Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors

Shots: The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A…

ByDipanshu DixitDecember 20, 2024

INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2024

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis PharmaShots has…

ByDipanshu DixitNovember 21, 2024

NEWS

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

Shots: The CHMP has recommended Alhemo (QD, SC) as a prophylactic treatment of hemophilia A/B with inhibitors in patients (≥12yrs.), with the EC’s decision anticipated within ~2mos. The opinion was based on the P-III (explorer7) study assessing the efficacy & safety of Alhemo to treat haemophilia A or B with inhibitors. Alhemo will be available…

ByDipanshu DixitOctober 18, 2024

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

Shots: Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…

BySaurabh ChaubeyMay 1, 2024

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2024

Shots: The first 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 Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…

BySenior EditorApril 1, 2024

NEWS

Novo Nordisk’s Awiqli Receives the CHMP’s Positive Opinion for the Treatment of Diabetes

Shots: Novo Nordisk’s Awiqli (QW basal insulin icodec) has received CHMP’s positive opinion and recommending it for the final approval which is anticipated in next ~67days/ ~2mos The opinion was supported by the six P-IIIa (ONWARDS) study assessing the safety & efficacy of Awiqli in type 1 & type 2 diabetes adults (n= >4,000) incl.…

ByDipanshu DixitMarch 21, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in September 2023

Shots: The US FDA approved 7 NDAs and 2 BLAs in September 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In September 2023, the major highlights drugs were Ojjaara (momelotinib) approval for myelofibrosis patients with anemia, and Entyvio (vedolizumab) for subcutaneous…

BySenior EditorOctober 18, 2023

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2023

Shots: Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…

BySenior EditorOctober 2, 2023

TOP 20

Top 20 Companies Spending on R&D in 2022

Shots: R&D (Research and Development) in the biopharma industry lays the foundation stone of innovative drugs. A robust R&D bolstered with new-age technological advances assures long-term sustainability in the future market With a global expenditure of $238B in 2022, the figures are anticipated to reach $285B by 2028. In 2022, AbbVie ranked the top among…

ByPrince GiriAugust 22, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in May 2023

Shots: The EMA approved 3 New Chemical Entity (NCE) and 7 Biologic Drugs in May 2023, leading to treatments for patients and advances in the healthcare industry In May 2023, the major highlights drugs were Breyanzi’s Approval for relapsed or refractory large B-cell lymphoma, Ultomiris (ravulizumab) for neuromyelitis optica spectrum disorder PharmaShots has compiled a…

BySenior EditorJune 26, 2023

Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors

EMA Marketing Authorization of New Drugs in October 2024

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

PharmaShots’ Key Highlights of First Quarter 2024

Novo Nordisk’s Awiqli Receives the CHMP’s Positive Opinion for the Treatment of Diabetes

Insights+: The US FDA New Drug Approvals in September 2023

PharmaShots’ Key Highlights of Third Quarter 2023

Top 20 Companies Spending on R&D in 2022

Insights+: EMA Marketing Authorization of New Drugs in May 2023

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