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The EMA has accepted Astellas Pharma (ALPMF) and Seagen's (SGEN) marketing authorization application ((MAA)) for enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing ...
Astellas Pharma ([[ALPMF]]) announced that its investigational oral, nonhormonal compound, fezolinetant yielded positive topline results in two Phase 3 trials evaluating its effect in moderate to severe vasomotor symptoms (“VMS”) – i.e., hot flashes associated with m...
Astellas Pharma (ALPMF) and Seagen (SGEN) have completed the submissions of two supplemental Biologics License Applications for the bladder cancer therapy PADCEV (enfortumab vedotin-ejfv), co-developed by the two companies.The first submission seeking to convert PADCEV's accelerated...
Seagen Inc. (SGEN) and Astellas Pharma (ALPMF) announced the interim results from the phase 3 EV-301 trial comparing PADCEV (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer.In the trial involving 600 patients...
Tweedy, Browne Company LLC provides investment advisory services. The Company offers portfolio management, financial planning, and consulting services for individuals, institutions, partnerships, pension and profit-sharing plans, charitable foundations, trusts, and offshore funds. Tweedy,...
Astellas Pharma Inc (ALPMF) Q3 2021 Earnings Conference Call January 29, 2021 2:00 AM ET Company Participants Naoki Okamura – Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer Yukio Matsui – Chief Commercial Officer Mike Kitagawa – Dev...
The following slide deck was published by Astellas Pharma Inc. in conjunction with their 2021 Q3 earnings call. For further details see: Astellas Pharma Inc. 2021 Q3 - Results - Earnings Call Presentation
Actinium Pharmaceuticals (ATNM) has announced a research collaboration with Astellas Pharma (ALPMF) for the development of targeted radiotherapies using its Antibody Warhead Enabling ((AWE)) technology platform.Under this agreement, Actinium will utilize its AWE Platform technology to develop...
Solid Biosciences (SLDB) down 13% premarket in sympathy with clinical data from Sarepta Therapeutics (SRPT) on Duchenne Muscular Dystrophy ((DMD)).Sarepta Therapeutics' Part 1 of Study SRP-9001-102 failed to meet primary endpoints, as a result of which shares dropped ~54% after-hour...
Astellas Pharma (ALPMF) announces that the FDA has granted priority reviews for marketing application seeking approval for mirabegron for oral suspension and supplemental application for Myrbetriq (mirabegron) tablets for neurogenic detrusor overactivity ((NDO)) in pediatric patient...
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Pharmaceutical stocks were initially expected to be largely immune to the COVID-19 economic downturn. Drugmakers, after all, generally produce products that are essential to daily life. However, the extreme social distancing that has become part and parcel of this unusual period has halted nume...
One of England's top healthcare watchdogs, the National Institute for Health and Care Excellence (NICE), has officially decided to stay the course and reject AstraZeneca 's (NYSE: AZN) lung cancer drug Tagrisso. A few months ago, the pharmaceutical giant argued that the drug should receive...
This past year proved profitable for investors in Incyte (NASDAQ: INCY) and Seattle Genetics (NASDAQ: SGEN) . Handily beating broad market and biotech indexes, these two drug manufacturers hit the $20 billion valuation mark and are poised to continue growing in the coming year -- unless, ...