FDA: Page 86
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Brexit could complicate marketing status of drugs, new licenses
The European pharma industry has strongly opposed a U.K. exit from the E.U. The U.K. votes in a June 23 referendum whether to stay or leave.
By Nicole Gray • March 23, 2016 -
Eli Lilly's ixekizumab gets green light from FDA
Marketed as Taltz, ixekizumab is the second anti-IL17A psoriasis drug to win approval in the U.S., following Novartis' Cosentyx.
By Ned Pagliarulo • March 22, 2016 -
In response to crisis, FDA mandates new warnings for opioid painkillers
Among other changes, the agency will require a boxed warning on the labels of all immediate-release opioid analgesics.
By Ned Pagliarulo • March 22, 2016 -
BioMarin's PKU drug meets primary goal in phase 3, but falls short on secondary endpoints
The company hopes to file for approval with the FDA by the end of the year.
By Nicole Gray • March 22, 2016 -
Indian court temporarily blocks government ban on sales of FDCs
The Delhi High Court has issued a stay on the ban until March 28.
By Nicole Gray • March 22, 2016 -
As FDA review approaches, Duchenne experts push for approval of Sarepta's eteplirsen
A group of 36 physicians and researchers sent a letter to the FDA recommending accelerated approval for the DMD drug.
By Nicole Gray • March 22, 2016 -
Deep Dive
Citing 'improper conduct,' Valeant attempts to oust former CFO from board
Howard Schiller refused to resign however, and denied wrongdoing related to the company's accounting.
By Ned Pagliarulo • March 21, 2016 -
WHO suspends all TB products from India's Svizera Labs
During an inspection last fall, the World Health Organization discovered poor-hygiene situations and faulty, inadequate record-keeping.
By Nicole Gray • March 21, 2016 -
EMA issues safety guidance for Gilead's Zydelig in wake of patient infections
Gilead previously halted six clinical trials due to safety concerns.
By Nicole Gray • March 21, 2016 -
U.K. cost regulator confirms final approval for Novartis' Entresto
The heart failure med had already been available under the U.K.'s Early Access to Medicine Scheme.
By Ned Pagliarulo • March 20, 2016 -
CDC issues new guidelines for prescribing opioids
The guidelines aim to reduce over-prescribing of opioid painkillers as rates of abuse and overdose deaths have steadily increased in the U.S.
By Nicole Gray • March 16, 2016 -
EMA finalizes clinical trial redaction guidelines
Pharmaceutical companies claim publication of all clinical trial data would compromise trade secrets. Advocates for transparency, on the other hand, argue more information is need to enhance the ability to replicate important findings.
By Nicole Gray • March 16, 2016 -
Lilly changes endpoint for phase 3 Alzheimer's trial
The endpoint change for solanezumab will affect data analysis, but not the actual conduct of the trial.
By Nicole Gray • March 16, 2016 -
Indian authorities withdraw alert on off-label use of Roche's Avastin
Two Indian states had previously halted sales of the drug after 15 patients were hospitalized with vision problems in Gujarat.
By Nicole Gray • March 15, 2016 -
As U.S. biosim market grows, FDA's regulatory work has cost nearly $82 million
An independent analysis showed a steady increase in the number of biosimilar programs being developed with guidance from the FDA.
By Nicole Gray • March 15, 2016 -
EU regulators investigating Gilead's Zydelig after infection deaths
Higher rates of adverse events were seen in three clinical trials involving Zydelig and other cancer drugs.
By Nicole Gray • March 14, 2016 -
Indian Health Ministry bans nearly 350 combo drugs
Fixed dose combinations have proliferated in India, making up nearly half of all drugs on the market in 2014 despite many being unapproved nationwide.
By Nicole Gray • March 14, 2016 -
Sarepta's Duchenne drug gets a new date for FDA review
Sarepta's stock had lifted on the news of the rescheduled review, but the outcome of the FDA's review is still very much in doubt. Other Duchenne drugs from Biomarin and PTC Therapeutics have been rejected by the regulator.
By Nicole Gray • March 11, 2016 -
House Oversight committee presses Valeant on details of withheld documents
The documents cover the company's pricing of two heart meds, Isuprel and Nitropress. Valeant has claimed attorney-client privilege as a basis for withholding some of the relevant materials.
By Ned Pagliarulo • March 10, 2016 -
First generic version of Viagra in the U.S. approved by FDA
The generic pill is made by the US division of Teva, which just won approval from the European Commission for its acquisition of Allergan's generics portfolio.
By Ned Pagliarulo • March 10, 2016 -
Death from French drug trial likely due to high doses of compound
The drug trial left one man dead and five others in the hospital in January. Portuguese drugmaker Bial had been testing an FAAH-enzyme inhibitor for the treatment of pain and mood disorders.
By Ned Pagliarulo • March 10, 2016 -
Whistleblower sues Indian drug regulators for poor oversight
Dinesh Thakur is a well-known whistleblower who previously exposed Ranbaxy Labs for its failure to properly test drugs for safety.
By Nicole Gray • March 10, 2016 -
Senate HELP Committee advances seven bills as counterpart to 21st Century Cures
Republicans and Democrats on the committee have been divided over funding for the NIH and FDA, as well as over changes to the FDA's approval process.
By Nicole Gray • March 10, 2016 -
Montgomery County Planning Commission
FDA accepts new Keytruda data, opening door for wider indication
However, Keytruda faces stiff competition from Bristol-Myers Squibb's Opdivo, another anti-PD1 therapy which has outpaced Keytruda.
By Nicole Gray , Ned Pagliarulo • March 9, 2016 -
Report: Theranos continued blood tests even as quality checks revealed flaws
The company has been under fire recently for alleged deficiencies in its proprietary finger-prick blood testing technology.
By Ned Pagliarulo • March 9, 2016
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