PharmaShots

Takeda Reports Results of Vedolizumab in its First Head-to-Head Biologic Study for Ulcerative Colitis

September 26, 2019September 26, 2019Tuba Khan

Shots: The P-IIIb VARSITY study involves assessing of Entyvio (vedolizumab, IV) vs Humira (adalimumab, SC) in 769 patients (anti-TNFα-naïve patients & anti-TNFα-experienced patients) [Read More...]

Ethicon Launches Echelon Circular as the First Powered Circular Stapler for Colorectal Gastric and Thoracic Surgery

September 25, 2019September 25, 2019Tuba Khan

Shots: The Echelon Circular powered stapler combines 3D stapling technology that evenly distributes compression with gripping surface technology (GST) which provides gentler handling [Read More...]

Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal Nocturnal Hemoglobinuria

September 25, 2019September 25, 2019Tuba Khan

Shots: The FDA’s BT designation is based on safety & efficacy data of ongoing P-II study assessing Danicopan in combination with C5 mAb [Read More...]

Bavarian Nordic’s Jynneos Vaccine Receives FDA’s Approval to Prevent Smallpox and Monkeypox Disease in Adults

September 25, 2019September 25, 2019Tuba Khan

Shots: The US FDA has approved Jynneos as the first non-replicating smallpox (in the US) & monkeypox vaccine to prevent smallpox and monkeypox [Read More...]

Amgen Reports Results of Blincyto (blinatumomab) in Two P-III Studies for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

September 25, 2019September 25, 2019Tuba Khan

Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT in pediatric patients with high-risk first relapsed B-cell ALL, being [Read More...]

Pfizer Expands its Collaboration with Flatiron Health to Integrate the Use of Real-World Evidence in Oncology

September 25, 2019September 25, 2019Tuba Khan

Shots: Pfizer will utilize Flatiron’s de-identified, real-world datasets and analytical expertise to inform development strategies for clinical development projects across multiple tumor types [Read More...]

Biocon Biologics Acquires Pfizer’s Research Facility to Expand its R&D Footprints

Biocon Biologics Acquires Pfizer’s Research Facility to Expand its Research and Development Footprint

September 25, 2019October 3, 2019Tuba Khan

Shots: Biocon Biologics has acquired Pfizer’s 60,000 sq. ft state-of-the-art, bench to pilot scale R&D facility at TICEL Bio Park in Chennai, India [Read More...]

Aldeyra’s ADX-2191 Receives FDA’s Fast Track Designation to Prevent Proliferative Vitreoretinopathy

September 24, 2019September 24, 2019Tuba Khan

Shots: The US FDA has granted FT designation to ADX-2191 for the prevention of proliferative vitreoretinopathy and provides it eligibility for Priority Review [Read More...]

Bristol Myer Reports Results of Orencia (abatacept) in P-IV Early AMPLE Study for Moderate-to-Severe Rheumatoid Arthritis #EULAR2019

BMS’ Opdivo (nivolumab) Receives CHMP Recommendation for Approval of its Four-Week Dosing Schedule

September 24, 2019September 24, 2019Tuba Khan

Shots: The EMA’s CHMP has recommended approval of Opdivo flat dosing schedule 240 mg infused over 30min. (q2w) or 480mg infused over 60min. [Read More...]

Takeda Collaborates with Evotec to Discover Clinical Candidates for Multiple Therapeutic Areas

September 24, 2019September 24, 2019Tuba Khan

Shots: Evotec to receive upfront, up to $170M pre/clinical & commercial milestones per program with royalties on sales of products. Takeda to get [Read More...]

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Month
September 2019

Takeda Reports Results of Vedolizumab in its First Head-to-Head Biologic Study for Ulcerative Colitis

Ethicon Launches Echelon Circular as the First Powered Circular Stapler for Colorectal Gastric and Thoracic Surgery

Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal Nocturnal Hemoglobinuria

Bavarian Nordic’s Jynneos Vaccine Receives FDA’s Approval to Prevent Smallpox and Monkeypox Disease in Adults

Amgen Reports Results of Blincyto (blinatumomab) in Two P-III Studies for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

Pfizer Expands its Collaboration with Flatiron Health to Integrate the Use of Real-World Evidence in Oncology

Biocon Biologics Acquires Pfizer’s Research Facility to Expand its Research and Development Footprint

Aldeyra’s ADX-2191 Receives FDA’s Fast Track Designation to Prevent Proliferative Vitreoretinopathy

BMS’ Opdivo (nivolumab) Receives CHMP Recommendation for Approval of its Four-Week Dosing Schedule

Takeda Collaborates with Evotec to Discover Clinical Candidates for Multiple Therapeutic Areas