The FDA approves Opdivo/Yervoy combination to treat melanoma; BioMarin acquires global rights to Kuvan; Allergan's Juvederm receives marketing approval for lip augmentation
Valeant acquires Sprout for $1 billion; AbbVie buys Priority Review voucher from United Therapeutics; FDA approval rate stands at 89% so far for 2015.
Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations
More patients are seeking treatments with even fewer side effects and shorter durations.
View on a quarter-by-quarter basis the competitive market for four new hepatitis-C treatments and track how Gilead Sciences' Harvoni became the market leader within months of receiving approval from the FDA.
UnitedHealth looks for refunds when drugs don't work; the European Medicines Agency recommends Sanofi's and Regeneron's PCSK9 inhibitor, Praluent, for approval; Biogen's multiple-sclerosis drug, Tecfidera, reports lower-than-expected sales growth
The modern healthcare landscape is complicated, and the terrain is even more gnarled for life sciences companies trying to bring new products to market.
The pharma business needs to take engagement far more seriously than it has in the past. At the same time, there are signs that the industry is finally acting with more urgency and even transparency.
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
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
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.
FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs
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.
HCV drugs and other specialty medications drove a 13% increase in last year's prescription spending, the CBO overestimated just how much healthcare reform would cost, and an FDA panel voted 17-0 in favor of Kythera's drug that can reduce double chins.
The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.
FDA approves the first biosimilar, judge rules that FDA panel members had conflicts of interest, and a new venture will evaluate the effectiveness of digital health technologies.
23andMe is back in the DTC game; Sanofi has named its new CEO; drug companies are contemplating a pay-for-performance sales model.
FDA approves Eisai's thryoid cancer drug two months early, Gilead and Germany agree to a Sovaldi price cut, and Valeant looks set to make a bid for Salix.
Google teams up with PwC for DOD EHR project bid; FDA approves first weight-loss device since 2007; research says opioid abuse may be on the decline.
The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.
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.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
Promacta was previously indicated for chronic immune thrombocytopenia.
Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.
The FDA has approved Arnuity Ellipta for asthma.
Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.
The FDA greenlighted the drug for three cancers.
Specialty medicines continue to be a hot category, one in which spending has surged behind products that treat medicine's most complex diseases. This eBook lays out the needs and hurdles along the specialty drug pathway, explaining how stakeholders are working to get meds into patients' hands and ease their experience. Click here to download.