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).

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for devices used in combination products per an FDA final rule published in 2016, but the FDA said in the 2018 draft guidance that the applicant of a drug- or biologic-led combo product must evaluate whether a malfunction of the device component would suggest a hazard for similar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.

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.

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). 

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.

Pharmaceutical and life sciences giant Bayer AG scored another indication for its MRI contrast agent, Gadavist (gadobutrol) injection, this time in adults with suspected coronary artery disease. The FDA nod makes Gadavist the first and only contrast agent approved for use in cardiac magnetic resonance (CMR) imaging.

Despite a February adcom meeting urging the agency to wait for more data, the FDA has approved Karyopharm Therapeutics Inc.'s selinexor, in combination with dexamethasone (dex), as a new treatment for certain adults with relapsed refractory multiple myeloma (MM). The approval covers patients who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody.

The FDA placed a clinical hold Wednesday on a phase I trial by Unum Therapeutics Inc. after a patient experienced serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection, and grade 4 respiratory distress.

With regulatory science always lagging innovation, ambiguity has long been a certainty at the FDA and is likely to become even more so as the pace of new technologies quickens.

The FDA's Center for Drug Evaluation and Research (CDER) issued 62% more warning letters under the first part of the Trump administration than it did during the last few years of the Obama administration. But the number of warnings for medical devices, food and tobacco products fell sharply under President Donald Trump, according to an investigative report being published in the July 5 issue of Science.