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Astrazeneca
News

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Shots:The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions Approval was based on P-III…
January 20, 20250Comments

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Daiichi Sankyo & Astrazeneca
News

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Shots:The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…
January 20, 20250Comments

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Amgen
News

Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)

Shots:The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients …
January 20, 20250Comments

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Exclusive_Dr. Ikshit Sharma_2025
EXCLUSIVE

Exclusive Coverage: Dr. Ikshit Sharma from AIMIL Pharmaceuticals in a Stimulating Dialogue Exchange with PharmaShots

Shots:Integrating innovation with the scientific principles of Ayurveda, AIMIL Pharmaceuticals caters to the growing needs of healthcare professionals, patients, and the animal healthcare sectorPharmaShots welcomes Dr. Ikshit Sharma, Director at AIMIL Pharmaceuticals, in a riveting conversation. Ikshit stresses the significance of making investments in research and development for creating novel therapies and addressing…
January 20, 20250Comments

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Weekly Snapshot

PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:  Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRIRead More: BayerOryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine…
January 17, 20250Comments

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InflaRx
News

InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS

Shots:The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO) Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with…
January 17, 20250Comments

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News

Ceva Animal Health Partners with Touchlight to Use its dbDNA Technology in Animal Healthcare

Shots:Ceva & Touchlight entered into an agreement & long-term collaboration for developing & manufacturing future animal health products, integrating the former’s development & marketing expertise with Touchlight’s dbDNA tech to develop DNA vaccines As per the agreement, Touchlight is entitled to upfront payment, development milestones & sales-based royalties, while the complete financial terms…
January 17, 20250Comments

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News

Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey

Shots:Bio-Thera & World Medicine entered into an exclusive license & commercialization agreement for BAT2206, a biosimilar to Janssen’s Stelara (ustekinumab), leveraging World Medicine’s marketing expertise & distribution network in Turkey As per the terms, World Medicine will hold market approval of BAT2206 in Turkey as well as its registration, imports, promotion & marketing, while…
January 17, 20250Comments

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J&J
News

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Shots:FDA received NDA of TAR-200 (J&J) for the treatment of Bacillus Calmette-Guérin (BCG) -unresponsive HR-NMIBC with CIS &/or papillary tumors the application will be reviewed under RTOR pathway, following receipt of BTD in Dec 2023 The NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in patients ineligible or opting out of…
January 17, 20250Comments

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News

Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Shots:NMPA approved limertinib (oral EGFRm TKI) to treat LA/M EGFR T790M-mutated NSCLC in adults, based P-IIb trial assessing limertinib in (n=301) NSCLC patients This study showed 68.8% ORR, 92.4% DCR, plus 11mos. mPFS with 11.1mos. mDoR. It also showed ORR & mPFS of 65.9% & 10.6mos., respectively in patients with assessable CNS lesions…
January 17, 20250Comments

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