BMS striving to push Opdivo past Keytruda

BMS striving to push Opdivo past Keytruda

Keytruda was the first of the new PD-1 class of immuno-oncology drugs to reach the US, but Bristol-Myers Squibb and Ono could run away with the competition, according to one analyst.

Merck osteoporosis drug does not wow

Merck osteoporosis drug does not wow

Analysts do not expect odanacatib to be a major earner.

NY sues over Forest Alzheimer's medication

NY's attorney general alleges that a formulation switch is an attempt to create monopoly.

Six things for pharma marketers to know: Tuesday, September 16

Six things for pharma marketers to know: Tuesday, September 16

Allergan inches closer to Valeant takeover; Mylan trials underway for Lantus biosimilar and generic Advair; FDA advisers to make decision tomorrow on whether testosterone products are being prescribed correctly and if the drugs' label merits change.

AbbVie, Biogen to file MS drug next year

AbbVie, Biogen to file MS drug next year

Phase-III results of the AbbVie-Biogen Idec experimental multiple sclerosis shot Zinbryta (daclizumab) indicate the drug bests Avonex (interferon beta-1a) on some measures among relapse-remitting MS patients.

Takeda backs Contrave with 900 sales reps

Takeda backs Contrave with 900 sales reps

Takeda's Director of Obesity Marketing Katie Andino told MM&M in a phone interview that the drugmaker will be taking a unique approach to woo patients, physicians and payers.

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: Monday, September 15

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, September 12

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are expected to ship in 2015.

Xtandi duo boosts rep force for pre-chemo push

Xtandi duo boosts rep force for pre-chemo push

With its label extended to the pre-chemo setting, the prostate cancer drug is poised to reach a new group of urologists, and could upend J&J's Zytiga.

Nurses undeterred by internet bans at work: study

Nurses undeterred by internet bans at work: study

Healthcare workers seek out health-related information on their own time, and through internet connections other than ones offered by their employers.

Merck's Keytruda is shipping

Merck's Keytruda is shipping

The first-in-class PD-1 was approved only last week.

Five things for pharma marketers to know: Thursday, September 11

Five things for pharma marketers to know: Thursday, September 11

EU grants Lilly/BI Lantus biosimilar approval; FDA approves Contrave weight-loss pill; Republicans take increased NIH funding off the table in Medical Innovation Act.

Opioid CME aims to alter prescribing, lift outcomes

Opioid CME aims to alter prescribing, lift outcomes

A series of CME initiatives, funded by Mallinckrodt, is designed to change opioid prescribing behavior.

CDC: children not receiving preventative care

CDC: children not receiving preventative care

A Centers for Disease Control and Prevention report indicates that following basic childhood care and prevention guidelines could catch health concerns before they become health problems that require costly medical services later in life.

Five things for pharma marketers to know: Wednesday, September 10

Five things for pharma marketers to know: Wednesday, September 10

Auxilium slashes headcount by 30%; poll finds majority of voters support action against tax inversions; FDA panel votes 6-4 against Actavis-backed blood-pressure pill.

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma

Novo seeks liraglutide obesity indication

Novo seeks liraglutide obesity indication

An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.

Five things for pharma marketers to know: Tuesday, September 9

Five things for pharma marketers to know: Tuesday, September 9

Mayo Clinic is reported to partner with Apple's iWatch for remote patient outreach; FTC sues AbbVie and Teva over pay for delay; JAMA study concludes that drugs given to patients with advanced dementia are not worth the price.

BI Spiriva combo has Phase-III success

BI Spiriva combo has Phase-III success

The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."

Fail-fast doctrine ups late-stage success

Fail-fast doctrine ups late-stage success

Thomson Reuters finds the pharmaceutical industry is getting better at abandoning failures earlier.

Five things for pharma marketers to know: Monday, September 8

Five things for pharma marketers to know: Monday, September 8

BMS files patent suit over Merck's Keytruda; Purdue says reformulated Oxycontin curtails abuse; Lilly sues CMS over Alzheimer's disease diagnostic agent.

Five things for pharma marketers to know: Friday, September 5

Five things for pharma marketers to know: Friday, September 5

Gilead in talks to license Sovaldi in several countries, CMS gets over 800 comments requesting CME exemption, pharmacist tied to meningitis scare is arrested, Keytruda wins approval, RTC rebrands to Wunderman

IBM's Watson rolls out to wider healthcare market

IBM's Watson rolls out to wider healthcare market

@Point of Care has integrated IBM's much-touted Watson cognitive technology into its real-time clinical-decision platform

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.

Merck scores first US PD-1 approval

Merck scores first US PD-1 approval

The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).

Drug spend will continue to rise through 2023

Drug spend will continue to rise through 2023

The numbers folks at the Centers for Medicare and Medicaid Services anticipate sluggish growth in US healthcare spend, but prescriptions look ready to take off.

Five things for pharma marketers to know: Thursday, September 4

Five things for pharma marketers to know: Thursday, September 4

PD-1 inhibitor launches in Japan with a lofty price tag; more Zohydro pushback; J&J developing Ebola vaccine.

Brown leaves ICC Lowe, takes reins at indie network

Brown leaves ICC Lowe, takes reins at indie network

Brown has stepped down as general manager of the IPG network to lead the GuideMark Health agencies as CEO.

Google-backed Calico signs $1.5B marketing deal with AbbVie

Google-backed Calico signs $1.5B marketing deal with AbbVie

Google's independent biotech announced today it will enlist AbbVie in its mission to cure death.

Sanofi prices Cerdelga

Sanofi prices Cerdelga

The $310,000 price for the Gaucher disease medication is typical of the rare-disease category.

Five things for pharma marketers to know: Wednesday, September 3

Five things for pharma marketers to know: Wednesday, September 3

AbbVie inks agreement for oncology asset; largest single day med device recall on record; US appeals court revives Botox improper labeling/marketing case.

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.

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