Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog
A House lawmaker called pricing strategies used by Turing and Valeant "repulsive."
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
Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets
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.
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
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
The Office of Prescription Drug Promotion said Pfizer subsidiary Hospira omitted information and misbranded the drug
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
While DTC advertising does significantly impact consumer demand, most evidence suggests the majority of this demand benefits the overall state of consumer health.
The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks
Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.
HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO
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.
Fitbit faces allegations of inaccurate heart monitoring; Viiv Healthcare to collaborate with Janssen; Guardant Health raises funding for its cancer blood tests
The FDA approved 45 new drugs in 2015; Baxalta signs immuno-oncology deal; pharma M&A activity may slow this year
Generic Nexium will be blue; researcher says scientific papers should be anonymous; patients with health insurance still struggle to cover the costs of drugs
Social listening can help all along the value chain—from research and discovery to developing marketing plans and strategy.
Generic-drug approval backlog criticized; KaloBios board members step down; Sovaldi costs as little as $4 in India
Clinton calls for Alzheimer's funding; an FDA approval of an older drug may mean higher prices; the FDA approves AstraZeneca's gout drug
Shkreli resigns from Turing; Keytruda approved as first-line melanoma treatment; drugmakers seek to fend off California pricing ballot initiative
The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges
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.
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
An FDA advisory committee voted 11-3, recommending approval of reslizumab in adults with severe asthma.
Sprout CEO departs; Senate committee sounds off on Valeant, Turing repricing, JAMA viewpoint raises safety concerns about Entresto
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
Opdivo receives another indication; increasing generic prescriptions may boost patient adherence; hep.-C drugs should be prescribed during earlier stages of disease
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
Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.
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
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
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
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 made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.
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
One analyst said he expects that the change in label "will meaningfully commercially impair Viekira Pak sales."
23andMe relaunches its DTC genetic test; Valeant's woes increase as shares plummet; the FDA questions the safety of AstraZeneca's gout drug
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
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
Sanofi's Aubagio reduces brain volume loss; cancer specialists avoid pricey cancer meds; analysis says placebo effect is on the rise
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
Hillary Clinton proposes stricter regulation of opioid painkillers; the FTC argues drugmakers make slight changes to drugs to prevent generics; MannKind layoffs continue
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.
Democrats request subpoena over Valeant price hikes; Clinton adds research incentive to drug-pricing proposal; Roche files approval for novel MS therapy
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
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
The agency announced a new committee to help integrate patient perspectives into the regulation of medical devices.
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
Obama nominates Robert Califf as FDA commissioner; The Huffington Post debuts investigative series on J&J; Amgen acquires cholesterol-lowering drug
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
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.
Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life
The presidential candidate is the latest critic of current laws that prohibit the government from negotiating drug prices for Medicare Part D.
Longer-term use of AstraZeneca's Brilinta approved; Google streamlines health-related searches; Zarxio's price is higher than expected
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.
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
Amgen's Repatha receives FDA nod; Mylan shareholders vote in favor of Perrigo deal; doctors push for below-average price of experimental cancer drug
The FDA is expected to announce this week whether it has approved the epilepsy drug as a monotherapy for partial-onset seizures.
The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
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
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.
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
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.
Could Kardashian West's now-notorious Diclegis social post be more than an OPDP case study?
Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations
State attorneys general accused the drugmaker of violating state consumer protection laws.
But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.
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
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
The FDA said Kim Kardashian West's promotion of morning-sickness pill Diclegis misbranded the product by understating its risks.
"Me-too" drugs may help lower costs; start-ups send doctors to your home; the FDA is likely to appeal the Amarin ruling
The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.
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
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
Spritam is a prescription epilepsy adjunct delivered orally.
Copaxone sales rise despite generic competition; Valeant to defend tax strategy; Bristol-Myers Squibb to test Opdivo with mogamulizumab in the US
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 agency plans to research extrinsic factors that influence the way a patient perceives a drug.
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.
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
PhRMA and the Epilepsy Foundation said 50-million Americans are affected by disorders such as Alzheimer's disease and multiple sclerosis.
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.
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.
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
Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin
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
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
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
It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.
Speakers at Klick Health's event criticized, lauded the role of technology in healthcare.
- Five things for pharma marketers to know: Friday, February 5, 2016
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- Ascension Health ups Ragone to chief marcomms officer
- House Oversight committee upbraids Turing, Valeant execs
- Burcin departs Havas network for Klick Health in senior-staffing push