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
Speakers at Klick Health's event criticized, lauded the role of technology in healthcare.
The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.
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
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.
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
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
FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
A House committee is looking into the FDA's warning letter publication process; Amgen and Roche collaborate on cancer combination drug; study shows online health information fails teenagers
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
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 legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.
FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs
Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease
Amarin sues FDA over off-label discussions; spike in HCV infections in US blamed on Endo opioid; Pfizer settles gambling, eating and sex addiction lawsuit
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
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 draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.
The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.
Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion
The FDA asked private biotech Genervon to release all available clinical trial data for its experimental ALS treatment.
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
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
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
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.
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
What does going "beyond the pill" actually mean? At MM&M's recent inaugural spring conference, audience members heard from real-world companies that are managing the organizational, technological, and promotional challenges inherent in this transition, such as partnering with health neophytes, harnessing technologies that allow deeper engagement with patients, and adopting a new commercial mindset to serve, not sell. Download here.
A wave of more effective anti-cancer drugs has set the oncology world on fire with enthusiasm. While many hail this as a new era, an equally vocal faction questions the money spent for the value gained. This medical and commercial trend report for marketers of anti-cancer modalities touches on many of the latest shifts that have expedited product launches and otherwise impacted promotion and reimbursement of these drugs. Click here.