IPP Bureau

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

By IPP Bureau - January 19, 2025

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo

Glenmark Life Sciences rebranded as Alivus Life Sciences
Glenmark Life Sciences rebranded as Alivus Life Sciences

By IPP Bureau - January 19, 2025

The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space

GCPB revokes closure order of Aarti Pharmalabs’s Vapi plant
GCPB revokes closure order of Aarti Pharmalabs’s Vapi plant

By IPP Bureau - January 19, 2025

The company has paid an Interim Environmental Damage Compensation of Rs. 3.40 lakh to GPCB

Heraeus acquires Umicore’s Platinum API business outside of South America
Heraeus acquires Umicore’s Platinum API business outside of South America

By IPP Bureau - January 19, 2025

The company ensures a reliable and strong portfolio at competitive prices without compromising on excellent quality

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

By IPP Bureau - January 18, 2025

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles

Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution
Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution

By IPP Bureau - January 18, 2025

Hyper-automated AI is a unified framework combining AI, ML, RPA, and NLQ to streamline data extraction, quality management, transformation, and actionable insights - all on a single platform

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

By IPP Bureau - January 18, 2025

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030

Calquence combination approved in US for untreated mantle cell lymphoma
Calquence combination approved in US for untreated mantle cell lymphoma

By IPP Bureau - January 18, 2025

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone

AstraZeneca receives CDSCO approval to launch eculizumab in India
AstraZeneca receives CDSCO approval to launch eculizumab in India

By IPP Bureau - January 17, 2025

Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome

Bajaj Healthcare receives exclusive rights for manufacturing, distribution & sales of finished formulation of Magnesium L Threonate
Bajaj Healthcare receives exclusive rights for manufacturing, distribution & sales of finished formulation of Magnesium L Threonate

By IPP Bureau - January 17, 2025

The brand Magtein by Threotech has a sales value of approximately US $438 million

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

By IPP Bureau - January 17, 2025

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations

Sun Pharma to acquire 100% stake in Antibe Therapeutics
Sun Pharma to acquire 100% stake in Antibe Therapeutics

By IPP Bureau - January 17, 2025

Antibe Therapeutics is a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation

AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma
AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma

By IPP Bureau - January 17, 2025

SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3

Alleima completes the acquisition of medical components firm Endox
Alleima completes the acquisition of medical components firm Endox

By IPP Bureau - January 16, 2025

In 2023, Endox had revenues of approximately SEK 65 million

Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences
Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences

By IPP Bureau - January 16, 2025

With over 28 years of experience in the pharmaceutical industry, he is a seasoned Techno? Commercial professional and accomplished top management leader

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