Novartis Gets Positive CHMP Opinion for Drugs, Biosimilar

Novartis Gets Positive CHMP Opinion for Drugs, Biosimilar

Novartis AG (NVS – Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Gilenya for the treatment of children and adolescents aged 10 to 17 years with relapsing remitting forms of multiple sclerosis (RRMS). The positive opinion was based on encouraging […]

The Most Promising Migraine Drug in Years Is Being Held Hostage by Our Healthcare Dystopia

The Most Promising Migraine Drug in Years Is Being Held Hostage by Our Healthcare Dystopia

Illustration: Chelsea Beck/GMG The last seven weeks have been some of the least painful I’ve lived since I was 16 years old. Normally, I have an incapacitating migraine roughly once a week and spend many other days each month enduring pounding, painful, and tiresome headaches that threaten to turn into full-blown migraines. Sometimes the migraines […]

Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab

Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab

MEDIA CONTACT Available for logged-in reporters only CITATIONS JAMA Internal Medicine Newswise — Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health.  The study, published Sept. 24 in JAMA Internal […]

FDA Pivotal Trial Costs Vary By More than $300 Million

FDA Pivotal Trial Costs Vary By More than $300 Million

Joseph S. Ross, MD, MHS In the first systematic evaluation of the estimated costs of clinical trials, a total of 138 pivotal clinical trials established the basis for approval of 59 new therapeutic agents by the US Food and Drug Administration (FDA) from 2015-2016—at a median estimated cost of $19 million. The new study identified […]

AstraZeneca diabetes drug cuts heart risks in major study

AstraZeneca diabetes drug cuts heart risks in major study

LONDON (Reuters) – AstraZeneca’s diabetes drug Farxiga met a key goal in a major clinical study designed to show its heart-protecting benefits in a wide range of patients, potentially distinguishing it from rivals in a crowded marketplace. The logo of the British pharmaceutical company AstraZeneca is seen at the company’s China Commercial Innovation Centre (CCIC) […]

Endo puts Vasostrict case against US FDA on hold

Endo puts Vasostrict case against US FDA on hold

REUTERS: Endo International Plc on Monday said it would stay its lawsuit against the U.S. Food And Drug Administration until the end of the year after the FDA made new commitments on the regulation surrounding the active ingredient in its blood pressure medicine Vasostrict. Endo’s lawsuit, filed by its subsidiaries in a district court in […]

Endo International (ENDP) Reports Additional Stay of FDA Litigation Following FDA's Commitment to Finalize …

Endo International (ENDP) Reports Additional Stay of FDA Litigation Following FDA's Commitment to Finalize …

News and research before you hear about it on CNBC and others. Claim your 2-week free trial to StreetInsider Premium here. Endo International plc (NASDAQ: ENDP) today announced that it has agreed to an additional stay of its litigation against the U.S. Food and Drug Administration (FDA) until December 31, 2018. The litigation, filed in […]

Drug Rebates Help Many, but Not Patients

Drug Rebates Help Many, but Not Patients

Photo: iStock/Getty Images Joseph Antos and James C. Capretta write in support of pharmacy-benefit managers (PBM) that are middlemen to middlemen, two orders of magnitude between the consumer and producer, with market discipline totally absent (“Drug Rebates Aren’t ‘Kickbacks’” (op-ed, Sept. 17). Certainly, in today’s electronic age pharmaceutical manufacturers could have websites for consumers to […]

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