The immuno-oncology drug is competing with Bristol-Myers Squibb's Opdivo.
The drugmaker told investors that the actual-use trial failed to meet the primary objectives.
Sanofi plans immuno-oncology collaboration with Regeneron; Merck considers hard-to-treat patient populations for its experimental hepatitis-C therapy; drugmakers did not report 10% of adverse events to the FDA within required timeframe
The integrated agency's pharmaceutical business now brings in half its billings.
Teva will acquire Allergan's generic drug business; AstraZeneca sells rights to cancer drug to Sanofi; the FDA approves two drugs heading into the weekend
Today's cancer therapies have an unlikely champion in their corner: the immune system. Scientists are training the natural disease defender to KO cancer for good—and pharma companies are drooling over the flashy premium prices and commercial success of marketed immunotherapies, which have ignited vigorous pipeline work. Rebecca Mayer Knutsen surveys the $32-billion US cancer segment
The agency approved Sanofi's and Regeneron's Praluent, one of the most hyped new drugs of 2015.
Test your knowledge in the inaugural edition of the MM&M Weekly News Quiz.
UnitedHealth looks for refunds when drugs don't work; the European Medicines Agency recommends Sanofi's and Regeneron's PCSK9 inhibitor, Praluent, for approval; Biogen's multiple-sclerosis drug, Tecfidera, reports lower-than-expected sales growth
Bristol-Myers Squibb reported a dip in US sales for the second quarter of 2015 but noted higher uptake for its immunoncology drug, Opdivo.
Oncologists criticize cancer drug prices; Mylan exercises option to fend off Teva takeover; Valeant buys IBS diagnostic in latest acquisition
The focus on boosting physician referrals might appear contrary to the current obsession with patient-centric marketing.
A next-generation cardiovascular drug is expected to be approved this week, but concerns abound about who will take it—and how much it will cost.
Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed
The modern healthcare landscape is complicated, and the terrain is even more gnarled for life sciences companies trying to bring new products to market.
The new campaign seeks to connect with millennial women.
Physicians criticize pricing of Orkambi, Vertex's new cystic-fibrosis drug; the EU approves Amgen's PCSK9 inhibitor Repatha; PhRMA boosts lobbying spending in the second quarter
New rules will require manufacturers to report some indirect payments made to physicians for CME activities.
The agency plans to research extrinsic factors that influence the way a patient perceives a drug.
Robert Ingram sounds off on drug transparency laws in WSJ op-ed; patients with certain forms of leukemia went into complete remission after taking Amgen's cancer drug; Eli Lilly's future in Alzheimer's disease pinned to new data surfacing this week
Gilead will limit financial assistance to patients to pressure payers; Biogen reports another PML case related to Tecfidera; Valeant buys Egyptian drugmaker
The National Organization for Rare Disorders and the University of Maryland will develop a training program to help caregivers and patients participate in research.
The pharma business needs to take engagement far more seriously than it has in the past. At the same time, there are signs that the industry is finally acting with more urgency and even transparency.
The backlash to expensive specialty medications has forced the drug industry to partner up to prove the benefits of their medicines in the real world, according to a PwC analysis.
The restructuring is expected to simplify the drugmaker's organization.
Celgene announces $7.2-billion bid for Receptos; Cytokinetics is using Ice Bucket Challenge donations to test experimental drug; GlaxoSmithKline conducts media review for its consumer health brands
Johnson & Johnson CEO Alex Gorsky said physicians are unlikely to switch the majority of patients to a biosimilar version of Remicade.
Vesey Street Capital Partners acquired Atlanta-based CME provider Imedex.
The FDA approves AstraZeneca's Iressa as a first-line lung-cancer therapy; Mylan and Dr. Reddy's launch generic versions of dementia treatment Namenda; health insurer consolidation may lead to pressure on drug prices
PhRMA and the Epilepsy Foundation said 50-million Americans are affected by disorders such as Alzheimer's disease and multiple sclerosis.
Harvoni is now prescribed more than Sovaldi; healthcare group says new hepatitis-C drugs are cost-effective; Roche antibody shrank tumors in certain bladder-cancer patients
21st Century Cures legislation passes the House; Novartis's heart-failure drug may launch with "beyond the pill" services; Purdue and GSK are working on using Apple's ResearchKit; the FDA issues warning letter on co-pay card
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
Pregnant women taking Prozac or Paxil have higher risks of birth defects; study finds J&J's experimental psoriasis drug works better than Humira; AstraZeneca divests global rights to Entocort
An FDA advisory panel will discuss the fate of Lilly's investigational lung-cancer antibody, necitumumab, which improved overall survival incrementally but also had one late-stage trial halted due to an "imbalanced number of deaths" attributed to blood clots.
The FDA approval this week of a new heart-failure drug is expected to spur interest among cardiologists seeking new ways to keep patients with heart failure out of the hospital.
CDC report finds prescription painkiller abuse contributed to an increase in heroin use; Novartis heart-failure drug gets FDA approval; Isis Pharmaceuticals obtains orphan-drug designation for volanesorsen
An analysis by a state insurance trade group forecast that paying for new HCV treatments could cost taxpayers billions of dollars.
Groups urge disclosure of payments to nurse practitioners and physician assistants; Horizon seeks $3-billion acquisition of Depomed; Sanofi closes $245-million agreement to buy priority-review voucher
The finalists in each of the 32 categories for this year's MM&M Awards are revealed here.
The Boston-based biotech saw its novel cystic-fibrosis drug, Orkambi, receive approval, but it could face an uphill climb in convincing payers to pay for it.
Vertex's cystic-fibrosis drug scores approval; Bloomberg Business analysis finds competitive product categories attract the most marketing dollars; Allergan makes a deal with developmental medical-device company
Biogen pursues orphan eye-disease treatments; Novo Nordisk will stop selling Tresiba in Germany over price controversy; the switch to Prevnar 13 is expected to lower costs
The social networking site for doctors also plans to expand to its first Spanish-speaking country next month.
The health insurance industry's trade association, along with other organizations, sent a letter to the FDA arguing that different names could lead to prescriber confusion and medication errors.
Purdue withdraws plans to participate in FDA meeting on painkillers; Allscripts takes 10% stake in NantHealth in advance of IPO; union advocates to end pharma support for CME
Vertex's cystic-fibrosis drug approval likely to come this week; Roche's multiple-sclerosis treatment hits primary and secondary endpoints; Regeneron/Sanofi debut film about high cholesterol
The government released new data showing how much pharma and device companies spent for research and marketing purposes last year.
A new Novartis drug shows promise; Samsung Group is poised to move on its next major growth sector; Valeant Pharmaceuticals is on the hunt again
Supreme Court affirmed the legality of the Affordable Care Act for a second time on Thursday
AbbVie says curative effects hold whether Viekira Pak used with or without ribavirin; House Republicans vote to eliminate IPAB; analyst sets high price target for Alexion.
Adults dominate the ADHD prescription category; the FDA approved The Medicine Company's anticlotting drug 10 years after issuing a CRL; a survey shows personalized content can build consumer goodwill
Clinical trial results for experimental antidotes to oral anticoagulants Pradaxa and Eliquis indicate they reverse blood thinners in a short time.
AstraZeneca, DigitasLBI New York take top prize in pharma category at Cannes Lions Health; Teva buys a stake in Mylan; Shire tops pharma reputation survey.
The inspirational value is clear for Lions Health attendees, but there is still confusion about what good looks like for branded pharma campaigns, and how the US fits in.
It's not only a venue to gain creative inspiration, but a good place to scout talent, and there are no lack of strategic meetings underway in Cannes.
It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.
AstraZeneca's "Take it from a Fish" took the top prize.
Teva loses Copaxone patent suit; Oncologists at Memorial Sloan Kettering Cancer Center developed cancer drug cost calculator; Bayer will invest $4.5 billion in R&D in the coming year.
The Lions Health award winners will be announced later Friday at an event in Cannes, France.
Its alliance with the Society of Hospital Medicine will expand the network's reach among medical professionals.
The Japan-based drugmaker recast its global organization in hopes of ensuring that emerging molecules make a smoother transition to market.
The effort is part of the consultancy's Startup Challenge that pairs health neophytes with mentors.
Merck settles a marketing lawsuit for $5.9 million; CVS plans to create diagnostic apps; a survey shows advertising agencies plan to keep head count steady for the rest of the year
Harvard's Dana-Farber Cancer Institute and the Sarah Cannon Research Institute signed on to help the drugmaker develop cancer treatments.
Drugmakers, experts discuss strategies to cope with costly new drugs.
Allergan acquires double-chin treatment manufacturer, Kythera, for $2.1 billion; Valeant eyes acquisition of Egyptian drugmaker; worldwide drug sales could reach $1 trillion by 2020
A dive into financial relationships between industry and doctors showed women receive less money for research, education and speaking than men.
Speakers at Klick Health's event criticized, lauded the role of technology in healthcare.
The drugmaker and university will work together to develop new treatments for eye-related diseases like age-related macular degeneration.
Novo Nordisk replaces Sanofi as the top marketer of metabolic drugs; Actavis changed its name to Allergan; access to Medicare Part D has not reduced overall Medicare costs
The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.
Cardiologists are more likely to prescribe the experimental drugs than are primary-care physicians.
CVS Health to buy Target's pharmacy business; experimental gene therapy improves condition of teen with sickle-cell disease; PatientsLikeMe partners with the FDA to improve postmarket surveillance
PhRMA files amicus brief in support of Amarin's off-label lawsuit; Public Citizen argues FDA wrongly expanded indication for Hetlioz; FDA panel recommends GSK's new asthma treatment for approval
An FDA letter says there was no need to go to court but experts tell MM&M this lawsuit highlights an issue that is bigger than a single pill.
Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.
Amgen's PCSK9 inhibitor is the second in its class to get an FDA panel endorsement; a new drug could threaten Shire's hold on a rare-disease category; a study shows pharma invests less in Hispanic audiences than in other groups
Medscape marked its 20th anniversary with a reunion this week that attracted staffers from the portal's earliest days.
The three-year-old campaign's youthful tone evolves as its audience ages.
Roche's Actemra is already approved for three forms of arthritis.
FDA panel recommends Sanofi/Regeneron's PCSK9 inhibitor for approval; Merck and Samsung collaboration says their rheumatoid arthritis biosimilars are equivalent to the biologic versions; Bayer offloads its diabetes-care business
An analysis by Avalere Health says 10 breakthrough therapy drugs will account for billions in spending.
A quarter of this year's 1,862 entries are in the pharma category.
There has been little talk about mepolizumab but an approval would fill out GSK's flagging respiratory category.
The drugmaker's once-daily diabetes treatment, lixisenatide, will be sent back to US regulators after Sanofi pulled the submission in 2013 to finish a cardiovascular outcomes trial.
Study shows Merck's Januvia does not increase heart risks; a former Genentech exec launches a behavioral health business; lawmakers want black-box warnings on more opioids
An FDA advisory committee will sound off on the future of cholesterol-lowering treatments this week, discussing if Sanofi/Regeneron's Praluent and Amgen's Repatha warrant marketing approval.
Jed Savage replaces Scott Wolf.
Concerns persist regarding the drug's impact on liver enzymes and fat.
Novartis CEO says pharma must regulate itself; Shire reportedly is in talks to buy biotech Actelion; Lilly insulin outperforms Lantus although safety concerns remain
FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs
Havas Health developed the inhaled insulin's advertising campaign, which is slated to kick off later this summer.
We need to view the patient journey as a starting place for much deeper analysis.
Genzyme's experimental enzyme-replacement therapy olipudase alfa is being investigated for the Type B form of the condition.
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
Employer-insured enrollees spend more on prescriptions than health-insurance exchange enrollees, but the groups spend the same amount of money when it comes to specialty medications, a study shows.
Teva is planning to up its stake in Mylan prior to a possible legal challenge; Perrigo acquires GSK OTC portfolio; Express Scripts considers creative ways to drive down drug costs
An inVentiv Health study indicates patient groups want more say in drug development and patient support.
As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.
The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.