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Takeda forecasts $1.7B loss after Shire integration; Flagship’s preclinical biotech Axcella closes IPO with $71M+ haul

? Takeda?s $TAK first set of financial results since consummating its $62 billion acquisition of Shire is in, and it?s giving analysts a negative surprise. Citing costs for integrating the Ireland-based Shire, the Japanese drugmaker forecasts an operat… […]

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BioNTech nabs PhI antibody and a new US base out of bankruptcy; Pfizer wins conditional drug OK

? BioNTech is buying MabVax?s labs $MBVX and a clinical asset out of bankruptcy as the German mRNA company establishes a satellite operation in San Diego. The biotech, which has evidently been kicking around a monster IPO, acquired the bankrupt operati… […]

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Esperion shares surge as FDA waves off panel review; Adaptimmune buoyed by a positive data snapshot

Derek Archila
? Esperion got a 15% bump on its stock price $ESPR this morning after the biotech reported that the FDA had said it didn?t expect to call an advisory panel together to review the newly accepted NDAs for bempedoic acid (BPA) and their bemp… […]

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GSK plans $100M makeover of US manufacturing site; La Jolla Pharma gets a ‘breakthrough’ with late-stage drug

? GSK $GSK announced today that it will be investing $100 million into its facility in Hamilton, MT to expand long-term vaccine manufacturing capabilities. The expansion will boost production capacity of key components of the adjuvant system used in se… […]

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Turning Point unveils $166M IPO; Aquestive’s riluzole film product is accepted for FDA review

? San Diego-based Turning Point Therapeutics has hit the high end of the range it set for their IPO, pricing an upsized set of 9.3 million shares at $18 a pop. They ended up with $166 million raise, which will go a long way to inspiring more industry I… […]

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Lynparza secures third EU nod; Protein degradation biotech grabs $16M launch round from Chinese VCs; Wave shares tumble on trial delay

? Lynparza, the first PARP inhibitor from AstraZeneca $AZN to win US approval in 2014, has secured its third EU approval. The drug won the EMA nod for use patients with germline BRCA1/2-mutations and who have human epidermal growth factor receptor 2 (H… […]

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TKI biotech lays out plans to raise about $125M in IPO; Hookipa sets terms for upsized $100M IPO

? San Diego-based Turning Point Therapeutics has laid out terms for its IPO, planning to sell 7.4 million shares at a range of $16 to $18 a share. Renaissance Capital reports that insiders expect to take about 40% of a total of around $125 million, whi… […]

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Rubius cites some preclinical progress; Xencor scores deal with Astellas; Eidos to restate quarterly filings

? Rubius Therapeutics $RUBY has posted some positive ? though preclinical ? study results on its red blood cell tech, saying they were able to track a desired immune response using their drugs.The therapies are designed to increase the flow of T cells … […]

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Pfizer takes its option in AnTolRx deal; Secura Bio scores access to $145M for cancer drug launches

? Two-and-a-half years after Pfizer stepped up to seed the biotech startup AnTolRx, the pharma giant has stepped in to take their option on an immune tolerance therapy for Type 1 diabetes. Based on the lab work of Francisco Quintana, a professor of neu… […]

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Pfizer takes its option in AnTolRx deal; Secura Bio scores access to $145M for cancer drug launches

? Two-and-a-half years after Pfizer stepped up to seed the biotech startup AnTolRx, the pharma giant has stepped in to take their option on an immune tolerance therapy for Type 1 diabetes. Based on the lab work of Francisco Quintana, a professor of neu… […]

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Pfizer takes its option in AnTolRx deal; Secura Bio scores access to $145M for cancer drug launches

? Two-and-a-half years after Pfizer stepped up to seed the biotech startup AnTolRx, the pharma giant has stepped in to take their option on an immune tolerance therapy for Type 1 diabetes. Based on the lab work of Francisco Quintana, a professor of neu… […]

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China vows to continue speeding up drug approvals, expand tax cuts; Sorrento/Yuhan JV receives $40M financing

? In the latest move to spur introduction of new medicines, China has announced it will reduce the value-add tax on 21 rare disease drugs the same way it offered tax breaks to imported cancer drugs in April 2018. While good news to all drugmakers, the … […]

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Equillium’s immuno-inflammatory drug wins FDA’s orphan drug status; Vanda sues FDA for mandating lengthy dog study

? San Diego-based Equillium has nabbed an orphan drug designation for EQ001 on the verge of beginning a Phase Ib/II for the immuno-inflammatory drug. Also known as itolizumab, the drug was in-licensed from India?s Biocon, which sells it in the country … […]

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Novo helps birth startup advancing an AstraZeneca castoff with $15M; Japan’s Fuji Pharma wagers $50M on Alvotech’s biosimilars

? With backing from Novo Holdings and a drug from AstraZeneca, Aristea Therapeutics is unveiling a $15 million Series A that will kickstart Phase II studies of its lead program, RIST4721. James Mackay, who used to run AstraZeneca-acquired Ardea Bioscie… […]

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Lilly, Incyte’s baricitinib wins fast-track status for hard-to-treat lupus; Synthorx hammers out $150M+ IPO

? Rheumatoid arthritis drug Olumiant?? approved for a narrower-than-expected patient population earlier this year to the dismay of its manufacturer Eli?Lilly $LLY and Incyte $INCY which had blockbuster dreams for the drug?? may be worth its weight in g… […]

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Lilly, Incyte’s baricitinib wins fast-track status for hard-to-treat lupus; Synthorx hammers out $150M+ IPO

? Rheumatoid arthritis drug Olumiant?? approved for a narrower-than-expected patient population earlier this year to the dismay of its manufacturer Eli?Lilly $LLY and Incyte $INCY which had blockbuster dreams for the drug?? may be worth its weight in g… […]