Pfizer bets on Duchenne MD treatment

Pfizer bets on Duchenne MD treatment

The company moves on three leading contenders in the muscular dystrophy segment with the start of a Phase II trial

Lilly psoriasis drug hits Phase-III endpoint

An investigational JAK inhibitor, baricitinib, bested placebo in moderate to severe plaque psoriasis in a Phase-III trial.

Trial recruiting looks to tap online community leaders

Trial recruiting looks to tap online community leaders

CureClick, TrialReach and WEGO team to leverage health communities and speed trial recruitment.

FDA approves Amgen leukemia immunotherapy

Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.

Lilly nabs rights for osteoporosis patch

The drugmaker inked a deal with Zosano worth up to $440 million for the product, which is about to enter Phase-III in clinical trials.

Gilenya fails to help primary progressive MS patients

Novartis released Phase-III study results Monday.

Vancouver tests prescription heroin

The north-of-the-border solution comes amid climbing heroin abuse in the US.

Five things for pharma marketers to know: Monday, November 24

Five things for pharma marketers to know: Monday, November 24

BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.

Five things for pharma marketers to know: Friday, November 21

Five things for pharma marketers to know: Friday, November 21

EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.

Analyses support Pradaxa safety profile

Analyses support Pradaxa safety profile

Results of two post-market studies, conducted in part by Boehringer Ingelheim, corroborate the billion-dollar blood thinner's benefit/risk profile.

PCSK9s stalk Merck's Vytorin

PCSK9s stalk Merck's Vytorin

A head-to-head comparison between Sanofi and Regeneron's experimental PCSK9 shows alirocumab lowers LDL levels more effectively than Merck's Zetia, which is part of the just-acquitted Vytorin.

Study finds new benefits in highly promising heart drug

A pipeline drug from Novartis has the potential to alter the progression of heart disease and keep patients out of the hospital.

Merck's IMPROVE-IT trial hits big, supports wider Zetia use

Merck's IMPROVE-IT trial hits big, supports wider Zetia use

Patients taking Vytorin experienced a 6.4% reduced relative risk for cardiovascular events, the company said.

Inovio sticks with prostate cancer drug

The Pennsylvania company says it will continue to develop its IO treatment, even without Roche's support.

2015 an "important year" for Pfizer's IO pipeline, analysts say

A 4-1BB agonist highlights a discussion with analysts on the drug giant's immunoncology pipeline, with a number of combination options to be tested next year.

Pradaxa antidote enters Phase III

Testing has already started abroad, and Boehringer says this is the first clinical trial that tests an antidote among patients taking a new oral anticoagulant.

Study shows challenge of CNS drug approvals

For example: Tufts Center for the Study of Drug Development reseachers say it takes 18% longer to develop CNS drugs than it does non-CNS drugs.

NIH tests second Ebola vax in humans

Canada's National Microbiology Laboratory developed the vaccine, which has been licensed to NewLink Genetics Corp.

Merck's weekly DPP-IV on par with daily Januvia: study

Merck's weekly DPP-IV on par with daily Januvia: study

Merck unveiled the DPP-IV clinical trial results at the European Association for the Study of Diabetes Annual meeting Thursday.

Merck osteoporosis drug does not wow

Merck osteoporosis drug does not wow

Analysts do not expect odanacatib to be a major earner.

BI Spiriva combo has Phase-III success

BI Spiriva combo has Phase-III success

The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.

New lipid agents are high on potency, low on doc awareness

New lipid agents are high on potency, low on doc awareness

The new PCSK9 class of cholesterol-lowering antibodies continues to look promising, but many doctors—particularly PCPs—have never even heard of the experimental drugs.

FDA lifts OncoMed partial hold

The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."

Research links estrogen and binge eating

Baylor College of Medicine researchers have found that an estrogen replacement suppressed binge-eating behavior among lab mice.

Novartis may have game-changing drug

Novartis may have game-changing drug

Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.

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.

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.

Study questions HDL medication benefit

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

Bayer's Nexavar disappoints in breast cancer

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

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.

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.

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.

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.

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.

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.

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.

NIH wants gender trial parity

The National Institutes of Health wants female lab animals to be part of the animal testing mix.

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.

Sarepta plans for 2015 drug review

Sarepta plans for 2015 drug review

The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.

Roche wraps quarter with two fewer pipeline medications

Roche wraps quarter with two fewer pipeline medications

Roche also announced first-quarter sales shrank 1%.

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.

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.

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.

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.

Clinical trial awareness campaign launches

PhRMA and the National Minority Quality Forum's "I'm In" campaign seeks to tackle clinical trial diversity (or the lack thereof).

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.

Merck adds heat to HCV competition

Merck adds heat to HCV competition

Phase-II data show reduced hepatitis-C RNA levels among HIV-positive patients, the drugmaker shared at a medical meeting. Boehringer also released co-infection data.


Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.

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