FDA: Page 83
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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 -
Bristol-Myers Squibb changes Chinese sales practices amid scrutiny
A few months after it settled with the SEC over claims it paid Chinese doctors to prescribe its medicines, the pharma giant reportedly cut entertainment expense and speaking engagement payments to doctors there.
By Randy Lilleston • March 9, 2016 -
CMS proposes overhaul to Part B drug reimbursement
The proposed rule would test changes to how doctors and outpatient departments are reimbursed for drugs they prescribe under Medicare Part B.
By Ned Pagliarulo • March 8, 2016 -
India will reportedly refrain from issuing compulsory drug licenses
The licenses enable local companies to override the patents of large pharmaceutical companies and manufacture cheap copies to boost patient access.
By Ned Pagliarulo • March 8, 2016 -
Senate HELP Committee to mark up 21st Century Cures legislation
The committee will consider seven bills in a morning session Wednesday as members seek to bridge a growing divide between Democrats and Republicans on a way forward.
By Nicole Gray • March 8, 2016 -
Counterfeit Harvoni from India found in Israel
Flagged by Swissmedic, the fake drugs were imported through a Swiss trading firm.
By Nicole Gray • March 8, 2016 -
Alex Wong via Getty Images
Industry groups, doctors ask CMS to withdraw proposed Part B experiment
Accidentally posted online earlier this year, the proposal would test changes to Part B drug reimbursement rates to doctors.
By Nicole Gray • March 8, 2016 -
EMA debuts new program to speed up review of innovative drugs
Called "PRIME," the program reinforces the existing accelerated assessment pathway and will increase regulatory support early in the development process of priority drugs.
By Ned Pagliarulo • March 7, 2016 -
Janssen, AbbVie's Imbruvica approved by FDA for first line treatment of CLL
The drug had previously been approved for second line treatment of chronic lymphocytic leukemia (CLL), and for a smaller subset of CLL patients
By Ned Pagliarulo • March 4, 2016 -
FDA approves first Zika diagnostic for emergency use
Zika MAC-ELISA is an antibody-based diagnostic developed by the Centers for Disease Control and Prevention (CDC).
By Nicole Gray • March 3, 2016 -
FDA opposes re-authorization of pediatric priority review program: GAO report
Since the priority review program for rare pediatric diseases launched in 2012, there have been 11 requests for a pediatric voucher. Six have been awarded.
By Ned Pagliarulo • March 3, 2016
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