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INSIGHTS+

New Drug Designations - June 2024
New Drug Designations – June 2024
Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices   This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…
Insights+ EMA Marketing Authorization of New Drugs in June 2024
Insights+: EMA Marketing Authorization of New Drugs in June 2024
Shots:   The EMA granted Positive Opinion to 4 Biologics and 3 New Chemical Entities in June 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were Merck’s Winrevair to treat Pulmonary Arterial Hypertension (PAH) and Roche’s PiaSky for Paroxysmal Nocturnal Haemoglobinuria (PNH)  PharmaShots has compiled a list of 5 drugs that…
Disease of the Month – Small Cell Lung Cancer
Disease of the Month – Small Cell Lung Cancer
Shots:  Small cell lung cancer (SCLC) aka Oat cell carcinoma is a rare & fast-growing lung cancer and ~15% of bronchogenic carcinomas are SCLC   In this reprise of our Disease of the Month report, we bring an illuminating account of SCLC with a dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy…
Know Your Investor: Invus (July’24 Edition)
Know Your Investor: Invus (July’24 Edition)
Shots:    Backed with an evergreen investment strategy, Invus makes investments across several company stages ranging from early growth to turnarounds   In 2023, Invus participated in 6 investment rounds in around 29 companies focusing on biopharma, manufacturing & services, and devices   For a curated report on a specific investor or venture capital, reach out to us…
Insights+ The US FDA New Drug Approvals in June 2024
Insights+: The US FDA New Drug Approvals in June 2024
Shots:    PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2024    The US FDA approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry      The major highlighted drug was Ipsen’s Iqirvo for the treatment…
Insights+ Key Biosimilars Events of June 2024
Insights+ Key Biosimilars Events of June 2024
Shots:    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 patients     The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…
PharmaShots' Key Highlights of Second Quarter 2024
PharmaShots’ Key Highlights of Second Quarter 2024
Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…
New Drug Designations - May 2024
New Drug Designations – May 2024
Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
Insights+ EMA Marketing Authorization of New Drugs in May 2024
Insights+: EMA Marketing Authorization of New Drugs in May 2024
Shots:   The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP  PharmaShots has compiled…
Insights+ The US FDA New Drug Approvals in May 2024
Insights+: The US FDA New Drug Approvals in May 2024
Shots:    PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2024    The US FDA approved a total of 3 new drugs including 2 new molecular entities and 1 biologic leading to treatments for patients and advances in the healthcare industry      The major highlighted drug was Amgen’s Imdelltra for the treatment…