There were several guidance updates from the FDA this week along with several new medicine approvals by the EMA. And the anticipated FDA layoffs have been delayed for now. Here is my summary of the top regulatory stories this week:
1. FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after September 30th if Congress has not yet passed legislation to reauthorize user fee agreements by then. (Previously, the FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by August 1st) http://www.raps.org/Regulatory-Focus/News/2017/07/25/28122/Gottlieb-FDA-Will-Delay-Sending-Layoff-Notices
2. This week the FDA issued updates related to two ICH guidelines, including a revised guideline on the efficacy portion of the common technical document and changes to ICH’s list for permitted daily exposure to solvents. http://www.raps.org/Regulatory-Focus/News/2017/07/24/28115/FDA-Updates-on-Two-ICH-Guidelines/
3. The FDA also issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants. http://www.raps.org/Regulatory-Focus/News/2017/07/24/28116/FDA-Issues-Guidance-on-Informed-Consent-Waivers-for-Minimal-Risk-Studies/
4. The FDA finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues. http://www.raps.org/Regulatory-Focus/News/2017/07/25/28120/FDA-Finalizes-GDUFA-QA-Guidance
5. The EMA recommended the approval of eight new medicines this week including Pfizer’s Bavencio (avelumab) to treat Merkel cell carcinoma and Novartis’ Rydapt (midostaurin) to treat acute myeloid leukemia. The agency also issued negative opinions for Nektar and Daiichi Sankyo’s breast cancer drug Onzeald (etirinotecan pegol) and Vanda Pharmaceuticals’ schizophrenia drug Fanaptum (iloperidone). http://www.raps.org/Regulatory-Focus/News/2017/07/21/28113/EMA-Backs-Eight-New-Medicines-Turns-Down-Drugs-From-Nektar–Vanda/
6. The FDA has granted orphan drug status to San Diego-based Samumed‘s SM04646 treatment for idiopathic pulmonary fibrosis. https://lungdiseasenews.com/2017/07/26/fda-grants-orphan-drug-status-to-pulmonary-fibrosis-therapy-sm04646/
7. Eagle Pharmaceuticals reported that the FDA declined to approve its drug Ryanodex to treat heat stroke and requested an additional clinical trial. Ryanodex is approved for the treatment and prevention of malignant hyperthermia. http://www.reuters.com/article/us-eagle-pharms-fda-idUSKBN1AB2D8
8. A panel of independent advisers to the FDA concluded that there is not enough evidence to support approval of Intellipharmaceutics International‘s long-acting opioid painkiller, Rexista. http://www.reuters.com/article/us-intellipharma-fda-idUSKBN1AB2V2?feedType=RSS&feedName=healthNews
In other news…
Endo International announced that it will cut 875 positions, which represents about 18 percent of its workforce, as part of plans to close its manufacturing and distribution facilities in Huntsville, Alabama over the next 12 months to 18 months. https://www.firstwordpharma.com/node/1490041
Teva Pharmaceutical said it would lay off some of its 7,000 employees in Israel in the coming months as it reorganizes in a drive to improve competitiveness. http://uk.reuters.com/article/uk-teva-pharm-ind-layoffs-idUKKBN1A80DQ?il=0
CSL has launched its hereditary angioedema med Haegarda which will compete directly with Shire’s Cinryze: http://www.fiercepharma.com/pharma/csl-launches-cinryze-rival-despite-shire-s-best-efforts-and-at-a-big-discount-too?
AstraZeneca announced initial results from its Phase III MYSTIC study of the combination of Imfinzi (durvalumab) and tremelimumab failed to improve progression-free survival versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic first-line non-small-cell lung cancer. https://www.firstwordpharma.com/node/1491563
South Korea’s Samsung Bioepis said it started U.S sales of its biosimilar version of Johnson & Johnson’s Remicade rheumatoid arthritis drug. http://www.reuters.com/article/us-samsung-bioepis-johnson-johnson-remic-idUSKBN1A91GL
Mitsubishi Tanabe announced that it will acquire NeuroDerm, an Israeli drug company focused on treatments for Parkinson’s disease: http://www.biopharmadive.com/news/mitsubishi-tanabe-to-acquire-neuroderm-for-11b/447731/
Nektar Therapeutics said it signed a $400 million partnership agreement with Eli Lilly on the development of an early-stage immmunological candidate. http://www.biopharmadive.com/news/nektar-eli-lilly-deal-collaboration-150-million-autoimmune/447732/
Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid (thalidomide) and Revlimid (lenalidomide) for unapproved uses. Celgene denied wrongdoing and said they settled to avoid uncertainty, distraction and expensive litigation. http://hosted.ap.org/dynamic/stories/U/US_CANCER_DRUGS_FALSE_CLAIMS?SITE=AP&TEMPLATE=DEFAULT
GlaxoSmithKline’s new CEO Emma Walmsley is making her move to reorganize the company’s development pipeline. Her plan calls for dropping 30 development projects and adding cancer and immuno-inflammatory diseases to its list of top R&D priorities: https://endpts.com/gsk-ceo-walmsley-is-reorganizing-rd-dropping-drugs-and-adding-a-new-focus-on-cancer-research/
A federal jury found that AbbVie Inc fraudulently misrepresented the risks of its testosterone replacement drug AndroGel and ordered the drugmaker to pay $150 million in punitive damages. http://www.reuters.com/article/us-abbvie-androgel-idUSKBN1A92D9?feedType=RSS&feedName=healthNews
Tesaro and Takeda announced a $100 million licensing agreement for the commercialization and clinical development of niraparib in Japan, South Korea, Taiwan, Russia and Australia. https://www.takeda.com/newsroom/newsreleases/2017/tesaro-and-takeda-enter-into-exclusive-licensing-agreement-to-developand-commercialize-novel-cancer-therapy-niraparib-in-japan/
Alexion plans to halt development of two clinical-stage programs (ALXN1101 and ALXN6000) and put them up for sale. It also plans to discontinue its preclinical partnerships with Moderna Therapeutics, Blueprint Medicines and Arbutus Biopharma. http://www.biospace.com/News/alexion-redefines-rd-strategy-discontinues/464252?type=email&source=GP_072717
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