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.

AstraZenca beefs up respiratory portfolio

AstraZenca 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?

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark underbelly

Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

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.

Study: Opioid deaths outnumber heroin-associated ones

Study: Opioid deaths outnumber heroin-associated ones

Researchers at Montreal's McGill University survey the explosion in prescription painkiller use and abuse.

ADA trims kid A1C levels

ADA trims kid A1C levels

The American Diabetes Association has established an across-the-board recommendation that children 18 and younger should keep A1C levels at 7.5% or lower.

Youthful insured not triggering cost spike

Youthful insured not triggering cost spike

An early look at healthcare reforms impact indicates that allowing children to stay on a parent's healthcare plan until they turned 26 did not translate into higher use of medical care, but did lower out-of-pocket healthcare costs for the 19-25 age group.

WebMD seeks to unify health data

WebMD seeks to unify health data

The health and lifestyle resource's latest app seeks to provide context for all that biometric data consumers are storing in wearables, wireless scales and glucometers.

Higher dose of Victoza helped patients drop weight

Higher dose of Victoza helped patients drop weight

Patients taking a high-dose form of Novo Nordisk diabetes drug Victoza saw an average weight loss of 5.9% of their body weight, data from a study show.

OPDP says phentermine site thin on details

OPDP says phentermine site thin on details

The bad-ad watchdog says the promotional website for the weight-loss medication Suprenza leaves out too much information.

Healthcare.gov round 2 suggestions

Healthcare.gov round 2 suggestions

The Urban Institute Health Policy Center says putting money behind call centers and person-to-person contact will increase insurance enrollments among Hispanics.

Patients dial up info while waiting for doctor: study

Patients dial up info while waiting for doctor: study

Patients are using their time in the waiting room to better prepare for upcoming discussions with their doctor. That makes it a good time for marketers to offer mobile-friendly info, researchers have found.

Patients paying more for diabetes medications

Patients paying more for diabetes medications

Yale researchers find patients are paying more money for newer diabetes medications as they gravitate towards insulin analogs, over human synthetic and animal insulin.

FDA pauses Orexigen drug approval

FDA pauses Orexigen drug approval

The regulator wants more time to discuss post-marketing requirements.

Researchers urge specialty Rx insurance plans

Researchers urge specialty Rx insurance plans

Researchers argue it makes economic sense to employ Value-Based Insurance Design plans for costly specialty medications.

Study finds researchers are social-media shy

Study finds researchers are social-media shy

Researchers find worries about being misunderstood or mixed in with "junk" news are among the reasons academic researchers are keeping their data points out of the social media swirl. Researchers say this fear is at the expense of a faster way to make an impact on public policy.

Merck buying Idenix in $4B bid for HCV market

Merck buying Idenix in $4B bid for HCV market

Merck will test if a pieced-together combo of Idenix's nucleotide inhibitor and its own Breakthrough Therapy regimen can take on the competitive HCV landscape.

Cigna expedites Crestor use

Cigna expedites Crestor use

The company signed a deal with AstraZeneca in which high-risk heart disease patients can bypass step therapy and go straight to the branded cholesterol fighter.

Campaigners want FDA to focus on women's sexual health

Campaigners want FDA to focus on women's sexual health

A coalition of organizations, including pharmaceutical company Sprout, kicked off a campaign urging the FDA to pay as much attention to women's sexual dysfunction needs as it does to men's.

Study: sales rep limits reduce off-label prescriptions

Study: sales rep limits reduce off-label prescriptions

Researchers found that limiting sales rep access and interactions reduces off-label prescriptions for the previously detailed drugs, while also upping off-label prescriptions of the drugs that had not been promoted.

Study finds delaying vaccines is risky

Study finds delaying vaccines is risky

A study shows that veering off the recommended vaccination schedule ups the risk for childhood seizures.

Study: Using Avastin over Lucentis could save $18B

Study: Using Avastin over Lucentis could save $18B

Researchers say switching patients from Lucentis to Avastin eye diseases could save the government $18 billion.

Everyday Health rolls out CancerRx app

Everyday Health rolls out CancerRx app

The bedside decision-making app includes clinical trial and drug information as well as breaking news.

ASCO highlights immuno-oncology challenges

ASCO highlights immuno-oncology challenges

The potential of immunotherapy is great, but the news from the 2014 medical meeting shows that great may not be gargantuan in terms of treatment reach.

CMS: docs can sign up for Sunshine peek

CMS: docs can sign up for Sunshine peek

Will docs line up to glimpse their payment data—and get a chance to correct mistakes—or will low awareness overshadow the latest milestone in the law's roll-out?

CVS specialty goes retail

CVS specialty goes retail

Patients will now be able to submit specialty prescriptions at the national chain's retail stores.

KV rebrands, becomes Lumara Health

KV rebrands, becomes Lumara Health

The post-Chapter 11 pharmaceutical company unveiled its new name Thursday.

Sanofi and Lilly to pursue non-Rx Cialis

Sanofi and Lilly to pursue non-Rx Cialis

The two drugmakers inked a deal under which Sanofi holds rights to market the ED pill to consumers without a prescription, if the drug can make the switch.

FDA examines DTC close up

FDA examines DTC close up

The regulator's latest study will use eye-tracking tools.

OTC Nexium launches amid generic uncertainty

OTC Nexium launches amid generic uncertainty

Pfizer is taking the heartburn drug from behind the counter to store shelf today. The launch coincides with the scheduled generic entry date.

Pfizer, AstraZeneca part ways

Pfizer, AstraZeneca part ways

Pfizer announced Monday that it will no longer pursue AstraZeneca, but industry watchers note it may not really be over.

WorldOne re-organizes, unifies around Sermo

WorldOne re-organizes, unifies around Sermo

The pharma market research major is working on unifying into one company with two main product lines, and is also in the process of a re-brand.

Takeda jumps into Humira space

Takeda jumps into Humira space

The FDA's approval of Takeda's Entyvio puts the drugmaker in the ulcerative colititis and Crohn's mix of prescription treatments.

Sun's FDA Warning Letter

Sun's FDA Warning Letter

The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.

GSK drug fails in lymphoma bid

GSK drug fails in lymphoma bid

The companies announced Tuesday that Arzerra, already indicated for leukemia, failed to outdo Roche's Rituxan in the lymphoma setting.

OPDP takes on sales aid for alcohol drug

OPDP takes on sales aid for alcohol drug

The advertising watchdog gave drugmaker Alvogen 15 days to make amends.

BI, InterMune tout lung drugs

BI, InterMune tout lung drugs

Both companies revealed Phase-III data for idiopathic pulmonary fibrosis treatments. The progressive disease generally kills patients within three years of diagnosis.

FDA says no to Novartis heart drug

FDA says no to Novartis heart drug

Novartis says the FDA wants more serelaxin efficacy data.

Study finds "weak alignment" between industry and policy leaders

Study finds "weak alignment" between industry and policy leaders

Research evaluating industry's reputation with stakeholders found that biopharma has an opportunity to improve its image with policymakers.

Novartis lands Gleevec patent reprieve

Novartis lands Gleevec patent reprieve

Novartis and Sun agreed generic Gleevec won't surface until February 2016.

FDA standing by its Zohydro approval

FDA standing by its Zohydro approval

The regulator defends its approval decision in a web post.

Teachable moment for new allergy tabs

Teachable moment for new allergy tabs

With pollen season approaching its peak, drugmakers are educating doctors on a new class of allergy tablets. It could be a while before they're made available for patients.

EHR deal puts Merck in the exam room

EHR deal puts Merck in the exam room

Merck's lead digital health strategist and his business partner offer a glimpse of what's possible through pharma and EHR collaborations.

Vieira, Everyday Health team up

Vieira, Everyday Health team up

The two-year collaboration leverages health content from Meredith Vieira's Lives project.

Omnicom, Publicis reset after failed merger

Omnicom, Publicis reset after failed merger

After their merger fell apart, Publicis and Omnicom sought a return to business as usual, including stemming any disruption to personnel or frayed client relationships.

Lilly basal poses uncertain threat to Lantus

Lilly basal poses uncertain threat to Lantus

Phase-III results for Eli Lilly basal insulin peglispro showed superior blood sugar reduction vs. Sanofi's Lantus in trials, but a number of safety issues could hurt its appeal.

Aegerion shows rare disease not slam dunk

Aegerion shows rare disease not slam dunk

Analyst reaction to this week's quarterly news reflected a need to woo investors, adding to some negative carryover from the previous year.

Novartis finds Europeans need heart facts

Novartis finds Europeans need heart facts

The company's 11-country poll found overall awareness about heart failure to be low. The geographic bloc is in the same bucket as the US in terms of mortality rates.

Survey finds pharma and payers not aligned

Survey finds pharma and payers not aligned

An EY report finds that pharma is not only failing to give payers the right type of drug data, but that industry has a lot of trust-building to do before they will accept it.

AZ appeal for independence seen as bargaining chip

AZ appeal for independence seen as bargaining chip

The firm laid out reasons for why it should remain independent of Pfizer, but analysts say projected earnings are a bit too optimistic and could be a ploy to up the offer.

Big Pharma's big cancer bet

Big Pharma's big cancer bet

Pharma has sunk a lot of money into a field that saw $91 billion in sales last year. But those bets come amid turmoil in the US healthcare market, including a tussle over price.

Bayer buys Merck OTC portfolio

Bayer buys Merck OTC portfolio

The $14.2-billion deal is expected to close in the second half of this year.

Pfizer posts weak Q1 sales, stands by AZ offer

Pfizer posts weak Q1 sales, stands by AZ offer

CEO Ian Read told investors Monday that an AZ merger would benefit Astra shareholders and add oomph to its marketing potential. Another exec said he could "envision" filing palbociclib this year, but made no promises.

Email Newsletters