Tags : Merck

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s

Tuba Khan July 19, 2021

Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 adults aged >18yrs. with IPD caused by 15 serotypes Results: Vaxneuvance showed a non-inferior immune response to PCV13 for 13 shared serotypes as assessed by OPA GMTs & superior immune […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Tuba Khan July 9, 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

Clinical Trials

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) +

Tuba Khan July 7, 2021

Shots: The companies collaborated to evaluate OncoSec’s TAVO + Merck’s Keytruda vs SoC in a P-III KEYNOTE-C87 trial in ~400 patients with metastatic melanoma who are refractory to immune checkpoint therapy across the US, Canada, EU & Australia The companies will responsible for internal costs with OncoSec covering the third-party costs. The trial is intended […]Read More

Regulatory

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded

Tuba Khan July 6, 2021

Shots: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA cSCC that is not curable by surgery or radiation Results: ORR (50%); CR (17%); PR (33%), 81% had DOR of 6mos. or longer, and 37% […]Read More

Biotech

Merck Amends Collaboration with NGM to Advance Novel Therapies for

Tuba Khan July 5, 2021

Shots: NGM to receive ~ $120M as research & development funding through Mar’24, including ~$86M for the period from Apr’21 through Mar’22 & additional option payments if Merck exercises license option The collaboration will initially focus on retinal and CVM diseases with NGM621 and MK-3655. Merck retains its option to license NGM621, currently being evaluated […]Read More

Insights+

PharmaShots’ Key Highlights of Second Quarter 2021

Tuba Khan July 1, 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

Pharma

Linnaeus Therapeutics Reports the Expansion of Clinical Collaboration with Merck

Tuba Khan June 16, 2021

Shots: Linnaeus will conduct 6 additional P-II cohorts evaluating LNS8801 + Keytruda in several cancer indications while the companies are currently evaluating the combination in patients who had previously responded to PD-1/L1 therapy and also LNS8801 as a monothx in patients unable to tolerate PD-1/L1 therapy due to serious immune-related AEs The companies will further […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Tuba Khan June 11, 2021

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]Read More

COVID-19 Pharma

Merck Signs ~$1.2B Supply Agreement with US Government for Molnupiravir

Tuba Khan June 10, 2021

Shots: Merck to receive ~$1.2B to supply ~1.7M courses of molnupiravir to the US government, if its receives EUA or approval from the US FDA and expects to have 10M+ courses of therapy available by the end of 2021 The therapy is currently being evaluated in a P-III MOVe-OUT study in non-hospitalized patients with COVID-19. […]Read More

Weekly Snapshot

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

Tuba Khan 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

Junshi Reports NMPA’s Acceptance of sNDA for Toripalimab + CT as 1L Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Janssen Amends its Agreement with Protagonist to Develop and Commercialize IL-23 Antagonists

Alnylam Signs a License Agreement with PeptiDream to Develop and Commercialize Peptide-siRNA Conjugates for Delivery of RNAi Therapeutics to a Broader Range of Extrahepatic Tissues

Lilly Collaborates with Kumquat to Develop Novel Small Molecules that Enhance Tumor-Specific Immune Responses

Viatris and Biocon’s Semglee (biosimilar, insulin glargine) Receive the US FDA’s Approval as the First Interchangeable Biosimilar for Diabetes

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Adagio Collaborates with Biocon to Provide COVID-19 Ab Treatment to Patients in India and Other Emerging Markets

Celltrion Collaborates with Inhalon to Develop Regdanvimab (CT-P59) for the Treatment of COVID-19 at Home

GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval for the Treatment of Chronic Rhinosinusitis with Nasal Polyps

Takeda’s TAK-994 Receives Breakthrough Therapy Designation for the Treatment of Narcolepsy Type 1

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia

Tags : Merck

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) +

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded

Merck Amends Collaboration with NGM to Advance Novel Therapies for

PharmaShots’ Key Highlights of Second Quarter 2021

Linnaeus Therapeutics Reports the Expansion of Clinical Collaboration with Merck

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Merck Signs ~$1.2B Supply Agreement with US Government for Molnupiravir

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

Latest Posts

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

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia

Alnylam Signs a License Agreement with PeptiDream to Develop and Commercialize Peptide-siRNA Conjugates for Delivery of RNAi Therapeutics to a Broader Range of Extrahepatic Tissues

Tags : Merck

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