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...]