Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression
The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.
CVS will buy institutional pharmacy Omnicare in a $12.7-billion deal; ProPublica says the FDA and GlaxoSmithKline failed to protect patients from misusing Advair; Regeneron and Sanofi expect to file RA drug sarilumab with the FDA in the fourth quarter of this year
The FDA's bad-ad group said the banner they saw at a professional conference was misleading.
McNeil Consumer Healthcare president Denice Torres was named woman of the year by the Healthcare Businesswomen's Association.
Perrigo says a Mylan deal is possible; new guidelines may reduce cancer screenings; Takeda petitions dictionaries to add a new definition for depression
Experts say Afrezza's tepid launch may have more to do with value proposition than product positioning.
Endo agrees to buy Par Pharmaceuticals for $8 billion; AstraZeneca deepens commitment to biologics; FDA cautions that certain diabetes drugs could lead to serious condition
Long-time practice lead Gil Bashe is tasked with unifying and building the health function at global firm Finn Partners.
Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease
An expert tells MM&M a key issue is whether unsubstantiated benefits were used in marketing efforts.
Precision medicine is a guiding force for many pipelines, but a study shows a gap between developing drugs with biomarkers as well as tests that match patients to treatments.
An economist wants $37 billion invested in antibiotic development; Roche plans to file an experimental lung-cancer drug with the FDA this year; Sandoz wants compensation for lost Zarxio sales
FDA panel votes in favor of Vertex's combination cystic fibrosis drug; MannKind blames marketing on slow Afrezza sales; Orexigen draws ire after Contrave study terminated
The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.
Value is a concept that concerns all healthcare stakeholders.
First-quarter results show prescription weight-loss drugs continue to struggle with market and mind share.
Mylan considers higher bid for Perrigo; Boehringer Ingelheim partners with health system on COPD; EMD Serono's experimental cancer drug gets Fast Track status
While the FDA is not required to follow the panel's recommendation, the agency's final decision on Orkambi is crucial to Vertex's future.
Molecular Partners said development for its experimental wet age-related macular degeneration treatment will go forward.
Mylan weighs Teva takeover; GSK and UNC launch research center and drug company; FDA approves Roche colorectal cancer drug diagnostic
An early review of the Apple Watch
A court halted the launch of Sandoz's biosimilar; GSK said it is concerned about Advair competition in the US; an FDA panel is expected to vote on a female sexual disorder drug
About 80% of polled dermatologists told Leerink Partners they would likely prescribe the experimental biologic dupilumab.
Spurred by consolidation, the life sciences industry spent more money on acquisitions in the first quarter than it did in all of 2014 combined.
AbbVie expected to submit chronic lymphocytic leukemia drug venetoclax to the FDA this year.
The company partnered with AstraZeneca and BioMarin to identify which patients respond to experimental cancer drugs.
Amgen raises price of Enbrel by 10%; pharma companies appear to raise diabetes drug prices in tandem; Alexion agrees to buy rare-disease drugmaker for $8.4 billion
A study found that cost-effectiveness and clinical-effectiveness measures often point to the same treatment protocol.
Worldwide spending on cancer medications hit $100 billion last year; Bayer adds an anticoagulant to its pipeline for $100 million; GlaxoSmithKline has a new chairman
The IMS Institute for Healthcare Informatics says makers of cancer drugs will need more than data points for payers to see the value in their pricey new treatments.
A Pfizer poll shows patients rely on over-the-counter medications but need help finding the right treatment.
Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways
Four start-ups presented their business models to pharma executives during the MM&M Transforming Healthcare conference on Thursday in New York City.
Nexium tops the list of Medicare's spending on brand drugs; Gilead Sciences doubles its first-quarter profit; Pfizer reportedly wants to buy a rare-disease drug company
The patient journey concept needs a reboot, according to executives at the inaugural MM&M Transforming Healthcare conference.
A deep dive by the think tank Center for Talent Innovation indicates pharma and payers need to widen their definition of health when communicating with women.
FDA advisory panel recommends Amgen's T-Vec; Teva again makes the case for a merger with Mylan; the FDA approves injection to treat double chins
The drugmaker brought in Anne Whitaker, citing her experience in the gastrointestinal space.
FDA approves generic Abilify; Mylan raises its offer to buy Perrigo; drugmakers are racing to develop drugs for celiac disease.
Newly approved Opdivo added $40 million to the quarter's product sales, which rose 8.9% compared to the year-earlier period.
Sales of the new cancer drug topped expectations since its February launch.
The manufacturer's SynchroMed drug-infusion pump was associated with 14 deaths.
PCSK9 antibodies reduced overall mortality and lowered LDL cholesterol levels in more than 10,000 patients in Phase-II/III clinical trials.
Merck said Januvia is not linked to higher heart-failure risk; Biogen plans to spend $2.5 billion on Alzheimer's disease; Mylan rejected Teva's bid
Briefing materials released before Wednesday's panel review indicate the regulator wants clearer data to assess Amgen's experimental melanoma treatment.
We know it's early days (the smartwatch been available for three days to be exact), but we'd like to know how it is going.
The Centers for Medicare and Medicaid Services last year published 4.45 million records about financial relationships between industry and HCPs.
More pharma companies hike drug prices post-acquisition; HCV linked to increased risk of cancer; a combined Teva-Mylan would control 25% of the US generic drug market
The drugmaker said its top-selling multiple-sclerosis drug Tecfidera's slowdown in sales is due to competition from Plegridy as well as new patient concerns about risks of a rare brain infection.
An AbbVie hep.-C drug nabbed priority review; Merck's hep.-C drug matches efficacy of Harvoni; Mylan increased its bid to buy Perrigo
The drugmaker touted new data for its doublet regimen at the International Liver Congress, but it will likely have to look to the margins to find an underserved patient population.
First-quarter sales fell 1% but the drugmaker expects 2015 to be a growth year.
The hepatitis-C drug is being sold under the name MyHep.
Novo Nordisk's Saxenda to cost $1,000 a month; Boehringer Ingelheim's drug receives priority review; AbbVie's hep.-C treatment Viekira Pak generates $231 million in first-quarter sales
Established products fueled at 12% jump in first-quarter sales.
A court sided with Actavis in one product-hopping lawsuit for acne drug Doryx.
Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.
Study finds vaccines still not linked to autism; investments in healthcare start-ups hit record high this year; biosimilars are already bearing down on prices overseas
Despite increasing income, many doctors are turning away from self-employment.
Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion
Genetic protein PD-L1 could have potential as a biomarker for a first-line treatment.
The FDA asked private biotech Genervon to release all available clinical trial data for its experimental ALS treatment.
Schools spent $23 million to bring conflict-of-interest policies in line with regulations aimed at ensuring federally funded research is unbiased.
A Massachusetts court upheld a 2013 decision that the drugmaker failed to provide sufficient risk information for Children's Motrin.
Teva eyes Mylan takeover; Keytruda shown to improve survival, shrink tumors in melanoma; ADHD abuse may follow grads into workforce.
The FDA approves generic Copaxone; AstraZeneca's experimental lung-cancer drug demonstrates that it can delay disease progression; PhRMA CEO John Castellani to step down
FDA approves Amgen heart failure drug; Pfizer halts breast-cancer drug trial over positive results; 30% of study participants asked docs about drug after seeing or reading an ad
Despite an FDA committee voting that AstraZeneca's diabetes medication carries an acceptable heart risk, analysts say a Merck study will determine the DPP-IV category's fate.
The drugmaker and patient network teamed up to establish a formal framework for deploying activity trackers for patients with MS and for capturing that data.
Late-stage results show Arzerra patients have a median progression-free survival rate almost double that of chemotherapy-only patients.
An FDA panel said heart risks should be part of Onglyza's label; the OIG will examine generic price increases; Abbott said its OTC glucose meter will save patients money
The company reported $7.7 billion in pharma revenue in the first quarter despite a drop in overall sales and profit.
IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza
Americans spent 13.1% more on prescription medications in 2014 than they did in 2013, but recent launches indicate competition in the specialty drug space is going to heat up.
Apple is putting the power of clinical trials in our pockets with ResearchKit.
Physicians will be notified when patient care is not meeting national guidelines for COPD and asthma.
The British drugmaker is reviewing the patient-oriented sales model it introduced in 2011.
Sanofi won't discount new insulin; Takeda appoints new US business head; insurers push back on expensive preventative genetic tests
AstraZeneca diabetes drug may have increased mortality rate; Pfizer accused of knowing about birth defect risks from Zoloft; Eisai to cut 25% of its US workforce
Wego Health says fixing this problem requires incorporating patient perspectives before and after a product launch.
The drugmaker is calling on researchers to investigate PCSK9s in specific areas of interest.
The app for the smartwatch includes secure encrypted messaging.
Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times
The panel will focus on heart failure hospitalization rates associated with the diabetes medication.
For all the scientific tools that have fallen into our hands in the past few years, we are still largely falling short in our efforts to influence our audiences' behaviors.
Generic giant Mylan proposed a deal valued at $30 billion to acquire Perrigo Company.
A study said many sales presentations fail to resonate with payer audiences.
The company has received seven warning letters since 2010.
FDA accepts previously rejected Novo Nordisk insulin application; Merck HCV doublet regimen receives Breakthrough designation for patients with kidney disease; researchers say that rising costs for cancer drugs aren't reasonable
Researchers say countries that spend the most on cancer care have better outcomes, but the explanation behind improved mortality is not clear.
A more general warning encourages consumers to engage in a personal discussion with their doctor about a drug, and it promotes engagement with longer-format printed or digitally-delivered information.
Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext
The pharma sales model increasingly relies on key account managers rather than sales reps.
The cancer and immunology drug may help patients with a condition that affects two people in every one million.
The study will include DTC and DTP advertising.
Pfizer exec said biosimilar interchangeability definition not happening anytime soon; AARP launches digital health tech studies with Pfizer and UnitedHealthcare; BMS inks gene therapy collaboration deal
Hedge fund activist challenges Shire patents; CMS issues documents on biosimilars; Astellas Pharma and the University of Texas MD Anderson Cancer Center partner on leukemia treatment
Walgreen alleges Endo conspired to keep generic Opana ER off the market.
Celltrion expects its Remicade biosimilar to hit the US this year; Vivus cuts its sales force; BMJ accuses Novartis of interfering with clinical trials
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