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.

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.

DOJ closes Brilinta investigation

AstraZeneca announced the end of the investigation Tuesday.

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.

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.

J&J pulls morcellator from market

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

Study questions HDL medication benefit

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

NIH: HPV test beats Pap for cancer assessment

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

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.

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.

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 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.

Study links DPP-IV medication to heart failure, hospitalization

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

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.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

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.

Expanding weightloss drug doesn't wow

An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.

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.

BI calls it quits in hep. C

BI says there is no unmet need for faldaprevir.

Marketing tone sinks GSK recruiter

GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.

Triglycerides, not HDL, may be cardio bad guys

Gene mutations lead researchers to rethink ways to protect the heart.

Novartis says it buried studies

The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.

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.

Genentech cancer med nabs Breakthrough status

The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.

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.

CDC: un-vaccinated behind measles outbreak

The CDC said Thursday that most of the 288 recent US measles cases were caused by un-vaccinated travelers who brought the virus home with them.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

BI's Pradaxa antidote progresses

The drugmaker is set to start patient testing.

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.

Clinical trial nabs SEC attention

The Securities and Exchange Commission alleges that two doctors illegally exploited their clinical trial affiliation for financial gain.

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.

Two more obesity meds circle Rx status

Gelesis is pouring money into its obesity "smart pill," and Novo reports weighty success among subjects taking liraglutide.

Bayer joins transparency push

The drugmaker announced Wednesday that researchers would be able to access clinical trial data.

GSK heart drug misses endpoint

GlaxoSmithKline announced Tuesday its Phase-III drug from the Human Genome Sciences acquisition failed to hit its primary endpoint.

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.

BI opens up data files

The company announced Monday that researchers will be able to seek out clinical trial data going back to 1998.

FDA nixes use of aspirin for primary prevention

FDA warned consumers against using aspirin for primary prevention, following its denial of Bayer's request to allow marketing of aspirin for that use.

Women's Health Initiative touts ROI

According to an analysis of final data from one of the WHI's trials, each dollar received results in a net economic value of $140.

Cancer drug marches toward filing

Merrimack Pharma said its candidate for pancreatic cancer increased overall survival, and that it plans to file applications in the US and EU this year.

New painkillers stalk Zohydro

New painkillers stalk Zohydro

Two drugmakers, Purdue Pharma and Teva, have abuse-deterrent hydrocodone medications either under FDA review or in late-stage testing.

Panel votes against painkiller

Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."

Bayer drug gets orphan label

Bayer drug gets orphan label

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

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.

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.

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.

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.

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.

Sanofi reports on Phase-II PCSK9 trial

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

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.

Possible Zohydro competitor surfaces

Possible Zohydro competitor surfaces

A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.

Prevnar 13 hits goals, but impact is uncertain

Prevnar 13 hits goals, but impact is uncertain

Pfizer hit its endpoints for preventing pneumonia among the elderly, but the data may not be robust enough to spur vaccination.

Nexavar fails recurrence target

Nexavar fails recurrence target

Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.

Lipid agents come under FDA scrutiny

Lipid agents come under FDA scrutiny

Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.

AbbVie's all-oral HCV combo shines in trial

AbbVie's all-oral HCV combo shines in trial

Data presented at a conference yesterday suggest AbbVie's all-oral regimen may be more effective than Gilead's at curing the virus in certain patients, but will it confer an edge?

Doctors, not friends, source of many opioids

A study says that more opioid abusers get their medications via prescription than they do second-hand.

Sanofi's heir to Lantus meets endpoint in trials

Sanofi's heir to Lantus meets endpoint in trials

Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.

Orexigen could enter weight-loss race June 2014

Orexigen could enter weight-loss race June 2014

The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.

Amgen PCSK9 drug passes safety test

New results from its Phase II safety trial show the LDL-cholesterol lowerer was not associated with a major increase in adverse events vs. standard of care.

GSK misses on late-stage CV drug

GSK misses on late-stage CV drug

An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.

Lemtrada's future in doubt after reviewers flag safety issues

Lemtrada's future in doubt after reviewers flag safety issues

Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.

Pfizer picks fight with NICE

The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.

Ariad pulls Iclusig from the market after FDA request

Ariad pulls Iclusig from the market after FDA request

The drug company is ceasing US distribution and marketing the leukemia drug after the FDA said it was worried about blood clots among clinical trial patients.

Amarin's hopes for Vacepa dim

The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.

Pediatricians want greater condom access

The AAP says greater access and education are critical in curbing STIs.

FDA briefing documents: Sofosbuvir safe, effective

The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.

Good news/bad news for Merck's pipeline

Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.

Poll suggests oncologists already using GSK melanoma drugs off-label

A report says oncologists may be using GSK's Tafinlar and Mekinist together in a non-FDA approved combination therapy.

Suddenly hot ViiV sends HIV cocktail to FDA

Suddenly hot ViiV sends HIV cocktail to FDA

Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.

Positive data for Eylea in branch form of occlusion

On Monday Regeneron reported more positive Ph. III data for its wet AMD/macular edema drug Eylea (aflibercept).

Doctors to resist uptake of biosimilar insulins: report

Doctors to resist uptake of biosimilar insulins: report

Lantus-like rivals can expect a wary reception from endocrinologists, even if these biosimilars reach market, researchers predict.

FDA boots Wellbutrin generic

The agency says the copycat antidepressant failed to meet bioequivalency requirements.

Do depot drugs really deliver?

Do depot drugs really deliver?

In schizophrenia, non-compliance can be disastrous. Do depot drugs really make a difference for patients?

Xeljanz line extension could lift drug's profile

Xeljanz line extension could lift drug's profile

An analyst notes that early Phase III results in a psoriasis clinical trial could change the drug's efficacy profile. It could also fill out the financial potential of a standalone innovative unit, should Pfizer divide.

Biogen Idec: Tecfidera not cause of patient's death

The drug maker says a patient's physician did not link the MS drug to her death.

Bayer: 5 new Phase III drugs expected in 2015

The drug maker says it is accelerating development of new drugs and focusing on expanding indications of current ones.

Racial gap still wide for use of statins, painkillers

Racial gap still wide for use of statins, painkillers

Recent studies underscore a need for greater engagement in multicultural communities.

Astellas inks neurodegenerative collaboration deal

Monday's announcement builds on a stream of recent R&D relationships.

Pharma paid for opioid influence, access to FDA officials

A public information request details closed-door meetings in which industry players paid to sit with government employees and talk pain-medication efforts.

Study shoots down AD drug class in mild patients

Researches say cognitive enhancers, a group which includes drugs like Aricept and Exelon, fail to slow decline in patients with Alzheimer's over the long term.

Lilly partners with NIH for rare-disease research

Eli Lilly is the first Big Pharma to team up with the agency in its rare-disease pre-clinical development program.

FDA expedites two GlaxoSmithKline treatments

GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.

Analysts haven't soured on Yervoy, despite miss in prostate cancer

Analysts haven't soured on Yervoy, despite miss in prostate cancer

Bristol-Myers Squibb said Thursday that the drug failed to hit its primary goal in a prostate cancer trial, but some analysts say the data is not the last word on its potential in this tumor type.

Advisory panel backs GSK drug for COPD

The advisory panel endorsed the treatment with an 11-2 vote.

FDA tightens indication and label for opioid sub-category

FDA tightens indication and label for opioid sub-category

The changes, which include tightening prescribing criteria of extended-release and long-acting opioids and a boxed warning for pregnancy, are part of an effort to curb abuse. Some said the FDA's effort is too limited

GSK inhaler contender faces FDA panel Tuesday

The experimental LAMA/LABA combination could shake up the category.

Analyst says smart money is on drugs for certain orphan diseases

Price, market potential and emotional pull make this subcategory of orphan diseases one to watch, an analyst writes. Hint: it's not oncology.

Blogs may smooth ups, downs of breast cancer: study

For women suffering from breast cancer, online tools appeared to be helpful in battling depression, a randomized trial showed.

Study backed by AZ, BMS: Onglyza OK for hearts

Researchers say a two-year study shows the DPP-IV drug is not linked to a higher cardiovascular risk.

Roche pursues a new eye-care angle

Squeezed in the wet AMD space, Roche could get some eye-care breathing room if it can snag first-to-market status in the dry AMD category. Early results bode well.

Gilead's sofosbuvir clears another HCV hurdle

Two of the most difficult-to-treat hepatitis C patient groups saw high cure rates in an NIH-led study, results released Tuesday show.

Rampant dissatisfaction with psoriasis drugs: study

Rampant dissatisfaction with psoriasis drugs: study

Sales may be rising, but a new study finds current psoriasis therapies leave room for improvement. Over half of patients said they want better options.

Acura's abuse-deterrent painkiller fails to displease

Phase II studies found recreational abusers were not significantly bothered by the mechanism meant to make a "deterrent" version unpleasant to snort.

Kyprolis growth prospects at center of Amgen-Onyx deal

Kyprolis growth prospects at center of Amgen-Onyx deal

Amgen's newest oncology asset could reach great heights, if the firm can capitalize on its existing commercial and R&D capabilities.

Takeda may be poised to expand IBS treatment category

Phase III results of its Crohn's and ulcerative colitis medication show positive patient response in a category among patients who have exhausted other options.

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