The Latest
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AbbVie accused of 'far-reaching' kickback scheme for Humira
A lawsuit filed by the California Department of Insurance puts AbbVie on the defensive over support programs for its top-selling biologic drug.
Legal -
SponsoredHow do doctors feel about robots in the exam room?
ZS’s 2018 research finds that only 25% of doctors are comfortable letting AI help with diagnosis.
Clinical Trials -
Phase 3 win underscores that Astellas is more than Xtandi
Though better known for the prostate cancer med, Astellas gets considerable revenue from bladder drugs and reported positive data Thursday for an experimental chronic kidney disease therapy.
Clinical Trials -
5th Humira biosimilar approved in EU as market entry nears
The world's top-selling prescription drug is set to soon face direct competition in Europe, a tantalizing prospect for biosimilar developers.
Marketing -
Pharming knocked back with CRL from FDA
Regulators are looking for more data from Pharming to support an expanded approval of the company's HAE drug Ruconest.
Clinical Trials -
Prescriptions, outpatient care drive healthcare spending growth: report
The Health Care Cost Institute found employer-sponsored insurance spending increased by 44% over the decade through 2016.
Manufacturing -
NICE says no to Kymriah for adult lymphoma despite offer on price
NHS recently agreed to cover Kymriah for certain pediatric leukemia cases. However, in its other indication, the Novartis therapy has hit a snag.
Regulatory / Compliance -
Clovis, execs pay up to settle charges of misleading investors
The SEC had accused Clovis, along with its CEO and former CFO, of knowingly misrepresenting the efficacy of its cancer candidate rociletinib.
Clinical Trials -
Thermo Fisher licenses CRISPR tech from Broad Institute
The instruments maker aims to meet the growing demand for contracting services from companies using CRISPR in drug R&D.
Manufacturing -
Novo's reorganizing claims more jobs, with R&D set to lose 400
Novo's R&D shake-up will also establish four research units focused on finding new therapies and technologies.
Corporate News -
Hospital group, on defense, pitches 340B 'stewardship'
The initiative amounts to the industry's riposte against calls for increased oversight of the program by watchdogs and lawmakers in both parties.
Marketing -
Viking shares soar as NASH drug impresses
Positive results from a small study suggested the San Diego-based biotech could compete in the race to develop therapies for the liver disease.
Clinical Trials -
Senate passes bill for FTC scrutiny of biosimilar 'pay-for-delay' deals
The legislation would require biologic and biosimilar makers to report settlement pacts to the Federal Trade Commission.
Regulatory / Compliance -
Deep DiveWhy payers are gobbling up PBMs
On Monday the Justice Department gave its blessing to a $67 billion acquisition of Express Scripts by Cigna.
Mergers and Acquisitions / Deals -
FDA lifts clinical hold on Mersana study, but shares slide
Mersana will soon restart the paused trial of a cancer candidate with modified dosing and tweaked protocols. Markets, though, didn't seem all that relieved.
Clinical Trials -
Will Ajovy lead Teva's turnaround?
The Israeli pharma is counting on the migraine drug to help it rebound from recent struggles. A competitive market, however, could mean the expected boost from Ajovy will take time to materialize.
Marketing -
Argenx's auto-immune drug headed for Phase 3 in ITP
Data from a proof-of-concept study showed "clinically meaningful" platelet count improvements for a variety of primary immune thrombocytopenia patients.
Clinical Trials -
Mylan biosimilar to stress test Amgen Neulasta franchise, analyst predicts
One new Wall Street analysis showed the stakes are high, not just for both companies, but for gauging the disruptiveness of biosimilars in the U.S. overall.
Marketing -
Cigna-Express Scripts merger cleared by DOJ
Federal regulators believe the $67 billion deal is "unlikely to result in harm to competition or consumers."
Regulatory / Compliance -
More data bolster AstraZeneca's 3-in-1 inhaler as other assets face setbacks
After clinical misses from Fasenra and Bevespi Aerosphere, AstraZeneca is hoping PT010 could give it another product to play with in the COPD market.
Clinical Trials -
Teva wins much-needed US approval of migraine drug
Ajovy will carry an annual list price of $6,900, matching the cost of Amgen and Novartis' rival preventive therapy Aimovig.
Regulatory / Compliance -
Pfizer showcases JAK pipeline with mid-stage results
The pharma will advance its JAK3 inhibitor in alopecia areata, while focusing its TYK2/JAK1 blocker on psoriasis, Crohn's and ulcerative colitis.
Clinical Trials -
Patient groups attack CVS use of ICER metrics, urge rethink
In an open letter, more than 90 organizations called on CVS to reconsider its decision to use ICER's drug value assessments for determining coverage.
Marketing -
Allergan's Bonti buy part of plan to double medical aesthetics business
Seeing a growing opportunity, Allergan is expanding its pipeline at the same time as it ups spending on DTC marketing for products like Botox.
Mergers and Acquisitions / Deals -
AstraZeneca wins FDA OK for leukemia drug
The approval gives a lift to AstraZeneca's efforts to expand its modest portfolio in hematological cancers.
Marketing