Five things for pharma marketers to know: Thursday, July 14, 2016

Five things for pharma marketers to know: Thursday, July 14, 2016

The FDA expands use for Pfizer's Prevnar 13 vaccine; an FDA panel votes in support of Novartis biosimilar; U.S. healthcare spending rises 5.5% in 2015

Five things for pharma marketers to know: Monday, July 11, 2016

Five things for pharma marketers to know: Monday, July 11, 2016

Purdue Pharma reportedly knew about OxyContin trafficking; Amgen's Repatha approved for monthly dosing option; Clinton proposes new healthcare measures

Five things for pharma marketers to know: Friday, July 8, 2016

Five things for pharma marketers to know: Friday, July 8, 2016

The FDA said Amgen's biosimilar of Humira is safe and effective; Juno trial halted due to patient deaths; the CMS bans Theranos founder

Five things for pharma marketers to know: Monday, June 27, 2016

Five things for pharma marketers to know: Monday, June 27, 2016

Former FDA commissioners said agency should be independent from HHS; Sanofi and BI confirm asset swap; FDA panel to vote on new Jardiance data

Five things for pharma marketers to know: Friday, June 24, 2016

Five things for pharma marketers to know: Friday, June 24, 2016

Brexit votes creates EU regulatory uncertainty; Obama plans to veto health saving accounts bill; broad Entresto adoption could prevent more than 28,000 deaths

Five things for pharma marketers to know: Thursday, June 23, 2016

Five things for pharma marketers to know: Thursday, June 23, 2016

Medicare cost-cutting panel will not be activated this year; more Americans are abusing opioids; BIO blasts ICER

Five things for pharma marketers to know: Thursday, June 16, 2016

Five things for pharma marketers to know: Thursday, June 16, 2016

A government watchdog criticizes the FDA; the FDA strengthens kidney warnings for Invokana and Farxiga; people with diabetes are living longer

Five things for pharma marketers to know: Tuesday, May 31, 2016

Five things for pharma marketers to know: Tuesday, May 31, 2016

Lawmaker calls for investigation of Purdue; Jazz to acquire Celator; Intercept's liver drug is approved

Five things for pharma marketers to know: Tuesday, May 24, 2016

Five things for pharma marketers to know: Tuesday, May 24, 2016

The FDA accepts Samsung's biosimilar for review; Sanofi retools executive committee; Entresto may get a boost from updated care guidelines

Five things for pharma marketers to know: Monday, May 23, 2016

Five things for pharma marketers to know: Monday, May 23, 2016

E.U. lifts warning on Pfizer's Chantix; Obama's Medicare Part B proposal panned by lawmakers; France to propose stricter rules for clinical trials

Industry criticizes FDA's proposed DTC studies

Industry criticizes FDA's proposed DTC studies

Pharma companies took issue with the methodology for the FDA's proposed studies of advertising tactics.

Lobbyists argue DTC ad tax deduction may be a casualty of reform

Lobbyists argue DTC ad tax deduction may be a casualty of reform

Advertising lobbyist said eliminating the DTC ad tax deduction is a real threat to the industry.

Five things for pharma marketers to know: Wednesday, May 4, 2016

Five things for pharma marketers to know: Wednesday, May 4, 2016

The FDA issues warning for certain antipsychotics; Shkreli may face more securities charges; Genentech and Stand Up to Cancer launch campaign

Five things for pharma marketers to know: Thursday, April 28, 2016

Five things for pharma marketers to know: Thursday, April 28, 2016

Pfizer settles rebate suit; Sanofi moves to acquire Medivation; AstraZeneca sells US rights to gout drug

Senate committee condemns Valeant's business model

Senate committee condemns Valeant's business model

The Senate committee on Aging said Valeant's missteps go beyond price hikes and that its business model is fundamentally to blame.

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

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

Pearson expected to say price hikes were too aggressive; Collegium's painkiller receives full FDA approval; most hospitals stop advertising infant formula

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

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

FDA panel says Duchenne drug is not effective; Bill Ackman to appear before Senate committee investigating pricing issues; Daiichi Sankyo to open new headquarters

Five things for pharma marketers to know: Wednesday, April 13, 2016

Five things for pharma marketers to know: Wednesday, April 13, 2016

Sanofi is reportedly interested in buying Medivation; Sean Parker funds $250 million cancer research institute; FDA will review Merck's allergy biologic

FDA committee votes no on Clovis lung-cancer drug

FDA committee votes no on Clovis lung-cancer drug

The FDA advisory committee voted 12-1 against approving the therapy, citing safety issues and requesting more data.

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

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

California bill would require price disclosures; AbbVie's and Genentech's blood-cancer drug is approved; FDA expands metformin use

The FDA approves AbbVie's and Roche's blood cancer drug

The FDA approves AbbVie's and Roche's blood cancer drug

Analysts have estimated the drug could reach $2 billion in sales in the next four years.

Five things for pharma marketers to know: Thursday, March 31, 2016

Five things for pharma marketers to know: Thursday, March 31, 2016

The FTC asks for more info about Pfizer-Allergan deal; the FDA loosens guidelines for abortion-inducing drug; startup to deliver Truvada through an app

Another physician group raises concerns about DTC

Another physician group raises concerns about DTC

The American College of Physicians questioned the role direct-to-consumer advertising plays in contributing to prescription drug costs.

Five things for pharma marketers to know: Tuesday, March 29, 2016

Five things for pharma marketers to know: Tuesday, March 29, 2016

Lawmakers call out high price of Xtandi; Novo Nordisk breaks ground in North Carolina; Sanofi poaches top research scientist from AstraZeneca

Amgen wins PCSK9 patent case against Sanofi and Regeneron

Amgen wins PCSK9 patent case against Sanofi and Regeneron

A jury ruled in favor of Amgen, saying its patents for Repatha are valid.

Five things for pharma marketers to know: Tuesday, March 15, 2016

Five things for pharma marketers to know: Tuesday, March 15, 2016

The FDA will prioritize certain generic drug applications; Valeant posts fourth-quarter loss; medical marijuana drug shines in Phase-III trial

The FDA wants to study DTC tactics

The FDA wants to study DTC tactics

The agency has proposed two studies to investigate the use of superimposed text and the use of animated characters.

Five things for pharma marketers to know: Wednesday, March 9, 2016

Five things for pharma marketers to know: Wednesday, March 9, 2016

Amarin settles with the FDA over off-label promotion suit; mobile apps often share medical information with third parties; drug spending rose 12% in 2014

Senators propose an end to pharma ad tax deduction

Senators propose an end to pharma ad tax deduction

The proposed legislation would forbid drugmakers from writing off advertising as a tax deduction.

Five things for pharma marketers to know: Friday, March 4, 2016

Five things for pharma marketers to know: Friday, March 4, 2016

New PhRMA CEO issues policy strategy; study assess patient response to immuno-oncology drugs; Twitter may be an effective way to talk about clinical trials

Five things for pharma marketers to know: Thursday, February 25, 2016

Five things for pharma marketers to know: Thursday, February 25, 2016

Senate approves Califf as FDA commissioner; one-fifth of published trial data is used for "marketing trials;" Valeant CEO Pearson is on the mend

Five things for pharma marketers to know: Tuesday, February 23, 2016

Five things for pharma marketers to know: Tuesday, February 23, 2016

The Senate clears Califf; Sanofi files new drug application for Lantus/Lyxumia combination; the FDA approves UCB's new epilepsy drug

Five things for pharma marketers to know: Thursday, February 18, 2016

Five things for pharma marketers to know: Thursday, February 18, 2016

Lawmaker seeks to stop DTC ads for newly approved drugs; testosterone therapy helps sexual function; the FDA requests more data about Catalyst's rare drug

Five things for pharma marketers to know: Wednesday, February 10, 2016

Five things for pharma marketers to know: Wednesday, February 10, 2016

SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes

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: 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: 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

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: 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: 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.

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.

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: 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

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

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

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

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: 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

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

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.

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 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.

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.

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.

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

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: 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

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.

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.

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

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.

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

FDA may tighten drug environmental rules

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

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 grants Pfizer lung-cancer drug Breakthrough Designation

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

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.

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.

Top insurance lobby backs New York AG in Actavis antitrust case

America's Health Insurance Plans offered its opinion of the Actavis Namenda IR antitrust case, giving its support to New York Attorney General Eric Schneiderman.

FDA releases new e-informed consent guidance in bid for more efficient trials

FDA releases new e-informed consent guidance in bid for more efficient trials

The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.

Device maker pays feds $2.8M over physician false claims

Device maker pays feds $2.8M over physician false claims

Medtronic, as part of the settlement, will pay $602,000 to a whistleblower to settle charges it caused physicians to submit false claims to federal health programs.

FDA updates DTC ad policy on risk information

FDA updates DTC ad policy on risk information

FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."

Five things for pharma marketers to know: Thursday, February 5

Five things for pharma marketers to know: Thursday, February 5

FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.

Five things for pharma marketers to know: Tuesday, February 3

Five things for pharma marketers to know: Tuesday, February 3

President Barack Obama states in budget proposal that government should negotiate drug pricing; J&J's rare cancer drug's review is expedited; inhalable insulin hits pharmacy shelves.

Five things for pharma marketers to know: Wednesday, January 21

Five things for pharma marketers to know: Wednesday, January 21

President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.

FDA appoints Office of Generic Drugs director

FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.

OPDP slams print ad in Untitled Letter

OPDP slams print ad in Untitled Letter

The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."

FDA panel recommends against steroid injection warning

An advisory panel voted against adding warnings to steroid injection labels.

FDA takes issue with metatags

The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.

Vancouver tests prescription heroin

The north-of-the-border solution comes amid climbing heroin abuse in the US.

FDA approves abuse-deterrent Hysingla ER

The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.

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