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.

Novartis apologizes for slow reporting

Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.

J&J pulls morcellator from market

The company is calling the move a withdrawal, as opposed to a recall.

Pfizer buys two Baxter vaccines

The meningitis and encephalitis medications earned a combined $300 million last year.

Healthcare.gov price rises

The cost of fixing healthcare.gov is hovering at around $1 billion, up from the $677-million figure quoted in December

Social media perceived as clinical trial risk

The Wall Street Journal reports that patients are sharing a plethora of information about their clinical trial experiences, from how to get picked, to how to figure out who is in a control group.

Cancer PSA features scientists

Stand Up To Cancer is kicking off a PSA that features Grammy-winner Jennifer Hudson and a Genentech scientist.

Lawmakers eye pricing

The Senate Judiciary Committee's antitrust panel is looking into how three major pharmaceutical manufacturers decided to set minimum prices for their contact lenses.

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.

AstraZeneca takes on pediatricians

The American Academy of Pediatricians says an AstraZeneca drug for preemies should be used less often, and the drugmaker is fighting back with an ad campaign that says the new guidelines put too many at risk.

UK generic use soared in 2013

Generics made up almost 75% of prescriptions in the United Kingdom last year.

GSK refutes consumer spin-off rumor

The company refutes a Financial Times rumor that one was happening soonish.

Study questions HDL medication benefit

A study indicates they may do little to reduce the risk of stroke or heart attack.

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.

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Reckitt Benckiser wants out of pharma

The company plans to spin off its pharmaceutical unit.

AZ seeks blood test to ID potential patients

AstraZeneca's hope is that the blood test could replace tissue samples and be used to identify patients who could benefit from its lung drugs.

Six new Parkinson's factors found

A National Institutes of Health-funded study of over 18,000 patients has identified six new genetic risk factors associated with Parkinson's Disease.

Bayer's Nexavar disappoints in breast cancer

The drug did not hit its Phase III primary target of improving progression-free survival.

Researchers hit links for charity

The PMR Charities Golf Classic teed up more than $20,000 for St. Jude Children's Research Hospital.

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.

FDA to review Neupogen biosimilar

Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.

FDA approves a new painkiller

Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.

Docs not fans of Valeant-Allergan mix

The Wall Street Journal reports that 44% of dermatologists and plastic surgeons polled in a Sanford Bernstein survey said they would consider Botox alternatives if Allergan becomes a Valeant subsidiary.

Pharma failures get second life

AstraZeneca, GlaxoSmithKline, Takeda, Pfizer and Eli Lilly are among seven drugmakers making their discarded molecules available in what amounts to a molecule library.

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.

Payment database confounds doctors

ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

Shire expands rare disease reach

A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.

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

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Court invalidates some healthcare subsidies

The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

NIH: HPV test beats Pap for cancer assessment

HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.

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.

Miss Idaho shows off diabetes pump

NPR reports that the move has made Sierra Sandison a type 1 diabetes hero and that users have given the Facebook photo over 4,000 "likes."

Roche is hungry, not starving for M&A

CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.

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.

AbbVie nabs Shire for $54B

AbbVie, in the latest example of a US drugmaker seeking to lower its tax rate, said today that it's buying Dublin-based Shire for $54 billion.

Leading AIDS researcher aboard downed flight MH17

Dr. Joep Lange was en route to the International AIDS Conference in Melbourne, Australia.

Digital sage Richman returns to healthcare

He started the Dose of Digital blog in 2008, then left healthcare. Now, after more than two years away, Jonathan Richman says he's back in the business.

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.

Haymarket launches psychiatry news, CME site

Haymarket Media launched the site PsychiatryAdvisor.com today.

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.

Treasury urges tax inversion action

Treasury Secretary Jacob Lew is urging lawmakers to prevent companies from "effectively renouncing their citizenship to get out of paying taxes," while also benefitting from the US-funded infrastructure.

Metric system boosts Rx accuracy

Researchers found that patients were more accurate when doling out medication measured in milliliters as opposed to teaspoons or tablespoons.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

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.

Industry trims support for CME

Industry reined in commercial support for CME in 2013—the sixth consecutive annual decrease—data released today by the ACCME show.

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.

Advocacy group alleges Sanofi-Shire conspiracy

An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.

Alzheimer's study to use healthy patients

Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.

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.

Abbott pairs generics with tax benefit

Abbott and Mylan are setting up a generics business. The all-stock deal will give some branded generics a new home and offer Abbott a tax benefit that will increase over time.

Lilly's Cyramza misses liver-cancer target

Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.

Study links Actos with delayed dementia

German healthcare data from 2004 through 2010 across a data set that included 146,000 patients shows dementia surfaced later among Actos patients.

Committee votes on two health bills today

The House Energy and Commerce Committee is putting two health-related bills to vote Monday. One covers new sunscreen ingredients, the other muscular dystrophy research.

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.

FDA quicker on approval trigger than EU: study

The FDA began its drug review at a median time of 103 days sooner than the EMA. Being first, researchers found, often resulted in quicker approval.

Allergan trims fat to halt takeover

Allergan will implement company-wide cost-cutting maneuvers, Bloomberg reports, to keep Valeant at bay.

Generics trigger wallet shock

Prices for some generics are rising, thanks to limited competition.

Experiment cuts cancer costs, ups drug spend

UnitedHealthcare finds drug costs more than doubled.

EU fines six for pay-for-delay

Servier and Teva have been fined for keeping a generic heart medication off the market.

"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.

Lilly, Yabao collaborate on diabetes

The companies will develop Lilly's glucokinase activator LY2608204.

CVS joins West Virginia pseudoephedrine fight

The drugstore chain will no longer sell Sudafed in West Virginia.

Sun recalls cancer drug

It's the generics maker's second recall of 2014.

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.

Study unlinks testosterone and heart attacks

The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.

Healthcare organization makes big data bigger

Credit card and loyalty program purchases will help Carolinas HealthCare System flag potential patient behavior issues.

Merck stifles ezetimibe criticism

The head of evidence-based medicine at Milan's health authority Alberto Donzelli has pulled down criticism of Merck's cholesterol drug ezetimibe from his website, after the drugmaker sent two cease-and-desist letters.

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 links DPP-IV medication to heart failure, hospitalization

Editorial says risk is small, researchers say it could be clinically relevant.

Zohydro's second act

Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.

EC cracks down on fraudulent drugs

The European Commission is rolling out a verified-account tag it hopes will connect Internet users with trustworthy drug sources.

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.

France ponders off-label Avastin

French lawmakers have the chance to vote for off-label use of Avastin, potentially eating into the turf of higher-priced Lucentis.

Insurers put in bid for biosimilar naming

Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

India's generics makers hire Beltway help

The Indian Pharmaceutical Alliance makes a bid for legislators' attention.

ACP says no need for pelvic exams

The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.

Merck rolls out MedEd website in India

The website is a joint effort between Merck and The Lancet.

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