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BioWorld - Tuesday, December 10, 2019
Home » Topics » FDA, BioWorld

FDA, BioWorld
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FrankYoung-11-27

Buoyed by optimism and love of family, former FDA chief Frank Young leaned into storms

November 27, 2019
By Randy Osborne
No Comments
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS crisis and public furor over drug tampering, said his son, Jonathan Young, co-founder and chief operating officer of South San Francisco-based Akero Therapeutics Inc. Post-FDA, Frank Young would help grapple with the opioid epidemic as well – a scourge that began with the passage of the Compassionate Pain Relief Act (CPRA), passed the year he was appointed. Young, 88, died Nov. 24 of B-cell lymphoma. 
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FDA expands Nucala label to include younger children

September 16, 2019
By Michael Fitzhugh
No Comments
Glaxosmithkline plc has won FDA approval to market Nucala (mepolizumab) for use in children as young as 6 with severe eosinophilic asthma (EA). The therapy already had FDA approval as an add-on maintenance treatment for kids with the same condition ages 12 and older. Approval of the sBLA, submitted last November, catches the U.S. market up to the EU, where Nucala has been approved as an add-on treatment for children ages 6 to 17 since August 2018.
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Ardelyx nabs FDA approval for Ibsrela in IBS-C

September 13, 2019
By Jennifer Boggs
No Comments
It's been a busy September for Ardelyx Inc. so far. Less than two weeks after the Fremont, Calif-based company reported promising pivotal data for tenapanor in chronic kidney disease patients with hyperphosphatemia, the sodium hydrogen exchanger 2 (NHE3) inhibitor won FDA approval for use in irritable bowel syndrome with constipation (IBS-C).
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Pharnext shares drop 40% as FDA requests second pivotal trial in CMT

September 3, 2019
By Cormac Sheridan
No Comments
DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003.
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U.S. biosimilar market 'thriving' without government intervention

September 3, 2019
By Mari Serebrov
No Comments
Drug pricing legislation will be high on the to-do list when the U.S. Congress returns from its August recess next week, as both the Senate and the House are expected to take action this month on competing packages of provisions aimed at controlling prescription drug prices.
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Another Humira biosimilar gets FDA nod, as Korea's Samsung Bioepis joins launch wait list

July 29, 2019
By Jihyun Kim
No Comments
HONG KONG – Samsung Bioepis Co. Ltd., a South Korean biosimilar developer, said the FDA approved its July 2018 application for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbvie Inc. blockbuster TNF-blocker Humira (adalimumab).
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Combo product reporting final retains 'similar product' language found in draft

July 26, 2019
By Mark McCarty
No Comments
Device makers have reporting responsibilities for devices used in combination products per an FDA final rule published in 2016, but the FDA said in the 2018 draft guidance that the applicant of a drug- or biologic-led combo product must evaluate whether a malfunction of the device component would suggest a hazard for similar combinations using that device. That provision appears in the final rule, and thus puts the onus on makers of drugs and biologics to do a job device makers say is theirs to handle.
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Lilly's Baqsimi sugar win may face pen headaches as Emgality gains ground

July 26, 2019
By Randy Osborne
No Comments
Eli Lilly and Co.'s FDA win with Baqsimi (glucagon) nasal powder, the first non-injected therapy to gain clearance for emergency treatment of hypoglycemia, makes the rescue of severely hypoglycemic patients quicker and easier, and coming down the pike are more treatments that could simplify therapy.
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FDA puts partial clinical hold on Regulus kidney disease trial

July 25, 2019
By Michael Fitzhugh
No Comments
Following more than a year of restructuring and recalibration, Regulus Therapeutics Inc. is facing a new partial clinical hold placed by the FDA on its phase I test of RGLS-4326, an oligonucleotide it's developing for the treatment of autosomal dominant polycystic kidney disease (ADPKD). 
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Lithe spirit: Agile's effort with Twirla near payday? Feels pleasant FDA draft

July 23, 2019
By Randy Osborne
No Comments
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
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