Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis, ligelizumab, (QGE031), Receives, US, FDA, Breakthrough designation, chronic spontaneous urticaria (CSU) Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment Published: Jan 15, 2020 | Tags: Philips, Merck KGaA, Personalized Fertility Treatment, […]Read More
Shots: The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. […]Read More
In a recent interview with PharmaShots, Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare shared information on the positive findings presented at the 2020 Infectious Diseases Society of America (IDWeek) and the impact of COVID-19 on the development of long-acting cabotegravir and rilpivirine. Shots: The company reported the positive findings of […]Read More
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy Published: Dec 22, 2020 | Tags: AMO Pharma, […]Read More
Shots: The approval is based on P-III ATLAS, FLAIR and ATLAS-2M studies assessing Vocabria (cabotegravir injection and tablets) + Janssen’s Rekambys (rilpivirine inj.) or Edurant (rilpivirine tablets) in 1200+ patients for HIV-1 infection in adults who are virologically suppressed The first long-acting injectable can enable people living with HIV to reduce the days they receive […]Read More
Shots: In the PROgress study, 200 people living with HIV were provided with a pre-visit survey to guide their conversation with their HCP and assess PROs covering a range of measures, including treatment adherence, mental health, substance abuse, and intimate partner violence Results: the inclusion of the pre-visit survey made their visit better overall (82%), […]Read More
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020) Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing […]Read More
Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 […]Read More
Shots: The company reported the positive findings of a pooled analysis of six ongoing clinical studies which includes P-IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE studies evaluating long-acting cabotegravir and rilpivirine regimen in 1,744 patients with HIV-1 infection across 16 countries The positive findings showed 93% of participants maintained their injection visits amid the […]Read More
The US FDA has approved multiple NDAs and BLAs in July 2020, 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 59 novel products so far in 2020, including 8 in July 2020. Additionally, […]Read More
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