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.

Novartis breakthough designation hat trick

The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.

GSK clears another flu vaccine, but patients may not be buying

GSK clears another flu vaccine, but patients may not be buying

The FDA approved GlaxoSmithKline's second quadrivalent flu vaccine, but a CVS study indicates that consumers are big fans of the vaccination, as long as they aren't the ones rolling up their sleeves.

Boehringer drugs, sans interferon, could vie for HCV niche

The data suggest Boehringer's hep. C combo could find a treatment niche.

MannKind inhaled insulin is back, baggage and all

Phase III data for MannKind's Afrezza is positive, but past experience shows inhaled insulin may not be an immediate win.

Eylea outduels Lucentis for physician mindshare, survey shows

Eylea outduels Lucentis for physician mindshare, survey shows

Data show doctors are increasingly leaning on Regeneron's Eylea over Roche's Lucentis, as the two battle for share of the wet-AMD market.

New daily HIV med could put Atripla on the defensive

New daily HIV med could put Atripla on the defensive

The GSK-Pfizer-Shionogi daily HIV medication gets the regulatory all-clear. The approval could put BMS/Gilead's best-selling daily med Atripla on the defensive.

Sleeper in Lilly oncology pipeline surprises Street

Phase III results of Eli Lilly lung cancer drug necitumumab took analysts by surprise on two levels: by helping it avoid the dustbin and in succeeding where Erbitux had failed.

"Sensor you swallow" passes psych test

"Sensor you swallow" passes psych test

Proteus Digital Health's ingestible sensor shows utility as an adherence tool for those on psych meds, a study suggests.

Regeneron seeks to edge Roche out of DME space

Regeneron seeks to edge Roche out of DME space

Regeneron says it will seek a diabetes macular edema indication for Eylea this year, potentially encroaching on yet another Lucentis market.

The complexity of cracking open the data door

The complexity of cracking open the data door

Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.

Report: FDA comfortable with EMA's diabetes conclusions

A report indicates that the FDA is siding with the European Medicines Agency's finding that GLP-1 diabetes medications are not conclusively linked to pancreatic cancer.

In wake of HCV setback, Vertex to contain marketing spend

While a strong launch of CF drug Kalydeco helped to hike the biotech's forecast, hep. C contender VTX-135 was hit with a partial clinical hold.

HPV vaccination rates losing ground, CDC reports

The CDC says HPV vaccination rates are not improving. The latest data comes just as a recent report shows the vaccine cannot only help fend off cervical cancer, but throat cancers as well.

GA101 looks more like a franchise-extender for Roche

The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.

With RA indication, J&J's Simponi an up-and-comer

Analysts gave the infusion therapy a warm reception in RA, despite stiff competition in this category.

Elan's beyond-the-plaque Alzheimer's med gets fast-tracked

Elan's strategy: focus on agitation and aggression associated with the disease.

Novartis hikes '13 forecast, thanks to generic Diovan delay

Ranbaxy's ban from US soil has softened the blow for Novartis 2Q sales.

Actavis gets go-ahead to expand generic painkiller portfolio

The drug maker can now add five new doses to its generic Opana ER offerings.

Approval clears Boehringer to enter oncology space

FDA's afatinib approval enables the drug maker set up shop in a new therapy space.

Amyvid tracer figures in Lilly's latest solanezumab trial

The drug maker's third round of testing will focus on mild Alzheimer's patients. Candidates must test positive for beta amyloid.

Janssen whizzes promising CLL agent over to regulators

Janssen submitted an NDA for its cancer hopeful ibrutinib, well ahead of competitors.

Email Newsletters