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Gilead files for fil­go­tinib in Japan; Alzheimer's flop forces some painful next steps at Neu­rotrope

→ Gilead has been right on the heels of its rival AbbVie with its JAK-inhibitor filgotinib. The company has now submitted an NDA for the drug to the Japanese Ministry of Health, Labor and Welfare for the treatment of adults with rheumatoid arthritis (RA). The submission is backed by data from the phase III FINCH trial, where “once-daily treatment with filgotinib demonstrated the potential to improve clinical signs and symptoms, to achieve low disease activity and remission and to inhibit structural damage for patients living with RA.”

DB­V's peanut al­ler­gy patch is fi­nal­ly un­der FDA re­view; Rit­ter swal­lows bit­ter pill to ex­plore strate­gic al­ter­na­tives

→ DBV Technologies $DBVT, which withdrew its application to market its peanut allergy patch late last year, essentially enabling rival Aimmune $AIMT to leapfrog it, on Friday announced that the FDA has accepted its latest BLA filing. The agency is expected to make its decision by August 5 — but will host an advisory panel meeting to discuss the immunotherapy.

→ Ritter Pharmaceuticals $RTTR did its best to make lemonade with the lemons it was dealt — by vaulting its lactose intolerance therapy toward a confirmatory trial, despite missing the main goal in the preceding Phase II/III study. Last month, the company reported its therapy, RP-G28, failed not only to secure a statistically significant improvement versus placebo in reducing lactose intolerance symptoms, but patients in the placebo group actually did better than the drug arm. Now, the LA-based company has appointed a financial advisor to explore strategic alternatives.

Em­ma Walm­s­ley joins #MeToo­Pay; Monopar post­pones $40M IPO

→ GSK CEO Emma Walmsley has rallied together with some of the UK’s most successful businesswomen to highlight the pay discrimination they face in comparison to their male counterparts in the campaign #MeTooPay. The website lamented the frustrations of the women, stating, “we’re frustrated to still read stories about women not getting the pay they deserve. Women should not be paid less than men to do exactly the same job. It’s just wrong.”

NICE fails to en­dorse Roche's Tecen­triq for breast can­cer; Eli­cio clos­es fi­nanc­ing round with $33M

→ UK’s cost-effectiveness watchdog NICE is not backing Roche’s PD-L1 checkpoint inhibitor Tecentriq (known chemically as atezolizumab), in another blow to the Swiss drugmaker who revealed the drug wasn’t strong enough to score approval in bladder cancer at the ESMO conference last weekend. NICE’s draft guidance, however, pertains to the immunotherapy’s use in advanced breast cancer in combination with the chemotherapy nab-paclitaxel.

More bad news for Sarep­ta; No­var­tis, Mi­crosoft join forces in AI pact

→ Sarepta $SRPT is still feeling the heat. A little more than a month after the FDA threw an unexpected surprise rejection for the company’s application for an accelerated approval of its Duchenne MD drug, golodirsen, the company faced more bad news today. A rival company in Japan, NS Pharma, said that it had submitted the necessary paperwork needed for approval of their new drug, viltolarsen, to treat Duchenne MD for children born with the disorder caused by a mutation in the DNA sequence exon 53. According to a STAT report, NS Pharma expects viltolarsen to be approved in the US by the middle of 2020, if not sooner — barring any setbacks.

For­mer Akcea pres­i­dent makes the leap to CEO seat at Avid­i­ty Bio­sciences; Astel­las in­vests $12.5M in­to two in­cu­ba­tors

→ After it was announced last week, in a surprise twist, that Akcea president Sarah Boyce along with her two top exec colleagues, CEO Paula Soteropoulos and COO Jeffrey Goldberg were hitting the exit at the Ionis spinoff, Boyce has found a new home. Boyce has been tapped to the helm of Avidity Biosciences — a company pioneering antibody-oligonucleotide conjugates (AOCs) — as their new CEO, president and board member. Boyce will draw from experience from her previous stints at Ionis, Forest Laboratories, Alexion Pharmaceuticals, Novartis Oncology and Roche.

Mer­ck touts Phase III da­ta for an­tibac­te­r­i­al Re­car­brio; Sanofi to ax 200 jobs in Japan — re­port

→ According to an anonymous source who reported to Reuters, French drugmaker Sanofi plans to ax 200 jobs in Japan across sales, regulatory affairs and operations. This adds to the ongoing plans of reorganization by research chief John Reed. Back in June, the company announced it would be placing 466 jobs in France and Germany on the chopping block and trimming of their staff in the US by offering employees an “early exit”. A Sanofi representative added, “Sanofi Japan plans to implement a voluntary retirement programme in order to adapt to the external environment changes and to transform our business models to continue our growth.”

T3 Phar­ma­ceu­ti­cals com­pletes sec­ond fi­nanc­ing round; Mod­er­na, Har­vard Med­ical School to tack­le im­muno­log­i­cal dis­eases

→ University of Basel, Switzerland spinout T3 Pharmaceuticals has raised 12 million CHF at the close of its second financing round. Current investors were joined by Boehringer Ingelheim Venture Fund and Reference Capital SA. The round will help propel the cancer-focused company’s lead product, T3P-Y058-739, into clinical testing, which is expected to begin in the middle of 2020.

In addition, the company welcomed aboard Claire Barton as CMO after having been with the company as a consultant for the past 18 months. Her previous stints include roles at GlaxoWellcome, Lilly and Roche.

BioN­Tech lays out plans for $251M IPO; Trio teams up to form joint lab to re­search chron­ic lung dis­eases

→ Earlier this month, German cancer drug developer BioNTech laid out plans for a $100 million public listing in the US, two months after unveiling a massive $325 million in an upsized round of financing. However, the company later revealed that shares worth about $97 million had been delayed due to the political unrest in Hong Kong and the ongoing trade tensions between the US and China. Today, the company announced its plans to offer 13.2 million American depository shares at a price range of $18 to $20 to raise $251 million. At the midpoint of the proposed range, BioNTech would command a fully diluted market value of $4.5 billion. The company plans to list under the symbol $BNTX.

Eli Lil­ly dish­es out first mile­stone pay­ment for Alzheimer's deal; ADC Ther­a­peu­tics, Viela Bio set terms for IPO

→ With others shying away from the Alzheimer’s field after the many clinical implosions and disasters, Eli Lilly is still chugging along with its $2 billion deal with AC Immune — despite its share of BACE woes. AC Immune is set to receive its first milestone payment of CHF30 million, almost a year after the deal was inked. The company said that the payment “is a recognition of progress in the collaboration between the two companies and follows initiation in July 2019 of the Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer in development for treatment of Alzheimer’s disease (AD) and other neurodegenerative disorders.” A second milestone payment of the same amount is scheduled for Q1 of 2020.