Tags : Amgen

Weekly Snapshot

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | […]Read More

Viewpoints

PharmaShots Interview: Guardant Health’s Justin Odegaard Shares Insight on the

In an interview with PharmaShots, Justin Odegaard, Vice President of Clinical Development at Guardant Health shares his views on the Guardant360 CDx approval as the first & only liquid biopsy companion diagnostic for Amgen’s Lumakras (sotorasib) KRASG12C inhibitor for use in advanced NSCLC. Shots: Guardant Health received the US FDA’s approval for Guardant360 CDx liquid […]Read More

M&A

Amgen to Acquire Teneobio for ~$2.5B

Shots: Amgen to acquire all outstanding shares of Teneobio for $900M as up front and $1.6B in cash as contingent milestones to Teneobio equity holders. The transaction is expected to be closed in H2’21 The acquisition will boost Amgen’s abilities to develop innovative therapies and expand its portfolio with the addition of early-stage oncology assets […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July […]Read More

Regulatory

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA

Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS The results demonstrated superiority in 1EP […]Read More

Insights+

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]Read More

Insights+

Insights+: The US FDA New Drug Approvals in May 2021

The US FDA has approved 4 NDAs and 1 BLAs in  2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 29 novel products in 2021. Additionally, last year in 2020, the US FDA […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: […]Read More

Insights+

Insights+ Key Biosimilars Events of May 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of May, Samsung initiated patient enrollment in the P-III […]Read More