Alphamd pharma bits and pieces

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1. Pharma Bits and Pieces AlphaMD logo

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2. Industry Updates Merck KGaA pays $230M for four Vertex cancer programs. Orchard Therapeutics announces a manufacturing alliance with PharmaCell. Ivantis bags $25M for glaucoma‐treating microstent. Singulex enters into collaboration with Qiagen to develop companion diagnostics. Amid insulin market scrutiny, Novo faces class action alleging 'collusive price fixing'. Eli Lilly's Alimta escapes early generics—and sales hit—with patent win over Teva. Daiichi axes 170‐person Indian R&D site.

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3. Treatments Under Development FDA extends review period for Baricitinib, an investigational rheumatoid arthritis treatment. Surprise Keytruda‐chemo FDA filing puts Merck ahead in I‐O combo race. Medicrea announces 510(k) submission for FDA clearance of proprietary 3D‐printed titanium spinal interbody devices. Ionis to get its heart drug volanesorsen in front of the FDA as soon as possible. CureVac's lead mRNA drug is down but not out, says CEO, after its lead drug failed a phase 2b trial in prostate cancer. FDA accepts BLA for Mylan and Biocon proposed biosimilar Trastuzumab. 4. Regulatory News FDA approves Egalet’s Arymo ER for severe pain. Novo Nordisk announced that the European Commission has granted marketing authorisation for Fiasp (fast acting insulin aspart) for the treatment of diabetes in adults. The authorisation covers all 28 EU member states. FDA grants Genentech’s cancer immunotherapy Tecentriq priority review in additional type of advanced bladder cancer. Aurobindo receives FDA nod for manufacture and market Levetiracetam. OptiScan earns CE mark for automated bedside glucose, lactate monitoring system. 5. Thank You


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