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1
Pharma Bits and Pieces
2
Pharmaceutical Project Manager
 Analyzes investments,
 Review market data, and
 Comes up with new promotions for
new drugs and devices
Industry Updates
 Merck KGaA pays $230M for fourVertex cancer programs.
 OrchardTherapeutics 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.
3
Pharmaceutical Project Manager
 Analyzes investments,
 Review market data, and
 Comes up with new promotions for
new drugs and devices
 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 biosimilarTrastuzumab.
Treatments Under Development
4
Pharmaceutical Project Manager
 Analyzes investments,
 Review market data, and
 Comes up with new promotions for
new drugs and devices
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 immunotherapyTecentriq 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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Pharma Bits and Pieces

  • 2. 2 Pharmaceutical Project Manager  Analyzes investments,  Review market data, and  Comes up with new promotions for new drugs and devices Industry Updates  Merck KGaA pays $230M for fourVertex cancer programs.  OrchardTherapeutics 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.
  • 3. 3 Pharmaceutical Project Manager  Analyzes investments,  Review market data, and  Comes up with new promotions for new drugs and devices  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 biosimilarTrastuzumab. Treatments Under Development
  • 4. 4 Pharmaceutical Project Manager  Analyzes investments,  Review market data, and  Comes up with new promotions for new drugs and devices 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 immunotherapyTecentriq 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.