New lipid agents are high on potency, low on doc awareness

New lipid agents are high on potency, low on doc awareness

The new PCSK9 class of cholesterol-lowering antibodies continues to look promising, but many doctors—particularly PCPs—have never even heard of the experimental drugs.

Novartis may have game-changing drug

Novartis may have game-changing drug

Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.

Five things for pharma marketers to know: Tuesday, September 2

Five things for pharma marketers to know: Tuesday, September 2

Sanofi and Regeneron unveil Phase-III results of their PCSK9; Merck will present data on its anti-PD-1 at the end of this month; WSJ op/ed suggests US should lead fight against Ebola; Novo Nordisk kills inflammatory business unit to shift resources to diabetes and obesity; generics firm Cipla could stand to gain from Advair patent expiry.

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, August 29

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.

Five things for Pharma Marketers to Know: Thursday, August 28

Five things for Pharma Marketers to Know: Thursday, August 28

Human testing of GSK's Ebola virus starts next week, menopause is a costly healthcare concern, and a small conversation with pharmacists may have a big impact.

Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex could be approved.

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

Promacta was previously indicated for chronic immune thrombocytopenia.

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, August 27

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.

Eli Lilly and BI's Jardiance hits shelves

Eli Lilly and BI's Jardiance hits shelves

The new SGLT-2 inhibitor is on shelves less than a month after FDA approval.

PhRMA Urges Court to Reject Off-Label Promotion Case

PhRMA Urges Court to Reject Off-Label Promotion Case

The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds

Five things for Pharma Marketers to know: Tuesday, August 26

Five things for Pharma Marketers to know: Tuesday, August 26

Merck and Pfizer pursue new pembrolizumab research, black box warnings are linked to fewer court visits, and the WHO says it needs $430M to fight Ebola.

FDA Cautions Consumers on Ebola Web Promotions

FDA Cautions Consumers on Ebola Web Promotions

FDA says that it is seeing and receiving consumer complaints about products sold online that claim to either prevent the Ebola virus or treat it.

Roche spends $8.3B for lung drug

Roche spends $8.3B for lung drug

Roche has beat out rumored competitors GlaxoSmithKline and Sanofi in a run-off to acquire California biotech InterMune.

Five things for pharma marketers to know: Monday, August 25

Five things for pharma marketers to know: Monday, August 25

Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.

Five things for pharma marketers to know: Friday, August 22

Five things for pharma marketers to know: Friday, August 22

Two new indications give Eliquis more juice, a new rule is making hydrocodone harder to get and the ALS Ice Bucket Challenge highlights a controversial aspects of drug discovery and development.

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.

Five things for pharma marketers to know: Thursday, August 21

Five things for pharma marketers to know: Thursday, August 21

An Ebola survivor is set to leave Emory University Hospital, but the cause of the cure is uncertain, the FDA has approved a new type 1 diabetes test, and the latest in the Allergan-Salix battle.

Sanofi expands Gaucher disease portfolio

Sanofi expands Gaucher disease portfolio

The oral medication Cerdelga joins Cerezyme in its Gaucher disease arsenal. Sanofi expects the drug will be priced "on par" with Cerezyme, which goes for around $300,000 a year in the US.

Amicus seeks to upset Fabry market

Amicus seeks to upset Fabry market

Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.

Five things for pharma marketers to know: Wednesday, August 20

Five things for pharma marketers to know: Wednesday, August 20

Novartis explores the virtual care space, a court has dismissed a lawsuit against IPAB, Doctors Without Borders calls the Ebola outbreak "a complete disaster" and Pfizer becomes the first pharma company to pair with the Crohn's and Colitis Foundation of America.

FDA kind of OKs Lilly/BI's Lantus look-alike

FDA kind of OKs Lilly/BI's Lantus look-alike

Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.

GSK relaunches COPD.com

GSK relaunches COPD.com

The refresh launched soon after the company encouraged investors to take a long view of GSK as the firm posted weak respiratory numbers.

Six things for pharma marketers to know: Tuesday, August 19

Six things for pharma marketers to know: Tuesday, August 19

Lilly/BI receives tentative approval for insulin biosimilar; Ebola death rate hits new high; LaMattina sounds off on Pfizer's oncology efforts; art therapy becoming the norm in hospitals.

Biogen twice-monthly MS drug approved

Biogen twice-monthly MS drug approved

Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.

FDA wants more info on Acura pain drug

FDA wants more info on Acura pain drug

FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.

Five things for pharma marketers to know: Monday, August 18

Five things for pharma marketers to know: Monday, August 18

Roche is rumored to be stalking a Chugai acquisition, Pfizer has hit its palbociclib filing deadline and Supernus scored a Fast Track designation for its experimental ADHD drug.

Five things for pharma marketers to know: Friday, August 15

Five things for pharma marketers to know: Friday, August 15

UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.

Kyprolis fails to wow in survival trial

Kyprolis fails to wow in survival trial

Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.

Endorsement could boost Pfizer vax

Endorsement could boost Pfizer vax

It could also eat into Merck's Pneumovax sales.

Five things for pharma marketers to know: Thursday, August 14

Five things for pharma marketers to know: Thursday, August 14

Merck insomnia aid nabs FDA approval, AZ's severe asthma drug advances to Phase III, Specialty med costs expected to comprise more and more Medicare Part D spending.

AbbVie makes inroads in orphan drugs

AbbVie makes inroads in orphan drugs

Not long after acquiring Shire to add to its orphan-drug portfolio, the drugmaker scored an orphan designation from both FDA and EMA last week.

US diabetes risk jumps to 40%

US diabetes risk jumps to 40%

African-American women had the highest risk of being diagnosed with diabetes—55%. Hispanic men and women were close behind, carrying a 50% risk of being diagnosed with diabetes.

Five things for pharma marketers to know: Wednesday, August 13

Five things for pharma marketers to know: Wednesday, August 13

Robin Williams's suicide highlights a trend among the Boomer generation, and governments resurrect a little-used strategy to contain Ebola.

Pharma vet Whitaker takes the helm at Synta

Pharma vet Whitaker takes the helm at Synta

The Sanofi and GSK marketing virtuoso has taken over as CEO and president at Synta Pharmaceuticals.

GAO tallies cost-effective interventions

GAO tallies cost-effective interventions

Half-measures, like diabetes educational materials without a part B, fared poorly.

Five things for pharma marketers to know: Tuesday, August 12

Five things for pharma marketers to know: Tuesday, August 12

The World Health Organization rules on untested Ebola drugs, while Mapp Biopharma has already run out of its experimental antibody.

One giant leap for MannKind: Sanofi to market Afrezza

One giant leap for MannKind: Sanofi to market Afrezza

After weeks of speculation as to whether MannKind would find a marketing partner for its inhalable insulin, the drugmaker said today that Sanofi would acquire global licensing rights to the drug for $925 million.

Roche seeks new Lucentis indication

Roche seeks new Lucentis indication

The company is seeking a diabetic retinopathy indication.

Britain's NICE sidelines Kadcyla

Britain's NICE sidelines Kadcyla

Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.

Pfizer settles off-label Rapamune case for $35M

Pfizer settles off-label Rapamune case for $35M

The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.

Daiichi increases efforts to break into opioid market

Daiichi increases efforts to break into opioid market

The drugmaker is collaborating with Charleston Laboratories in the development and commercialization of hydrocodone products. The deal means Daiichi Sankyo now has two pipeline opiates.

Zohydro to get marketing overhaul

Zohydro to get marketing overhaul

The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.

Bayer's Xofigo carves out niche

Bayer's Xofigo carves out niche

Approved in May 2013, the cancer drug earned $57 million in the second quarter, and the firm expects it will hit annual sales of $1.31 billion.

Lilly and BI's Jardiance could shake up SGLT-2 market

Lilly and BI's Jardiance could shake up SGLT-2 market

Better late than never: Although Lilly and BI's Jardiance is the third SGLT-2 inhibitor to hit the U.S. market this year, it may also be the most successful.

Roche buys Santaris

Roche buys Santaris

The $250 million cash deal includes an additional $200 million in milestone payments.

Kyprolis data fuel Amgen oncology aspirations

Kyprolis data fuel Amgen oncology aspirations

Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.

Belviq scripts jump on DTC, rep push

Belviq scripts jump on DTC, rep push

Arena's recent quarter shows weight-loss drug Belviq is on the rise. It follows a DTC push and the recent addition of reps by co-marketer Eisai.

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.

HHS shows how diabetes adds up

HHS shows how diabetes adds up

A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.

AstraZeneca beefs up respiratory portfolio

AstraZeneca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.

Amgen Q2 sales rise, company to lay off up to 2,900

Amgen Q2 sales rise, company to lay off up to 2,900

The majority of the layoffs will be in the US.

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to display Sunshine payment data

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like meals, travel, gifts, consulting and research

Pfizer Q2 sales slip, but still beat expectations

Pfizer Q2 sales slip, but still beat expectations

Patent losses and lost co-promotion agreements put a dent in sales.

Lack of marketing partner delays Afrezza launch

Lack of marketing partner delays Afrezza launch

Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on horizon

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs same product

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union

Rep access continues to shrink

Rep access continues to shrink

Sales reps are experiencing even more limited physician access, according to a report by Chicago consultancy ZS Associates.

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% of workforce

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.

Shire, AbbVie join forces for $55B

Shire, AbbVie join forces for $55B

The deal includes a $1.6-billion fee if AbbVie tries to walk away.

Next target for hep. C drugmakers: co-infections

Next target for hep. C drugmakers: co-infections

An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.

Biogen poised to shake up hemophilia market

Biogen poised to shake up hemophilia market

Less-frequent dosing and competitive pricing could spur a shift in market share among products that treat the hereditary blood disorder.

FDA gets treatment guidance from patient advocates

FDA gets treatment guidance from patient advocates

Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

CME commercial support cuts narrow

CME commercial support cuts narrow

The rate of decrease in industry's budget for continuing medical education (CME) slowed last year.

Visual continuity key to patient adherence

Visual continuity key to patient adherence

Researchers at the Brigham and Women's Hospital found that continuity in color and shape have a significant impact on whether patients stick with a prescription regimen.

J&J logs $19.5B in Q2 sales

J&J logs $19.5B in Q2 sales

Hepatitis C medication Olysio was a star, but the company cautions competition is coming.

Roche seeks Avastin cervical-cancer indication

Roche seeks Avastin cervical-cancer indication

The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.

Shire asks AbbVie for more money

Shire asks AbbVie for more money

Shire and AbbVie's courtship has entered round five. A deal would offer AbbVie tax relief, and possibly make it an acquisition target.

Senators press Gilead over Sovaldi price

Senators press Gilead over Sovaldi price

In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.

BMS readies nivolumab for melanoma filing

BMS readies nivolumab for melanoma filing

Bristol-Myers Squibb is moving forward with its FDA filing of PD-1 Opdivo (formerly known as nivolumab) for patients with advanced melanoma who have been previously treated with the BMS drug Yervoy.

Salix heads to Ireland

Salix heads to Ireland

Salix Pharmaceuticals joins the tax-inversion migration by purchasing Cosmo Technologies.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

AbbVie ups ante in Shire takeover bid

AbbVie ups ante in Shire takeover bid

Two weeks after its $46-billion bid was shot down, AbbVie has revised its offer in hopes of opening up negotiations with Shire.

OPDP slaps Gilead with Untitled Letter

OPDP slaps Gilead with Untitled Letter

The drugmaker received a notice from the advertising watchdog over promotion of hep. B treatment Viread in a sponsored link on Google AdWords.

Purdue pain drug gets priority status

Purdue pain drug gets priority status

Purdue Pharma expects the FDA to vote yea or nay on the drug by October.

Key to successful digital outreach: think small

Key to successful digital outreach: think small

Patients want to do more with mobile and see doctors less. Two studies outline the types of digital interventions patients are interested in.

CMS plans to end CME Sunshine exemption

CMS plans to end CME Sunshine exemption

In what amounts to a sudden about face, CMS wants to delete the Sunshine rule's exclusion for continuing medical education.

Study reveals ways to fight antibiotic resistance

Study reveals ways to fight antibiotic resistance

The solution: talk to patients.

Merck consumer guide gets 21st-century treatment

Merck consumer guide gets 21st-century treatment

The consumer-facing edition of The Merck Manual Go-To Home Guide for Symptoms is being released as a mobile app.

CDC: US is biggest Rx opioid market

CDC: US is biggest Rx opioid market

The Centers of Disease Control reports that prescribers wrote enough painkiller prescriptions to give one bottle to every adult in the US in 2012.

Allergan updates pipeline

Allergan updates pipeline

Allergan's latest pipeline news was a mix of the good and the bad. The good: a potential Lucentis competitor is progressing. The bad: migraine medication Semprana has stalled.

Researchers give FDA social media advice

Researchers give FDA social media advice

Researchers from Boston Children's Hospital, Harvard Medical School and Brigham and Women's Hospital are offering a bit of internet advice for the Food and Drug Administration: do more.

MannKind's Afrezza approved

MannKind's Afrezza approved

The FDA approved the inhaled insulin last week.

Did you make the cut? Announcing the MM&M Awards finalists 2014...

Did you make the cut? Announcing the MM&M Awards finalists 2014...

Following two comprehensive rounds of scoring by more than 100 independent industry judges, the results are in for the MM&M Awards 2014. Here are the five finalists for each of the 31 categories

IMS to buy Cegedim CRM

IMS to buy Cegedim CRM

IMS is offering $520 million cash to add Cegedim's CRM and strategic data business. Cegedim says it will use the money to pay down debt.

Panel votes against AZ's olaparib

Panel votes against AZ's olaparib

An FDA advisory panel voted 11-2 against an accelerated approval for AstraZeneca's experimental PARP inihibitor. The panel recommends getting more data before giving the drug the all-clear.

BMS cuts nivo' trial short, eyes approval pathway

BMS cuts nivo' trial short, eyes approval pathway

The firm ended the Phase III trial for its ballyhooed immunotherapy, which showed superior survival compared to chemo in advanced melanoma.

Drug sales to hit $1T by 2020, researchers say

Drug sales to hit $1T by 2020, researchers say

EvaluatePharma's World Preview 2014 has pharma soaring to new lucrative heights in six years' time, buoyed by biologics and a formidable pipeline.

Omega-3 drugs angle for trig-lowering awareness

Omega-3 drugs angle for trig-lowering awareness

Celebrity endorsement, co-pay cards and online edutainment are some of the ways marketers are dueling for attention in the prescription omega-3 space.

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year

Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.

FDA adds to "low-T" drugs' warning label

FDA adds to "low-T" drugs' warning label

Four months after announcing a review of low-testosterone treatments for risk of heart attack and stroke, the regulator expanded the classes' warning label to include a general risk of blood clots.

Sifting social media for the "why" behind Rx switching

Sifting social media for the "why" behind Rx switching

Platform lets pharma firms mine big data, and monitor whether millions spent on ad campaigns or medical education are having the desired effect

Study finds Alzheimer's misunderstood

Study finds Alzheimer's misunderstood

An Alzheimer's Association survey finds 59% think the degenerative disease is just part of aging.

Clinical researchers dip toe into social media

Clinical researchers dip toe into social media

Researchers are increasingly using social media to recruit patients, albeit oftentimes in an arms-length manner.

FDA Twitter guidance greeted with caution

FDA Twitter guidance greeted with caution

Guidance on promoting products in 140 characters and correcting misinformation serves as a guarded green light, says one observer.

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