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Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.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

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

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

FDA open-data platform gains traction

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

Health Data Ushers in a New Era for Healthcare Communicators

Health Data Ushers in a New Era for Healthcare Communicators

Patients benefit when they can directly access their health data. Studies suggest that direct patient access to healthcare information could improve patient participation in healthcare and possibly quality.

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.

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.

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.

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.

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.

Five things for pharma marketers to know: Wednesday, March 11

Five things for pharma marketers to know: Wednesday, March 11

Zogenix spins off painkiller business; Biogen Idec investigates the use of wearables in MS patients; J&J sues Celltrion and Hospira to delay Remicade biosimilar.

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.

Five things for pharma marketers to know: Wednesday, March 4

Five things for pharma marketers to know: Wednesday, March 4

FDA adds new language to low-T drug labels; Afrezza's launch has a poor start, investors say; BMS acquires prostate-cancer vaccine in a deal worth $975 million.

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer

A treatise on understanding the FDA's latest guidance of low-risk general wellness products.

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.

Obama gives details on Precision Medicine Initiative

Obama gives details on Precision Medicine Initiative

President Barack Obama's recently unveiled Precision Medicine Initiative hopes to develop a new model of patient-driven research with the promise of accelerating biomedical discoveries and provide clinicians with new tools, knowledge, and therapies.

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: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.

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: Thursday, January 22

Five things for pharma marketers to know: Thursday, January 22

Takeda COO Weber refuses Sanofi CEO post; J&J seeks $7.2 billion from Boston Scientific over 10-year old-Guidant acquisition; UCB submits epilepsy drug for US and EU approval.

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.

Five things for pharma marketers to know: Friday, January 16

Five things for pharma marketers to know: Friday, January 16

CMS head Marilyn Tavenner has resigned; Depomed acquires Nucynta pain pill from J&J; Merck's innovation lead leaves for insurer.

FDA appoints Office of Generic Drugs director

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

Five things for pharma marketers to know: Wednesday, January 14

Five things for pharma marketers to know: Wednesday, January 14

Pharma ad budgets are growing, says IPG; Medical device tax debate rages on; Pfizer has PCSK9 pill in the works.

Five things for pharma marketers to know: Thursday, January 8

Five things for pharma marketers to know: Thursday, January 8

Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.

Washington Insider

Washington Insider

One issue lurking for marketers is the potential elimination of the tax exemption for advertising

Kalydeco gains expanded use

The cystic fibrosis drug adds approval for treating a 10th gene mutation.

Breakthrough drugs post banner year

Nine drugs that promised meaningful advances over existing treatments earned the coveted status from FDA and were approved.

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 issues long-awaited plan for electronic labeling

The much hashed-over initiative would require pharma firms to distribute the professional insert electronically.

Five things for pharma marketers to know: Friday, December 12

Five things for pharma marketers to know: Friday, December 12

Judge rules Actavis must keep Alzheimer's drug on the market; Wyeth CEO joins Roche board, dispelling rumors he may be next Sanofi CEO; Two senators propose new FDA designation which would award 15 years of marketing exclusivity.

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

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

GSK opts to hold onto $1.6 billion portfolio of older drugs; Sanofi upheavals continue with exit of US diabetes sales exec; Takeda gains breakthrough status on AL amyloidosis therapy.

Incyte drug gains expanded indication for bone marrow disease

Jakafi becomes the first drug approved for treating polycythemia vera.

Five for things pharma marketers to know: Thursday, December 4

Five for things pharma marketers to know: Thursday, December 4

Despite drugmaker discount, VA still can't afford Sovaldi without additional funds; Ousted Sanofi CEO Viehbacher faces lawsuit for an alleged kickback scheme; GSK slims sales and R&D workforce.

FDA approves Amgen leukemia immunotherapy

Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.

Five things for pharma marketers to know: Wednesday, December 3

Five things for pharma marketers to know: Wednesday, December 3

An Italian court backs the anti-trust's stand that Novartis and Roche colluded in Lucentis marketing; AstraZeneca is the test case for the court's new interpretation of pay-for-delay; early-stage results prompt Biogen Idec to take its experimental Alzheimer's treatment to Phase-III.

Washington Insider - Dec 2014

Washington Insider - Dec 2014

I come not to bury government but to praise it—at least the singular agency I know best: FDA

BMS proposed HCV therapy gets cold shoulder from regulators

BMS proposed HCV therapy gets cold shoulder from regulators

FDA issued a complete response letter on daclatasvir.

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.

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

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

AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.

FDA tempers opioid approval impact

FDA tempers opioid approval impact

The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.

Vancouver tests prescription heroin

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

India to reorg pharmaceutical agencies

The reason: coordination and effectiveness.

Five things for pharma marketers to know: Monday, November 24

Five things for pharma marketers to know: Monday, November 24

BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.

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

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

EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.

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.

Unsealed court documents shed light on opioid marketing

Drug makers favor big spending on speakers' events and doctor outreach.

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

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

Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.

FDA delays rule on generic drug labeling amid controversy

As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.

FDA clears new tool for Ebola arsenal

A US Senate bill would also make treatments for the disease eligible for priority review vouchers.

OPDP says sales aid for insomnia drug omits risk info

OPDP says sales aid for insomnia drug omits risk info

The Office of Prescription Drug Promotion took aim at a professional sales aid for Sciecure's insomnia drug Doral, saying the brochure omits risk info, material facts and makes unsubstantiated superiority claims.

Mediation fails in Roche-Cipla patent battle

The two drugmakers have failed to reach an agreement.

Washington Insider: Mistruths and half-truths about oncology meds

Washington Insider: Mistruths and half-truths about oncology meds

Demonizing new treatments distracts from the real problem: policies that focus on the near-term

Withdraw FDA scientific pubs distribution guide: Public Citizen

Withdraw FDA scientific pubs distribution guide: Public Citizen

Public Citizen tells FDA it should withdraw draft guidance that it believes will allow drugmakers to tell physicians marketed drugs are less risky than their labels indicate.

Ireland's drugmakers resist price cuts

The country's drug ministry has identified drugs as an area for savings.

India bans plastic packaging for drug liquids

Widely used plastics such as PET will have to be replaced with more costly glass containers.

Make all Rx contraceptives OTC, lawyer urges FDA

Make all Rx contraceptives OTC, lawyer urges FDA

The former FDA director of medical device compliance has petitioned the agency to make oral contraceptives over-the-counter.

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

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

Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.

J&J offers government payer hep. C guarantee

The drugmaker is offering Scotland's NHS a money-back guarantee for Olysio patients.

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

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

FDA commissioner Hamburg says agency wants to hasten medical device approvals; Amgen nets priority review for Phase-II leukemia drug; Novartis employee pleads guilty to bribery allegations.

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

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

Pfizer settles Chantix litigation; BMS scales back HCV efforts; FDA defends Zohydro approval.

Five things for pharma marketers to know: Friday, October 3

Five things for pharma marketers to know: Friday, October 3

Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep

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

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

Ebola lands in the US; CMS's Open Payments database shows docs received $3.5 billion in last five months of 2013; Endo pays over $400 million to settle vaginal mesh suits.

Washington Insider : Science, Not Ideology

Washington Insider : Science, Not Ideology

A charge of sexism against the FDA clouds the views surrounding a drug's application

Five things for pharma marketers to know: Thursday, September 25

Five things for pharma marketers to know: Thursday, September 25

Shire pays $56-million fine to resolve improper ADHD marketing claims; FDA updates Chantix labeling to reflect new safety studies; GSK names new chairman.

US Treasury takes action on tax inversions

US Treasury takes action on tax inversions

The Treasury announced Monday it would eliminate certain techniques companies use to facilitate so-called tax inversions, which a number of drug companies have undertaken in the past six months.

Five things for pharma marketers to know: Tuesday, September 23

Five things for pharma marketers to know: Tuesday, September 23

Treasury Department takes action against corporate tax inversions; CDC pegs Ebola worst case scenario at 1.4 million infected by new year; NIH allocates $10 million in grants to increase female clinical trials.

OPDP slams cholesterol drug's e-mail claims

OPDP slams cholesterol drug's e-mail claims

The Office of Prescription Drug Promotion took aim at Cipher Pharmaceuticals and its marketer Kowa, in an Untitled Letter over an e-mail alert making what it said were unsubstantiated assertions.

Five things for pharma marketers to know: Friday, September 19

Five things for pharma marketers to know: Friday, September 19

Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.

FDA panel votes against taking drugs for "low-T"

FDA panel votes against taking drugs for "low-T"

An FDA advisory panel voted overwhelmingly against the use of testosterone-replacement drugs for "low-T" Wednesday, saying the label should narrow and that more safety information is needed.

Five things for pharma marketers to know: Thursday, September 18

Five things for pharma marketers to know: Thursday, September 18

FDA panel votes overwhelmingly against Low-T drugs; Stenda approved for fast-acting ED treatment; and Bayer hones life-sci focus, spins off material sciences business.

Regeneron's Eylea scores Breakthrough label

The designation is for diabetic retinopathy for patients with diabetic macular edema.

NY sues over Forest Alzheimer's medication

NY's attorney general alleges that a formulation switch is an attempt to create monopoly.

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma

FDA sanctions don't kill a business

Bloomberg reports that India's Wockhardt has become an M&A target.

FDA lifts OncoMed partial hold

The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, August 29

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Washington Insider: Open Payments

Washington Insider: Open Payments

Problems and changes have set ablaze criticism over the Sunshine Act's implementation

J&J, Vivus patent suit ends

J&J subsidiary Janssen has abandoned its patent lawsuit over the anti-seizure medication topiramate, which is part of Vivus's prescription weight-loss drug Qsymia.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.

The 2015 healthcare agency questionnaire, for firms hoping to be featured in the Top 100 Agencies issue, is live. Click here to be considered.

Email Newsletters