USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore

Aurobindo's subsidiary Tergene Biotech receives SEC recommendation for pneumococcal 15 valent vaccine

The company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Alembic receives USFDA final approval for Fulvestrant Injection

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US $71 million for twelve months ending Sep 2022 according to IQVIA

Lupin receives USFDA approval for Brivaracetam Tablets

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH

Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules

Pregabalin Capsules have an estimated market size of US $244 million for twelve months ending Sep 2022 according to IQVIA

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable

Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers

Positive opinions based on significant survival benefit

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting

Sun Pharmaceutical receives warning letter from USFDA for Halol facility

The Halol facility was placed under Import Alert by USFDA.

European Commission approves SPEVIGO for generalized pustular psoriasis flares

EC grants conditional marketing authorization based on the EFFISAYIL trial

Alembic receives USFDA final Approval for Desonide Cream

Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022

BASF Pharma Solutions excipient accepted into FDA Pilot Program

Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients

Zydus receives final approval from USFDA for Estradiol Transdermal System

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad