The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
GSK studying Breo Ellipta in lung-cancer patients; researchers develop strains of yeast for painkillers in a lab; Wolters Kluwer acquires CME provider
CVS will not negotiate PCSK9 inhibitor pricing until Amgen's Repatha receives approval; more companies are looking inward for marketing help in lieu of agencies; AstraZeneca inks oncology collaboration
Findings of a new report suggest ways pharma should rethink its commercial and R&D decisions in light of improved survival rates associated with some cancers.
Shire offers to buy Baxalta for $30 billion; CVS reports strong sales in specialty pharmacy; Reuters reports that new drug launches hit 17-year high in 2014
Shire buys Foresight Biotherapeutics for $300 million; Novartis sold off three investigational drugs into Mereo BioPharma; new blood thinners linked to 8,000 deaths since 2010
The immuno-oncology drug is competing with Bristol-Myers Squibb's Opdivo.
Teva will acquire Allergan's generic drug business; AstraZeneca sells rights to cancer drug to Sanofi; the FDA approves two drugs heading into the weekend
Today's cancer therapies have an unlikely champion in their corner: the immune system. Scientists are training the natural disease defender to KO cancer for good—and pharma companies are drooling over the flashy premium prices and commercial success of marketed immunotherapies, which have ignited vigorous pipeline work. Rebecca Mayer Knutsen surveys the $32-billion US cancer segment
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
Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed
Johnson & Johnson CEO Alex Gorsky said physicians are unlikely to switch the majority of patients to a biosimilar version of Remicade.
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
An FDA advisory panel will discuss the fate of Lilly's investigational lung-cancer antibody, necitumumab, which improved overall survival incrementally but also had one late-stage trial halted due to an "imbalanced number of deaths" attributed to blood clots.
The promise of an Opdivo/Yervoy combination, now awaiting FDA approval, has more to do with payer strategy than efficacy, analysts say.
Teva loses Copaxone patent suit; Oncologists at Memorial Sloan Kettering Cancer Center developed cancer drug cost calculator; Bayer will invest $4.5 billion in R&D in the coming year.
Harvard's Dana-Farber Cancer Institute and the Sarah Cannon Research Institute signed on to help the drugmaker develop cancer treatments.
An analysis by Avalere Health says 10 breakthrough therapy drugs will account for billions in spending.
The first of seven games aimed at teaching about immuno-oncology lets players fling antibodies at cancer cells.
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
The pharmacy benefits manager wants oncology treatments priced according to how well they treat a specific cancer as opposed to using the current one-price-fits-all approach.
The test seeks to identify patients with metastatic pancreatic cancer and high levels of hyaluronan.
Express Scripts seeks to pay more for top-performing cancer drugs; Olympus plans to settle marketing investigation; Novartis is collaborating on a robotic pill
A horse race between Merck and Bristol-Myers Squibb, and the importance of one biomarker, will be a focus at the American Society of Clinical Oncology's annual meeting.
CVS will buy institutional pharmacy Omnicare in a $12.7-billion deal; ProPublica says the FDA and GlaxoSmithKline failed to protect patients from misusing Advair; Regeneron and Sanofi expect to file RA drug sarilumab with the FDA in the fourth quarter of this year
Parties in the effort say the novelty of wearing an Apple Watch, along with a newly developed app, may help clinicians refine treatment plans and patient support.
Perrigo says a Mylan deal is possible; new guidelines may reduce cancer screenings; Takeda petitions dictionaries to add a new definition for depression
Precision medicine is a guiding force for many pipelines, but a study shows a gap between developing drugs with biomarkers as well as tests that match patients to treatments.
An economist wants $37 billion invested in antibiotic development; Roche plans to file an experimental lung-cancer drug with the FDA this year; Sandoz wants compensation for lost Zarxio sales
Mylan considers higher bid for Perrigo; Boehringer Ingelheim partners with health system on COPD; EMD Serono's experimental cancer drug gets Fast Track status
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.