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.
The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.
CVS Health to buy Target's pharmacy business; experimental gene therapy improves condition of teen with sickle-cell disease; PatientsLikeMe partners with the FDA to improve postmarket surveillance
An FDA letter says there was no need to go to court but experts tell MM&M this lawsuit highlights an issue that is bigger than a single pill.
Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.
Amgen's PCSK9 inhibitor is the second in its class to get an FDA panel endorsement; a new drug could threaten Shire's hold on a rare-disease category; a study shows pharma invests less in Hispanic audiences than in other groups
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
Study shows Merck's Januvia does not increase heart risks; a former Genentech exec launches a behavioral health business; lawmakers want black-box warnings on more opioids
FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
A House committee is looking into the FDA's warning letter publication process; Amgen and Roche collaborate on cancer combination drug; study shows online health information fails teenagers
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.
The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.
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
Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease
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
Nexium tops the list of Medicare's spending on brand drugs; Gilead Sciences doubles its first-quarter profit; Pfizer reportedly wants to buy a rare-disease drug company
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