Five things for pharma marketers to know: Friday, February 5, 2016

Five things for pharma marketers to know: Friday, February 5, 2016

Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog

House Oversight committee upbraids Turing, Valeant execs

House Oversight committee upbraids Turing, Valeant execs

A House lawmaker called pricing strategies used by Turing and Valeant "repulsive."

Five things for pharma marketers to know: Thursday, February 4, 2016

Five things for pharma marketers to know: Thursday, February 4, 2016

Valeant to push for changes to financial-assistance rules; House to hold hearing on drug-pricing practices; FDA committee says Lundbeck can add information to leaflet

Five things for pharma marketers to know: Wednesday, February 3, 2016

Five things for pharma marketers to know: Wednesday, February 3, 2016

Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets

Speeding up FDA Approvals Calls for Pause

Speeding up FDA Approvals Calls for Pause

The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.

Five things for pharma marketers to know: Wednesday, January 27, 2016

Five things for pharma marketers to know: Wednesday, January 27, 2016

The FDA plans to release new guidance on advertising in 2016; Trump supports Medicare price negotiations; Novartis CEO: golden days of drug pricing are over

Five things for pharma marketers to know: Tuesday, January 26, 2016

Five things for pharma marketers to know: Tuesday, January 26, 2016

The FDA accepts bid for new label for Jardiance; Markey puts on a hold on Califf's FDA nomination; GSK is studying the Zika virus

FDA slams Pfizer subsidiary for "misleading" Precedex video

FDA slams Pfizer subsidiary for "misleading" Precedex video

The Office of Prescription Drug Promotion said Pfizer subsidiary Hospira omitted information and misbranded the drug

Five things for pharma marketers to know: Tuesday, January 19, 2016

Five things for pharma marketers to know: Tuesday, January 19, 2016

Government pressure can influence drug-pricing decisions; Samsung's biosimilar version of Enbrel is approved in Europe; J&J to cut jobs in medical-devices business

What the AMA's Proposed DTC Ban Overlooks

What the AMA's Proposed DTC Ban Overlooks

While DTC advertising does significantly impact consumer demand, most evidence suggests the majority of this demand benefits the overall state of consumer health.

Five things for pharma marketers to know: Friday, January 15, 2016

Five things for pharma marketers to know: Friday, January 15, 2016

The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks

Senate committee clears Califf as FDA head

Senate committee clears Califf as FDA head

Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.

Five things for pharma marketers to know: Tuesday, January 12, 2016

Five things for pharma marketers to know: Tuesday, January 12, 2016

HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

Five things for pharma marketers to know: Thursday, January 7, 2016

Five things for pharma marketers to know: Thursday, January 7, 2016

Fitbit faces allegations of inaccurate heart monitoring; Viiv Healthcare to collaborate with Janssen; Guardant Health raises funding for its cancer blood tests

Five things for pharma marketers to know: Monday, January 4, 2016

Five things for pharma marketers to know: Monday, January 4, 2016

The FDA approved 45 new drugs in 2015; Baxalta signs immuno-oncology deal; pharma M&A activity may slow this year

Five things for pharma marketers to know: Thursday, December 31, 2015

Five things for pharma marketers to know: Thursday, December 31, 2015

Generic Nexium will be blue; researcher says scientific papers should be anonymous; patients with health insurance still struggle to cover the costs of drugs

Leadership Exchange: Social Listening

Leadership Exchange: Social Listening

Social listening can help all along the value chain—from research and discovery to developing marketing plans and strategy.

Five things for pharma marketers to know: Tuesday, December 29, 2015

Five things for pharma marketers to know: Tuesday, December 29, 2015

Generic-drug approval backlog criticized; KaloBios board members step down; Sovaldi costs as little as $4 in India

Five things for pharma marketers to know: Wednesday, December 23, 2015

Five things for pharma marketers to know: Wednesday, December 23, 2015

Clinton calls for Alzheimer's funding; an FDA approval of an older drug may mean higher prices; the FDA approves AstraZeneca's gout drug

Five things for pharma marketers to know: Monday, December 21, 2015

Five things for pharma marketers to know: Monday, December 21, 2015

Shkreli resigns from Turing; Keytruda approved as first-line melanoma treatment; drugmakers seek to fend off California pricing ballot initiative

Five things for pharma marketers to know: Thursday, December 17, 2015

Five things for pharma marketers to know: Thursday, December 17, 2015

The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges

The FDA settles with Pacira, rescinds warning letter

The FDA settles with Pacira, rescinds warning letter

The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.

Five things for pharma marketers to know: Tuesday, December 15, 2015

Five things for pharma marketers to know: Tuesday, December 15, 2015

Valeant agrees to cut prices in deal with Walgreens; FDA committee votes against Merck's Vytorin claims; Pacira settles off-label marketing case with the FDA

FDA advisory panel recommends Teva asthma antibody

FDA advisory panel recommends Teva asthma antibody

An FDA advisory committee voted 11-3, recommending approval of reslizumab in adults with severe asthma.

Five things for pharma marketers to know: Thursday, December 10, 2015

Five things for pharma marketers to know: Thursday, December 10, 2015

Sprout CEO departs; Senate committee sounds off on Valeant, Turing repricing, JAMA viewpoint raises safety concerns about Entresto

Five things for pharma marketers to know: Wednesday, November 25, 2015

Five things for pharma marketers to know: Wednesday, November 25, 2015

FDA advisers vote against BioMarin's Duchenne drug; the FDA approves Lilly's lung-cancer drug; criticism mounts for Pfizer's proposed deal with Allergan

Five things for pharma marketers to know: Tuesday, November 24, 2015

Five things for pharma marketers to know: Tuesday, November 24, 2015

Opdivo receives another indication; increasing generic prescriptions may boost patient adherence; hep.-C drugs should be prescribed during earlier stages of disease

Outlook 2016: A Pharma Pile-On

Outlook 2016: A Pharma Pile-On

To hear politicians tell it—especially the ones seeking President Obama's job—pharma is motivated by profit and needs to be brought to heel. The reality of the situation, inside DC and out, is just a tad more complex. Larry Dobrow takes a closer look at what might be coming down the policy pipeline Illustration by Alex Fine

Five things for pharma marketers to know: Wednesday, November 18, 2015

Five things for pharma marketers to know: Wednesday, November 18, 2015

Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday

Valeant woes continue, with lawsuit and new Philidor allegations

Valeant woes continue, with lawsuit and new Philidor allegations

The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.

Five things for pharma marketers to know: Thursday, November 12, 2015

Five things for pharma marketers to know: Thursday, November 12, 2015

Not-for-profit ranks Gilead Sciences and Sanofi as the lowest-scoring drugmakers in terms of clinical trial transparency; Perrigo shareholders to vote on Mylan deal; new Valeant allegations

Five things for pharma marketers to know: November 11, 2015

Five things for pharma marketers to know: November 11, 2015

Dr. Reddy's is blocked from selling generic purple Nexium; the FDA approves Roche's melanoma drug; Novartis says Entresto keeps heart-failure patients from being readmitted to the hospital

Industry watches Pacira's off-label case against the FDA

Industry watches Pacira's off-label case against the FDA

The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.

Five things for pharma marketers to know: Tuesday, October 27, 2015

Five things for pharma marketers to know: Tuesday, October 27, 2015

Novartis to pay $390 million to settle a lawsuit over drug sales; researchers examine why some patients respond better than others to immuno-oncology drugs; experimental heart-failure drug to get late-stage trial

Valeant subsidiary discloses subpoena over doctor payments

Valeant subsidiary discloses subpoena over doctor payments

Valeant made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.

Five things for pharma marketers to know: Monday, October 26, 2015

Five things for pharma marketers to know: Monday, October 26, 2015

FDA panel recommends AZ gout drug for approval; Valeant to form committee to examine specialty pharmacy ties; patients treated with Keytruda had longer survival than those who took chemo

FDA issues safety warning for AbbVie's HCV drugs

FDA issues safety warning for AbbVie's HCV drugs

One analyst said he expects that the change in label "will meaningfully commercially impair Viekira Pak sales."

Five things for pharma marketers to know: Wednesday, October 21, 2015

Five things for pharma marketers to know: Wednesday, October 21, 2015

23andMe relaunches its DTC genetic test; Valeant's woes increase as shares plummet; the FDA questions the safety of AstraZeneca's gout drug

Five things for pharma marketers to know: Thursday, October 15, 2015

Five things for pharma marketers to know: Thursday, October 15, 2015

Valeant receives subpoenas over drug pricing; BMS signs new immuno-oncology deal with Five Prime Therapeutics; Pfizer CEO says insurance coverage to blame in price debate

Five things for pharma marketers to know: Friday, October 10, 2015

Five things for pharma marketers to know: Friday, October 10, 2015

Critics question the FDA's decision to approve OxyContin for children; AstraZeneca temporarily stops to lung-cancer trials; Sanders will oppose Califf's nomination as FDA commissioner

Six things for pharma marketers to know: Thursday, October 8, 2015

Six things for pharma marketers to know: Thursday, October 8, 2015

Sanofi's Aubagio reduces brain volume loss; cancer specialists avoid pricey cancer meds; analysis says placebo effect is on the rise

Five things for pharma marketers to know: Wednesday, October 7, 2015

Five things for pharma marketers to know: Wednesday, October 7, 2015

Califf reportedly removes name from research questioning FDA oversight of clinical trials; Express Scripts to cover both PCSK9 inhibitors; trial for experimental cancer drug halted after patient death

Five things for pharma marketers to know: Friday, October 2, 2015

Five things for pharma marketers to know: Friday, October 2, 2015

Hillary Clinton proposes stricter regulation of opioid painkillers; the FTC argues drugmakers make slight changes to drugs to prevent generics; MannKind layoffs continue

Omitting risk info in ads is top reason for FDA warning

Omitting risk info in ads is top reason for FDA warning

An analysis conducted by J&J executives found that 58% of FDA warning letters and untitled letters over the last two years omitted risk information.

Five things for pharma marketers to know: Tuesday, September 29, 2015

Five things for pharma marketers to know: Tuesday, September 29, 2015

Democrats request subpoena over Valeant price hikes; Clinton adds research incentive to drug-pricing proposal; Roche files approval for novel MS therapy

Five things for pharma marketers to know: Monday, September 28, 2015

Five things for pharma marketers to know: Monday, September 28, 2015

PhRMA hires Ubl as CEO; two drugs report superior results in kidney-cancer trials compared to the standard of care; Novo Nordisk's shares rise on Tresiba approval

Five things for pharma marketers to know: Wednesday, September 23, 2015

Five things for pharma marketers to know: Wednesday, September 23, 2015

Turing CEO backs down on price hike; Amgen's and Allergan's cancer biosimilar shows positive results; study finds text message reminders can change health behavior

FDA forms first patient engagement committee

FDA forms first patient engagement committee

The agency announced a new committee to help integrate patient perspectives into the regulation of medical devices.

Five things for pharma marketers to know: Thursday, September 17, 2015

Five things for pharma marketers to know: Thursday, September 17, 2015

New analysis says Paxil is not safe or effective for teens; some FDA reviewers voted against Addyi approval over side effects; HHS partners with AstraZeneca on antibiotic development

Five things for pharma marketers to know: Wednesday, September 16, 2015

Five things for pharma marketers to know: Wednesday, September 16, 2015

Obama nominates Robert Califf as FDA commissioner; The Huffington Post debuts investigative series on J&J; Amgen acquires cholesterol-lowering drug

Five things for pharma marketers to know: Friday, September 11, 2015

Five things for pharma marketers to know: Friday, September 11, 2015

Proteus and Otsuka seek approval of "digital" drug; J&J moves its US media-buying business back to UM; FDA committee votes no on Purdue's new opioid

Off-label cases against the FDA move forward

Off-label cases against the FDA move forward

Amarin begins legally promoting off-label uses of its prescription fish-oil drug, while Pacira sues the FDA over the label for its pain drug, Exparel.

Five things for pharma marketers to know: Wednesday, September 9, 2015

Five things for pharma marketers to know: Wednesday, September 9, 2015

Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life

Sen. Sanders joins drug-pricing fray

Sen. Sanders joins drug-pricing fray

The presidential candidate is the latest critic of current laws that prohibit the government from negotiating drug prices for Medicare Part D.

Five things for pharma marketers to know: Friday, September 4, 2015

Five things for pharma marketers to know: Friday, September 4, 2015

Longer-term use of AstraZeneca's Brilinta approved; Google streamlines health-related searches; Zarxio's price is higher than expected

Judge's ruling allows Sandoz to begin marketing its biosimilar Zarxio

Judge's ruling allows Sandoz to begin marketing its biosimilar Zarxio

The motion denied Amgen's bid for a temporary injunction that would have prevented the launch of Zarxio, the first FDA-approved biosimilar and a competitor to Amgen's Neupogen.

Five things for pharma marketers to know: Monday, August 31

Five things for pharma marketers to know: Monday, August 31

Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors

Five things for pharma marketers to know: Friday, August 28

Five things for pharma marketers to know: Friday, August 28

Amgen's Repatha receives FDA nod; Mylan shareholders vote in favor of Perrigo deal; doctors push for below-average price of experimental cancer drug

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.

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