FDA approves Glaxo's GLP-1

Type-2 diabetes injection Tanzeum, also known as albiglutide, scored the approval Tuesday.

Insurers get personal to nip costs

Healthcare insurers seek to curb diabetes costs with interventions that may include house calls.

Novartis dials down RNA research

The drugmaker says the therapeutic approach has a narrow treatment potential.

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.

GSK accused of wrongdoing in Poland, Wellbutrin generic revoked

Poland joins the list of countries in which GlaxoSmithKline is accused of misconduct. Meanwhile, bioequivalence issues have prompted the FDA to revoke its approval of GSK's Wellbutrin generic.

UK court OKs Herceptin biosimilar

A London court knocked down two Roche/Genentech patents, making a clearer path for biosimilars of the breast cancer drug. The primary patent lapses in July.

Sebelius leaves HHS

Politico calls her departure an "everybody wins" situation.

PhRMA names new leadership

New leaders include Pfizer's Ian Read, Merck's Kenneth Frazier and Biogen Idec's George Scangos.

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

Researchers say Tamiflu a waste of money

Complete data sets have prompted researchers to say Tamilflu and Relenza fail at their key reason for being: preventing flu pandemics.

Medicare numbers trigger physician anger

Wednesday's coverage of doctor pay roiled physicians who say the CMS data set oversimplifies payment information and skews reality.

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.

Sunshine data highlights major billers

Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.

Crowdsourcing patient information

23andMe cofounder Linda Avey is taking crowdsourced patient experiences to the web with a soft July launch of a platform called Curious.

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.

Louisiana sends Takeda $9-billion Actos bill

The drugmaker is accused of burying cancer risks associated with the diabetes medication.

FDA won't review Afrezza until July

The regulator has put off the inhaled insulin's PDUFA date by three months.

Alkermes to submit schizophrenia med this year

Phase-III results prompted the drugmaker to pursue a third-quarter filing.

Study: Anti-vaxxers immune to PSAs

Researchers find public service announcements and physician information don't change minds, but a California practice found one way it could.

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.

Sun Pharma to buy Ranbaxy

The announcement will create the fifth largest generics drug maker, reports Reuters.

Roche seals two deals in one weekend

The Swiss drugmaker has scooped up Oryzon's experimental acute myeloid leukemia treatment and private Massachusetts diagnostics firm IQuum.

GSK reportedly being investigated for Mideast behavior

WSJ's sources say allegations of misconduct are similar to those leveled against the company in China.

Baxter acquiring gene-therapy firm

Almost a week after announcing Baxter was going to break into two divisions, the Illinois company is already expanding.

Kaiser adds to payer ire over Sovaldi price

Kaiser Permanente is swallowing the cost of Gilead's hepatitis C treatment Sovaldi, but is angry about the $84,000 cost.

Speaker pay curbed for UK doctors, too

The top 34 UK drug companies paid medical professionals around $64 million last year, for services that included speeches, medical study participation and third-party meeting sponsorships.

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.

ViiV adds Tivicay to UN patent pool

The GSK-Pfizer-Shionogi joint venture said it will add HIV med Tivicay to a United Nations patent pool, cutting its price for developing countries and granting access for generics firms.

GSK stops lung-cancer vaccine trial

The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.

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.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

SCOTUS to hear out Teva on Copaxone delay

The Israel-based drugmaker will try to extend the MS treatment's patent life until September 2015.

Sanofi reports on Phase-II PCSK9 trial

The drugmaker saw positive results in demonstrating LDL reductions in Japanese patient populations.

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.

Apollo taps W2O as LAP-BAND AOR

Apollo EndoSurgery has tapped W2O Group as its agency of record for its LAP-BAND weight reduction system.

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.

New OTC Nexium approved

The FDA has approved a 24-hour version of Pfizer's heartburn medication.

J&J gets out of diagnostics

The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.

Insurers struggle with Sovaldi angst

A report indicates that Sovaldi's high price may hurt health-insurance investors.

Massachusetts bans Zohydro

The Bay State is saying no to the controversial prescription painkiller.

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.

Pfizer's PCSK9 meets Phase-II primary endpoint

Pfizer's investigational LDL-C lowering treatment bococizumab reduced LDL cholesterol in patients also taking statins.

GSK recalls OTC weight-loss drug alli

Tampering concerns prompted the company's action.

Takeda reports additional data from Nesina CV outcomes trial

Takeda's DPP-4 diabetes treatment, Nesina, showed no effect on CV mortality rates or hospitalization for heart failure in sub-analyses.

Healthcare reform lawsuits continue

With just days before the enrollment deadline, courts are pulsing with legal opposition to heatlhcare reform insurance subsidies.

HHS extends insurance deadline

The March 31 deadline for health insurance is not the be-all-and-end-all, while a survey found that 50% of the uninsured intend to stay that way.

FDA says generics study is wrong

The regulator disputes findings that generic heart drugs made abroad were contaminated.

Boerhinger funds ADA initiative

The three-year collaboration includes $1.5 million for chronic kidney disease research.

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.

FDA panel votes no on Novartis heart failure drug

Novartis's acute heart failure drug was not recommended for approval, according to an FDA advisory panel.

Lilly freezes pay, AbbVie CEO doubles his

Flagging sales and patent expirations are keeping Lilly's pay rates static. AbbVie's CEO's paycheck reflects his new digs.

ASCO will grade drugs

The professional association says it's necessary, because high prices do not indicate impact.

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.

IMS to go public in April

The IPO could be the third largest of the year.

Xolair indicated for hives

The FDA's approval makes Genentech's drug the first biologic for chronic hives.

EU may expand Tresiba indication

The new indication would mean Tresiba and Victoza could be prescribed in tandem.

Color keeps GSK generic off the market

GlaxoSmithKline claims that Sandoz needs to change the packaging for its generic Advair.

Court reverses Risperdal decision

The Arkansas Supreme Court's decision puts $1.2 billion back into J&J's coffers.

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.

Healthcare PR campaign of the year

Chandler Chicco Agency and Mylan Specialty's "Raise Your Hand for Anaphylaxis Awareness" program is named Healthcare Campaign of the Year at PRWeek Awards

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.

GSK drug fails in lung patients

The company says it will continue to test its MAGE-A3 cancer drug among a subset of non-small cell lung cancer patients and among melanoma patients.

Novartis not sweating generics turmoil

The drugmaker's CEO tells Reuters it is in a good position to weather troubles in India's generics industry.

Hawaii sues BMS, Sanofi over Plavix

The state's attorney general says the drugmakers did not reveal that the drug could have a different impact—if any—on patients with East Asian or Pacific Islander heritage.

US Judge calls payments for patent settlements into question

A Wall Street Journal blog post claims that a recent US district court judge's opinion regarding patent settlements may call into question the very definition of "reverse settlements."

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.

Belviq partners up with phentermine

Arena and Eisai are testing Belviq with appetite suppressant phentermine.

Astellas seeks new Xtandi indication

Astellas and Medivation have applied for a pre-chemo indication for the cancer drug.

FDA wants parents to back off fetus selfies

The regulator says at-home ultrasounds and heart monitoring systems are a bad idea.

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.

Pfizer fights for Viagra patent

The company is suing Torrent Pharmaceuticals, which wants to market a drug before the patent lapses in 2019.

ASCO defines meaningful

A working group set out parameters for what counts as a meaningful outcome for pancreatic, breast, lung and colon cancer clinical trials.

Study says fat may not be the villain

Researchers say saturated fat may not cause heart disease, but critics say the study is too narrow.

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.

Glaxo onboards promotional doctors

The drugmaker revealed part 2 of its plan not to pay doctors to speak on GSK's behalf: it will make them employees.

Senator seeks anti-Zohydro legislation

West Virginia's Joe Manchin has sponsored a bill to push pain medication Zohydro off the FDA's approval list.

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