IPP Bureau

EMA approves Biocon Biologics’ new mAbs facility in India
EMA approves Biocon Biologics’ new mAbs facility in India

By IPP Bureau - June 24, 2024

Renews GMP certifications for India and Malaysia sites

CCRAS to organize national consultative meet on ‘Research Priority Settings in Traditional Medicine’ in collaboration with WHO
CCRAS to organize national consultative meet on ‘Research Priority Settings in Traditional Medicine’ in collaboration with WHO

By IPP Bureau - June 24, 2024

The consultative meet, a first of its kind, will bring together representatives from diverse domains of Traditional Medicine (TM) in India

Cipla gets 6 observations from USFDA for Goa facility
Cipla gets 6 observations from USFDA for Goa facility

By IPP Bureau - June 24, 2024

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time

Ami Organics raises Rs. 400 crores through QIP
Ami Organics raises Rs. 400 crores through QIP

By IPP Bureau - June 24, 2024

The Issue opened on June 18, 2024 and closed on June 21, 2024

AstraZeneca Pharma India updates on exploring contract manufacturer
AstraZeneca Pharma India updates on exploring contract manufacturer

By IPP Bureau - June 24, 2024

The company will now explore a buyer for its manufacturing site and exit in due course

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer
Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

By IPP Bureau - June 22, 2024

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population

AbbVie appoints Roxanne S. Austin as Lead Independent Director of the Board of Directors
AbbVie appoints Roxanne S. Austin as Lead Independent Director of the Board of Directors

By IPP Bureau - June 22, 2024

Austin assumes role from Glenn F. Tilton, who will continue to serve as an independent director

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC
Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

By IPP Bureau - June 22, 2024

Second FDA approval for KRAZATI - reinforcing its potential across tumor types

Zealand Pharma announces positive topline results from the Phase 1b 16-week multiple ascending dose clinical trial with long-acting amylin analog petrelintide
Zealand Pharma announces positive topline results from the Phase 1b 16-week multiple ascending dose clinical trial with long-acting amylin analog petrelintide

By IPP Bureau - June 22, 2024

Zealand Pharma anticipates initiation of a Phase 2b clinical trial in H2 2024

Sumitomo Pharma presents new clinical data on DSP-5336 at the European Hematology Association 2024 Congress
Sumitomo Pharma presents new clinical data on DSP-5336 at the European Hematology Association 2024 Congress

By IPP Bureau - June 20, 2024

DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia

Ascentage Pharma aims global license agreement with Takeda for Olverembatinib
Ascentage Pharma aims global license agreement with Takeda for Olverembatinib

By IPP Bureau - June 20, 2024

Ascentage Pharma has executed an Exclusive Option to License Global Rights to Olverembatinib worldwide other than China and a few other areas

Sensitech acquires Berlinger & Co. Monitoring Solutions to strengthen life sciences cold chain solutions
Sensitech acquires Berlinger & Co. Monitoring Solutions to strengthen life sciences cold chain solutions

By IPP Bureau - June 20, 2024

Berlinger brings a suite of proprietary and high-quality hardware and software solutions that broaden Sensitech's end-to-end cold chain monitoring product portfolio

Roche receives FDA clearance on its digital pathology solution for diagnostic use
Roche receives FDA clearance on its digital pathology solution for diagnostic use

By IPP Bureau - June 20, 2024

This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules
Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

By IPP Bureau - June 19, 2024

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients

Cipla EU to invest an additional € 3 million in Ethris
Cipla EU to invest an additional € 3 million in Ethris

By IPP Bureau - June 19, 2024

Cipla had earlier invested € 15 million in Ethris in 2022

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