Hi folks. This was a relatively quiet week without the approval of any new molecular entities. Here is my recap of the top regulatory news stories this week:
The FDA agreed to expand the label for AstraZeneca’s immunotherapy Imfinzi (durvalumab) to reduce the risk of non-small-cell lung cancer progression in patients with stage III disease whose tumors cannot be surgically removed after treatment with chemotherapy and radiation. https://www.raps.org/news-and-articles/news-articles/2018/2/imfinzi-approved-to-reduce-risk-of-nsclc-progressi?utm
Mylan announced tentative approval from the US FDA under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its NDA for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets as a first-line regimen for people being treated for HIV/AIDS. https://www.firstwordpharma.com/node/1543728?tsid=2
Lupin announced that it has received final approval for its Oseltamivir Phosphate for Oral Suspension from the US FDA to market the generic version of Hoffman-La Roche’s Tamiflu for Oral Suspension. https://www.firstwordpharma.com/node/1543894?tsid=2
Prometic Life Sciences announced that an orphan drug designation status has been granted to its Inter-Alpha-Inhibitor-Proteins for the treatment of necrotizing enterocolitis by the US FDA. https://www.firstwordpharma.com/node/1543296#axzz57fVo20Qv
The FDA granted Evofem Biosciences Fast Track designation for Amphora (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel to prevent urogenital chlamydia infection in women. https://www.biospace.com/article/fda-grants-evofem-biosciences-amphora-fast-track-designation/
Soleno Therapeutics announced the successful completion of and receipt of minutes from its End-of-Phase 2 Meeting with the US FDA concerning Diazoxide Choline Controlled-Release (DCCR) for the treatment of Prader-Willi syndrome. https://www.firstwordpharma.com/node/1543826?tsid=2
An FDA advisory group rejected Pacira’s pitch for expanded use of pain drug Exparel as a regional pain blocker: https://endpts.com/fda-advisory-group-rejects-paciras-pitch-for-expanded-use-of-pain-drug/
Clovis Oncology received a positive trend vote from the EU’s CHMP regarding the ongoing review of their MAA for rucaparib ovarian cancer treatment. https://www.firstwordpharma.com/node/1544190?tsid=2
Puma told investors that the EU CHMP has recommended the refusal of their MAA for neratinib as a treatment of early-stage HER2-positive breast cancer. https://endpts.com/hit-by-an-expected-ema-rejection-puma-plans-to-appeal-negative-opinion-on-neratinib/
The FDA’s Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2018 to Collegium Pharmaceutical over an exhibit promoting the company’s opioid drug Xtampza ER (oxycodone). In the letter, FDA says Collegium’s exhibit booth misrepresented the product’s risks by placing all risk information on a side panel located several feet away from the principle display. https://www.raps.org/news-and-articles/news-articles/2018/2/fda-s-opdp-sends-first-untitled-letter-of-2018?utm
Bellicum issued a statement outlining what the FDA wants before lifting its hold on their lead cell therapy program: https://endpts.com/bellicum-outlines-a-few-quick-steps-the-fda-wants-before-lifting-its-hold-on-lead-car-t/
In other news…
Abbvie has signed a $69 million deal with Voyager Therapeutics to develop gene therapy tools for Alzheimers and other neurodegenerative diseases. https://www.xconomy.com/boston/2018/02/20/with-69m-deal-abbvie-turns-to-voyager-for-an-alzheimers-gene-therapy/?utm
Gilead has entered into a $3.5 billion gene editing alliance with Sangamo for off-the-shelf CAR-T drugs https://endpts.com/all-in-gilead-maps-a-3-15b-alliance-with-sangamo-for-off-the-shelf-car-t-drugs/
Merck plunked down $394 million to acquire Australia-based Viralytics and its oncolytic immunotherapy treatments. https://www.biospace.com/article/merck-drops-394-million-to-acquire-virus-based-cancer-company-viralytics/
Winding down its R&D operations in Wallingford, CT, Bristol-Myers Squibb has cut 107 more staffers in the next step of the big revamp. https://endpts.com/bristol-myers-axes-107-more-staffers-as-it-completes-an-rd-overhaul/
Achillion posted a net loss of $23.2 million in the fourth quarter and announced it would reduce its workforce by about 20% to save cash. https://www.fiercebiotech.com/biotech/bleeding-cash-achillion-to-cut-20-workforce?mkt_tok=eyJpIjoiTWprd1ptSTJORE0wTWpFMCIsInQiOiJcL25GZkhQQjF4U0dWTHAycFIzeW9ZXC9RQ1NzbVFaUTIxdlJcL1huNFBSZEx4TitGSXpJblpzbUFjak5la0l5eEk3QWY2dDl0RVwvWGRjd2hDRW83YW1xM25xWUlcL3FPMmZ0R3pxM1NSNjd6VnkwVjcwXC9ZVkRnTWtpY1o3a2RKVUlmWCJ9&mrkid=944305
This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com