Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.
FDA advisory panel recommends Amgen's T-Vec; Teva again makes the case for a merger with Mylan; the FDA approves injection to treat double chins
The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.
The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.
The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.
The drugmaker said its top-selling multiple-sclerosis drug Tecfidera's slowdown in sales is due to competition from Plegridy as well as new patient concerns about risks of a rare brain infection.
Novo Nordisk's Saxenda to cost $1,000 a month; Boehringer Ingelheim's drug receives priority review; AbbVie's hep.-C treatment Viekira Pak generates $231 million in first-quarter sales
Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.
Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion
The FDA approves generic Copaxone; AstraZeneca's experimental lung-cancer drug demonstrates that it can delay disease progression; PhRMA CEO John Castellani to step down
Amgen's attempt to delay Zarxio was denied by a US District Court, which said the argument was speculative.
IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza
AstraZeneca diabetes drug may have increased mortality rate; Pfizer accused of knowing about birth defect risks from Zoloft; Eisai to cut 25% of its US workforce
Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times
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's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.
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.
The government agency found that more children are treated with medication than behavioral therapy.
Two former Teva sales representatives claim the drugmaker used speaker programs to hide kickbacks for prescribing drugs Copaxone and Azilect.
The proposal is part of the 21st Century Cures initiative and would permit drugmakers to provide information about "scientific and medical developments" when communicating with providers and payers.
Delivering smarter dynamic communications rather than static timed communications based on self-reported data can help connect patients to information and support that drive brand loyalty and program success.
The Paris-based drugmaker's global president of R&D said that jumping through different and inconsistent regulatory hoops puts an "enormous" cost on drugmakers.
New data suggest Amgen's PCSK9 may reduce risks of heart attacks, Salix bidding is war too rich for Endo's blood, Actavis bipolar drug use is expanded to 10- to 17-year-olds.
The 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.
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.
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.
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.
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.
A treatise on understanding the FDA's latest guidance of low-risk general wellness products.
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.
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 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."
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.
FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.
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.
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.
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.
CMS head Marilyn Tavenner has resigned; Depomed acquires Nucynta pain pill from J&J; Merck's innovation lead leaves for insurer.
FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.
Pharma ad budgets are growing, says IPG; Medical device tax debate rages on; Pfizer has PCSK9 pill in the works.
Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.
One issue lurking for marketers is the potential elimination of the tax exemption for advertising
The cystic fibrosis drug adds approval for treating a 10th gene mutation.
Nine drugs that promised meaningful advances over existing treatments earned the coveted status from FDA and were approved.
The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."
The much hashed-over initiative would require pharma firms to distribute the professional insert electronically.
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.
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.
Jakafi becomes the first drug approved for treating polycythemia vera.
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.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
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.
I come not to bury government but to praise it—at least the singular agency I know best: FDA
FDA issued a complete response letter on daclatasvir.
An advisory panel voted against adding warnings to steroid injection labels.
The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.
AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
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.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
The reason: coordination and effectiveness.
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.
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.
The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.
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.
Drug makers favor big spending on speakers' events and doctor outreach.
Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.
As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
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.
The two drugmakers have failed to reach an agreement.
Demonizing new treatments distracts from the real problem: policies that focus on the near-term
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.
The country's drug ministry has identified drugs as an area for savings.
Widely used plastics such as PET will have to be replaced with more costly glass containers.
The former FDA director of medical device compliance has petitioned the agency to make oral contraceptives over-the-counter.
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.
The drugmaker is offering Scotland's NHS a money-back guarantee for Olysio patients.
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.
Pfizer settles Chantix litigation; BMS scales back HCV efforts; FDA defends Zohydro approval.
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
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.
A charge of sexism against the FDA clouds the views surrounding a drug's application
Shire pays $56-million fine to resolve improper ADHD marketing claims; FDA updates Chantix labeling to reflect new safety studies; GSK names new chairman.
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.
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.
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.
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.
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.
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.
The designation is for diabetic retinopathy for patients with diabetic macular edema.
NY's attorney general alleges that a formulation switch is an attempt to create monopoly.
The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma
Bloomberg reports that India's Wockhardt has become an M&A target.
The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."
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.
Problems and changes have set ablaze criticism over the Sunshine Act's implementation
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.
The FDA has approved Arnuity Ellipta for asthma.
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.'"
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.
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