The FDA is expected to announce this week whether it has approved the epilepsy drug as a monotherapy for partial-onset seizures.
The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
US patent office declines to review two Ampyra patents; the FDA expands indication for Promacta; the Biosimilars Council argues against CMS proposal for biosimilar coding
Contrary to popular belief, Addyi is not the female Viagra. That's the message drug-maker Sprout must get across to doctors and patients in the coming weeks.
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
A new poll conducted by the Kaiser Family Foundation found that most Americans believe drugmakers should be required to release information to the public about how they set drug prices.
Could Kardashian West's now-notorious Diclegis social post be more than an OPDP case study?
Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations
State attorneys general accused the drugmaker of violating state consumer protection laws.
But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.
Court blocks generic competition for Opana ER until 2023; lawmakers question Valeant drug price hikes; Roche's immuno-oncology drug meets primary endpoint in mid-stage trial
The FDA pushed back Opdivo's PDUFA date in light of new data; lawmakers argue about vet co-pays; Merck and MD Anderson Cancer Center to evaluate Keytruda in stomach and liver cancers
The FDA said Kim Kardashian West's promotion of morning-sickness pill Diclegis misbranded the product by understating its risks.
"Me-too" drugs may help lower costs; start-ups send doctors to your home; the FDA is likely to appeal the Amarin ruling
The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.
AstraZeneca signs two immuno-oncology collaboration deals; UK cost watchdog goes after Pfizer over epilepsy medication price tag; Boston Globe reports drugmakers are funneling more money through CME programs
The FDA updates Gilenya's label over definite case of PML; generic drug companies are consolidating for negotiating power; the FDA revises guidance on DTC risk information
Spritam is a prescription epilepsy adjunct delivered orally.
Copaxone sales rise despite generic competition; Valeant to defend tax strategy; Bristol-Myers Squibb to test Opdivo with mogamulizumab in the US
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
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
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.
The FDA discusses working with Google to identify unknown drug side effects; Tavenner named chief of insurer lobby group; drugmakers are starting to use cultural experts to better understand patient experience.
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.
Pharma's efforts to evolve restrictions about off-label marketing move forward.
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
Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.
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
Last year's increase in CME support from manufacturers came after six straight years of declining budgets.
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
Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin
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
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
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
It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.
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.
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
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
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
Bristol-Myers Squibb's Opdivo serves up lukewarm lung-cancer results; new cancer drugs are too expensive, Sloan Kettering oncologist tells ASCO attendees; Teva settlement could stymie industry use of pay-for-delay patent tactics
Teva reached a settlement with the Federal Trade Commission to resolve an antitrust suit that charged the drugmaker's subsidiary Cephalon with illegally blocking generic competition for narcolepsy drug Provigil.
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.
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
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.
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.
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
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
Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.
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.
The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.
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.
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
Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.
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
Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.
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
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.
FDA's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.
Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext
The government agency found that more children are treated with medication than behavioral therapy.
Two former Teva sales representatives claim the drugmaker used speaker programs to hide kickbacks for prescribing drugs Copaxone and Azilect.
Opioids lacking abuse-foiling technology will remain available.
Regeneron's Eylea won its fourth indication; Sun Pharma wants to revive trust in its products; confidentiality agreements keep Amgen from telling patients their cancer risk
The proposal is part of the 21st Century Cures initiative and would permit drugmakers to provide information about "scientific and medical developments" when communicating with providers and payers.
Delivering smarter dynamic communications rather than static timed communications based on self-reported data can help connect patients to information and support that drive brand loyalty and program success.
Eleven new drugs with blockbuster potential are expected to launch this year; a bill would require FDA to quickly review drugs approved in the EU; Biogen reinforces its focus on hard-to-treat diseases
A judge rules against Amgen in Neupogen case; FDA advisory panel recommends Breio Ellipta for adults with asthma; AstraZeneca partners with Daiichi Sankyo to sell Movantik
The Paris-based drugmaker's global president of R&D said that jumping through different and inconsistent regulatory hoops puts an "enormous" cost on drugmakers.
New data suggest Amgen's PCSK9 may reduce risks of heart attacks, Salix bidding is war too rich for Endo's blood, Actavis bipolar drug use is expanded to 10- to 17-year-olds.
The SEC said some company drug prices can be made public, 23andMe launched an R&D division, and Public Citizen is asking the FDA to withdraw a proposal it says will undermine drug safety information.
The CMS said the issues should be resolved this week and will not affect this month's deadline for companies to submit payment data from 2014.
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