Sunovion prepares for FDA decision on Aptiom

Sunovion prepares for FDA decision on Aptiom

The FDA is expected to announce this week whether it has approved the epilepsy drug as a monotherapy for partial-onset seizures.

Five things for pharma marketers to know: Thursday, August 27

Five things for pharma marketers to know: Thursday, August 27

The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision

Five things for pharma marketers to know: Tuesday, August 25

Five things for pharma marketers to know: Tuesday, August 25

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

Experts: Sprout needs to show Addyi is not Viagra for women

Experts: Sprout needs to show Addyi is not Viagra for women

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.

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

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

The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra

Poll: Majority of Americans support government negotiation of drug prices

Poll: Majority of Americans support government negotiation of drug prices

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.

Editor's Desk: Kim Kardashian West's tempest in a bottle

Editor's Desk: Kim Kardashian West's tempest in a bottle

Could Kardashian West's now-notorious Diclegis social post be more than an OPDP case study?

Five things for pharma marketers to know: Wednesday, August 19

Five things for pharma marketers to know: Wednesday, August 19

Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations

Amgen settles off-label case with states

Amgen settles off-label case with states

State attorneys general accused the drugmaker of violating state consumer protection laws.

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma

But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.

Five things for pharma marketers to know: Monday, August 17

Five things for pharma marketers to know: Monday, August 17

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

Five things for pharma marketers to know: Thursday, August 13

Five things for pharma marketers to know: Thursday, August 13

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

Bad ad watchdog slams Kardashian's social-media post

Bad ad watchdog slams Kardashian's social-media post

The FDA said Kim Kardashian West's promotion of morning-sickness pill Diclegis misbranded the product by understating its risks.

Five things for pharma marketers to know: Tuesday, August 11

Five things for pharma marketers to know: Tuesday, August 11

"Me-too" drugs may help lower costs; start-ups send doctors to your home; the FDA is likely to appeal the Amarin ruling

Judge grants relief to Amarin in off-label case

Judge grants relief to Amarin in off-label case

The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.

Five things for pharma marketers to know: Thursday, August 6

Five things for pharma marketers to know: Thursday, August 6

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

Five things for pharma marketers to know: Wednesday, August 5

Five things for pharma marketers to know: Wednesday, August 5

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

FDA okays 3-D print technology for drug

Spritam is a prescription epilepsy adjunct delivered orally.

Five things for pharma marketers to know: Thursday, July 30

Five things for pharma marketers to know: Thursday, July 30

Copaxone sales rise despite generic competition; Valeant to defend tax strategy; Bristol-Myers Squibb to test Opdivo with mogamulizumab in the US

Five things for pharma marketers to know: Tuesday, July 28

Five things for pharma marketers to know: Tuesday, July 28

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

Praluent's FDA review looms, but questions persist

Praluent's FDA review looms, but questions persist

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.

Five things for pharma marketers to know: Wednesday, July 22

Five things for pharma marketers to know: Wednesday, July 22

Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed

CMS updates CME guidance

CMS updates CME guidance

New rules will require manufacturers to report some indirect payments made to physicians for CME activities.

The FDA seeks comments on DTC ad perception

The agency plans to research extrinsic factors that influence the way a patient perceives a drug.

Five things for pharma marketers to know: Thursday, July 16

Five things for pharma marketers to know: Thursday, July 16

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.

Five things for pharma marketers to know: Tuesday, July 14

Five things for pharma marketers to know: Tuesday, July 14

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

More than 400 drugs in development for neurological disorders

PhRMA and the Epilepsy Foundation said 50-million Americans are affected by disorders such as Alzheimer's disease and multiple sclerosis.

21st Century Cures, Amarin Court Case Advance

21st Century Cures, Amarin Court Case Advance

Pharma's efforts to evolve restrictions about off-label marketing move forward.

Five things for pharma marketers to know: Friday, July 10

Five things for pharma marketers to know: Friday, July 10

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

FDA panel says benefits outweigh risks for Lilly's lung-cancer drug

Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.

House expected to vote on 21st Century Cures

House expected to vote on 21st Century Cures

The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.

Five things for pharma marketers to know: Thursday, July 9

Five things for pharma marketers to know: Thursday, July 9

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

Drug industry's CME support swings to a 2% gain

Drug industry's CME support swings to a 2% gain

Last year's increase in CME support from manufacturers came after six straight years of declining budgets.

Novartis bets on demand for new heart-failure drug Entresto

Novartis bets on demand for new heart-failure drug Entresto

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.

Five things for pharma marketers to know: Wednesday, July 8

Five things for pharma marketers to know: Wednesday, July 8

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

FDA advisory panelists describe decision to recommend approval of "female Viagra"

FDA advisory panelists describe decision to recommend approval of "female Viagra"

Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin

Five things for pharma marketers to know: Tuesday, July 7

Five things for pharma marketers to know: Tuesday, July 7

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

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.

Five things for pharma marketers to know: Wednesday, July 1

Five things for pharma marketers to know: Wednesday, July 1

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

Novartis exec: Pharma culture can be stumbling block to creativity

Novartis exec: Pharma culture can be stumbling block to creativity

It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.

Clinton tells pharma to explain drug prices

Clinton tells pharma to explain drug prices

Speakers at Klick Health's event criticized, lauded the role of technology in healthcare.

Amicus briefs pile up in Amarin lawsuit

The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.

Five things for pharma marketers to know: Monday, June 15

Five things for pharma marketers to know: Monday, June 15

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

Amarin lawsuit about more than fish oil

Amarin lawsuit about more than fish oil

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.

Public health officials to distribute Truvada in fight against HIV

Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.

Five things for pharma marketers to know: Thursday, June 11

Five things for pharma marketers to know: Thursday, June 11

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

Five things for pharma marketers to know: Wednesday, June 10

Five things for pharma marketers to know: Wednesday, June 10

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

Five things for pharma marketers to know: Tuesday, June 9

Five things for pharma marketers to know: Tuesday, June 9

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

Five things for pharma marketers to know: Friday, June 5

Five things for pharma marketers to know: Friday, June 5

FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs

Five things for pharma marketers to know, Thursday, June 4

Five things for pharma marketers to know, Thursday, June 4

Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting

Five things for pharma marketers to know: Tuesday, June 2

Five things for pharma marketers to know: Tuesday, June 2

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

Five things for pharma marketers to know: Monday, June 1

Five things for pharma marketers to know: Monday, June 1

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 settles pay-for-delay case for $1.2 billion

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.

New bill seeks to spur FDA to form clearer social media rules

New bill seeks to spur FDA to form clearer social media rules

Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.

Court orders Actavis to keep Namenda IR on market

An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.

Five things for pharma marketers to know: Friday, May 22

Five things for pharma marketers to know: Friday, May 22

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

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.

OPDP finds fault with Rapaflo website

The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.

Five things for pharma marketers to know: Wednesday, May 20

Five things for pharma marketers to know: Wednesday, May 20

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

Five things for pharma marketers to know: Friday, May 15

Five things for pharma marketers to know: Friday, May 15

Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease

Five things for pharma marketers to know: Wednesday, May 13

Five things for pharma marketers to know: Wednesday, May 13

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

HHS says Namenda switch could cost $6 billion

The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.

Five things for pharma marketers to know: Tuesday, May 12

Five things for pharma marketers to know: Tuesday, May 12

Mylan considers higher bid for Perrigo; Boehringer Ingelheim partners with health system on COPD; EMD Serono's experimental cancer drug gets Fast Track status

FDA panel to review Vertex CF combo therapy on Tuesday

FDA panel to review Vertex CF combo therapy on Tuesday

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.

Five things for pharma marketers to know: Friday, May 8

Five things for pharma marketers to know: Friday, May 8

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

Five things for pharma marketers to know: Monday, May 4

Five things for pharma marketers to know: Monday, May 4

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

Five things for pharma marketers to know: Friday, May 1

Five things for pharma marketers to know: Friday, May 1

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

FDA may tighten drug environmental rules

Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.

Five things for pharma marketers to know: Thursday, April 30

Five things for pharma marketers to know: Thursday, April 30

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

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

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.

FDA takes aim at Abilify marketing material

The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.

FDA finalizes biosimilar guidance

The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.

Tecfidera sales slow, Biogen to maintain "significant" sales force

Tecfidera sales slow, Biogen to maintain "significant" sales force

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.

Five things for pharma marketers to know: Thursday, April 23

Five things for pharma marketers to know: Thursday, April 23

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

FDA grants Pfizer lung-cancer drug Breakthrough Designation

Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.

Five things for pharma marketers to know: Tuesday, April 21

Five things for pharma marketers to know: Tuesday, April 21

Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion

FDA takes unusual stance on ALS drug

FDA takes unusual stance on ALS drug

The FDA asked private biotech Genervon to release all available clinical trial data for its experimental ALS treatment.

Five things for pharma marketers to know: Friday, April 17

Five things for pharma marketers to know: Friday, April 17

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 motion to delay Neupogen biosimilar denied

Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.

Five things for pharma marketers to know: Tuesday, April 14

Five things for pharma marketers to know: Tuesday, April 14

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

Five things for pharma marketers to know: Friday, April 10

Five things for pharma marketers to know: Friday, April 10

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

Five things for pharma marketers to know: Thursday, April 9

Five things for pharma marketers to know: Thursday, April 9

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

FDA Onglyza panel review set for Tuesday

FDA Onglyza panel review set for Tuesday

The panel will focus on heart failure hospitalization rates associated with the diabetes medication.

Hospira gets fifth FDA warning in two years

The company has received seven warning letters since 2010.

Five things for pharma marketers to know: Wednesday, April 8

Five things for pharma marketers to know: Wednesday, April 8

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

How to Make DTC Ad 'Warnings' More Effective

How to Make DTC Ad 'Warnings' More Effective

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 open-data platform gains traction

FDA's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.

Five things for pharma marketers to know: Tuesday, April 7

Five things for pharma marketers to know: Tuesday, April 7

Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext

CDC examines how US treats ADHD in children

The government agency found that more children are treated with medication than behavioral therapy.

Teva concealed kickbacks in speaker program, former reps allege

Teva concealed kickbacks in speaker program, former reps allege

Two former Teva sales representatives claim the drugmaker used speaker programs to hide kickbacks for prescribing drugs Copaxone and Azilect.

FDA finalizes opioid guidance

Opioids lacking abuse-foiling technology will remain available.

Five things for pharma marketers to know: Thursday, March 26

Five things for pharma marketers to know: Thursday, March 26

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

Lawmakers propose allowing pharma companies to share some off-label information

Lawmakers propose allowing pharma companies to share some off-label information

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.

The New Holistic Approach to Leveraging a Multi-Channel Contact Center

The New Holistic Approach to Leveraging a Multi-Channel Contact Center

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.

Five things for pharma marketers to know: Monday, March 23

Five things for pharma marketers to know: Monday, March 23

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

Five things for pharma marketers to know: Friday, March 20

Five things for pharma marketers to know: Friday, March 20

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

Sanofi R&D lead takes aim at global drug regulations

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.

Five things for pharma marketers to know: Monday, March 16

Five things for pharma marketers to know: Monday, March 16

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.

Five things for pharma marketers to know: Thursday, March 12

Five things for pharma marketers to know: Thursday, March 12

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.

Open Payments glitches limit submissions

Open Payments glitches limit submissions

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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