the International Liver Congress in London this past weekend showed strong efficacy for Gilead's Sovaldi and AbbVie's combo regimen when paired with ribavirin.

PDR expands its services beyond the book

PDR expands its services beyond the book

Physicians Desk Reference is on a mission to expand its image beyond just being that heavy book doctors consult for information

Merck looks poised to challenge Gilead

Merck looks poised to challenge Gilead

Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.

CDM Group elevates Prince to president

CDM Group elevates Prince to president

CDM, the Omnicom network of healthcare agencies, named Josh Prince, previously the group's chief creative officer, to president. He replaces Carol DiSanto.

Diabetes costliest among non-specialty Rx

Diabetes costliest among non-specialty Rx

Express Scripts said treatments for diabetes are the most expensive of the traditional medications, while specialty drugs are eating up a significant portion of total drug spend.

Halozyme pancreatic drug study on FDA hold

Halozyme pancreatic drug study on FDA hold

The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.

Study links patient confidence to Rx adherence

Study links patient confidence to Rx adherence

Researchers found a correlation between patients feeling involved and how well they stick—if they stick—to their medication regimens.

Lilly's CDK 4/6 inhibitor a cancer contender

Lilly's CDK 4/6 inhibitor a cancer contender

Analysts say the Indianapolis, IN, drugmaker's Phase-I results show CDK 4/6 inhibitors will have a role in breast cancer treatment and that Pfizer's palbociclib will not clear the field.

Gilead's HCV combo scores priority review

Gilead's HCV combo scores priority review

The drugmaker said today that FDA has granted the company a Breakthrough Therapy designation and a priority review for its sofosbuvir/ledipasvir combo.

Pfizer palbociclib news divides investors

Pfizer palbociclib news divides investors

Sunday's data readout has divided the Street between the enthusiastic and the disappointed. The key reason: progression-free survival gains were not as high as anticipated.

GSK's Paxil plant cited in warning letter

GSK's Paxil plant cited in warning letter

GlaxoSmithKline got some unwelcome attention from the FDA inspectors: a March 27 warning letter about unacceptable manufacturing and communications at a Cork, Ireland, manufacturing site where it found contamination issues.

For consumer-directed plan members, fewer prescriptions

For consumer-directed plan members, fewer prescriptions

A recent study shows that generic fill data, often used to promote the cost-savings associated with generic drugs, may hide the impact some health insurance plans have on patient medication use.

Health reform spurs Rx growth, data show

Health reform spurs Rx growth, data show

The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.

AOL lands J&J marketing vet

AOL lands J&J marketing vet

Praised for helping navigate the shift by advertisers into digital, media vet Kim Kadlec is leaving pharma for a new role at AOL.

One small step for MannKind: Afrezza gets panel nod

One small step for MannKind: Afrezza gets panel nod

MannKind's inhalable insulin, a pipeline contender for 14 years, scored a near unanimous vote from an FDA advisory committee yesterday.

Lilly Alimta patent extended to 2022

Lilly Alimta patent extended to 2022

A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.

Trials confirm potent efficacy of PCSK9s

Trials confirm potent efficacy of PCSK9s

Detailed Phase-III results from several PCSK9 candidates confirm the clinical ability of the newest class of cholesterol-lowering treatments.

Novartis announces good heart drug results

Novartis announces good heart drug results

The drugmaker said successful results prompted an independent Data Monitoring Committee to recommend stopping the trial. The news follows an uneven week of pipeline drug news.

Novartis lung drug rivals Pfizer's

Novartis lung drug rivals Pfizer's

Phase-I tests show Novartis's ceritinib works on Xalkori-resistant patients.

Baxter to split in 2015

Baxter to split in 2015

The company, which expects a 9% to 10% sales jump in 2014, says it will split into two independent companies by the middle of next year.

GSK pulls EMA Tafinlar/Mekinist application

GSK pulls EMA Tafinlar/Mekinist application

The company said it wants to wait for more data to come in.

Survey shows Pharma digitally failing patients

Survey shows Pharma digitally failing patients

A study by consulting firm Accenture shows that patients not only expect digital outreach, but that their desire to be engaged is consistently being ignored.

Merck diversifies its Big Data agenda

Merck diversifies its Big Data agenda

Merck has broadened its analytics approach to include team-ups with a slate of organizations at the intersection of Big Data and health IT.

NICE says no to Xofigo, Zaltrap

NICE says no to Xofigo, Zaltrap

The UK's National Institute for Health and Care Excellence says it bounced Bayer's drug for failing to compare itself to current treatments, and Sanofi's over cost.

Analyst gives PCSK9 preview

Analyst gives PCSK9 preview

Analyses by Jefferies indicate that although doctors are interested in the experimental anti-cholesterol drugs, CV data will be a critical differentiator.

AbbVie art gallery: a glimpse into patient POV

AbbVie art gallery: a glimpse into patient POV

AbbVie's "Perspectives—Art, Inflammation and Me," an exhibit centered around inflammatory diseases, looks to offer patient perspective through an artistic medium.

Waxman takes aim at Gilead over Sovaldi pricing

Waxman takes aim at Gilead over Sovaldi pricing

Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.

FDA approves oral psoriatic arthritis drug

FDA approves oral psoriatic arthritis drug

Celgene is looking to market the $22,500-a-year-drug as a pre-biologic, which means jumping ahead of rivals like Enbrel and Humira.

EMA advisory panel backs Lilly/BI's empagliflozin

EMA advisory panel backs Lilly/BI's empagliflozin

The Committee for Medicinal Products for Human Use endorses the SGLT2 inhibitor. The FDA refused to approve the drug earlier this month because of manufacturing issues.

J&J to submit schizophrenia drug in 2014

J&J to submit schizophrenia drug in 2014

The drugmaker halted Phase III trials of a three-month medication based on good efficacy feedback.

Study anticipates higher statin use

Study anticipates higher statin use

The 2013 guidelines add 12.8 potential statin users to the pool, but this growth does not necessarily mean still-experimental PCSK9s will be able to capitalize on the greater patient population.

FDA delays Biogen Idec's long-acting MS drug

FDA delays Biogen Idec's long-acting MS drug

Biogen Idec announced yesterday that FDA will extend Plegridy's review data for three months; regulators did not request additional studies be done, the drugmaker said.

Old guidelines boosted Zetia prescriptions

Old guidelines boosted Zetia prescriptions

Researchers find that Canada has been a significant contributor to Zetia sales.

Survey finds doctors ok with working for others

Survey finds doctors ok with working for others

A recent Medscape survey found that under-40s were more likely to work for a healthcare organization than were their older colleagues, trading autonomy for work-life balance and income predictability.

Agnitio launches Rainmaker marketing tool

Agnitio launches Rainmaker marketing tool

The company unveiled the mix-and-match marketing management tool at the Eye for Pharma conference in Barcelona.

Eliquis enters the DVT business

Eliquis enters the DVT business

The FDA approved the blood drug to prevent deep vein thrombosis and pulmonary embolism among hip- and knee-replacement patients. The approval means BMS and Pfizer may encroach upon the territory of J&J's Xarelto.

Amgen's PSCK9 shows rare disease potential

Amgen's PSCK9 shows rare disease potential

The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.

Possible Zohydro competitor surfaces

Possible Zohydro competitor surfaces

A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.

Celebrex patent loss to inflict EPS pain, but little more

Celebrex patent loss to inflict EPS pain, but little more

Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.

EHR use up 10%, as small practices tame data crunch

EHR use up 10%, as small practices tame data crunch

A report of over 270,000 US medical sites signals that EHR adoption is no longer a luxury reserved for hospitals and health systems.

OPDP slams Facebook page

OPDP slams Facebook page

The FDA's bad-ad unit took a drugmaker to task for what it calls a misleading Facebook page. History shows the social media surveillance should take no one by surprise.

Prevnar 13 hits goals, but impact is uncertain

Prevnar 13 hits goals, but impact is uncertain

Pfizer hit its endpoints for preventing pneumonia among the elderly, but the data may not be robust enough to spur vaccination.

Adults increasingly using ADHD medications

Adults increasingly using ADHD medications

Express Scripts notes that these prescriptions may not, in fact, be for ADHD.

Nexavar fails recurrence target

Nexavar fails recurrence target

Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.

Study shows sample-drug adherence link

Study shows sample-drug adherence link

A survey of patients found greater prescription drug adherence among patients who received a free 30-day sample in addition to a prescription.

Lipid agents come under FDA scrutiny

Lipid agents come under FDA scrutiny

Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.

Draftfcb Healthcare rebrands to FCB Health, acquires UK shop

Draftfcb Healthcare rebrands to FCB Health, acquires UK shop

Draftfcb Healthcare has rebranded to FCB Health, and has also acquired UK healthcare agency Halesway, effective immediately, the agency announced today

Stakeholders blast Obama's budget for FDA, NIH

Stakeholders blast Obama's budget for FDA, NIH

Biopharma lobbying groups attacked the president's FY 2015 budget as soon as the ink had dried on the $3.9-trillion document

Merck adds heat to HCV competition

Merck adds heat to HCV competition

Phase-II data show reduced hepatitis-C RNA levels among HIV-positive patients, the drugmaker shared at a medical meeting. Boehringer also released co-infection data.

Merion renames NP, PA print publication

Merion renames NP, PA print publication

The newly titled Nurse Practitioner Perspective rolls out this month, keeping pace with an educational shift in the nursing field.

CRL stalls Lilly/BI's empagliflozin

CRL stalls Lilly/BI's empagliflozin

The issue: Boehringer's manufacturing site. The FDA is not asking for new clinical studies.

BMS jumps to Ph.III lung cancer study

BMS jumps to Ph.III lung cancer study

The drugmaker announced Tuesday that it will pursue a Phase-III Yervoy-nivolumab study.

AbbVie's all-oral HCV combo shines in trial

AbbVie's all-oral HCV combo shines in trial

Data presented at a conference yesterday suggest AbbVie's all-oral regimen may be more effective than Gilead's at curing the virus in certain patients, but will it confer an edge?

Off-label guidance may not be publishing boon

Off-label guidance may not be publishing boon

The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.

ACCME tables logo ban again

ACCME tables logo ban again

After a wave of feedback, the accreditor has deferred a ban on use of corporate logos in disclosures of commercial support.

Sanofi seeks to revive Kynamro launch

Sanofi seeks to revive Kynamro launch

Kynamro's slow start, coupled with competition, has prompted Sanofi to add sales reps.

Regulators split difference over diabetes meds

Regulators split difference over diabetes meds

Spurred by a 2013 report of a possible link between drugs like Merck's Januvia and pancreatitis or pancreatic cancer, the FDA and EMA said they have not found a definitive link but will continue to collect data.

Remedy debuts long-form sponsored stories

Remedy debuts long-form sponsored stories

The publisher aims to bring patient stories to life through long-form multimedia narratives.

Tot obesity drops, market ceiling still high

Tot obesity drops, market ceiling still high

A national survey indicates that obesity rates for children ages 2 to 5 has fallen since the early 2000s, yet overall numbers remain largely unchanged and high.

Lilly's GLP-1 contender takes a step forward

Lilly's GLP-1 contender takes a step forward

Phase-III results, top-lined today, show Lilly's investigational GLP-1 drug is well-positioned to eat into the multi-billion-dollar diabetes market now dominated by Novo Nordisk.

Lidoderm reps inflated drug's uses

Lidoderm reps inflated drug's uses

Endo settled off-label charges for $192 million, resolving civil "whistleblower" suits filed by two sales reps and a physician.

Pfizer Prevnar data could boost Rx numbers

Pfizer Prevnar data could boost Rx numbers

The drugmaker revealed efficacy data that analysts say could prompt the health agencies to emphasize adult vaccination.

FDA's Hamburg says India is a significant pharma partner

FDA's Hamburg says India is a significant pharma partner

The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.

Market research vies for more of pharma's ear

Market research vies for more of pharma's ear

Suppliers are touting a deeper level of analysis, in some cases bypassing the market-research function and reaching the highest levels of their pharma clients.

Advil hearts menstrual cramps

Advil hearts menstrual cramps

Pfizer's consumer website for Advil in South Korea offers a strange appeal to women who experience menstrual pain.

Merck sends HPV vax to FDA

Merck sends HPV vax to FDA

The drugmaker's new vaccine has more brawn, but vaccination rates among boys and girls remain low.

Lilly's ramu' has squamous, non-squamous potential

Lilly's ramu' has squamous, non-squamous potential

The drugmaker was scant on details, but Phase-III ramucirumab results among non-small cell lung cancer patients showed increased overall and progression-free survival vs. placebo.

Study finds doctor reviews matter to some extent

Study finds doctor reviews matter to some extent

A report published by JAMA indicated that online reviews sway a percentage of patients, but that personal recommendations hold more weight.

Actavis buys Forest, bolsters specialty biz

Actavis buys Forest, bolsters specialty biz

The drugmaker, hitherto known for its generic expertise, says the purchase could mean that half its future revenue will come from branded, specialty drugs.

Novartis expands immuno-oncology presence

Novartis expands immuno-oncology presence

The drugmaker's purchase of private biotech CoStim Pharmaceuticals comes with a host of experimental immuno-oncology agents.

Merck latest rival in race to copy Lantus

Merck latest rival in race to copy Lantus

Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.

J&J cancer med adds indication, lower dose

J&J cancer med adds indication, lower dose

The fast-tracked drug netted another indication today, this one for a form of leukemia. Lower dosage of the drug for that indication shrinks the price compared to lymphoma.

Advocates cry foul over 'female Viagra' delay

Advocates cry foul over 'female Viagra' delay

FDA's request for additional Phase-I research has some consumer groups claiming regulatory bias toward male sex drugs during the approval process.

Novartis to rein in pharma costs

Novartis to rein in pharma costs

The CEO told Leerink analysts the pharma business needs better margins, not unfettered R&D budgets.

Few employers contain specialty Rx costs: study

Few employers contain specialty Rx costs: study

The third Pharmacy Benefit Management Institute specialty medication survey expects specialty medications, which average around $3,000 per month per patient, will account for 50% of the drug spend within four or five years.

FDA takes closer look at AZ's saxagliptin

FDA takes closer look at AZ's saxagliptin

The regulator says a 2013 study that indicated a higher rate of heart failure compared to placebo—but not death—has prompted a second look at the diabetes medication.

Pharma M&A activity rebounds in 2013: report

Pharma M&A activity rebounds in 2013: report

Driven by a number of high-profile buys in 2013, pharma saw a return to investment through acquisition after a 2012 dip.

Engaging mobile diabetes management

Engaging mobile diabetes management

A six-month pilot program at the University of Chicago improved glycemic control and engaged patients and HCPs through one key device: a mobile phone.

LOEs continue to buffet AstraZeneca

LOEs continue to buffet AstraZeneca

The drugmaker expects to return emerge from 2016 with over 5,000 fewer employees and return to growth mode in 2017.

Sanofi muddles through 2013

Sanofi muddles through 2013

Constant exchange rates provide a positive framework for quarterly and year-end totals, whereas straight percentages indicate lower sales.

Indie ad agency forms new network

Indie ad agency forms new network

Chicago-based shop GA Communication Group says it's striving for the middle ground in an increasingly polarized agency landscape.

Merck: 2014 is the year of the rebuild

Merck: 2014 is the year of the rebuild

The company expects to return to growth in 2015 as it focuses on immunotherapy collaborations.

Must biosimilar names be distinct? No, experts argue

Must biosimilar names be distinct? No, experts argue

Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.

Report: cancer rates will continue to rise

Report: cancer rates will continue to rise

The proposed solutions include education, access and low-cost interventions.

Medicate responsibly, urges maker of Tylenol

Medicate responsibly, urges maker of Tylenol

J&J's campaign picks up where the FDA left off when it alerted physicians to concerns about prescribing acetaminophen-containing drugs but deferred action relative to OTC products.

Pfizer releases Ph. II palbociclib data

Pfizer releases Ph. II palbociclib data

The company said in a statement that it is talking with the FDA about next steps. Data on overall survival—a key metric for how oncologists view new cancer meds—remains under wraps.

Testosterone drugs under FDA review

Testosterone drugs under FDA review

Studies associating the therapies with higher heart risks triggered the review.

AbbVie hep. C combo wows in hard-to-treat

AbbVie hep. C combo wows in hard-to-treat

The regimen continues to show strong efficacy in a certain subtype, but it won't be easy to overcome the competitive advantages in Gilead's favor, analysts say.

Agencies step up recruiting to capitalize on unrest

Agencies step up recruiting to capitalize on unrest

Last year's merger of two big ad networks prompted indie shops to step up recruiting, and get creative. Blanketed media buys, organ-themed T-shirts and ice cream giveaways are among tactics.

Lilly says 2014 will not be "trough year"

Lilly says 2014 will not be "trough year"

Higher prices helped insulate Q4 and annual sales, which fell and rose 2%, respectively. Lilly said its insulin glargine biosimilar will go nowhere if it is not substantially different from the competition.

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