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
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.
Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed
New rules will require manufacturers to report some indirect payments made to physicians for CME activities.
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.
Pharma's efforts to evolve restrictions about off-label marketing move forward.
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
Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
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
Last year's increase in CME support from manufacturers came after six straight years of declining budgets.
Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.
Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.
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
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 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.
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.
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
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
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
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
The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.
Mylan considers higher bid for Perrigo; Boehringer Ingelheim partners with health system on COPD; EMD Serono's experimental cancer drug gets Fast Track status
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.
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
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
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
As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.
The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.